the power of research networks

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5/20/2015 1 The Power of Networks: Building a Learning Healthcare System with Practice-based Research Networks (PBRNs) Jonathan N. Tobin, PhD President/CEO Clinical Directors Network (CDN) Co-Director, Community Engaged Research Core The Rockefeller University Center for Clinical & Translational Science [email protected] PRESENTED AT : 2015 Community Engagement Symposium: Developing and Enhancing Collaborations for the Translation of Research San Antonio Texas May 2, 2015 THE POWER OF RESEARCH NETWORKS Define PracticeBased Research Networks (PBRNs) Examine types of research that can be embedded into care Present examples of prior and current CDN and N 2 PBRN studies and future NYCCDRN/PCORnet studies Discuss challenges and opportunities for scaleup and building a Learning Healthcare System www.CDNetwork.org www.CDNetwork.org Primary Care PBRNs Group of ambulatory care practices Organizational structure transcends a single research project Link practicing clinicians with experienced investigators Enhance research skills of network clinician members Ongoing commitment to network activities Mission: Service - primary care of patients Goal - improve quality of primary care Investigation - questions related to community-based practice Source: AHRQ PBRN www.ahrq.gov/research/pbrn/pbrnfact.htm 4 Source: http://pbrn.ahrq.gov/pbrn-registry/pbrn-map; Data as of Oct. 2013 AHRQ PBRN REGISTRY (2013) N=155

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Page 1: THE POWER OF RESEARCH NETWORKS

5/20/2015

1

The Power of Networks: Building a Learning Healthcare System

with Practice-based Research Networks (PBRNs)

Jonathan N. Tobin, PhD President/CEOClinical Directors Network (CDN)Co-Director, Community Engaged Research CoreThe Rockefeller University Center for Clinical & Translational [email protected]

PRESENTED AT :2015 Community Engagement Symposium:

Developing and Enhancing Collaborations for the Translation of ResearchSan Antonio Texas

May 2, 2015

THE POWER OF RESEARCH NETWORKS

• Define Practice‐Based Research Networks (PBRNs)

• Examine types of research that can be embedded into care

• Present examples of prior and current CDN and N2‐PBRN studies and future NYC‐CDRN/PCORnet studies

• Discuss challenges and opportunities for scale‐up and building a Learning Healthcare System

www.CDNetwork.orgwww.CDNetwork.org

Primary Care PBRNs

• Group of ambulatory care practices

• Organizational structure transcends a single research project

• Link practicing clinicians with experienced investigators

• Enhance research skills of network clinician members

• Ongoing commitment to network activities

• Mission:

• Service - primary care of patients

• Goal - improve quality of primary care

• Investigation - questions related to community-based practice

Source: AHRQ PBRN www.ahrq.gov/research/pbrn/pbrnfact.htm 4Source: http://pbrn.ahrq.gov/pbrn-registry/pbrn-map; Data as of Oct. 2013

AHRQ PBRN REGISTRY (2013)

N=155

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Models of Practice-Based Research

• Top-Down– Researcher-focused

– Funder-focused

• Bottom-up– Clinician-focused (PBRN)

– Patient-focused (CBPR)

• Mixed Model (Bi-directional)

Clinician Researcher5

CER/PCORCEnRPCTs

Practice‐Based Research Networks  (PBRNs)The Importance of Setting

• Ambulatory care represents the ambient conditions under which most people present for care and under which most care (Usual Care) is provided

• PBRNs in ambulatory care settings (such as Primary Care PBRNs) represent organized practices in which care is provided and carecan be studied systematically

• Conduct Studies that follow Clinical Workflow in order to minimize disruption to the practices, clinicians, staff and patients

• PBRNs also represent an established mechanism for thedissemination and implementation of medical innovations

Practice‐Based Research Networks  (PBRNs)

MIXED MODEL PBRNS:

• Can potentiate the bi-directional exchange of what is bestin each model of research (lab vs. field)

• Provide the venue for translating practice into research,thereby changing the pattern of information flow

• Serve as both the venue for conducting research and the mechanism for disseminating research results

Types of Research Conducted in PBRNs

• Descriptive 

• Observational

• Experimental – Randomized Controlled Trials (RCTs)

– Comparative Effectiveness Research (CER)

– Patient Centered Outcomes Research (PCOR)

– Cluster RCTs

• Dissemination & Implementation (D&I)

• Quality Improvement

• ?Mechanistic Studies

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Source: Westfall, et al., “Practice-Based Research—‘Blue Highways’ on the NIH Roadmap” JAMA 2007; 297: 403-406

Full Spectrum of Translational Research

NIH “Blue Highways”

T4PublicHealth Impact

T0Basic

Science

• PBRN Practice-based Research Networks

• CER Comparative Effectiveness Research

• PCOR Patient Centered Outcomes Research-------------------------------------------------------------------------------------------------------------------------------------------------------------------------

• CEnR Community-Engaged Research

• CBPR Community-based Participatory Research-------------------------------------------------------------------------------------------------------------------------------------------------------------------------

• PCT Pragmatic Clinical Trials

Types of T2 T3 T4 Research

Comparative Effectiveness Research (CER)

• “A rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients” (OMB)

• Includes Randomized Controlled Trials (RCTs), pragmatic, and observational trials and cost analysis comparing drugs, treatments, or diagnostic tools

• CER is closely related to  Patient‐Centered Outcomes Research (PCOR)

Lauer MS. Comparative Effectiveness Research: The View From the NHLBI. Journal of the American College of Cardiology. 2010;53(12):1084-1086.

Source: Hatch J, Moss N, Saran A et al. Community research: Partnership in Black communities. Am J Prev Med 1993 Nov-Dec;9(6 Suppl):27-31; discussion 32-34.

Persons consulted by the researchers are at the periphery of the community.

Researchers retain total control of the project.  There is community involvement, but it is passive.

Community leaders are asked not only for endorsement of the project, but for guidance in hiring community residents to serve as interviewers,outreach workers, etc.

Community members are first among equals in defining the research agenda.

Four‐Stage Model of Community‐Engaged Research (CEnR)

One Two Three Four

GOALS OF COMMUNITY‐ENGAGED RESEARCH• Build Trust & Capacity• Enlist new resources and allies• Create better communication

• = Improve overall health outcomes  Public Health Impact

*CBPR

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MacPherson’s Key Steps inConducting a Pragmatic Clinical Trial

1. Appropriate research question

2. Defining the patient group

3. Identify a comparison group

4. Defining the treatment protocol

5. Ensuring adequate sample size

6. Referral, recruitment and randomisation

7. Outcomes

8. Analysis

9. Reporting and dissemination

Source: MacPherson H. Pragmatic clinical trials. Complementary Therapies in Medicine. 2004. 12:136‐140.

Pragmatic‐Explanatory Continuum Indicator  Summary (PRECIS) Tool

Source: Thorpe KE et al. A pragmatic‐explanatory continuum indicator summary tool (PRECIS): a tool to help trial designers. CMAJ 2009; 180(10):E47‐57.

Challenges for PBRNs A common aim behind Comparative Effectiveness Research (CER) and 

Practice‐based Research Network (PBRN)‐conducted research is to produce new evidence‐based medical knowledge that fills gaps between primary care practice realities and findings produced by academic/tertiary‐care research and clinical trials

Less control over 

Patient characteristics

Variability in practice clinical and research capacity

Multiple IRBs 

Significant resource problems that impede research

Other challenges include: 

selecting studies that meet network’s & practices’ priorities

working within an adequate and sufficient budget

developing study teams and agreements among team members 

training practice staff for participation 

WHY RESEARCH NETWORKS?

