ethics application section anm[1]
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For office use only:REC Protocol NoDate recd:
APPLICATION FOR ETHICAL APPROVAL
Please tick the Committee you are apply ing to:
Sub-Committees (RESC)
PNM RESC SSHL RESC(Psychiatry , Nursing & Midwifery) (Social Sciences, Humanities & Law
High Risk)
BDM RESC (Health)(Biomedical & Health Sciences, Dentistry, Medicineand Natural & Mathematical Sciences)
Research Ethics Panels (REP)For SSPP, Humanities and Law (non-high risk only)
E&M REP GGS REP(Education & Management) (Geography, Gerontology, SCWRU)
Humanit ies REP Law REP War Studies Group REP
Notes for all applicants
Please read the guidelines before filling out the application form and refer to the specific guidelines abouteach section when filling in the form. (http://www.kcl.ac.uk/research/ethics/applicants/)
Refer to the Guidelines for the submission deadlines for your Committee and the number of copies tosubmit (including electronic versions if applicable).
All applications should be submittedby 5pm on the deadline day.
All Sub-committee applications should be submitted to the Research Ethics Office, 5.11 Franklin WilkinsBuilding, (Waterloo Bridge Wing), Waterloo Campus, Kings College London, Stamford Street, London SE19NH.
All Research Ethics Panel applications should be submitted to SSPP Ethics Administrator, K0.58 GroundFloor Strand Building, King's College London, The Strand, London WC2R 2LS.
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SECTION A TO BE COMPLETED BY ALL APPLICANTS
1. APPLICANT DETAILS
1.1 RESEARCHER
Researcher s Name: ProfessorGraham ThornicroftResearchers Department & School: Health Service and Population Research Department
Status:
Undergraduate Taught Postgraduate MPhil / PhD/ Specialist Doctorate Staff Research
If Student:
Name of course/qualification:
If Staff:
Researchers Post: Professor Of Community Psychiatry, Head Of Health Service And Population Research Department
1.2 CONTACT DETAILS
Email: [email protected]
Telephone number: + 44 (0) 20 7848 0736
Address: Health Service and Population Research department, Institute of Psychiatry,King's College London, de Crespigny park, London, SE5 8AF
1.3 SUPERVISOR - COMPLETE FOR ALL STUDENT PROJECTS (Including PhD)
Name of Supervisor:
Supervisors Post:
Supervisors Department (if di fferent to student):
Supervisors email address:
1.4 OTHER INVESTIGATORS, COLLABORATORS, ORGANISATIONS
List any other investigators/collaborators involved with the study, and ensure that their role (e.g. collaborator, gatekeeper)and responsibilities within the project are explained. You should include any draft/preliminary approach letters togatekeeper organisations and confirm that you will have permission letters available for inspection if requested for auditpurposes.
NB: For other investigators/collaborators clarify if their employer is not Kings College London.
Professor Norman Sartorius (Professor; President of the Improvement of Mental Health Programmes): PrincipalInvestigator. Professor Sartorius manages the study and advises on study design, implementation, analysis anddissemination.
Dr Diana Rose (Service User Evaluation And Social Scientist): Investigator. Dr Rose has been involved in the studydesign and will be involved in analysing qualitative aspects of the project. Furthermore, Dr Rose is an expert in serviceuser-led research, and has been involved in ensuring service user representation throughout the project.
Dr Nisha Mehta (Trainee Psychiatrist): Investigator. Dr. Mehta has been involved in the study design and will advise on,implementation, analysis and dissemination.
Ms. Estelle Malcolm (Research Worker): Coordinator. Ms. Malcolm will manage the study, including coordinating datacollection, analysis and dissemination.
2. PROJECT DETAILS2.1 Project Title
Inpatient Discharge: Experiences and Analysis (IDEA)
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2.2 Projected Start Date of Project
This should be when you intend to start work with participantsMarch
2.3 Expected Completion Date of Project March 2012
2.4 Sponsoring Organisation
Your sponsor will be assumed to be Kings College Londonunless stated otherwise. NB: Do not put N/A
Association for the Improvement of Mental HealthProgrammes and Kings College London
2.5 Funder
(e.g. self-funded, Kings College London, ESRC, AHRB, EU)
self funded
2.6 DOES THE STUDY INVOLVE HUMAN PARTICIPANTS OR FOR OTHER REASONS REQUIRE ETHICAL APPROVAL?
NB: It may be the case that research does not involve human participants yet raises other ethical issues
with potential social or environmental implications. In this case you should still apply. Please consult with the Research
Ethics Office ([email protected]) if in doubt.
Yes No
2.7 OTHER INFORMATION RELATING TO RISK
Will the study place the researcher at any risk greater than that encounteredin his/her daily life? (e.g. interviewingalone or in dangerous circumstances, or data collection outside the UK).
Yes No
If applicable:
Does the study involve the using a Medical Device outside of the CE mark approved method of use? (seeguidelines) If you are using a medical device off label (outside of the approved method of use) then a risk assessment needs to becompleted. For further information on medical devices see the Medicines and Healthcare Products Regulatory Agency webpages:http://www.mhra.gov.uk/Publications/Regulatoryguidance/Devices/index.htmandhttp://www.mhra.gov.uk/Publications/Regulatoryguidance/Devices/GuidanceontheECMedicalDevicesDirectives/index.htm.
Yes No
If you have ticked yes to either of the above:
Yes,and I have completed a risk assessment which has been co-signed by the Head of Department/ I have discussedthe risks involved with my supervisor or Head of Department and agreed a strategy for minimising these risks.
2.8 OTHER PERMISSIONS, ETHICAL APPROVALS & CRIMINAL RECORDS BUREAU CLEARANCE REQUIRED
ANOTHER REVIEWING BODY/PERMISSIONS - Are any other approvals by another reviewing body (including otherethics committees, gatekeepers and peer review) required? If yes, give details and say when these will be obtained. Ifthey have already been obtained you should provide a copy of the approval with the application otherwise you will need tosupply it when ready.
YES NO Each Investigator will seek ethical approval with the relevant ethics body in their own country before anycommences.
CRIMINAL RECORDS BUREAU - Is Criminal Records Bureau clearance necessary? If so, please confirm that clearance
will be sought before commencement of the project. YES NA
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2.9 HUMAN TRIALS QUESTIONNAIRE
Does ahuman trials questionnaire need to be submitted? YES NO
(http://kcl.ac.uk/about/structure/admin/finance/staff/insurance/trials.html )
If yes, confirm that the Human Trials Questionnaire will be submitted prior to the start of the study. YES
3. AIMS, OBJECTIVES & NATURE OF STUDY
The purpose of the IDEA study is to explore the experiences of patients in 13 different countries (not in the UK) and 24sites who have received in-patient treatment by interviewing them on their discharge date. The study aims to use the datacollected from the interviews to:
a) propose the use of the questionnaire for routine use in mental health institutions
b) develop versions of the interview that could be used in other types of servicesc) publish the results of the multi-site, international comparative study of user satisfaction
d) carry out a follow-up study of the views of patients about the value of services, including the impact that patientsassessments and suggestions may have had on the service where the interview took place.
4. STUDY DESIGN/METHODOLOGY, DATA COLLECTION & ANALYSIS
Provide a brief outline of the step-by-step procedure of your proposed study, in no more than 1 pagewhere possible. (An example of a flow chart that could be used is in the Guidelines.)
The evaluation of mental health services relies heavily on data recorded in the health service system and on information
received from health care personnel. The IDEA project explores ways of ensuring that patients views and suggestionsconcerning care become known and used in the improvement of mental health care. It is proposed to explore theexperience of patients who have been treated in a mental health institution (eg hospital or department of psychiatry) byinterviewing patients at the point of their departure from the institution.
The design of the study will be in a two phase approach, of which phase one which was a service evaluation has occurred(therefore ethical approval is not needed for phase one, however its design will be outlined below). The role of theInvestigators at the Institute of Psychiatry is to coordinate the study and analyse the results so that internationalcomparisons can be made. All data collection will take place outside of the UK and collaborators will seek the relevantethical approval at their institutions.
Phase 1This stage of the study was a pilot and a feasibility stage for phase 2. Ten sites from eight different countries were involvedin the pilot phase. Psychiatrists at each site gained ethical approval from the relevant ethics body. Semi-structuredinterviews were carried out with 10 to 30 consenting participants. The data collected was sent to the Institute of Psychiatry,Kings College London for analysis and results will be sent back to each site so that they can be immediately usable toimprove current practice at each of the sites.
