Pre-screening Clinical System (PSS) User Guide

Revised August 2016 by Robin Richardson

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Contents 1.0. Introduction to Pre-screening Clinical System (PSS) .................................................................. 3

2.0. Creating a Pre-Screening .................................................................................................................... 3

2.1. Searching for a Patient .................................................................................................................... 4

2.2. Submitting a Patient for Pre-Screening .................................................................................... 5

2.2.1. If the Patient is Eligible for Pre-Screening ......................................................................... 6

2.2.2. If There is Not Enough Information on the Patient ....................................................... 6

3.0. Using the Provider Portal.................................................................................................................... 12

3.1. Navigating to the Provider Portal ............................................................................................... 12

3.2. Selecting a Provider and Patient for Pre-Screening ............................................................. 14

3.3. Accepting or Declining a Patient ................................................................................................ 16

3.3.1. Accepting a Patient ................................................................................................................. 16

3.3.2. Declining a Patient .................................................................................................................. 17

3.4. Viewing Accepted Patients ........................................................................................................... 18

3.4.1. Pre-Screenings Needing a Research Nurse Review ...................................................... 18

3.4.2. Pre-Screenings Reviewed by Research Nurse ................................................................ 21

3.5. Viewing Accepted Patients Who are Entered in C3PR ....................................................... 22

3.6. Viewing Accepted Patients Who Declined to Participate .................................................. 23

3.7. Viewing Declined Patients ........................................................................................................... 23

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1.0. Introduction to Pre-screening Clinical System (PSS) PSS allows you to create a pre-screening of a potential subject for a clinical trial.

A pre-screening consists of three parts:

1. A patient

2. A study

3. A contact provider

If a patient is found to be a good candidate for a clinical trial, a pre-screening will create an association between the three elements above. Notifications are then sent to certain clinical staff.

The pre-screening must be approved or declined from the list of pending pre-screenings for the selected contact provider—usually the principal investigator (PI)—for the selected study, by the PI or other appropriate clinical staff.

This guide will walk you through the steps of creating a pre-screening in PSS and setting the patient’s status in regards to the clinical trial.

2.0. Creating a Pre-Screening There are several ways to navigate to the Create Pre-screening page.

• Click Create Pre-screening from the main menu bar (Figure 1).

Figure 1. One way to get to Create Pre-screening is directly from the main menu bar.

• Click Create a new pre-screening from the Quicklinks menu on the PSS home page (Figure 2).

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Figure 2. You may begin creating a new pre-screening from the link on the Quicklinks menu.

• Click Portal Home on the main menu bar (Figure 3), then click Create a new pre-screening from the portal menu (Figure 4).

Figure 3. You may also begin to create a new pre-screening from the Portal Home link.

Figure 4. Select Create a new pre-screening from the portal menu.

Once you have navigated to the Create Pre-screening page, follow the steps below:

2.1. Searching for a Patient The first thing you must do to create a pre-screening is to select a patient.

1. Enter search parameters.

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• In order to search for a patient, you need, at a minimum, his or her full name or MRN, as well as a Visit date range.

Searches without Provider criteria may take much longer to complete.

• One commonly used option is to view a physician’s upcoming schedule, then enter a Provider name (first and last name or last only) and Visit date range.

• To show only patients who have had a radiology scan within so many weeks, check the Radiology scan box and enter a number of weeks. (The weeks are calculated back in time from “today,” regardless of the visit date range entered.) To show new patients (even those without a scan), in addition to the radiology scan patients, check the or new patient box. The or new patient selection only has an effect if the Radiology scan box is checked.

2. Click Search.

3. You may sort by any of the columns.

• The Most recent event column displays the patient’s most recent event in PSS. The presence of an event does not mean a new pre-screening cannot be created for the patient.

• A Provider with NF at the end of the name indicates that no unique identifying information, such as username or email, could be cross-referenced. In that case, the Patient provider at pre-screening creation field will not be set when pre-screening is created.

• It is best to use the Back and Select another patient buttons at the bottom of the page when reviewing a provider schedule, as the results are cached and load faster than performing a new search.

Select a patient from the results by double-clicking on the appropriate row.

2.2. Submitting a Patient for Pre-Screening Once you have selected a patient, you will either see only a Review studies button, or you may get that button plus one that says, Not enough information on patient, assess at later date. The following subsections explain how to get from the patient selection page to submission confirmation.

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2.2.1. If the Patient is Eligible for Pre-Screening If the patient you select is eligible for pre-screening (you do not see the Not enough information… button), simply click Review studies to move on to the Create Pre-screening page, then follow the steps outlined in 2.2.2.2. Selecting Review Studies.

2.2.2. If There is Not Enough Information on the Patient If you see the button labeled, Not enough information on patient, assess at later date, you may either click that button or continue to Review studies (Figure 5).