Advantages:  Accelerate study start‐up & conduct Follow clinical workflow and embed  at point of care 

Build shared infrastructure Facilitate data‐sharing Conduct full spectrum of translationalresearch

Opportunities for dissemination & scale‐up

www.CDNetwork.orgwww.CDNetwork.org

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THE POWER OF RESEARCH NETWORKS

• Structure of CDN and N2‐PBRN 

• Examples of prior and current PBRN studies conducted by CDN and N2‐PBRN

www.CDNetwork.org

Clinical Directors Network

A Practice‐based Research Network (PBRN) 

that works with Primary Health Care Safety‐net Practices 

‐‐‐‐Research Infrastructure to build a Learning 

Healthcare System

CDN Recognition

US Department of Health & Human Services

Award for “Outstanding Contribution Toward

the Elimination of Racial and

Ethnic Disparities in Health”

(2001)

NIH Roadmap Initiative

Designated “Best Practice” Clinical Research Network

(2006)

AHRQ Designated “Center of

Excellence” (P30) For Practice-based

Research and Learning (2012)

Improving Healthcare Systems (2012)Eliminating Health Disparities (2013) Clinical Data Research Networks x2 (NYC & Chicago, 2013)

CDN’S OVERALL GOAL

• CDN is dedicated to providing and improving comprehensive and accessible community oriented Primary and Preventative Health Care services for poor, minority, and underserved populations

• CDN’S overall goal is to engage communities, clinicians and patients  to translate clinical research into clinical practice for the elimination of health disparities

CDN’S Primary Activities• Practice‐based Research• Education and Training• Professional Development

www.CDNetwork.org

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CDN: Beginnings

• “CDN was created in 1985 by agroup of community health centerdental and medical directors withthe encouragement and support ofofficials of Region II of the PublicHealth Service (PHS).”

• “CDN has responded to the needsarticulated by clinicians at healthcenters…has provided managerialtraining and clinical education,strategies for increased involvementof clinicians in health centermanagement and opportunities forengagement in community‐basedprimary care research.”

Peer Support: Retention/Recruitment of Clinicians into Health Centers

• “… while salary and benefit levels are a major variable in retention, other factors related to personal and professional satisfaction are also significant. These include workload, relationship to other staff, sense of mission, health center morale, reputation of the center and participation in decision‐making within the organization.”

• The most satisfying aspects of their jobs:– “team‐building", 

– "diversity and versatility of their role“

– "working with the community and community groups“

– "taking a larger view of health care in the community“

– “Clinical leadership and administrative skills” 

– "personal commitment to the job and the mission”

Sardell A. (1996) “Clinical Networks and Clinician Retention: The Case of CDN.” J Community Health. 21(6):437-51.

Factors Contributing to Physician Retention in FQHCs

• John Snow study of national retention rates of physicians at Community/Migrant Health Centers examined conditions which contribute to professional satisfaction or dissatisfaction. 

• Retention was found to be positively related to job satisfaction 

• Perception that the management of the health center had created a professionally satisfying environment (& connected to mission)

Sardell A. (1996) “Clinical Networks and Clinician Retention: The Case of CDN.” J Community Health. 21(6):437-51.

Mission  External Validity Generalizability  Social Justice

‐ People: Eligibility ‐ inclusion/exclusion criteria

‐ Place: Setting ‐ types of services available

‐ Time: Seasonality ‐ novel/established

Ideal vs. Real World:• Practice Settings• Populations• Heterogeneity

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The HRSA Primary Health Care Safety‐Net (2013)

Source: www.hrsa.gov  www.healthdisparities.net

Grantees, Delivery Sites and FTE Clinicians (2013)

Source: HRSA BPHC UDS, 2013– Special Tabulation

USA New York

Grantees

Delivery Sites

1,202

9,203

57

632

Physicians 10,734 1,074

Nurses 13,278 1,326

NPs, PAs, and Midwives8,156

578

Medical Providers 32,168 2,978

Dentists 3,479 338

Dental Assistants, Technicians and Hygienists

8,371 627

Dental Providers 11,850 965

Mental Health Providers 5,694 524

Community Health Center Patients by 

Race/Ethnicity (2013)

Source: HRSA BPHC UDS, 2013– Special Tabulationwww.CDNetwork.org

Patient Income Percent of 

Poverty Level (2013) 

Race/Ethnicity (%) National New YorkAsian/Pac Island 4.1 5.2Native American 1.2 0.3Black 20.3 26.6White 56.2 32.1Unknown/NR 14.9 23.0Hispanic/Latino 34.8 35.3

Community Health Center Patients by Diagnosis, USA (2013)

Source: HRSA BPHC UDS, 2013– Special Tabulation)

Selected Diagnoses and Services National New York

Hypertension 3,642,869 216,171 (2)

Immunizations 2,699,959 232,287 (1)

Overweight and Obesity 2,228,089 179,258 (4)

Diabetes Mellitus 1,882,608 120,704 (6)

Pap Smear 1,787,256 158,736 (5)

Depression 1,644,559 94,888 (10)

Contraception 1,221,493 102,963 (8)

Tobacco Use Disorders 1,181,415 101,650 (9)

Anxiety Disorders including PTSD 1,096,079 63,696 (12)

Asthma 1,092,389 117,516 (7)

HIV Tests 1,079,505 182,227 (3)

Other Mental Disorders 988,999 82,583 (11)

Otitis Media/Eustachian Disorders 841,327 50,483 (14)

Heart Disease 602,687 42,991 (16)

Dermatitis/other Eczema 599,743 51,582 (13)

Mammogram 424,376 41,538 (17)

Chronic Bronchitis/Emphysema 320,862 17,633 (19)

Hepatitis C Test 296,349 46,666 (15)

Hepatitis C 145,309 11,245 (20)

Symptomatic HIV, Asymptomatic HIV 115,421 19,045 (18)

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CDN’S  RESEARCH PORTFOLIOMIXED MODEL

 

HIV/AIDS  NIAID NIMH, HRSA, CDC, AmFAR, BMS, DMP, Roche    

MRSA  NCATS    

HIT  NIDDK, NCI    

CANCER PREVENTION and CONTROL  NCI, AHCPR, PCORI    

DEPRESSION  NIDA, SAMHSA, NIMH, PCORI    

STRESS MANAGEMENT  NIMH, CDC    

HYPERTENSION  NHLBI    

DIABETES  HRSA, NIDDK, NIDCR    

IMMUNIZATIONS  CDC, HRSA, Pharma    

MIGRAINE/HEADACHE  Merck    

ANEMIA; BLEEDING DISORDERS  Ortho Biotech, NCATS    

ASTHMA  EPA, DEP, HRSA    

HPV SCREENING & VACCINATION  NYC DOHMH    

TEEN MENTAL HEALTH SCREENING  Columbia University    

PALLIATIVE CARE  NCI    

NUTRITION/PHYSICAL ACTIVITY  RWJ, NYS Atty Gen    

PERIODONTAL DISEASE  NIDCR    

GENETICS  March of Dimes    

PREGNANCY/PRENATAL CARE  NIMH 

ACADEMIC PARTNERS & CER/PCOR PROJECTSYALE SCHOOL OF PUBLIC HEALTH • Centering Pregnancy RCT(NIMH)

DARTMOUTH MEDICAL SCHOOL • Cancer Control  RCT (NCI; PCORI)

COLUMBIA UNVERSITYCollege of Physicians and SurgeonsMailman School of Public Health

• CAATCH Hypertension in African Americans RCT (NHLBI)• BP Adherence RCT  (NHLBI)• Cancer Caregiver Support RCT (NCI)• Web‐based Rx Support Tool for HIV (HRSA)• Problem‐Solving in Diabetes Management RCT (NIDDK)

RAND CORP &  UCLA • PTSD Among Refugees (NIMH)• PTSD Care Management RCT (NIMH)

UNIVERSITY OF MICHIGAN                  School of Dental & Oral Surgery & Public Health

• Periodontal Disease/Diabetes (NIDCR)

UNIVERSITY OF MIAMI Miller School Of Medicine

• Stress Management & HIV RCT (3) (NIMH & CDC)