Phase 2
This stage of the study will involve 24 sites from 13 different countries (Azerbaijan, Hungary, Italy, Nigeria, Romania,Serbia, Uganda, Ukraine, Germany, Croatia, Ireland, The Netherlands, Macedonia). After gaining ethical approval fromthe relevant ethics body, Psychiatrists from each site will interview 30 consenting patients on their date of discharge.
Depending on the resources available, the Psychiatrist at each site will offer the opportunity to participate in the study toevery patient on discharge until the target of 30 is reached. If this is not possible because too many patients are
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discharged in one day, a random selection of patients will be interviewed. The Psychiatrists will have been involved in localservice delivery but not directly involved with the care of the patients they interview. If they have directly been involved inthe care of the patients they will interview, another member of staff will carry out the interview. Interviews will take placeover a three month period from the time the Psychiatrist receives the study materials. The areas to be included in the semi-structured interviews are: (1) Overall do you feel your stay in hospital was beneficial? (2) Satisfaction with the staff (3) Doyou feel that you came to any harm during your stay in hospital (through other patients and/or members of the staff)? (4)Were your individual preferences and rights taken into account? (5) Was your right to confidentiality observed? (6) Whatare the main improvements that should be made to this service? Participants will rate their answers on a Visual AnalogueScale and notes of their answers will be made during the interview. Interviews will be carried out in the preferred languageof the patient and translated into English to enable comparative analysis between centres. Psychiatrists at each site will beprovided with DVDs outlining examples of a good interview and interview techniques. Demographic information will alsobe collected for each participant such as age, sex and level of education.
The Psychiatrist at each site will collect information about the psychiatric institution to help further determine factors thatcorrelate/contribute to a patients inpatient experience. The information that will be recorded includes; environmentalaspects of the psychiatric institution such as size, location and accessibility; staff ratio to residents; organizational factorssuch as the number of beds and available facilities; and complaints procedures.
Analysis
Quantitative analysis will take the form of an aggregation per centre of results on the Visual Analogue Scale (VAS) for eachquestion in the proforma with a view to comparing between centres. The VAS will also be analysed by demographicindices within centres (e.g. gender, age) to see whether different groups have different experiences.
The notes made of the patients answers to questions will form the qualitative data set. It will be analysed thematically,both within and between centres, identifying core themes for each domain and core themes for the protocol as a whole.Anonymised quotations will be used to illustrate themes.
We will use the data collected about the institution to gain a better understanding of the size, structure and staffing of theinstitutions which are included in the study, which will help us with our observations about inpatient experiences by puttingthem in context. This will also help us to take into account variations in the type of institutions involved in the study andtherefore in our wider recommendations.
5. PARTICIPANTS TO BE STUDIED
5.1 PROJECTED NUMBER OF PARTICIPANTS
Number: 720 If applicable: How many will be male and female .
Justification for the sample size: 24 sites have been enrolled to be involved in the IDEA study and each site willinterview 30 patients. It was decided that 30 patients was a feasible number that each Psychiatrist could interview within a
three month time period. Alsocentral limit theorem proposes that with sample sizes of at least 30 it can be assumedthat the sampling distribution is approximately normal.
If an upper age limit is needed you must provide a justification. The institutions that will be enrolled in the study are adultinpatient facilities; therefore patients are over the age of 18.
Upper Age Limi t: N/A Lower age limit: 18
5.2 SELECTION CRITERIA
Participants will be those who have received inpatient treatment at one of the sites in the study.
5.3 RECRUITMENT
Describe how participants wi ll be (i) identified and (ii) approached.i) Depending on the resources available, the Psychiatrist at each site will offer the opportunity to participate in
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ii) When the date of discharge is known the psychiatrist will approach the patient with the study materials andexplain the purpose of the study and if they would consent to participate. Psychiatrists will inform the patient
that they will be conducting the interview and arrange a time for it to take place in a quiet place where theycan talk confidentially. The Psychiatrists will have been involved in local service delivery but not directlyinvolved with the care of the patients they interview. If the Psychiatrist has been directly involved in the careof the patient they will interview, another member of staff will carry out the interview.The interviewer/s willhave viewed the DVD on interviewing techniques, had training on the aims of the study and had training onthe use of the IDEA project patient interview questionnaire form
5.4 LOCATION
State where the work will be carried out e.g. public place, in researchers of fice, in private office atorganisation.
The interviews will be carried out in a private room where participants can speak confidentially in the institution where theywere an inpatient.
6. ETHICAL CONSIDERATIONS
6.1 INFORMED CONSENT
Describe the process you will use to ensure your participants are freely giving fully informed consent to participate. Thiswill always include the provision of an information sheet and will normally require a consent form unless it is a purely self-completion questionnaire based study or there is a justification for not doing so (this must be clearly stated). Templates forthese are at the end of this document and they should be filled in and modified where necessary.
The Psychiatrist at each site will ask patients once their discharge date is known whether they would like to participate inthe IDEA study on their discharge day. As part of the recruitment process participants will be assessed by the Psychiatristin terms of their capacity to participate in the study. The Psychiatrists will have been trained in assessing capacity so willbe experienced in being able to determine whether participants are able to make informed consent. Before enrolment in
the study all participants will be informed about the aims of the IDEA study. Interested participants will be provided with aninformation sheet and consent form. The Psychiatrist will ensure that the potential participant can understand and retain theinformation provided by the information sheet and give them the opportunity to ask questions. The Psychiatrist will assesswhether the potential participant is able to process the information provided and is able to come to an informed decisionthat they can communicate to the Psychiatrist. Verbal responses that potential participants make during discussions aboutthe research and availability of when they can be interviewed will enable the Psychiatrist to determine if individuals are ableto process the given information. If the Psychiatrist has any doubts regarding capacity or there has been a change incircumstance relating to capacity after informed consent has been given, such as there being a change in an individualsmental state, the interview will not take place. If needed the Psychiatrist can contact the Principal Investigator for advice.The Principal Investigator is a Consultant Psychiatrist with working knowledge of the Mental Capacity Act (2005) so will beequipped to answer questions regarding the topic of informed consent.
6.2 RIGHT OF WITHDRAWAL(Participants should be able to withdraw from the research process at any time and also should be able to withdraw theirdata if it is identifiable as theirs and should be told when this will no longer be possible (e.g. once it has been included inthe final report). Please describe the exact arrangements for withdrawal from participation and withdrawal of datadepending on your study design).
The interviews will contain some patient demographic information but no names will be recorded and the information aboutparticipants in the study will be strictly anonymised. If a participant wishes to withdraw from the study they are free to do soand their information will then not be used in the analysis. However once the data has been collated and analysed as agroup it will no longer be possible for participants to withdraw and they will be informed of this during the consent process.Participants will have the contact details of the study collaborator in their own country, who they may contact at any time ifthey have concerns about their participation in the study.
6.3 RISK CHECKLISTWhere you have ticked Yes on the risk checklis t, provide details of relevant qualifications and experience withreference to those sections. This must include the researcher and/or supervisor as well as other collaborators (if
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applicable) involved in those sections marked as presenting risk. (Do not submit a c.v.)Prof. Thornicroft is a Consultant Psychiatrist and has extensive experience of research with human participants.
Prof. Thornicroft has led or collaborated with these relevant research projects:
The END study developing and piloting the new MICA (Mental Illness: Clinicians Attitudes) scale to measureattitudes of clinicians to people with mental illness, underway.
Within END, a controlled intervention study with trainee psychiatrists designed to reduce stigmatisation.
The INDIGO study, which looked at the global pattern of anticipated and experienced discrimination againstpeople with schizophrenia. (Thornicroft G, Brohan E, Rose D, Sartorius N, 2009) completed.
Use of this pilot scale DISC within the INDIGO study to assess the cross-national experiences of discrimination bypeople with schizophrenia in 28 countries worldwide, also using qualitative data on reported discriminationworldwide, initial field-testing complete.
The GAMIAN project, an evaluation of reported self-stigma among people with anxiety-related disorders in 15 EUcountries, underway.
You must also specifically address the ethical issues raised from those sections here.
