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Applying Research in a Practice-Based Environment

Lillian Gelberg, MD, MSPHUCLA Dept. Family Medicine, School of Public

Health

Presented at: 2010 National Health Care for the Homeless Conference &

Policy Symposium, Pre-Conference Institute:Conducting Practice-Based Health Care for The Homeless

Research: Implications for Health Practice, Policy and Advocacy

June 2, 2010HCH PBR Experience 2010.06.01

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Practice-Based Research• Hepatitis B and C Among Homeless Adults (NIDA/CDC)• Primary Care HCV Tx Program for Homeless (CSP)• Hepatitis B & C NIDA/CDC among Health Care for the Homeless Program

Patients (BPHC & HCH Clinicians’ Network)• Improving Health Habits in Impoverished Populations (NIH/ NCI & NIDDK)• Preventing Drug Use in Low Income Clinic Populations (NIDA)• SELPH: Study of End of Life Planning for Homeless Persons (NINR)• OpenMRS in LA• Improving Access to Effective Contraception by Homeless Women (1st Official HCH

PBRN Study) (Saver, Weinreb, Gelberg)

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NIDA/CDC Hepatitis B and C Among Homeless Adults (2001-2005)

• Research Question Is hepatitis C an epidemic among homeless persons?

• Project – Community – based probability survey of 541 homeless

adults in 41 shelters and meal programs in Skid Row– Face-to-face computer assisted personal interviews,

blood draw, pre and post test counseling• Results

– More than ¼ of homeless were HCV+– Most HCV+s were not aware of being HCV+, and have

not been tested, counseled, or treated for HCV

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NIDA Hepatitis Study: CDC Supplements

• HBV, HCV, and HIV Medical Follow-Up Care among Homeless Adults– Infection positive respondents referred to one of our 3

community health center partners– One month follow-up telephone interviews– Medical record reviews

• Hepatitis Vaccination in Homeless Adults– HBV negative respondents referred to one of our three

community health center partners for HBV vaccination– Free Twinrix (HBV + HAV) vaccination– Medical record reviews

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Hepatitis B and CHepatitis B and CAmong Clients ofAmong Clients of

Health Care for the Homeless Health Care for the Homeless ClinicsClinics

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Partnership• Bureau of Primary Health Care, funder of the study• Hepatitis C Task Force, HCHCN• University Collaborators• Collaborative process to design and oversee this

study from its inception, including development of:– Fieldwork protocol– Data collection instruments– Data analysis– Manuscripts / presentations

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Why Hepatitis B & C as the Topic?

• Met at a conference• Wanted to work together• Discussed priority areas in common for

research, practice, and policy• Hepatitis emerged as the leading issue

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Hepatitis C Task ForceHCH Clinicians’ Network

• Ed Farrell, MD (Chair), Stout Street Clinic, Denver• Aaron Strehlow, RN PhD FNP-C (Chair), UCLA/Union Rescue Mission• Lillian Gelberg, MD, MSPH , UCLA, Principal Investigator• Lisa Arangua, MPP, UCLA• Adele O’Sullivan, MD, Maricopa County DPH• Marjorie Robertson, PhD, Alcohol Research Group, Berkeley (Co-Principal

Investigator)• Catherine Rongey, UCLA, VA-SF (joined team during data analysis phase

as a fellow and then junior faculty)• Amy M. Taylor, MD, Bureau of Primary Health Care• Suzanne Zerger, MA, National HCH Council, Project Director

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AIMS• To describe the prevalence of hepatitis B (HBV) and

hepatitis C (HCV) among homeless clients in eight HCH clinics

• To describe the level of “hidden” infection in this high risk group

• To assess basic knowledge about HBV and HCV risk factors.• To document risk behaviors and risk groups for HBV and

HCV.By documenting prevalence and risk behaviors for HBV and HCV exposure, we hope to inform future interventions that will reduce the rates and consequences of these infections in this high risk population.

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Selection of HCH Study Clinics

• Lead clinicians from the HCH Hepatitis C Task Force – Volunteered their clinics as study sites– Agreed to lead its onsite data collection

• Additional clinics were recruited for geographic distribution– All eight clinics were in urban settings– Although the clinics were not randomly selected, they were

distributed among regions across the United States• A $500 incentive was provided to each participating

clinic to partially offset staff time

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The Lead Clinicians and Their Clinics

• Albuquerque, NMAlbuquerque HCH, Inc.

Sarah Langwell PA-C• Birmingham, AL

HCH Coalition IncZakir Khan, MD

• Denver, COColorado Coalition for Homeless, Stout St. Clinic

Ed Farrell, MD• Des Moines, IA

Primary Heath Care, Inc.Lorna Hines, CMA

• Los Angeles, CAUnion Rescue MissionAaron Strehlow RN PhD

• Milwaukee, WISt. Ben’s Clinic, St. Mary’s HospitalCarol Sejda MN APNR RN

• Phoenix, AZMaricopa County DPH

Adele O’Sullivan MD• Providence, RI

Crossroads Rhode IslandLinda M. Dziobek, BA, RN

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Human Subjects Protection• Who would serve as the IRB for 8 clinics and 2

Universities?– All agreed to have UCLA as the IRB for each site and investigator– UCLA had to agree to serve as the IRB for each clinic site– Individual clinics’ IRB review (if clinic org had own IRB)

• UCLA IRB served as the multiple project assurance agency that approved the study

• Federal Office of Management and Budget, also reviewed and approved the study, since funded by BPHC

• IRB certification obtained– All research and clinic personnel involved in the study completed

an online University of California Los Angeles (UCLA) institutional review board (IRB) course in protection of human subjects

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Human Subjects Protection

• IRB process was complicated and lengthy– Very long process (>1 year)– Vulnerable population– Sensitive issues: Drug use, prison history,

homelessness– Review by multiple IRBs and OMB

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Pilot Work• Pilots

– Study protocols were piloted at three sites to further refine study forms and procedures.