THE ROCKEFELLER UNIVERSITYCenter for Clinical & Translational Science

• CA‐MRSA Project (NCATS; AHRQ; PCORI)• Bleeding Phenotype (NCATS)• Research Participant Survey (NCATS)• Hepatitis‐C Screening & Treatment (NCATS; Helmsley Trust)

NYU Langone School of Medicine • Hypertension in African Americans RCT (NHLBI)• Cancer Caregiver Support  RCT (NCI)

UNIVERSITY OF ROCHESTER • Technology Enabled Patient Self Management (NCI, PCORI)• BP Visit  Intensification Study (NHLBI)

ALBERT EINSTEIN COLLEGE OF MEDICINE Collaborative Cancer Care Among Low‐Income Urban Women (PCORI)N2 PBRN ‐ Network of Networks (AHRQ P30)

WEILL CORNELL Medical College NYC‐CDRN (PCORI)

CDN RECRUITMENT EXPERIENCE1992‐Present

64,067 Patients enrolled

74 % Female

49 % African‐American

40 % Latino/awww.CDNetwork.org

MIXED MODEL

CDN has successfully employed the “Mixed Model” 

in a variety of experimental and observational studies conducted in primary care practices serving low‐income and minority communities, including :

– Community/Migrant Health Centers (CHCs)

– Diagnostic and Treatment Centers (DTCs)

– Health Department Clinics (DOH)

– Public/Voluntary Hospitals (HOSP)

– Primary Care Residency Programs (PCRPs)

– Managed Care Organizations (MCOs)

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Employing the Mixed Model, Significant Improvements Have Been Achieved In:

• Clinical Preventive Services • Disease Management• Health Behavior Change• Integration of Primary Care & Mental Health• Quality of Life• Clinical/Biological Outcomes• Beginning to demonstrate Public Health Impact

Drivers of New PBRN Growth

CHALLENGES TO SUSTAINABILTYWHICH LEAD TO GROWTH OF NETWORKS

Enormous financial investment

Need for new markets (practices, clinicians)

Saturation of existing practices

Limited bandwidth & competing priorities

Time Constraints

Competition for funding 

Inconsistent, partial or poor      translation of research into practice

Outside demand for expertise & access

Geographic diversity/diverse health needs

POTENTIAL SOLUTIONS

High quality data collection Simplified, less costly forms

Clinicians who are engaged and serve as investigators, early adoptersand disseminators

Vigorous communication and discussion of  efficacy and effectiveness among collaborating PBRNs

Models of collaboration 

Accelerated model of translation 

Inter‐operable EHR systems 

Drivers of Growth & Expansion: Scalable

CDN N2 ‐PBRN : Building a Network of Safety Net PBRNs

(“Network of Networks”)

A collaboration among:◦ Access Community Health Network (ACCESS)

◦ Alliance of Chicago (ALLIANCE)

◦ Association of Asian Pacific Community Health Organization (AAPCHO)

◦ Center for Community Health Education Research and Service (CCHERS)

◦ Clinical Directors Network (CDN) [Lead PBRN]

◦ Community Health Applied Research Network (CHARN)

◦ Fenway Institute (FENWAY)

◦ New York City Research and Improvement Group (NYCRING)

◦ Oregon Community Health Information Network (OCHIN)

◦ South Texas Ambulatory Research Network (STARNet)

Funded by AHRQ Grant: P30 HS 021667Principal Investigator:  Jonathan N. Tobin, PhD (CDN)

Project Officer: Rebecca A. Roper, MS, MPH Director, AHRQ PBRN Initiative

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CDN Webcast Partners<

• Alliance of Chicago Community Health Services

• Alliance of Chicago Community Health Services

• Erie Family Health Center, Inc.• GLIDE Health Services• Heartland Health Outreach• Howard Brown Health Center• Near North Community Health Center• North Country Healthcare• Lurie Children’s Hospital/NU• Academic Partners:• University of Michigan• Michigan Public Health Institute• Northwestern University

• Association of Asian Pacific Community Health Organizations(AAPCHO)

• Asian Health Services Community Health Center

• Charles B. Wang Community Health Center

• Waianae Coast Comprehensive Health Center

• Waimanalo Health Center• Academic Partner• University of California, Los Angeles

• Fenway Health• Fenway Health • Chase Brexton Health Services• Beaufort-Jasper-Hampton Comprehensive Health Services• Academic Partner• University of Washington

• OCHIN• Open Door Community Health Center• Virginia Garcia Memorial Health Center• Multnomah County Health Department• OHSU Family Medicine at Richmond• Academic Partner• Oregon Health and Science University(Academic Partner)

• Kaiser Permanente Center for Health Research – Data Coordinating Center

• Center for Health Research

Funded by HRSA

N2 PBRN Academic Partners

Virtual Faculty• Albert Einstein College of Medicine 

of Yeshiva University/MontefioreMedical Center    

• Boston University 

• Columbia University

• Dartmouth Medical School 

• Harvard University

• Kaiser Permanente Center for Health Policy Research

• New York University

• Northwestern University

• Oregon Health and Science University

• RAND Corporation

• The Rockefeller University

• Tufts University

• University of California/San Francisco 

• University of Chicago

• University of  Illinois at Chicago

• University of  Miami 

• University of Michigan

• University of Oregon

• University of Washington

• Yale University 

N2 LEARNING COLLABORATIVE

TRACKS

1. PBRN Research Management Innovations (for PBRN Senior Staff)

2. PBRN Methods (for PBRN Senior Staff  & Academic Collaborators)

3. Introduction to Research (for CHC Nodes Staff & New PBRN Staff)

4. PBRN Study Results (for CHC Nodes, CHC Partners, PBRN Senior Leadership & Staff, Academic Partners)

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Aims to enhance the skills of current PBRN researchers and practicing clinicians who are interested in participating in clinical research. 

Tracks:

• Evidence‐based practices and best practices demonstrated to be effective at transforming clinical research into a more clinician‐engaged, accelerated research and translation model, with significant clinical and public health impact

• A “Virtual Faculty” of N2 PBRN Directors and their PBRN‐related research

• N2 PBRN Academic Partners “Virtual Faculty” and their PBRN‐related research

• Training in research methodology for practicing clinicians who wish to become more active and engaged in practice‐based research

• New content added on Pragmatic Clinical Trials, CER & PCOR Research methods

The N2 PBRN Online Training Curriculum Research Training for Clinical Leaders 2012‐2013

Funded in part by AHRQ Grant: P30 HS 021667

• Study Design and Implementation

– To enable practicing clinicians to develop their research interests and skills, through didactics on the scientific and statistical aspects of study design as well as through hands‐on experience in preparing and implementing a research project

• Epidemiology and Biostatistics

– To develop and provide oral and written research dissemination/presentation skills at local, regional and national forums

• IRB/Human Subjects Protection

– IRB Application

– Informed Consent

• Grant Writing 

– To provide technical assistance in grant‐writing and identifying potential funding sources, including training exercises and assistance in developing budgets, staffing plans, work‐scopes, and timelines

• 60 CME/CNE/CDE Credits for Participation

Community Health Center Patient Centered Outcomes Research (PCOR) Training Program

“Enhancing Community Health Center PCORI Engagement” (EnCoRE) PCORI Grant No. NCHR 1000-30-10-10 EA-0001

Key Partners:• Access Community Health Network• Association of Asian Pacific Community Health Organizations (AAPCHO)• Clinical Directors Network (CDN) [JN Tobin, PI; M Dziok, PD]

• Community Health Applied Research Network (CHARN)• Institute for Community Health (ICH) at Harvard University• National Association of Community Health Centers (NACHC) [M.Proser, Co-PI]

• South Carolina Primary Healthcare Association (SCPHA)

Goal:

To adapt, enhance, and implement an existing year-long training curriculum designed to educate and engage health center teams including patients, clinical and administrative staff in PCOR