All study investigators are qualified psychiatrist who have been through relevant training in their own countries and have acode of conduct which they must abide by. The only relevant ethical issue that could arise from this study is the possibledisclosure of professional misconduct of a member of staff within an institution that a participant was an inpatient. Ifevidence of professional misconduct is uncovered requiring action the participant will:
a) First be asked whether they consent for this information to be disseminated to the relevant complaint body(depending on the nature of the disclosure this could be the police, the hospital complaints body, the head of
service / clinical director equivalent).b) If possible, the participant would be asked if anyone is already aware of this, and find out who e.g. social
services, the police, their mental health professional.
c) The interview would end.
d) A member of the IDEA research team would be contacted immediately and the situation would be explained tothem and they would provide advice as to what further action should be taken.
NB:If you ticked yes to any point in E i -vi of the checklist, you must also complete and submit Section B of theapplication form.
6.4 OTHER ETHICAL ISSUES
Please consider whether there are other ethical issues you should be covering here. Further, if applicable, please alsoadd the professional code of conduct you intend to follow in your research.http://www.kcl.ac.uk/research/ethics/training/codes.html
6.5 BENEFITS & RISKS
Please describe any expected benefits and ri sks to the research participant.
There are no direct benefits to participants personally being involved in the study. However, we hope there will be benefitsto other people in the future who will be treated in the institutions that are part of the study as well as those which are not.The recommendations made by patients for improvements to psychiatric institutions will help improve inpatient care in the
future.
The interview questions are not intended to be embarrassing or harmful in any way, however if at anytime participants feel
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uncomfortable or distressed and not able to continue, the interview can be stopped at any point. If participants feel thestudy has harmed them in anyway they will be provided with the contact details of Kings College London and thecollaborator in their own country to gain advice and information if needed.
6.6 CRIMINAL OR OTHER DISCLOSURES REQUIRING ACTION
Is it possible that criminal or other disclosures requiring action (e.g. evidence of professional misconduct) couldbe made during this study?
YES NO
If yes, detail what procedures will be put in place to deal with these issues. The Information Sheet should make it clear under whichcircumstances action may be taken by the researcher.
Strictly anonymised demographic information would be collected about each participant. The Psychiatrist or member ofstaff at the institution will ensure participants that whatever they disclose, no names of staff or other patients will berecorded and that the suggestions about the services will be made available to the chief of the service in a format which willnot enable identification of individuals taking part. If evidence of professional misconduct is uncovered requiring action theparticipant will:
a) First be asked whether they consent for this information to be disseminated to the relevant complaint body
(depending on the nature of the disclosure this could be the police, the hospital complaints body, the head ofservice / clinical director equivalent).
b) If possible, the participant would be asked if anyone is already aware of this, and find out who e.g. socialservices, the police, their mental health professional.
c) The interview would end.
d) A member of the IDEA research team would be contacted immediately and the situation would be explained andadvice would be sought as to what further action should be taken.
7 FINANCIAL INCENTIVES, EXPENSES AND COMPENSATION
7.1 Will travelling expenses be given? If yes, this should be stated on the Information Sheet
YES NO
7.2 Is any reward, apart from travelling expenses to be given to participants? If yes, please provide details and ajustification for this. It is recommended that participants are informed of the compensation on the information sheet.
YES NO
7.3 Is the study in collaboration with a pharmaceutical company or an equipment or medical devicemanufacturer? If yes, please give the name of the company and indicate what arrangements exist for compensating patients orhealthy volunteers for adverse effects resulting from their participation in the study (in most cases, the Committee will only approveprotocols if the pharmaceutical company involved confirms that it abides by APBI (The Association of the British PharmaceuticalIndustry) guidelines. A copy of the indemnification form (Appendix C) should be submitted with the application.
YES NO
7.4 No fault compensation scheme If your study is based in the UK you must offer the No-fault compensation scheme toparticipants unless there is a clear justification for not doing so (if this is the case this must be stated and you should bear in mind thatthe Sub-Committee reserves the right to make this a condition of approval).
YES, I am making the scheme available to participants
NO, the study is based outside the UK and so the scheme is not applicable
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NO, the study is within the UK but the No-fault compensation scheme is not offered for the following reason:
8. DATA PROTECTION, CONFIDENTIALITY, AND DATA AND RECORDS MANAGEMENT
8.a. Confirm that all processing of personal info rmation related to the study wi ll be in full compliance with the DataProtection Ac t 1998 (DPA) including the Data Protection Principles).If you are processing any personal information outside of the European Economic Area you must explain how compliance with theDPA will be ensured.
YES NO
8b. What steps will be taken to ensure the confidentiality of personal information? Give details of anonymisationprocedures and of physical and technical security measures. Please note to make data truly anonymous all information that couldpotentially identify a participant needs to be removed in addition to names.
A Master File will be set up at the beginning of the study at the Institute of Psychiatry and will be password-protected. Alldocuments (consent forms and questionnaires) will be kept in a secure, locked filing cabinet, and all folders will beaccurately labelled at each site involved in the study. Each site will make a photocopy of all study data and return the
originals to the Institute of Psychiatry by Courier. When we contact the site to confirm safe receipt of the data the copiesthey made will be destroyed, except for a copy of the patient consent form which will be stored securely. Psychiatrists willnot be collecting any identifiable information such as date of birth or name, so patients can only potentially be indentified ifthey ask for their data to be removed and can provide their age, sex, length of stay and date of discharge, which is theinformation collected at the beginning of the interview. Any data files, successive versions of the data, or analysis, eithercomputerised or in hard copy made at Kings College London or any of the site will be either password-protected or kept ina secure locked filing cabinet respectively. All data files will be kept anonymous and held confidentially in line with the UKData Protection Act 1998.
8c. Who will have access to personal information relating to this study? Confirm that any necessary wider disclosuresof personal information (for instance to colleagues beyond the study team, translators, transcribers auditors etc) have been properlyexplained to study participants.
Strictly anonymised demographic information would be collected about each participant. Study participants will only havetheir questionnaire forms (which will not contain any identifiable information) viewed by their interviewer where they were aninpatient and the team at Kings College London. The interviewer will reassure participants that disclosures made will bestrictly confidential unless they have given information relating to a criminal offence or abuse that has occurred at theinstitution which will be dealt with as outlined in 6.6. Names of staff or other patients will not be recorded and patients willbe informed that the suggestions about the services that they make will be made available to the chief of the service in aformat which will not enable identification.
8d. Data and records management responsibil ities during the study. The Principal Investigator is the namedresearcher for staff projects and the supervisor for student projects.
I confirm that the Principal Investigator will take full responsibility for ensuring appropriate storage and security for all studyinformation including research data, consent forms and administrative records and that, where appropriate, the necessary
arrangements will be made in order to process copyright material lawfully.
YES NO
8e. Data management responsibilities after the study.
Statehow long study information including research data, consent forms and administrative records will be retained, whatformat(s) the information will be kept in and where the data will be stored. For example, where within Kings CollegeLondon? (http://www.kcl.ac.uk/iss/igc/tools/researchers.html)All data files will be kept anonymous and held confidentially in line with the UK Data Protection Act 1998. A Master File willbe set up at the Institute of Psychiatry at the beginning of the study and will be password-protected. All documents (consentforms and questionnaires) will be kept in a secure, locked filing cabinet, and all folders will be accurately labelled at eachsite involved in the study. Each site will make a photocopy of all study data and return the originals to the Institute ofPsychiatry by Courier. When we contact the site to confirm safe receipt of the data the copies they made will be destroyedexcept for the patient consent form which will be kept and stored securely for 7 years as it contains patient identifiable
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information. Any data files, successive versions of the data or analysis, either computerised or in hard copy will be eitherpassword-protected or kept in a secure locked filing cabinet respectively at the Institute of Psychiatry. The dissemination ofthe results of the IDEA study or possible subsequent studies has no definitive end, therefore the anonymised data files willbe retained indefinitely and will remain password-protected.
In addition, confirm whether the storage arrangements comply with the Data Protection Act 1998 and the Collegeguidelines.
YES NO
Will data be archived for use by other researchers?
NO
YES (in anonymised form) If you intend to share anonymised data with other researchers, you must make this clear on theinformation sheet.
YES (in identifiable form following the guidance below)
Will any personal information related to this study be retained and shared in unanonymised form? If you tick yes you mustensure that these arrangements are detailed in the Information Sheet and that participant consent will be in place.