Figure 5. At this point, you may Review studies or click Not enough information...

2.2.2.1. Selecting Not Enough Information on Patient If you click Not enough information on patient, assess at later date, you will be taken to the Not enough information to confirm page, where you may enter notes and either select Confirm or Go back to the search page (Figure 6):

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Figure 6. Either Confirm that there is not enough information on the patient or Go back and search again for another patient.

If you select Confirm, for reporting purposes, the patient will be logged into the system as not having enough information for pre-screening, but he or she may be added to a new or different pre-screening in the future (see Figure 7). You also have the option to Select another patient.

Figure 7. When you click Confirm, the patient is logged as not having enough information to be pre-screened.

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However, you may contact a provider to get the patient into a pre-screening, as explained in the next subsection.

2.2.2.2. Selecting Review Studies If you select Review studies, you may still create a pre-screening.

1. Once you have double-clicked the patient’s name in the search results, click Review studies. You will be directed to the Create Pre-screening page (Figure 8).

Figure 8. You will select studies and contact providers on the Create Pre-screening page.

2. Click the plus (+) sign next to the type of study for which you want to pre-screen the patient. You will see the studies that are currently being conducted in that area (Figure 9).

Figure 9. There are several studies going on for Head & Neck.

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Because there is not enough information on the patient, the Yes/No boxes next to the IRB numbers for the listed studies will all be set to No.

3. Click the plus (+) sign next to the IRB number of the study for which you want to pre-screen your patient. You will see a summary of that study and the providers associated with the study, as well as a link to the study in TrialSearch where you can learn more about it (Figure 10).

Figure 10. If you select a provider from the Contact Providers lists, you may enroll your patient for pre-screening.

4. Contact one of the study providers to get your patient cleared for pre-screening. Once the provider has approved the patient, you can select Yes in the box next to the name of the provider you contacted. When you select Yes next to the provider, the box next to the IRB number will also change to Yes (Figure 11).

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Figure 11. Once you select Yes to contacting a provider, your patient becomes eligible for pre-screening.

You may repeat the above steps with more than one study.

5. Scroll to the bottom of the screen and click Submit selected studies.

Figure 12. Click Submit selected studies to choose the studies for which you want to pre-screen your patient.

You also have the option to select No applicable studies found for this patient if you cannot contact the provider to get permission to pre-screen the patient. If you select that option, you will be directed to the No applicable studies found page, where you will click Confirm, and the patient will be logged as having no applicable studies (Figure 13).

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Figure 13. When you click Confirm, the patient will be logged as having no applicable studies.

If you select Submit selected studies, you will then see a Pre-screening confirmation page (see Figure 14). This page contains, among other information, the date and time the patient is scheduled for pre-screening and the provider he or she will be seeing. You may also Print the page, Go Back to the previous screen, or Cancel the pre-screening.

Figure 14. The Pre-screening confirmation page shows the date and time of the pre-screening appointment.

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6. Click Submit Proposed Studies for Review to continue the process of pre-screening the patient for the study. You will see the following Pre-screening Submitted page (Figure 15).

Figure 15. You may Print Confirmation Page or Select another patient from the Pre-screening Submitted page.

3.0. Using the Provider Portal As a provider, you may change the patient’s status and move him or her forward in the study participation process.

3.1. Navigating to the Provider Portal There are several ways to navigate to the Provider Portal.

• Click Provider Portal from the main menu bar (Figure 16).

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Figure 16. One way to get to the Provider Portal is directly from the main menu bar.

• Click Provider Portal from the Quicklinks menu on the PSS home page (Figure 17).

Figure 17. You may access the Provider Portal from the link on the Quicklinks menu.

• Click Portal Home on the main menu bar (Figure 18), then click Provider Portal from the Portal Home menu (Figure 19).

Figure 18. You may also get to the Provider Portal from the Portal Home link.

Figure 19. Select Provider Portal from the Portal Home menu.

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3.2. Selecting a Provider and Patient for Pre-Screening Once you have navigated to the Provider Portal page (see Figure 20), follow these steps to find information about providers and pre-screenings they are conducting or have conducted:

Figure 20. You may sort the provider list by name, email, or pre-screenings.

1. Select the provider of interest. To make locating the provider easier, you may sort the list by last name, first name, email, or pre-screenings. You will be directed to a page with several tabs, and you will land on the Pre-screenings tab for that provider, which includes a list of patients with pending pre-screenings (Figure 21).

Figure 21. The Pre-screenings list shows the patients who have been or will be pre-screened by that provider.