Objectives:

• Build infrastructure to strengthen research capacity of health centers as they develop or expand their own research infrastructure and engage in PCOR

• Develop, implement, and disseminate broad innovative training content and delivery approaches

• targeted to and accessible at no cost to all health centers and other primary care practices

• content will prepare health center patients, staff, and researchers in the conduct of community-led PCOR

• Evaluate, refine, and disseminate training resources to health centers nationally

ENCORE: Community Health Center Patient CenteredOutcomes Research (PCOR) Training

(Funded by a PCORI Eugene Washington Engagement Award -NCHR 1000-30-10-10 EA-000)

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CDN  N2

Case Presentations of CDN & N2‐PBRN Studies:

• Prevention Care Management for ImprovingCancer Early Detection (NCI, AHRQ, PCORI)

• CA‐MRSA Project (NCATS, AHRQ, ?PCORI)

www.CDNetwork.orgwww.CDNetwork.org

THE POWER OF RESEARCH NETWORKS

Prevention Care Management (PCM) Projects to Improve Cancer Screening in Primary Care

Principal Investigator:Allen Dietrich, MD

Geisel School of Medicine at Dartmouth

Co‐Principal Investigator:Jonathan N. Tobin, Ph.D.

Clinical Directors Network (CDN)

PCM1, PCMT & PCM2 Projects

Funded by: NCI Grants R01-CA87776 (PCM1, PCMT)& R01-CA119014 (PCM2)

Funded by NCI Grants R01-CA87776 & RO1-CA119014(A. Dietrich, PI; J.N. Tobin, Co-PI)

Dissemination &ImplementationEfficacy Effectiveness

PCM1(2000-2004)

PCMT(2003-2005)

PCM2(2006-2012)

Framework: Prevention Care Management (PCM) Projects (2000‐2012) PCM1 CONSORT: Health Centers

Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge, RG. Telephone Care Management To Improve Cancer Screening among Low‐Income Women. Ann Intern Med. 2006; 144:563‐571.

Recruitment Timeline:

November 2001 ‐October 2002

Follow‐up:

18 months after recruitment; all follow‐up completed by April 2004

Efficacy

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PCMT  CONSORT: MMCO (n=1)

Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Reh M, Romero KA, Flood AB, Beach ML. Translation of an Efficacious Cancer‐Screening Intervention to Women Enrolled in a Medicaid Managed Care Organization. Ann Fam Med. 2007; 5:320‐327.

Effectiveness

PCM2 CONSORT: MMCO (n=3)

Dietrich AJ, Tobin JN, Robinson CM, Cassells A, Greene MA, Dunn VH, Falkenstern KM, De Leon R, Beach ML. Telephone Outreach to Increase Colon Cancer Screening in Medicaid Managed Care Organizations: A Randomized Controlled Trial. Ann Fam Med. 2013; 335‐343.

Dissemination &Implementation

Screening OutcomesPCM1

18 months: Up-to-Date

1 Year HFOBT5 Years: SigmoidBarium Enema10 Years: Colonoscopy

By MMCO Claims Data

PCM2

8 months: Up-to-Date Pap, mammogram

1 Year HFOBT5 Years: SigmoidBarium Enema10 Years: Colonoscopy

By MMCO Claims Data

PCMT

18 months: Up-to-DatePap, mammogram

1 Year HFOBT5 Years: Sigmoid10 Years: Colonoscopy

By Chart Review

Dissemination &Implementation

Efficacy

Effectiveness

Intervention Implementation

PCM1 PCMT PCM2

Total Number of Participants

696 663 562

N (%)  Reached 633 (91%) 268 (40%) 340 (60%)

Intervention Period 18 months 8 months 18 months

Staff Research Staff at CDN Health Plan Staff Heath Plan Staff

Targeted Cancers Breast, Cervical and Colorectal Breast, Cervical and Colorectal Breast, Cervical and Colorectal*

Identification of Eligible Participants

• Medical records review (excluded women who were up‐to‐date for breast, cervical and colorectal cancer screening)

•  Administrative claims data • Administrative claims data

Phone Calls 

Mean # of calls (range)4 (range 1 to 20)

(support was given in no more than 3 calls)

3

Average call length[# minutes (range)]

Initial17(6‐48) − 14 (1‐53)

Subsequent14(1‐62) − 7(1‐21)

PCM  Intervention Delivery

52

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PCM Intervention Components

53

PCM1 PCMT PCM2

Intervention Components

Mail clinician recommendation letter to patient

√−

Mail activation card to patient√

−√

Mail screening test‐specific educational material to patient

√−

Confirmed and updated screening dates

√ √ √

Discuss and provide support on barriers using script 

√ √ √

Schedule screening appointments√

− √ (as needed)

Reminder calls √

− √ 

Reminder letters√

− √ 

Organizational Characteristics

54

Organizational Characteristics PCM1 PCMT PCM2

Study Period  2000‐2004 2003‐2005 2006‐2012

Insurance of Study Participants (%)

Medicaid 80 100 100

Medicare 21 ‐ ‐

Employer/other 9 ‐ ‐

No Insurance  5 0 0

Practice Types Involved (%)

Community Health Center (publicly funded) 100 100 45

Diagnostic & Treatment Center (publicly funded) 0 0 37

Private Practice 0 0 18

Primary Care Clinicians at All Centers per Study

Total Clinicians, n 116 ‐ 364

Family Practitioners (%) 26 ‐ 12

General Internists (%) 35 ‐ 35

Nurse Practitioners and Physician's Assistants (%) 39 ‐ 15

“‐” = data not available

Patient Characteristics

55

PCM1 PCMT PCM2

Total Number of Participants 1390 1316 2240

Age Inclusion Criteria 50‐69 40‐69 50‐63

Age at Baseline ‐Mean  58.1  50.0 55.8

Primary Language (%) *

English 36.9% 49.6% 69.3%

Spanish 62.8% 9.4% 24.8%

Other  0.3% 0.5% 6.0%

Years Receiving Care at CHC/Practice (%)

<3 28.5% 57.8% ‐

>3 68.3% 42.2% ‐

Unknown 3.2% 0.0% ‐

Comorbidities at Baseline (%)

Diabetes 37.8% ‐ 29.0%

Hypertension 70.9% ‐ 60.8%

High Cholesterol 39.6% ‐ 37.5%

Smoking Status (%)

Current 17.6% ‐ 18.6%

Former 13.0% ‐ 13.8%

Never 63.9% ‐ 67.6%

Body Mass Index

Mean kg/m2 32 ‐ 30

Normal (%) 11.4% ‐ 20.0%

Overweight (%) 27.3% ‐ 34.6%

Obese  (%) 51.3% ‐ 44.9%

‐ = data unknown/not available

Statistical Methods for Meta‐Analysisof 3 PCM RCTs

• Unadjusted Comparisons of the main effects for the three PCM RCTs 

• Random effects meta‐analysis 

• Random effects meta‐regression model using the aggregate level data on the log scale was used to estimate a decrease in effectiveness over the three trials – More complete data were available for PCM1 and PCM2 

– PCM1  & PCM2 were combined to provide a covariate‐adjusted estimate using logistic regression models 

• p‐value < 0.05 (2‐tailed) statistical significance

• 95% confidence intervals are reported 

56

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15

Meta‐analysis of Odds Ratios from 3 CDN PCM RCTs

57

PCM1

PCMT

PCM2

I2 = 54.8%, p =0.109

Forest Plot

Proportion of Spanish Speakers

64%

27%

0

10

20

30

40

50

60

70

PCM1 PCM2

% Span

ish Speakers

Proportion of Spanish Speakers ‐ PCM1 vs PCM2

58

Odds Ratios Stratified by Language:Heterogeneity of Treatment Effects

+ P <0.10 * P < 0.05 ** P <0.01 *** P<0.001

NS: PCM1 vs. PCM2 Sig: Eng vs. Span

Interpretation• While the effect sizes for PCM1 versus PCM2 appear to be different, they are 

not 

• The distribution for Spanish and English speakers differs between 

PCM1 (64%) and PCM2 (27%)