YES NO
9. AUTHORISING SIGNATURES
9.1 RESEARCHER/APPLICANT
I undertake to abide by accepted ethical principles and appropriate code(s) of practice in carrying out thisstudy. The information supplied above is to the best of my knowledge accurate. I have read the ApplicationGuidelines and clearly understand my obligations and the rights of participants, particularly in so far as toobtaining valid consent. I understand that I must not commence research with human participants unti l Ihave received full approval from the ethics committee.
Signature Date.9.2 SUPERVISOR AUTHORISATION FOR STUDENT PROJECTS (inc luding PhD)
I confirm that I have read this application and will be acting as the student researchers supervisor for thisproject. The proposal is viable and the student has appropriate skil ls to undertake the research. TheInformation Sheet and recruitment procedures for obtaining informed consent are appropriate and the ethicalissues arising from the project have been addressed in the application. I understand that research withhuman participants must not commence without full approval from the ethics committee.
If applicable:
The student has read an appropriate professional code of ethical practice
The student has completed a risk assessment form
Name of Supervisor:
Signature Date
9.3 MEDICAL SUPERVISION (if appropr iate see the Guidelines)
Name of Medical Supervisor:
Medical Supervisors MDU/MPS (or other insurance provider) number:
Signature of Medical Supervisor:. Date..
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10. INFORMATION SHEET AND CONSENT FORM
Remember to submit your information sheets for participants and consent form (if necessary) with your application.Failure to do so will cause delays to your applications.
The information sheet for participants should be composed according to the guidelines. The text in red should bedeleted or modified as appropriate. If the language in the template is not suitable for your intended participantgroup it can be modified. There is also a template consent form that can be used. Please refer to the guidelines forfurther information on how these documents should be used.
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TheIDEAProject
InpatientDischarge:ExperiencesandAnalysis
AnInternationalCollaborativeStudy
PrincipleInvestigatorsProfessorNormanSartorius
President
AssociationfortheImprovementofMentalHealthProgrammes
14CheminColladon
1209Geneva
Switzerland
ProfessorGrahamThornicroft
ProfessorofCommunityPsychiatry
Head
of
Health
Service
and
Population
Research
Department
InstituteofPsychiatry,King'sCollegeLondon
DeCrespignyPark,LondonSE58AF
UnitedKingdom
TABLEOFCONTENTS
DOCUMENT1:EXECUTIVESUMMARY&HEADOFSERVICECONSENTFORM
DOCUMENT2:COPYOFEXECUTIVESUMMARY&HEADOFSERVICECONSENTFORM
DOCUMENT3:IDEAPROJECTPROTOCOL:HOWTOCONDUCTTHESTUDY
DOCUMENT4:PATIENTINFORMATIONSHEET
DOCUMENT5:SCRIPTFORCONSENTINGPATIENTS
DOCUMENT6:PATIENTCONSENTFORM
DOCUMENT7:IDEAPROJECTDATAPART1(INSTITUTIONINFORMATION)
DOCUMENT8:IDEAPROJECTDATAPART2(PATIENTINTERVIEWQUESTIONNAIREFORM)
DOCUMENT9:IDEAPROJECTDATAPART3(ADDITIONALINFORMATION)
DOCUMENT10:QUICKREFERENCEGUIDE:IDEAPROJECTCHECKLISTFORRESEARCHERS
DOCUMENT11:HOWTORETURNDATA&STUDYCOORDINATORCONTACTDETAILS
ALSOENCLOSED
2COPIESOFDVDCONTAININGINFORMATIONABOUTTHEIDEAPROJECTANDANEXAMPLEOFHOW
TOCARRYOUTAGOODINTERVIEW
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DOCUMENT1
IDEAPROJECT:InpatientDischarge:ExperiencesandAnalysis
AnInternationalCollaborativeStudy
EXECUTIVESUMMARY&INSTITUTIONALCONSENTFORM
(TOBESIGNED&RETAINEDBYHEADOFPSYCHIATRICSERVICE)
Theevaluationofmentalhealthservicesreliesheavilyondatarecordedinthehealthservicesystemandon
informationreceivedfromhealthcarepersonnel.The IDEAprojectexploreswaysofensuring thatpatients
viewsandsuggestionsconcerningcarebecomeknownandusedintheimprovementofmentalhealthcare.It
isproposed toexploretheexperienceofpatientswhohavebeen treated inamentalhealth institution(eg
hospital or department of psychiatry) by interviewing patients at the point of their departure from the
institution.
Theinterviewswillbesemistructuredi.e.whilethethemesthatshouldbetoucheduponinthe interview
aresetitwillbeuptothepatientandtheinterviewertofindthebestwaytoprovideinformationaboutthe
itemsincludedintheinterview.Theinterviewsshouldtakenolongerthan2030minutestocomplete.
Thestudyaimstousetheexperiencegainedintheinterviewsforseveralpurposes:a)toproposetheuseof
thequestionnaireforroutineuse inmentalhealth institutions;b)todevelop versionsofthe interviewthat
couldbeused inother typesof services;c)publish the resultsof themulti site, internationalcomparative
study of user satisfaction; and d) carry out a follow up study of the views of patients about the value of
servicesincludingtheimpactthatpatientsassessmentsandsuggestionsmayhavehadontheserviceabout
whichthe interviewstookplace.Thestudy investigatorsareyoungpsychiatristsfromseveralcountrieswho
haveparticipatedinrecentcoursesonleadershipandprofessionalskills.
Itisproposedtointerviewapproximately30patientsperinstitutiononthepointofdischargefromhospital.In
addition to the questionnaire for the interview with the patient there is a questionnaire to describe the
institution and a brief description of the person(s) carrying out the interviews. Strictly anonymised
demographic informationwouldbecollectedabouteachparticipatingpatientandparticipantsof thestudy
wouldensurethattheheadsoftheservicesfromwhichtheusersaredischargedunderstandthatnonamesof
stafforotherpatientswillberecordedandthatthesuggestionsabouttheserviceswillbemadeavailableto
thechiefoftheserviceinaformatwhichwillnotenableidentificationofindividualstakingpart.Thechiefsof
servicewouldbegivenanopportunitytocommentonmanuscriptsofpublicationsoftheresultsofthestudy.
ThescientificcoordinationofthestudyanddataanalysiswouldbecarriedoutattheInstituteofPsychiatry,
KingsCollegeLondon.
ThePrinciple InvestigatorsofthestudyareProfessorNormanSartorius,PresidentoftheAssociationforthe
ImprovementofMentalHealthProgrammes,Geneva,SwitzerlandandProfessorGrahamThornicroft,Health
ServicesandPopulationResearchDepartment,InstituteofPsychiatry,KingsCollege,London.
IAGREETHAT(nameofinstitution)________________________________________ mayparticipate
intheIDEAProject
Signed___________________________________ Date___________
PrintName&Title________________________________________________
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DOCUMENT2COPYFORRESEARCHCOLLABORATORpleaseretainfor
yourrecords
IDEAPROJECTEXECUTIVESUMMARY&INSTITUTIONALCONSENTFORM
(TOBESIGNEDBYHEADOFPSYCHIATRICSERVICE)
Theevaluationofmentalhealthservicesreliesheavilyondatarecordedinthehealthservicesystemandon
informationreceivedfromhealthcarepersonnel.The IDEAprojectexploreswaysofensuring thatpatients
viewsandsuggestionsconcerningcarebecomeknownandusedintheimprovementofmentalhealthcare.It
isproposed toexploretheexperienceofpatientswhohavebeen treated inamentalhealth institution(eg
hospital or department of psychiatry) by interviewing patients at the point of their departure from the
institution.
Theinterviewswillbesemistructuredi.e.whilethethemesthatshouldbetoucheduponinthe interview
aresetitwillbeuptothepatientandtheinterviewertofindthebestwaytoprovideinformationaboutthe
itemsincludedintheinterview.Theinterviewsshouldtakenolongerthan2030minutestocomplete.
Thestudyaimstousetheexperiencegainedintheinterviewsforseveralpurposes:a)toproposetheuseof
thequestionnaireforroutineuse inmentalhealth institutions;b)todevelop versionsofthe interviewthat
couldbeused inother typesof services;c)publish the resultsof themulti site, internationalcomparative
study of user satisfaction; and d) carry out a follow up study of the views of patients about the value of
servicesincludingtheimpactthatpatientsassessmentsandsuggestionsmayhavehadontheserviceabout
whichthe interviewstookplace.Thestudy investigatorsareyoungpsychiatristsfromseveralcountrieswho
haveparticipatedinrecentcoursesonleadershipandprofessionalskills.