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2. Click the plus (+) sign next to the patient’s name you want to view, and you will see information about the patient, his or her pre-screening appointment, and the study for which the patient is being screened (see Figure 22). You may also do the following:

• Accept or Decline the patient for the study (see 3.3. Accepting or Declining a Patient)

• View Change History of the patient’s pre-screening status

• View the study in TrialSearch

• Contribute to a discussion about the patient’s pre-screening

• Print the patient’s pre-screening information

• Print all pending pre-screenings

Figure 22. The patient's pre-screening information also includes the ability to set the pre-screening for Accept or Decline.

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3.3. Accepting or Declining a Patient You may Accept or Decline a patient for a study from the Pre-screening tab.

3.3.1. Accepting a Patient Follow these steps to Accept a patient for a study:

1. Click Accept.

2. In the Confirm acceptance box, click Accept pre-screening (Figure 23).

Figure 23. Select Accept pre-screening to continue in the approval process.

3. The patient’s Approval Status will change to Accepted (see Figure 24). You will also see a link to Create Registration in C3PR to register the patient to the study. (See the C3PR Registration Guide for more information.)

Figure 24. The approval status changes to Accepted.

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3.3.2. Declining a Patient Sometimes a patient will not be eligible for a study pre-screening.

1. Click Decline. A box will display asking for a reason and any comments about why the patient was declined (Figures 25 and 26).

Figure 25. You must select a reason, and you may include any comments about why the patient was declined.

Figure 26. There are several reasons a patient may be declined for a study pre-screening.

2. Select a Reason from the drop-down list and add any comments you may have about the pre-screening.

3. Click Submit. The status will now change to declined, and the reason and comments will show under Approval Status (Figure 27).

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Figure 27. A Declined status will also include the Reason and Comments about the pre-screening.

3.4. Viewing Accepted Patients Once a patient is accepted, he or she will no longer show on the Pre-screening tab but will move to the Accepted tab. The Accepted tab shows whether or not the patient’s pre-screening needs to be reviewed by a research nurse (Figure 28).

Figure 28. The Accepted tab shows all patients who have been approved for a pre-screening.

3.4.1. Pre-Screenings Needing a Research Nurse Review By clicking Need research nurse review, you (the research nurse) may view information about a patient and the relevant study, go to C3PR to register the patient, or Revoke the patient’s acceptance to the study from the acceptance tab (Figure 29).

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Figure 29. If necessary, the research nurse may revoke approval on the Accepted tab.

3.4.1.1. Revoking Approval You may click Revoke approval if the patient turns out to be ineligible for the study.

1. Click Revoke approval. A Confirm revocation box will display with a warning that revoking the patient may affect the study reporting, depending on at what point in the study the patient was revoked (see Figure 30). Only revoke a patient if there are clear reasons why the patient should not have been approved.

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Figure 30. Only revoke a patient approval if there is a good reason to do so.

2. If you are sure the approval must be revoked, click Revoke approval decision.

A patient who has had approval revoked will reappear on the Pre-screening tab, and he or she may be accepted or declined for pre-screening again.

3.4.1.2. Confirming Review by a Research Nurse Once the you have reviewed the patient’s pre-screening information and decided whether to accept the approval decision or revoke it, click Reviewed by Research Nurse to change the patient’s review status on the Accepted tab (Figure 31).

Figure 31. The research nurse must click Reviewed by Research Nurse to change the patient's review status.

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3.4.2. Pre-Screenings Reviewed by Research Nurse When you select a patient on the Accepted tab who has the status, All pre-screenings reviewed by research nurse, the page looks similar to the page for the status Need research nurse review, with one exception: under Approval Status, there is an option to indicate that the patient declined to participate in the trial (Figure 32).

Figure 32. The research nurse may select Patient declined trial after the pre-screening has been reviewed.

After clicking Patient declined trial, a confirmation box will appear in which the nurse may enter comments and confirm that the patient declines participating in the trial (Figure 33).

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Figure 33. The research nurse enters comments then clicks Patient declined trial.

3.5. Viewing Accepted Patients Who are Entered in C3PR The tab Accepted (in C3PR and reviewed) offers the same information as what you will find on the Accepted tab, but you will also see that the patient has been accepted and registered in C3PR (see Figure 34). You may still Revoke approval at this point, and/or patient can decline to participate in the trial. You may View Change History for the patient as well.

Figure 34. "Accepted" and "Patient registered in C3PR" are not clickable.

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3.6. Viewing Accepted Patients Who Declined to Participate The tab Accepted (patient declined and reviewed) has basically the same information as what you will find on the Accepted tab, but you will also see in the Approval Status area at what point in the process the patient declined and any comments included (see Figure 35). You may Revoke approval at this point as well.

Figure 35. The Approval Status for this tab will include the reasons patient declined.

3.7. Viewing Declined Patients The Declined tab contains similar information to the others, but the Approval Status area includes the reason the patient was declined when being evaluated for pre-screening eligibility (Figure 36).

Figure 36. You will see the reason the patient was declined on the Declined tab.