• This language effect drives the difference in ORs 

• The difference between 1.69 (PCM2) versus  1.31 (PCM1) is best explained by language differences 

• This represents Simpson’s Paradox:• The possibility that a measure of association may reverse

direction upon stratification by a third variable

• Simpson's paradox can occur in meta‐analysis because the sum of the data or results from a number of different studies may be affected by confounding variables that have been excluded by design features from some studies but not others

• It is an extreme extreme violation of COLLAPSIBILITY, in which results of the data analysis in every mutually exclusive stratum or subgroup are the opposite of the crude results. (see also CONFOUNDING BIAS)"

Source: M. Porta, A Dictionary of Epidemiology (University Press, 2008)

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Source: 2008 C5

SCALE-UPNYC DOHMH Colo-rectal Cancer Screening

Patient Navigator Program

SCALE-UPNYC DOHMH Colo-rectal Cancer Screening

Patient Navigator Program

Source: 2008 C5

Source: 2008 C5Source: 2014 C5

Source: 2008 C5Source: 2014 C5

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P30 Curriculum, Web Portals and Resource Library Development

For Patients and Clinicianswww.CDNetwork.org/RussianCRC

Funding: NYC DOHMH, NYS DOH, CDC

Next Steps: Using Collaborative Care to Reduce Depression and Increase Cancer Screening

Among Low-Income Urban Women Project

NYC Colonoscopy Screening Data Booklet, 2010 Community Health Survey, C5

Collaborative Care to Reduce Depression and Increase Cancer Screening Among

Low‐Income Urban Women Project (PCM3‐MH)

A collaboration among:

Clinical Directors Network (CDN) ‐ Jonathan N. Tobin, PhD, Andrea Cassells, MPH, TJ Lin MPHAlbert Einstein College of Medicine ‐ Elisa Weiss, PhD, Nan Xue, PhD 

Montefiore Family Care Center ‐ Elisabeth Ihler, MDMorris Heights Health Center ‐ Alison Maling, LCSW 

Urban Health Plan ‐ Alejandra Morales, PsyDNYCRING – Claudia Lechuga, MPHBronxWorks ‐ John Weed, LMSW

Good Shepherd Services ‐ Ellen O’Hara‐Cicero, LCSWGeisel School of Medicine at Dartmouth University – Allen Dietrich, MD

Grant  IH‐12‐11‐4522  (PCM3‐MH)1 P30‐HS‐021667

N2 PBRN: NYCRING

• The New York City Research and Improvement Networking Group is a partnership of thirty‐five practices 

• Exclusively focuses on the urban underserved

• NYCRING provides visits to over 600,000 low income, minority primary care patients

• Access to research, data, clinical and administrative resources made available through the Albert Einstein College of Medicine and Montefiore Medical Center

www.nycring.org

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18

Bronx Partners Bronx Partners1  Montefiore 

Family Care Center

2 Morris Heights Health Center

3  Urban Health Plan

4 BronxWorks

5  Good Shepherd Services

6  Albert Einstein College of Medicine

Goals and Objectives• To determine whether addressing and reducing depression are necessary steps to increase rates of cancer screening among low‐income depressed women ages 50‐64 across     3 Bronx health centers

• We implemented a CER/PCOR study comparing the effectiveness of two year‐long interventions for: – 756 women ages 50‐64 – screen positive for depression (PHQ‐9 > 8)– have not completed recommended screenings for 

cervical, breast, and/or colorectal cancer

• Comparing the Effectiveness of: 1) Collaborative Care Intervention (CCI) that addresses Depression and 

Cancer Screening needs simultaneously2) Prevention Care Management (PCM) Patient Navigation Cancer    

Screening Intervention

Prevention Care Management – PCM(Comparison Arm)

• In the PCM condition, the Care Manager will focus on cancer screening, providing

– Education

– Patient navigation

– Motivational support to overcome screening barriers and form favorable attitudes towards screening

• Patients in the PCM condition will be referred to their primary care clinicians for their depression, if they are not in treatment 

CDN Online Tools: Staff Intervention Training Resources at NCI/SAMHSA Cancer Control Planet RTIPS

http://rtips.cancer.gov/rtips

http://rtips.cancer.gov/rtips/viewProduct.do?viewMode=product&productId=295815

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Collaborative Care Intervention (CCI)

• Collaborative Care Intervention facilitates decision‐making and action to engage in screening AND reduce depression.  A Care Manager (CM) will:– educate patients about cancer screening and 

depression;– provide patient navigation to improve access to 

and use of cancer screening services, and connect patients to outside services

– provide depression care management and motivational support (includes addressing barriers) for self‐care with respect to screening, depression, and other conditionsand

– act as a critical link between primary care, mental health care provider, and the patients, helping to develop and implement a treatment plan

Three Component Model (TCM)

http://prevention.mt.gov/suicideprevention/13macarthurtoolkit.pdf

CDN Online Tools:Clinician Training Resources (CME)

www.CDNetwork.org

WWW.CDNetwork.orgCME accredited through AAFP

Screening Outcomes

75

12 months: Up-to-DatePap, mammogram

1 Year HFOBT5 Years: Sigmoid10 Years: Colonoscopy

By Electronic Health Records

PCM3

(2012-2015)

PCM1

18 months: Up-to-DatePap, mammogram

1 Year HFOBT5 Years: Sigmoid10 Years: Colonoscopy

By Chart Review

8 months: Up-to-Date Pap, mammogram

1 Year HFOBT5 Years: SigmoidBarium Enema10 Years: Colonoscopy

By MMCO Claims Data

PCMT

18 months: Up-to-DatePap, mammogram

1 Year HFOBT5 Years: SigmoidBarium Enema10 Years: Colonoscopy

By MMCO Claims Data

PCM2

Dissemination &Implementation

Efficacy

Effectiveness

Pragmatic Clinical Trial:All EHR‐based Cancer Screening, Mental Health, 

Treatment Data, Process and Outcomes Measures 

– Past history of medication use for mental health

– Past history of psychotherapy

– Present medication use (names and reported side effects)

– Barriers to medication or psychtherapy use

– Present psychotherapy/counseling and frequency

– Initiation of medication or psychotherapy while enrolled

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Results and Lessons LearnedResults

• Both FQHCs and Community Based Organizations (CBOs) arenow significantly engaged in project implementation activities

• Key facilitators to study implementation include presence of astudy champion, a robust Electronic Health Record (EHR)system and a multi‐disciplinary team

• Challenges include bureaucratic systems that slow the hiringof study staff, competing priorities and lack of a central IRB

Conclusions

• This study is designed to increase our understanding ofintegrating mental health and cancer screening in primarycare, and how to best support this population in makingscreening decisions

CONCLUSIONSPrevention Care Management (PCM) intervention

1. Addresses multi‐level barriers to screening

2. Effective at increasing CRC screening rates

3. Impact is greater for the Latina population

4. Can be translated and implemented successfully across a wide range ofclinical settings in medically underserved communities

5. Is robust and transferable across CHC, DTC and MMCO settings

6. Is an important strategy to be implemented in primary care systems tobe effective and sustainable

7. May need to add CCI components added to address depression andother mental health, but care management framework may enhanceoutcomes for both mental health and cancer screening

78

Policy Implications

1. CHCs, DTCs, PCPs and other primary care practices withlarge numbers of Spanish speaking patients can benefitfrom the PCM intervention

2. PCM is an innovative and effective strategy that can beimplemented in MCOs, ACOs, and PCMHs to enhanceCRC screening rates and reduce cancer health disparities