Itisproposedtointerviewapproximately30patientsperinstitutiononthepointofdischargefromhospital.In
addition tothequestionnairefor the interviewwiththepatient there isbeaquestionnairetodescribethe
institution and a brief description of the person(s) carrying out the interviews. Strictly anonymised
demographic informationwouldbecollectedabouteachparticipatingpatientandparticipantsof thestudy
wouldensurethattheheadsoftheservicesfromwhichtheusersaredischargedunderstandthatnonamesof
stafforotherpatientswillberecordedandthatthesuggestionsabouttheserviceswillbemadeavailableto
thechiefoftheserviceinaformatwhichwillnotenableidentificationofindividualstakingpart.Thechiefsof
servicewouldbegivenanopportunitytocommentonmanuscriptsofpublicationsoftheresultsofthestudy.
ThescientificcoordinationofthestudyanddataanalysiswouldbecarriedoutattheInstituteofPsychiatry,
KingsCollegeLondon.
ThePrinciple InvestigatorsofthestudyareProfessorNormanSartorius,PresidentoftheAssociationforthe
ImprovementofMentalHealthProgrammes,Geneva,SwitzerlandandProfessorGrahamThornicroft,Health
ServicesandPopulationResearchDepartment,InstituteofPsychiatry,KingsCollege,London.
IAGREETHAT(nameofinstitution)________________________________________ mayparticipate
intheIDEAProject
Signed___________________________________ Date___________
PrintName&Title________________________________________________
COPYFORLOCALSTUDYCOLLEAGUE/INVESTIGATORpleaseretainthiscopyforyourrecords
andreturnaphotocopyofthisformwiththestudydata.
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DOCUMENT3
IDEAPROJECTPROTOCOL:
HOWTOCONDUCTTHESTUDY
AIMOFTHE
STUDY
The aim of
thisstudyisto
exploretheexperienceofpeoplewhohavebeentreatedasinpatientsinamentalhealthsetting(eg
hospitaldepartmentofpsychiatry)byinterviewingpatients,usuallyonthedayofdischarge.
THE
INFORMATION
IN
THIS
DOCUMENT
IS
PRIMARILY
INTENDED
TO
AID
RESEARCH COLLABORATORS IN LOCAL CENTRES IN PLANNING, SETTING UP,
CARRYINGOUTTHESTUDYANDARRANGINGFORRETURNOFSTUDYDATATO
BEANALYSEDATTHEINSTITUTEOFPSYCHIATRY,KINGSCOLLEGE,LONDON
PLANNING/STEPSTOTAKETOPREPAREFORPARTICIPATION
1. Approachtheheadof institutiontoaskforpermissiontocarryoutthe IDEAproject.Please
show them Document 1 and allow them to read any of the documents contained in this
protocoltohelpthemdecidewhethertogivetheirconsentforyoutocarryoutthestudyin
yourproposedinstitution.
2. IfyourheadofinstitutionagreestoallowtheIDEAprojecttogoaheadpleaseaskhim/herto
sign the consent forms at the bottom of Document 1 and Document 2. Leave the signed
Document1with theheadof institution to retain in their recordsandkeepa copyof the
signedDocument2inyourownrecords.PleasemakeacopyofDocument2andreturnitto
thestudycoordinatorwithyourdata.
3. Approach your local ethics committee or equivalent to obtain the appropriate ethical
approval to carry out the study. The interviews will contain some patient demographic
information but no names will be recorded and the information about participants in the
study will be strictly anonymised. The aggregated results of the institution will be made
available to the head of service. You may find the information in Document 4 (patient
informationsheet)usefulindraftingyourethicsapprovalapplication.
4. Youwillneedtoobtain informedconsent fromeachpatientwhoparticipates inthisstudy.
Youwillneed to translate the textof thepatient information sheet (Document4) into the
patientsownlanguageandgiveittothepatient.Youwillalsoneedtodiscussthestudywith
thepatient.Wehaveprovidedasuggestedscriptthatyoucouldreadouttothepatient inDocument 5 (in the patients own language). This contains all the information the patient
needsandwillhelpthemmakeaninformeddecision.
5. Itisimportantthatthepatientsignsaconsentformtoindicatetheirwillingnesstoparticipate
inthestudy.1copyofthisformisprovidedinDocument6.Pleaseaskthepatienttosignthis
copyand thenmake2 furtherphotocopies.Onecopy is tostay in thepatientsnotes.The
secondcopyisforyoutokeepinyourrecords.Youwillneedtostorethissecurelyfor7years
asitcontainspatientidentifiableinformation.Itmustthenbedestroyed.Thethirdcopyisto
bereturnedwiththestudydatatobekeptwiththestudycoordinatorsinLondon.
CARRYINGOUTTHESTUDYSAMPLINGMETHOD
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1. Weaskthatyouinterview30patientsonthedayofdischargefromtheward.Theinterview
shouldbepreferablydonebyamemberofstaffwhowasnotdirectlyinvolvedinthecareof
thepatientwhileinhospital.Iftheinterviewerthereforecannotbeyourselfthenpleaseaska
seniorclinicalcolleague(doctor,seniornurseetc)tocarryouttheinterview.Thismaymean
that the person carrying out the interviews changes during the study. The interviewer/s
shouldhavehadthechancetoviewtheDVD,hadtrainingontheaimsofthestudyandhad
trainingontheuseoftheIDEAprojectpatientinterviewquestionnaireform(Document8).
2. Depending on the resources available each institution should offer the opportunity to
participateinthestudytoeverypatientondischargeuntilthetargetof30isreachedovera
threemonthperiods.Thismaynotbepossiblebecausetoomanypatientsaredischargedat
anyonetimeforyoutobeabletokeepup. Ifthishappensyoushould interviewarandom
selectionofpatients(egeverysecondpatientoreverythirdpatient).Youshouldstatewhat
youhavedoneinDocument9(IDEAprojectdataadditionalinformationform).Ifyoufindat
anypointduringyourinterviewingperiodthatyouchangethewayyouinterview(egatfirst
you interview every patient but you then fall behind for a time and interview every 3rd
patient) thenplease stateany changesyoumake inyour interviewingpattern.Pleasealso
explainthestepsyouhavetakentoensurethatyourselectionprocessisstillrandomasthisis
importanttoensuretheresultsofthestudyareunbiased.
3. Tofurtherensurestudyresultsareunbiasedweaskthatyoucarryoutallinterviewsovera3
monthperiodfromthetimethatyoureceivethestudymaterials.
CARRYINGOUTTHESTUDY DATARECORDINGANDINTERPRETATION
1. You will first need to complete Document 7 (Idea Project Data Part 1 Institution
Information). This only needs to be completed once as it contains questions about the
participatinginstitution.
2. Foreachpatientwhomyourecruittothestudyyouwillthenneedtoprint/photocopyand
completeacopyofDocument8(IdeaProjectDataPart2Patient InterviewQuestionnaire
Form).Theinterviewsaresemistructuredandtosummarisedatainthepatientsownwords
/ from their own experiences. For this reason we suggest the optimal way to collect and
recorddataismakenotesdirectlyduringtheinterviewtocapturethekeypointsmadebythe
patient.Weencourageyoutousedirectquotationstotryandcapturetheexperienceinthepatientsownwords.
3. The interviewer should also ask the patient to indicate an overall assessment for each
questionontheVisualAnaloguescaleaddedtothequestion.Thepatientmustindicatetheir
answer by placing a cross at the relevant part of the scale line which provides a readily
comparablemeasureacrosscountriesandculturestohelp intheanalysisofoverallpatient
experience.
4. Weaskthattheinterviewiscarriedoutinthelanguageofyourdiscretionbutweaskthatthe
returns
that
you
send
to
London
be
translated
into
English
to
enable
comparative
analysis
betweencentres.Thismaymeanthatyouwrite interviewnotesatthetime inthepatients
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5. PleasewatchtheDVDthataccompaniesthisdocumentwhichcontainsanexampleofagood
interviewandshouldgiveyousomeideasongoodinterviewingtechnique.Pleasealsoshow
thisDVDtoanyothercolleagueswhomaybeconductinginterviewsforyou.
6. A written example of how to conduct an interview question and fill out the proforma is
providedbelow:
Question1:Overalldoyoufeelthatyourstayinhospitalwasbeneficial?
Howwellwasyourillnesstreated/doyoufeelbetter?
Physicalneedsfood/shelter/hygiene Ifpatientalsohadanotherillness(e.g.a
cardiovasculardisorder):wereyougivengoodcareforyourotherillnesses
Whichformoftherapydidyoufindparticularlyuseful(e.g.participationintherapygroups
individualpsychotherapy,ECT,medications)
Question1:Pleaserecordwritteninterviewnotes"ationshere:
Feels was treated well for the most part and now feels better. Does feel that physicalneeds were overlooked at times as has diabetes which did not always receivemedication for on time / with meals. sometimes I thought they didnt care about myblood sugar Feels the accommodation was not ideal as had to share with anotherpatient who was quite unwell and this was very upsetting for me Did not feeltherapy groups were very useful as did not get much opportunity to speak thoughthinks that encouragement to take medications in healthcare setting helped get himon road to recovery.
Interviewerdiscussesthisquestionwiththepatientinasemistructuredformatusingtheitalicised
bulletpointsasaguideandrecordswrittennotesintheboxprovidedintheproforma.
Interviewerthenaskspatienttoscorehis/heranswertoquestion1overallonthevisualanalogue
scalebelow:
ExcellentNone
7. AttheendofthestudypleasecompleteDocument9(IdeaProjectDataPart3Additional
Information).Onthisblanksheetyoushouldletusknowanyinformationyouthinkisrelevant
tothestudyyouhavecarriedoutlocallyincludinganyvariationsinsamplingprocedure,any
difficultiesyouencounteredwithanyaspectof the study thatmightbiasor impacton the
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resultsandany informationabouthowyouthinkthestudyworkedwellandanycomments
aboutwhatcouldhavebeenimproved.
AFTERDATACOLLECTIONRETURNINGTHEDATAFORANALYSIS
Attheendofthestudyyoushouldhavethefollowingdocumentation:
1. 2signedconsentformsfromtheheadofinstitutionagreeingtoallowyourinstitutiontotake
partinthestudy
2. 1copyofthesignedconsentformfromtheheadoftheinstitution
3. Ethicsapprovalfromyoulocalethicscommitteetoproceed
4. 3x30signedconsentformsofthepatientsyourecruited(Document6)
5. 1completedcopyofDocument7:IDEAProjectDataPart1InstitutionInformation
6. 30completedcopiesofDocument8:IDEAProjectDataPart2PatientInterview
QuestionnaireFormTranslatedintoENGLISH
7. 1completedcopyofDocument9:IDEAProjectDataPart3AdditionalInformation
WenowneedtocoordinatethesafejourneyofthefollowingofthesedocumentstotheInstituteof
Psychiatry,Londontoallowustocommencetheanalysis:
1. 1copyofthesignedconsentformfromtheheadoftheinstitution
2. 1x30copiesofthesignedconsentformsofthepatientsrecruitedtothestudy
3. 1completedcopyofDocument7:IDEAProjectDataPart1InstitutionInformation
4. 30completedcopiesofDocument8:IDEAProjectDataPart2PatientInterview
QuestionnaireFormTranslatedintoENGLISH
5. 1completedcopyofDocument9:IDEAProjectDataPart3AdditionalInformation
WeaskthatyoumakeaphotocopyofallstudydataandreturntheoriginalstoLondonbyCourier.
Whenwecontactyoutoconfirmsafereceiptofyourdatapleasedestroythecopyofthestudydata
youhavemade(fordataprotection/confidentialityreasons)
YouwillfindcontactdetailsforreturningdatabycourierinDocument11(StudyCoordinator
ContactDetails)
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DOCUMENT4
PATIENTINFORMATIONSHEET
Ourstudy
Weareconductingaresearchstudyonpatientsexperiencesofspendingtimeinpsychiatric
hospitals,asyouhavejustdone. Wehopethatthefindingsofthestudywillimproveconditionsin
suchhospitals. Theoriginalaspectofourstudyisthatwethinksuchimprovementscanbestbe
madeifwetalktopatientsabouttheirexperiences,bothgoodandbad,andbaserecommendations
forimprovementonwhatpatientstellus.
Consideringwhethertotakepart
Itisimportantthatyouunderstandwhatthestudyisaboutbeforeyoudecidetotakepart. Oneof
ourteamwillgothroughthiswholeinformationsheetwithyoutomakesurethisisthecase. You
canaskasmanyquestionsasyoulikeandpleasefeelfreetotalktootherpeopleaboutit.
WhyamIbeinginvited?
Youarebeinginvitedbecauseyouarejustabouttobedischargedfromyourinpatientstayandthis
meansyouhaveexperienceofthehospitalwardatthistime. Weplantoinclude30peoplebeing
dischargedfromthesamehospitalasyou.
DoIhavetotakepart?
Itisentirelyuptoyouwhetherornotyoutakepart.Ifyoudecidenotto,thiswillhavenoeffecton
thecareyoureceive.
WhatwillhappentomeifItakepart?
Youwillbeinterviewedandaskedquestionsaboutyourexperiencesduringthishospitalstay. The
interviewisintendedtogiveyoutheopportunitytotellus,inyourownwords,howyourstayhas
beenandwhathavebeenthegoodandbadthingsaboutit. Theinterviewcoversthingslikewhether
younowfeelbetter,thephysicalconditionsinthehospital,yourexperienceoftreatments,your
satisfactionwiththestaff,yourconfidentialityandprivacy,whetheryoufeltsafeandwhetheryour
rightswererespected. Theinterviewwilltakeabout20minutes.
Willmytakingpartinthestudybekeptconfidential?
Yes. Yournamewillnotberecordedontheinterviewformandnothingyousaycanbeassociated
withyoupersonally. Yourinterviewerwillkeepwhatyoutellthemprivate. Youwillnotbeinterviewedbysomeonewhohasbeencentrallyinvolvedintreatingyousoyoushouldbeableto
speakopenlyaboutyourexperienceswhilstbeingassuredthatwhatyousaywillbekept
confidential. Ifyoutellusanythingregardingthemisconductofamemberofstaffortheactionsof
anotherpatientwewouldnotsharethisinformationwiththerelevantcomplaintsbodyunlessyou
gavepermission. Anynamesorinformationthatcouldleadtotheidentificationofanotherperson
(suchastheirphysicaldescription,age,ethnicityetc.)willnotberecorded. Thesuggestionsabout
theservicesthatyoumakewillbemadeavailabletothechiefoftheserviceinaformatwhichwill
notenableidentificationofyourself,sowillbeanonymous.
What
will
happen
if
I
want
to
withdraw
from
the
study?
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Youcanstoptheinterviewatanytimewithoutgivingareason. If,atalaterdate,youwantto
withdrawyourwholeinterviewfromthestudyyoucandothattoo. Onceyourdatahasbeen
collatedandanalysedasagroupitwillnolongerbepossibleforyoutowithdrawfromthestudyas
yourdetailswillbecompletelyanonymised.
Whatarethebenefitsoftakingpart?
Therearenodirectbenefitstoyoupersonally. Butwehopetherewillbebenefitstootherpeoplein
thefuturebecauseyourparticipationwillhelpformthebasisofrecommendationsforimprovements
topsychiatrichospitals.
Whatifthereisaproblem?
Ifyoufeelbadlytreatedduringtheresearch,pleasefirstofalltellyourinterviewerwhowilltryto
resolvethis.Ifyoudonotwanttodothis,oryourcomplaintcannotberesolved,pleasecontactone
ofthestudycoordinators(seebelow).
Whatwillhappentothestudyfindings?
Thefindingswillbeusedtoevaluatepatientsexperiencesinpsychiatricinstitutionsinseveral
countries. Theywillhelpensurethatpatientsviewsandsuggestionsbecomeknownandusedin
ordertoimproveconditionsinpsychiatrichospitals. Lateron,wehopetoextendthestudytoother
typesofmentalhealthservices.
Whoisorganisingandfundingtheresearch?
Yourdoctorwillnotbepaidforincludingyouinthisstudy. ItisbeingcarriedoutbyTheAssociation
fortheImprovementofMentalHealthProgrammesandtheHealthServicesandPopulationResearch
Department,InstituteofPsychiatry,KingsCollegeLondon,UK.