3. PCM is transferrable and can be adapted into cancerearly detection Quality Improvement (QI) Initiatives

4. PCM can be generalized to address mental health needsof underserved populations ?

79

Examples

CDN  N2

Case Presentations of CDN & N2‐PBRN Studies • Prevention Care Management for Cancer Early Detection (NCI, AHRQ, PCORI)

• CA‐MRSA Project (NCATS, AHRQ, ?PCORI)

www.CDNetwork.orgwww.CDNetwork.org

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21

The Rockefeller University Center for Clinical and Translational Science 

Clinical Directors Network CHC Partnership 

Conducting CER/PCOR with Embedded Mechanistic Studies

Supported in part by grant # UL1 TR000043 from the National Center for Advancing Translational Sciences (NCATS, National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program

Translational Science

Public Health

Impact

ComparativeEffectiveness

Research(CER) /PatientCentered

OutcomesResearch(PCOR)

DisseminationandImplementation

Research

EffectivenessResearch

EfficacyResearch

Pre‐Clinical/PhaseI&IIResearch

EmbeddedMechanisticStudies

A collaboration among:

The Rockefeller University Center for Clinical & Translational Science (CCTS)

Clinical Directors Network (CDN) 

Community Health Centers (CHCs) 

The Community-Associated Methicillin-Resistant Staphylococcus aureus (CA-MRSA) Project (CAMP):

Establishing a CA-MRSA Surveillance Network

Funded by The Rockefeller University Center for Clinical and Translational Science (CCTS) Pilot Grants and  an 

NIH Administrative Supplement(NIH‐NCATS Grant #8 UL1 TR000043) and AHRQ Grant # P30 HS 021667

BRONX

CA‐MRSA Project TeamRockefeller‐Clinical Directors Network‐Community Health 

Centers

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22

Dentist3%

Pediatrician16%

Internist20%

Family physician

9%Podiatrician

1%Obstetricia

ns & Gynecologi

sts3%

Optometrist1%

Nutritionist1%

Nurse practitioner

26%

School Health Nurse

5%

Physician Assistant

4%

Medical Assistant

4%Other7%

CHC CME Attendees

Stakeholder Engagement and Study DesignStudy Start‐Up:

1. Continuing Medical Education (CME) accredited sessions: 5 CHCs; 72 attendees

Elements:

• Active discussions between scientists & healthcare providers

• Agreed incision & drainage of infection site is a simple & effective treatment

• Emphasized importance of community hygiene

Challenges recognized: 

• Tracking infected patients

• Therapy commonly used for CA‐MRSA in a CHC setting

2. EHR Extraction of Prevalence data (2008 – 2010):

Cumulative # Diagnoses (2008-2010) from 3 CHCs

Diagnosis ICD-9-CM code TotalUrban Health

PlanOpen Door Family

Health CenterHudson River Health Care

Inflammatory Disease of Breast 611 373 139 130 104Carbuncle and furuncle 680 18 18 0 0Cellulitis and abscess of finger and toe 681 77 77 0 0Cellulitis/abscess 682.8 31 0 0 31Impetigo 684 791 0 487 304Infection of skin/subcutaneous NOS 686.9 267 110 45 112Folliculitis 704.8 642 0 320 322Hydaradenitis 705.83 333 208 50 75Other skin and soft tissue infections 683 (acute lymphadenitis), 686

(pyoderma),728 (myosistis), 771.4 (omphalitis of the newborn), 771.5 (neonatal infective mastitis) 88 1 0 87

Total 2620 553 1032 1035Average # per Year 873 184 344 345Average # per Month 73 15 29 29Average # over 6 Months 437 92 172 17350% Consent / recruitment 218 46 86 86

Stakeholder Engagement and Study Design

Workflow Exercise Worksheet

Inclusion Criteria

•The patient presents with signs and symptoms of a SSTI

•7 to 70 years of age

•Fluent in English or Spanish

•Plans to receive care in this community health center during the next year

Exclusion Criteria

•The patient is unwilling to provide informed consent

•The patient is acutely sick (for example, crying, wheezing, bleeding, screaming or shaken) and unable to participate in a discussion about the study

•The patient is unable to understand the information shared about the study

CAMP Results

Lesion Location (n=152)

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Laboratory/Microbiological Results:S. aureus clones (n=129)

• 54 MRSA isolates ( 36 wounds + 18 colonization sites)

– 42 MRSA isolates ST8-USA 300 (28 wounds + 14 colonization sites)– 3 MRSA isolates ST30-USA 1100 “SouthWest Pacific clone” (2 wounds + 1

colonization site)– 2 MRSA isolates ST8-NY cloneV (2 colonization site)– 1 MRSA isolate ST5-USA 100 “NewYork/Japan clone” (1 wound)– 1 MRSA isolate ST 72 (1 wound)– 5 MRSA isolates to be typed

• 37 MSSA isolates ( 17 wounds + 20 colonization sites)

– 7 MSSA isolates ST8-USA 300 (4 wounds + 3 colonization sites)

– 8 MSSA isolates ST30-USA 1100 “SouthWest Pacific clone” (4 wounds + 4 colonization sites)

– 2 MSSA isolates ST8-NY cloneV (1 wound + 1 colonization site)

– 4 MSSA isolates ST5-USA 100 “NewYork/Japan clone” (2 wounds + 2 colonization sites)

– 7 MSSA isolates ST15 (2 wounds + 5 colonization sites)– 2 MSSA isolates ST121 (1 wound + 1 colonization site)– 1 MSSA isolate USA 400 (1 colonization site)– 1 MSSA isolate to be typed

1.00E+00

1.00E+01

1.00E+02

1.00E+03

1.00E+04

1.00E+05

1.00E+06

1.00E+07

1.00E+08

1.00E+09

1.00E+10

0 0.75 1.5 3 6 12.5 25 50 100 200 400 800

CF

U/m

l

Oxacillin (µg/ml)

UHP/CAMP-016-wound-homo*

UHP/CAMP-016-w

UHP-16-w-homo*1

UHP-16-w-homo*2

UHP-16-w-homo*3

UHP-16-w-homo*4

UHP-16-w-homo*5

UHP-16-w-homo*6

UHP-16-w-homo*7

UHP-16-w-homo*8

UHP-16-w-homo*9

UHP-16-w-homo*10 1.00E+00

1.00E+01

1.00E+02

1.00E+03

1.00E+04

1.00E+05

1.00E+06

1.00E+07

1.00E+08

1.00E+09

1.00E+10

1.00E+11

0 0.75 1.5 3 6 12.5 25 50 100 200 400 800

CFU

/ml

Oxacillin (µg/ml)

UHP/CAMP-016-nasal-homo*

UHP/CAMP-016-n

UHP-016-n-homo*1

UHP-016-n-homo*2

UHP-016-n-homo*3

UHP-016-n-homo*4

UHP-016-n-homo*5

UHP-016-n-homo*6

UHP-016-n-homo*7

UHP-016-n-homo*8

UHP-016-n-homo*9

UHP-016-n-homo*10

Wound and colonizing isolates share identical phenotypes of heterogeneous beta-lactam resistance

UHP/CAMP-016— wound

UHP/CAMP-016— nasal USA 300

spa type MLST mecA SCCmec pvl ACME

Wound t008 ST 8 + IVa + type I

Nasal t008 ST 8 + IVa + type I

Treatment and Recurrence of Staph aureus cases (n=75)

Retrospective Recurrence: History of SSTIs /MRSA before enrollmentT1: Recurrent Infection

T1: Received treatment of this lesion from other doctors before

T3: Previously documented MRSA infection or colonization

Fisher’s Exact Test:P= 2.206E‐04p‐value = 0.0040 

Prospective Recurrence: Subsequent incident of SSTIs/MRSA after enrollment T3: Re‐occurring complaint of SSTI at more recent primary care visit

Hospital‐Acquired MRSA (HA‐MRSA) Pilot Project:Expanding the CA‐MRSA Surveillance Network

Goals:

• To study the clinical and microbiological characteristics of HA‐MRSA in the same communities as the CHCs, in order to allow for simultaneous phenotypic and genotypic comparisons of both HA‐MRSA and CA‐MRSA clones

• To understand the increasing occurrence of CA‐MRSA strains in nosocomial settings and HA‐MRSA strains appearing in individuals who are not exposed to hospitals

Method:

To engage and recruit two hospitals in the Greater New York Metropolitan Area to enroll in‐patient (HA‐MRSA) and out‐patient (CA‐MRSA) patients for clinical and microbiological analyses, and expand our CA‐MRSA Surveillance Network to a wider range of healthcare providers

Participating Hospitals: 1) Lincoln Medical Center, Bronx, NY2) Lutheran Medical Center, Brooklyn, NY

Cases of Community-Acquired MRSA (CA-MRSA) Among Immigrants Seen in

NYC Community Health Centers

Presented at the 13th

Conference of the 

International Society of Travel 

Medicine,May 19‐23, 

2013, Maastricht, The Netherlands, with special recognition during the Poster Tour Session on Returning Travelers.

Presented by: Nancy Jenks, FNPDirector of Internal MedicineHudson River Community Health

Recurrent Furunculosis in a Community-Acquired S. aureus

Infection Caused by a Strain Belonging to the USA300 Clone of MRSA

Presented at SCTS Translational Science Conference 2013, April 17‐19, Washington, DC by:

• Shirish Balachandra, MD

Section Head, Walk‐In Dept.

Urban Health Plan, Inc.

• Maria Pardos de la Gandara, MD, PhD

Postdoctoral Associate

Laboratory of Microbiology and Infectious Diseases

The Rockefeller University

CAMP Dissemination

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Recurrent Furunculosis in a Community-Acquired S. aureus

Infection Caused by a Strain Belonging to the USA300 Clone of MRSA

Presented at SCTS Translational Science Conference 2013, (Washington, DC) by:

• Shirish Balachandra, MD

Section Head, Walk‐In Dept.

Urban Health Plan, Inc.

• Maria Pardos de la Gandara, MD, PhD

Postdoctoral Associate

Laboratory of Microbiology and Infectious Diseases

The Rockefeller University

CAMP Dissemination

• Previous studies have shown the receptiveness of male barbershop owners, employees, and patrons to learning more about disease prevention  and occupational safety and health

• SSTIs/lesions are often observed on face, scalp, head, neck, arms, hands 

• About 20% of CAMP participants’ lesions presented in these locations

• Barbers and their clients were highly receptive to inquiries and information about MRSA

• Barbers welcome an in‐depth public health education in the barbershop setting

Community-Engaged Research Pilot Project:Expanding the Study of SSTIs/CA-MRSA To Barbershops and Beauty Salons in NYC

Key: Barberhop

Unisex Beauty Salon

Nail Salon

Hair Braiding

Eyebrow Threading

Waxing

Cosmetics

Infection Prevention Knowledge: Paired T‐Test (p‐value)Baseline to T1: 2.59  (0.0135)Baseline to T2: 4.12 (0.0003)

MRSA Knowledge: Paired T‐Test (p‐value)Baseline to T1: 6.81 (<.0001)Baseline to T2: 6.25 (<.0001)

N2 PBRN: Network of Networks

Community Health CentersHospitals

Clinical Directors Network(CDN)

+ +

Access Community Health Network

(ACCESS)

+

Hudson River

Health Care

Urban Health Plan

Brookdale Family Care

Center

Open Door Family Health Center

Manhattan’s Physician

Group 95th

Street

Manhattan’s Physician

Group 125th

Street

Lutheran Family Health Centers

(LFHCs)Incubator PBRN

Park Slope LFHC

Family Physician

LFHC

Kling Adult Medicine

Madison Family Health

South Texas Ambulatory Research Network

(STARNet)

Trevino Family Clinic

University Health System

4 PBRNs

12 CHCs

159 Patients

318 Specimens

Funded in part by AHRQ Grant: P30 HS 021667

PBRN PilotCAMP

Rockefeller/Tomasz Lab 

for Molecular EPI & Whole Genome Seq

Local Clinical Labs

(Culture & Sensitivity)(+) MRSA & 

MSSA

Incision/ Drainage Specimens & Nasal Specimens

BioReference Labs (Culture & Sensitivity) (Antibiograms)                    (Purified Sub‐Cultures)

CAMP 

• Protocol• Consent

oEnglishoSpanish

•Methods•Database•Ontology• BiospecimenRepository

CDN PBRN2

CDN (New York)

PBRN PilotCAMP

Rockefeller/Tomasz Lab 

for Molecular EPI & Whole Genome Seq

Local Clinical Labs (Culture & Sensitivity)

(+) MRSA & 

MSSA

Incision/ Drainage Specimens & Nasal 

Specimens

BioReference Labs (Culture & Sensitivity) 

(Antibiograms)                    (Purified Sub‐Cultures)

SPECIMENSn=318

PATIENTSn=159

CHCsn=12

PBRNsn=4

StarNet

(Texas)

ACCESS

(Chicago)

CHC

LFHC(Family 

Physician)

n=0

CHC

LFHC(Park Slope)

n=8

CHC

University Health System

n=7

CHC

Treviño Family Clinic

n=8

CHC

Madison Adult 

Medicine

n=0

CHC

Kling Adult Medicine

n=0

LFHC*

(New York)CHC

Brooklyn Family Care Center

n=2

CHC

Open Door Family Health Centern=23

CHC

Manhattan’s Physician 

Group 95 St.

n=6

CHC

Manhattan’s Physician 

Group 125 St.

n=14

CHC

Hudson River Health Care

n=34

CHC

Urban Health Plan

n=50

*Incubator PBRN

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N2 PBRN: STARNetSan Antonio TX

• The South Texas Ambulatory Research Network is composed of small group practices or solo clinicians. 

• Members are primary care physicians, clinical staff, medical students who provide service for patients from the San Antonio area to the Lower Rio Grande Valley and Corpus Christi communities.  

https://iims.uthscsa.edu/STARNet/home

N2 PBRN: Access Community HealthCHICAGO IL

• Composed of 40 health centers that provide preventive care, chronic disease management, and support services to underserved communities

• Advance a continuum of care by partnering healthcare providers with outreach staff, case managers, social workers, and substance abuse counselors

• Largest provider of primary care for Medicaid beneficiaries in Illinois 

http://www.accesscommunityhealth.net/

N2 PBRN: Lutheran Family Health Centers Network

BROOKLYN NY (incubator PBRN)• The Lutheran Family Health Centers (LFHC) network provides high 

quality, affordable outpatient primary health care and support services close to home. 

• As one of the largest Federally Qualified Health Center (FQHC) networks in the nation, LFHC includes 9 primary care sites, 28 school based health/dental clinics and numerous social support services. With approximately 86,000 patients, the LFHC network handles nearly 530,000 visits annually

https://www.lutheranhealthcare.org

CAMP Town Halls & Focus Groups:

• Patients:  Responses from the RPPS patient focus group indicated that many patients participated in the CAMP study in order to contribute to knowledge about CA‐MRSA transmission and recurrence. Outcomes that patients were most concerned about include: recurrence, pain and inability to work.

• Clinicians: “[It is assumed that] colonization is ongoing, because we’ve had patients return with recurrent infections. …If you just use systemic antibiotics, the nasal colonization persists. Another question to consider is if the source is in the house. We can take all measures to decolonize the person but if the infection is still in the house (pet, towel, sheets, etc), then it’s a huge factor.” –Dr. Balachandra

• Laboratory Investigators: “Does the MRSA recurrent phenotype reflect a single or multiple genotypes?