Furtherinformationandcontactdetails
EstelleMalcolm
HealthServicesandPopulationResearchDepartment
InstituteofPsychiatry,King'sCollegeLondon
DeCrespignyPark,LondonSE58AF
UnitedKingdom
EmailAddress:[email protected]
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DOCUMENT5
SCRIPTFORCONSENTINGPATIENTS
Interviewersintroductoryscriptsuggestedscripttotranslateandreadtopatientwhenobtaining
consenttorecruittotheIDEAproject:
Hello,X,mynameisYandIampleasedtomeetyou. Ifyoudontmind,Iwouldliketotalktoyou
abouta researchstudy thatwearedoing. Is thatokay? Wewant to talk topatientsabout their
experiences, goodandbad,ofbeing inpsychiatrichospitals like thisone. Ouraim is to improve
conditions inpsychiatrichospitals forpatientsandwe think thebestway todo that is to findout
frompatientsthemselveswhatitisliketospendtimeinhospitalslikethis. Wehaveputtogethera
short interviewwhichcoversthings likethephysicalconditions in institutions,yourexperiencesof
treatments like medication, ECT and talking treatments, your satisfaction with the staff, your
confidentiality,privacyanddignity,howsafeyoufeltwhileinhospitalandwhetheryourrightswere
respected. Theinterviewtakesabout20minutesanditiscompletelyconfidential. Wewantpatients
tospeakopenlysoeverythingsaidwillbekeptprivate. Wearecarryingouttheinterviewsacouple
ofdaysbeforepeoplearedischargedsothattheyhavethefullexperienceoftheirinpatientstay. I
wouldliketointerviewyoufortheresearchstudyasyouareduetobedischargedsoon. Wouldyou
agree todo this? Ifyouare interested, Ihavesomemore informationhere. It isawrittensheet
whichgivesyouallthedetailsandwecangothroughittogetherandyoucanaskmeanyquestions
youhaveabout thestudy. Shallwedothatnoworwouldyouprefertohavemore time to think
aboutitorareyouperhapsnotreallyinterested?
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DOCUMENT6:
CONSENT FORM FOR PARTICIPANTS IN RESEARCH STUDIES
Please complete this form after you have read the Information Sheet and/or listened to an explanation aboutthe research.
Country:
Institution Name:
Title of Study: Inpatient Discharge: Experience & Analysis: An International Collaborative Study
King s College Research Ethics Committee Ref:________________
Institution Eth ics Committee Ref: ________________
Thank you for considering taking part in this research. The person organising the research must explainthe project to you before you agree to take part.
If you have any questions arising from the Information Sheet or explanation already given to you,please ask the researcher before you decide whether to jo in in. You wil l be given a copy of thisConsent Form to keep and refer to at any time.
I understand that my participation is voluntary and that if I decide at any time during the research thatI no longer wish to participate in this project, I can notify the researchers involved and withdraw fromit immediately without giving any reason and without my medical care or legal rights being affected.
Furthermore, I understand that I will be able to withdraw my data up to the po int when the data will beanalysed.
I understand that relevant sections of my medical notes and data collected during the study, may belooked at by individuals from, where it is relevant to my taking part in thisresearch. I give permission for these individuals to have access to my records.
Participants Statement:
I _____________________________________________________________________
agree that the research project named above has been explained to me to my satisfaction and I agree to takepart in the study. I have read both the notes written above and the Information Sheet about the project, andunderstand what the research study involves.
Signed Date
Name of Researcher Date
Signature of Researcher taking consent
When completed make 2 further photocopies of signed form:
1 for participant; 1 for researcher site file; 1 (original) to be kept in medical notes.
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DOCUMENT7
IDEAPROJECTDATAPART1
INSTITUTIONINFORMATION
ONECOPYofthisdocumenttobecompletedtoprovidesomedetailedinformationaboutthetypeof
psychiatricinstitutioninvolvedinthestudy.Thereisnoneedtocompletethisformforeverypatient
includedinthestudy.
Describethelocationoftheinstitution.
Isitlocatedinaruralorurbansetting?
Howaccessibleisitbypublictransport?
Howfarisitfromthenearesttown?
Aretheregates,orcanyou/visitors/residents walk
inandout(referheretolegallyvoluntaryresidents?Isthereaguard/visitorcheckinandcheckout
system?
Howistheinstitutionfinanced?(eg.what%bya
ministry,localgovernment,residents,private
individuals,localcommunity,church,etc
Whatistheapproximateannualturnover/budgetof
theinstitution(pleasestateclearlythefullnameof
thecurrency)
Howmanybeds/placesarethereintheinstitution?
Approximate%ofmenandofwomen?
Approximate%softhoseaged(i)under18;(2)18
65;(3)over65?
Mostpeopleinthisunit/institution areinwhichof
thefollowingcategories:(1)peoplewithamental
healthdiagnosis;(2)peoplewithanintellectual
disabilitydiagnosis;(3)peoplewithasubstanceor
alcoholabusediagnosis;(4)peoplewitha
neurodegenerativediagnosis(e.g.Alzheimersor
dementia)?
InstitutionDescriptionQuestions Interviewertocomplete
Name,address,country,telephonenumberof
institution
Nameandemailofthedirector
Typeofinstitution(i.e.hospital,socialcarehome,
residential/longtermpsychiatricinstitution)
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Aboutwhat%oftheresidentsaredeprivedor
restrictedoflegalcapacity(underguardianship)?
Whoaretheguardiansegfamilymembers,
professional staff,thedirectoroftheinstitution)
Whatistheaveragelengthofstayinthis
unit/institution?
Whatisthetotalnumberofstaffwhoworkinthis
unit/institution?(fulltimeequivalentstaffnumbers)
Howmanyofthestaffare:
Psychiatrists
Nonpsychiatricdoctors
Qualifiednursingandalliedstaff
Nonqualifiednurses
Psychologists
Howdoresidentsmakecomplaintsaboutanyaspect
oftheinstitution?
Doresidentsknowabouttheprocess?
Aretheresidentsprovidedwiththenecessarymeans
tocomplain(e.g.pens,paper,secureboxes)?
Arerecordskeptaboutcomplaints?
Isthereanannualreportpublishedandreviewed
aboutcomplaints?
Whatarethestepstakentodealwithunresolved
complaintsandisthereanysystemofadvocacy?
Arethefacilitiesgenerallyovercrowded(givedetails)
Isthereadequateaccesstooutdoorareas
Areallfacilitiesaccessibleforpeoplewithphysical
andsensorydisabilities?
Isthereanadequateprovisionofseparateareasfor
menandwomen?
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DOCUMENT8
IDEAPROJECTDATAPART2
PATIENTINTERVIEWQUESTIONNAIREFORM
SECTION1:ANONYMISEDPATIENTINFORMATION(tobecompletedbytheinterviewer,pleasedo
notwritethepatientsnameonthissheet)
InterviewNumber(outof30)
Interviewer
initials
and
position
(psychiatrist
/
nurse
/
psychologist
etc)
PatientAge
PatientSex
Lengthofstayforcurrentadmission
DateofDischarge
DateofInterview
PrimaryClinicalDiagnosis
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Totalnumberofpsychiatrichospitalisations(inthisinstitutionorothersgivebestestimateof
totalnumberofadmissions)
Legalstatusforthisadmission(pleasecircle)
Voluntaryinformal/ Legallydetainedforatleastsomepartofadmission
PatientLevelofEducation(pleasecircle)
Noeducation/primaryschool/secondaryschool/college/university
Marital/FamilialStatus(pleasecircle)
Single / married / divorced / widowed
Employment status(pleasecircle)
Student / employed / unemployed / retired
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SECTION2.SURVEYPROFORMA
Noteto Interviewer:Whenaskingthequestions inthisproformapleasetry
andkeeptheinterviewformatinformalandsemistructuredandtalkaround
themainquestionsandassociatedbulletpoints inblack.However if specificpointersareneeded
thenthequestionsinitalicsmaybeusedtohelpaidtheflowoftheinterview.Theinterviewshould
takenomorethan20minutesintotal.Pleaseonlyusethequestionsinitalicsasanaidetohelpthe
flowofconversationasnecessary.Thequestionsdonotneedtobeaskedintheorderindicatedhere
butpleasecoveralltheareassuggestedbythequestions.Pleaserecordverbatimquotations from
patientsasmuchaspossible.