• Clinical Investigators: 31% of MRSA+ wounds and 28% of MSSA+ wounds are recurrent

Qualitative Findings Demonstrated Convergence of CER/PCOR Interests

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To compare outcomes, for patients presenting with SSTIs and diagnosed with CA‐MRSA, randomized to one of two interventions:

[1] Standard CDC‐Guidelines Directed Usual Care, including incision, drainage, and oral antibiotics

[2] CDC‐Guidelines‐directed Usual Care combined with interventions conducted in the home setting to reduce re‐infection and transmission to family/household members

Pragmatic Clinical Trial Infrastructure (PCTi) Use Case: CA‐MRSA RECURRENCE PREVENTION CER/PCOR Study

•Principal Investigator, Patient Centered Outcomes Research Institute (PCORI) “Patient-centered CER Study of Home-based Interventions to Prevent CA-MRSA Infection Recur

Patient Centered Outcomes Research Institute (PCORI) “Patient-centered CER Study of Home-based Interventions to Prevent CA-MRSA Infection Recurrence (CAMP-2)” (PI: Jonathan N. Tobin, PhD, Clinical Directors Network, Inc. (CDN) and The Rockefeller University) (PCORI Grant No. CER-1402-10800)

Team Grant‐writing TasksEach Team consisted of:

– CHC Clinician

– Rockefeller Investigator

– CDN PBRN Staff Member

Group Discussion (30 minutes)

– Brainstorming and writing

– Discussion, Review

– Editing

– References added by CDN Staff

Task One: Home Assessment1. Community Health Worker 

Training Module2. Identifying Household 

Members3. Approach and Consent4. Conducting Patient Education

Task Two: Home Intervention1. Administering Questionnaire2. Self‐Sampling for CA‐MRSA    

Carriage3. Environmental Sampling for 

MRSA Contamination4. Specimen Transport

CAMP2 Specific Aims & Logic Model

Aim 1: To evaluate the comparative effectiveness of a CHW/Promotora-delivered home intervention(Experimental Group) as compared to Usual Care (Control Group) on the primary patient-centeredand clinical outcome (SSTI recurrence rates) and secondary patient-centered and clinical outcomes (pain, depression, quality of life,care satisfaction) using a two-arm randomized controlled trial (RCT).Aim 2: To understand the patient-level factors (CA-MRSA infection prevention knowledge, self-efficacy, decision-making autonomy,prevention behaviors/adherence) and environmental-level factors (household surface contamination, household membercolonization, transmission to household members) that are associated with differences in SSTI recurrence rates.Aim 3: To understand interactions of the intervention with bacterial genotypic and phenotypic variables on decontamination,decolonization, SSTI recurrence, and household transmission.Aim 4 [Exploratory]: To explore the evolution of stakeholder engagement and interactions among patients and other communitystakeholders with practicing community-based clinicians and academic laboratory and clinical investigators over the duration of thestudy period.

CDN  N2 PCORnet

CDN PBRN & N2 ‐PBRN• Adaptation of Existing Templates• Models of Stakeholder Engagement

– Communities– Clinicians– Patients– Researchers– Policy‐makers

• Scalability

www.CDNetwork.orgwww.CDNetwork.org

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Reach

CDN N2 NYC‐CDRN PCORnet

Efficacy

EffectivenessDissemination & Implementation Scale‐Up Sustainability

Effectiveness Dissemination & Implementation

Scale‐Up

Building a Learning Healthcare System RequiresDesigning Studies with these Principles:

• Analyzing, reviewing & providing feed‐back of EHR data to practices and clinicians at multiple levels:

– patient

– clinician 

– practice

• Disseminating and implementing research on evidence‐based (EB)/effective interventions and best practices

• Linking routine workflow with EB‐interventions

• Carrying this out within each clinical practice nested within multiple Healthcare Systems

• Aligning incentives

NYC‐CDRN Key Collaborators

Health Systems

• Clinical Directors Network (CDN)

• Columbia/P&S

• Montefiore/Einstein

• Mount Sinai/Icahn

• New York‐Presbyterian 

• NYU/Langone

• Weill Cornell (Lead Organization)

Key Scientific/Technical Partners

• The Rockefeller University Hospital• NY Genome Center (NYGC)

• Biomedical Research Alliance of NY (BRANY)

• HealthIX• Bronx RHIO (BRIC)

Clinical Research Data

• Demographics

• Diagnoses

• Procedures

• Medications

• Test Results (Labs, Radiologic Scans)

• Health Insurance Claims

• Omics

• Patient‐Reported Outcomes

PI:

Co-PI:

Co-PI:

Rainu Kaushal, MD MPH Weill Cornell Medical CollegeJonathan N. Tobin, PhD CDN/Rockefeller UniversityGeorge Hripcsak, MD MS Columbia University

108PCORnet Organizational Structure

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Source: “Introducing PCORnet: The National Patient-Centered Clinical Research Network,” http://pcornet.org/resource-center/other-resources/

Successful PBRNs = Power of ConnectivityImplications for Clinical Care, Teaching, 

Research & Public Health

• Acceleration of study conduct and  implementation of results

• Integration of all activities across the full translational research spectrum

• Development of high performing workforce, including • new types of clinician‐investigators who spend most of their career 

seeing patients in practice‐based settings

• carrying out research in practice‐based settings 

• engaging clinicians as investigators who design, conduct, analyze, disseminate and implement studies

• Real‐time flow of data and information extracted from care settings used for population health planning and evaluation, as well as individual patient treatment  

• Increasing patient engagement in decision‐making and governance

Each dot (node) represents one individual and the line (edge) between them represents a connection between those individuals. The darknessof the edges between nodes indicates a stronger connection between the two nodes. The strongest connections between individuals areclustered in the center of the graph, and include stakeholders representing The Rockefeller University, CDN and the CHCs. This networkvisualization includes data from a period of three years, and represents the cumulative total of opportunities for the network of stakeholdersto build connections to each other (since interim communications, such as those via small‐group face‐to‐face, telephone and email are notrepresented, the densities may actually underestimate the level of connectivity across stakeholders).

Exploring the Use of Social Network Analysis to Measure Stakeholder Engagement: CAMP Team Connectivity CDN eLearning

• CDN weekly listserv course announcements reaches 

25,135 Clinicians, Clinical Researchers and Healthcare Policy‐makers

• As of February 2015:

– 815 Webcasts

– 640 Hours of CME/CDE

CECH/CESW Credits awarded

– 30,110 Total Participants• 20,200 Live Participants

• 9,910 Library Participants

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Summary:Learning Healthcare Initiatives

Why Efforts are Working• Strong Academic-PBRN Partnerships• Strong Community-PBRN Partnerships• Strong PBRN-PBRN Partnerships

Keys to Success • Diverse topic offerings• Protocol specific topic offerings• Offer timely, relevant Continuing Education (CME, CNE, CDE, CECH, CESW)

Key Barriers • Clinical demands/productivity protected time• Competing Priorities (JCAHO, PCMH, MU, ACO)• ACA Uncertainties • Lack of clear linkage between QI & Research

Summary: Participating in PBRNs and Learning Healthcare Initiatives

Enhances Retention and Recruitment Professional Development Training and Education Role Diversification Job Satisfaction

Improves Clinical Skills Clinical Guidelines and Best Practices Adoption Clinical Quality

Decreases Implementation Time Stress & Burnout

Jonathan N. Tobin, Ph.D.

President/CEOCLINICAL DIRECTORS NETWORK, INC. (CDN)

Co‐Director for Community Engaged Research & Adjunct ProfessorAllen and Frances Adler Laboratory of Blood and Vascular Biology 

Center for Clinical and Translational ScienceTHE ROCKEFELLER UNIVERSITY

Professor, Department of Epidemiology & Population HealthALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY

Clinical Directors Network (CDN)5 West 37th Street, 10th FloorNew York, NY 10018 USA

TEL 212‐382‐0699 ext. 234FAX 212‐382‐0669

[email protected]

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