Please conduct the interview in a language of your discretion but please ensure this proforma is
completedandreturnedinEnglishtoenablecomparativeanalysis.
1. Overalldoyoufeelyourstayinhospitalwasbeneficial? Howwellwasyourillnesstreated/doyoufeelbetter?
Physicalneedsfood/shelter/hygiene Ifpatientalsohadanotherillness(e.g.a
cardiovasculardisorder):wereyougivengoodcareforyourotherillnesses
Whichformoftherapydidyoufindparticularlyuseful(e.g.participationintherapygroups
individualpsychotherapy,ECT,medications)
Question1:Pleaserecordwritteninterviewnotes"ationshere:
Question1:PleaseaskpatienttorecordoverallanswerforQ1onVisualAnalogueScale:Overalldoyou
feelyourstayinhospitalwasbeneficial?
CompletelyNot at all
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2. Satisfactionwiththestaff Didyouknowwhichdoctorwasresponsibleforyourtreatment?
Didyourpsychiatristseemtobeknowledgeable?
Didyourpsychiatristseemtobeempathicand/orcommitted?
Didyougetenoughsupportfromyourpsychiatrist?
Wasyourpsychiatristrespectfultowardsyou?
Didyouhaveenoughtimetospeakwithyoupsychiatristaboutyourdisorder?Whatabout
nursingstaff?Didtheytreatyouwell?Doyoufeelthattheypaidenoughattentiontoyour
requests?Ordidtheyspendtoomuchtimeonadministrativeissues?Doyoufeelthattheyare
knowledgeable?
Whataboutotherstaffthatyoumetpsychologists,socialworkers,nursingaids?
Question2:Pleaserecordwritteninterviewnotes"ationshere:
Question2:PleaseaskpatienttorecordoverallanswerforQ2onVisualAnalogueScaleHowsatisfied
wereyouwiththestaff?
Not at all Completely
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3.Doyoufeelthatyoucametoanyharmduringyourstayinhospital(throughotherpatientsand/or
membersofthestaff)?
Physicalsafety
Emotionalharm doyoufeelyouhademotionalsufferingasaresultofyourhospitalstay?
Staffingadequatestaffinglevelstomeetyourneeds
Doyoufeelthatyoucametoanyharmduringyourstayinhospital?
Question3:Pleaserecordwritteninterviewnotes"ationshere:
Question3:PleaseaskpatienttorecordoverallanswerforQ3onVisualAnalogueScale:Doyoufeel
thatyoucametoanyharmduringyourstayinhospital?
Experienced a great
deal of harm
Experienced
no harm
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4. Wereyourindividualpreferencesandrightstakenintoaccount? Respectingofvalues/expressedneeds
Frustration/Fairness/Handlingofaggressionontheward
Clarityqualityofinformationgiventopatient
Wereyouinformedbythestaffaboutyourrightsasapatient?
Wasthelevelofinformationaboutyourrightsasapatientsatisfactory? Wastheexplanationofyourdiagnosisandtreatmentclearandunderstandable?
Didyougetenoughinformationaboutbenefits/risksofthemedicationyouwere/areusing?
Haveyoueverfeltstigmatisedbyanymemberofthestaffduringhospitalisation?Forexample
didanymemberofstaffmakenegativecommentsaboutyourillness?
Haveyoubeendiscriminatedagainstbecauseofyourmentalillness?Forexamplehaveyou
everlostajobwhenyouremployerfoundoutyouhadamentalillness?
Question4:Pleaserecordwritteninterviewnotes"ationshere:
Question4:PleaseaskpatienttorecordoverallanswerforQ3onVisualAnalogueScale:Wereyour
individualrightsandpreferencestakenintoaccount?
Not at all Completely
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5. Wasyourrighttoconfidentialityobserved? Dignityandprivacy
Involvementoffamilyandfriends
Doyouconsiderthatthestaffrespectedyourconfidentiality?Didtheydiscussyourcasewith
inappropriatepeople(egotherpatients/familymemberswithoutyourpermission)
Wasyourfamilyadequatelyinformedandengagedinthetreatmentprocess?
Did youobtainanaccesstothetelephoneorotherfacilitiesenablingcontactwithyourfamily
and/orfriends?
Question5:Pleaserecordwritteninterviewnotes"ationshere:
Question5:PleaseaskpatienttorecordoverallanswerforQ3onVisualAnalogueScale:Wasyourright
toconfidentialityobserved?
Not at all Completely
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6. Whatarethemainimprovementsthatshouldbemadetothisservice? Ifyoucould,wouldyouchangesomethinginthisservice?Whatwouldyouchange?
Doyouhaveanycomments,suggestionsorsomethingtoaddforthetreatmentinthis
hospital/ward?
Wouldyourecommendthishospital/wardfortreatment tosomeoneelsewhoneededit?
Wouldyouvisitthesamehospital/wardagainifyouneededhelp?
Question6:Pleaserecordwritteninterviewnotes"ationshere:
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DOCUMENT9
IDEAPROJECTDATAPART3
ADDITIONALINFORMATION
Pleaseusethissheettorecordanyadditionalinformationthatyoufeelwouldbeofusetothe
analysisofthestudydata.Thiscouldincludevariationsinsamplingprocedure,concernsabout
difficultiesindatacollectionorrecording,commentsaboutwhatwentwellduringthestudyand
whatcouldbedonebetterinfuturestudies.YouonlyneedtoreturnONEcopyofthisdocumentwith
thestudydata.Pleasecontinueontoaseparatesheetifnecessary.
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DOCUMENT10
QUICKREFERENCEGUIDE:IDEAPROJECTCHECKLISTFORRESEARCHERS
oReadIDEAProjectProtocol&watchaccompanyingDVD
oApproachHeadofInstitutionforpermissiontocarryoutstudy(usingexecutivesummaryinDocument2)
oObtain2xsignedconsentformsfromHeadofInstitution(Document2&Document3)oObtainlocalethicscommitteeapprovaltocarryoutstudyoWorkoutstrategyforrecruitmentof30patientstostudyusingdetailedguidancein
Document6
oEnsurepatientinformationsheetandscript(Documents4&5)havebeentranslatedintolocal/patientlanguageoCommencestudybycarryingout30interviewswithpatientswithin2daysofdischarge.
Ensureaconsentformissignedbyeachpatientandthatyoumake2furtherphotocopies
oftheoriginal
oAllinterviewstobecompletedovera3monthperiodoEnsureallinterviewstranslatedintoEnglishandallinterviewproformasarecompletedin
EnglishinpreparationforreturningtoLondon
oArrangeforreturnof 1PHOTOCOPYofheadofserviceconsentform(Document2)
1ORIGINALof30patientconsentforms(Document6)
1completedDocument7(Part1InstitutionInformation)
30completedDocument8(Part2PatientInterviewQuestionnaireForm)
1completedDocument9(Part3AdditionalInformation)
ToInstituteofPsychiatry,KingsCollegeLondonforcommencementofanalysis(see
Document11forfurtherinformationonhowtoreturndata)
Anyquestionsatanytime?PleasecontactstudycoordinatorEstelleMalcolm,InstituteofPsychiatry,KingsCollegeLondon
EmailAddress:[email protected]
TelephoneNumber:+44(0)2078480612
Fax:+44(0)2072771462
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DOCUMENT11
HOWTORETURNDATA&STUDYCOORDINATORCONTACTDETAILS
Pleasereturnalldatabycouriertothestudycoordinator.
Ms.EstelleMalcolm
HealthServicesandPopulationResearchDepartment
InstituteofPsychiatry,King'sCollegeLondon
DeCrespignyPark,LondonSE58AF
UnitedKingdom
EmailAddress:[email protected]
TelephoneNumber:+44(0)2078480612
Fax:+44(0)2072771462
Ifthereisfundingavailablefromyourinstitutionforthisreturnweaskthatyouusethissourceto
paytocourierthestudydatasafely.IfthisisnotpossiblepleasecontactEstelleMalcolm,study
coordinator,whowillbeabletoassistwithfundingcourierreturns.
PLEASECONTACTMs.EstelleMalcolm,THESTUDYCOORDINATOR,FORALLQUERIESREGARDING
ANYASPECTOFTHESTUDY.GOODLUCK!