• Tailoring of Protocol to Each Site– Researchers and HCH project staff worked with clinical

teams at each clinic to tailor the standard research protocol to each site.

– Each clinical team piloted data collection and fieldwork protocols at their own sites.

• Training– Training in laboratory procedures was similarly carried out

between the lead clinicians, Project Director– Project coordinator from the laboratory met with individual

sites to discuss lab protocol including blood testing, storage and mailing procedures.

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Support of Clinical Data Collection Teams

• Support– During the data collection period, the HCH

Project Director and the researchers were available on-call throughout the data collection process to address emerging issues and concerns

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Method: Sample Selection • Target Population

– 400 homeless adult clients from eight HCH clinics– 50 patients from each clinic

• Sample– Convenience sample of eight clinics (volunteers)– Systematic random sample of clients within each clinic (sampled

from intake logs, random start, for example, sampling every 5 th client for example)

– Screened for eligibility– Selection criteria

• Age 18+• Previous night in shelter or on “streets” (federal def literal homeless)• English or Spanish speaking

– September, 2003 through July, 2004

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Fieldwork:Overseen by Lead Clinician

• Initial Contact • Structured interview, 20 minutes• Pretest counseling • Blood draw

– One tube for HBV, HCV, liver function– One tube (if volunteered) for storage

• $10 Incentive• Invitation to return for results

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Fieldwork

• Second Contact– Notification of hepatitis and LFT results– Post-test counseling– Referrals for local medical care– e.g. HBV vaccination if indicated, monitoring, etc.– No cash-value incentive for return

• Medical Record Review– Charts were reviewed within 90 days by Lead

Clinician

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Data Transfer

• Interviews mailed to HCHCN Project Director for data entry, cleaning and analysis

• Blood test results mailed by laboratory to the HCHCN Project Director

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Role of Lead Clinician• The lead clinician (nurse practitioner or physician) for

each clinic completed the data collection as part of the regular medical visit.

• Clients were invited to return in about two weeks for test results.

• Any appropriate follow-up care due to blood tests was integrated into their usual medical care at the clinic with the clinician. – i.e. further evaluation and assessment for treatment,

immunizations, harm-reduction counseling.

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Primary Care HCV Tx Program for Homeless Persons (2007-2010)

• Research Question: Since virtually no homeless person in Skid Row had been treated for HCV, would they be able to comply with the grueling treatment regiment?

• Goal: – Virtually no HCV+ homeless persons in Skid Row had ever

received HCV treatment– Design an accessible, feasible, sustainable and replicable model

for treating Hepatitis C among the homeless using community based participatory principles

• Team– Catherine Rongey, MD (fellow)– Lillian Gelberg, MD, MSPH (faculty mentor)– Paul Gregerson, MD, MBA (HCH-JWCH Weingart Clinic)

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HCV Tx Program for Homeless (cont.)• Program Components

– Primary care physicians deliver treatment– Community partnership approach– Sheltered housing identified– Education and group self management– Toolkits developed to improve adherence

• Data Collection– Patients and Providers: semi-structured and structured interviews, pre-tx/ tx completion/ 6

months post tx– Medical record abstraction

• Results– 100% medication compliance

• Associated Outcomes– Several patients became peer Hepatitis C educators– 1 patient had his first art gallery opening– Several patients visited other shelters to educate administrators and patients about HCV

treatment

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Healthy Lifestyles (2007-2009)

• Research Question: What is the feasibility of a diet and exercise intervention that teaches low-income persons without any chronic conditions to stay healthy?

• Funders – NCI, NIDDK• Goal – Prevention of obesity and chronic disease• Practice-Based RCTs

– 200 homeless and low-income patients, largely Latino immigrants, in 4 community health centers and HCHP sites, randomized to usual care, or patient priority setting for health

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NIDA QUIT (2008-2011)• Research Question: Can we prevent substance abuse in primary

care settings, by identifying those with problem drug use, using screening, very/very/very brief intervention, referral and treatment

• Project: screen 10,000 patients, in 2 busy HCH community health centers, randomize 500 homeless and low-income patients with problem stimulant use, QUIT message from clinician, telephone drug reduction counseling (20 min x 2)

• Using novel information technology to support the patient in behavior change

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SELPH: Study of End of Life Planning for Homeless Persons

• PI: John Song, U of Minnesota (2007-2010)• Funder – NIH/ NINR• Partners – shelters, hospitals, EDs• RCT for advance care planning for homeless persons

found in community settings using an advanced care directive tailored to their needs

• Advance care directives added onto medical records in local hospitals and EDs

• Medical records to identify whether ACDs improved health care at end-of-life

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OpenMRS in LA• OpenMRS in LA is a multi-year pilot study that

examines the benefits of establishing a Health Information Exchange for the Skid Row area of Los Angeles.

• Skid Row Homeless Health Care Initiative– Lead Clinician, Paul Gregerson, MD, MBA– Partnership of >27 health and social service agencies to

improve health care and efficiency for homeless persons living in the Skid Row are of LA

– Decided key issue was IT• Invited University Partners to collaborate

– Josh Newman, MD; Lillian Gelberg, MD, MSPH• IT Task Force met many times over a year to decide on a

plan

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OpenMRS in LA (cont.)

• HIPAA lawyers worked the miracle of crossing the divide so that medical and social services could share information.– MOU, BAA– Annual renewal of consent to share data

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OpenMRS in LA (cont.)• Phase 1: OpenMRS as a TB registry and encounter management tool.• A unified encounter history that includes both medical and non-medical visits,

which serves to:– Provide data for epidemiological TB research– Provide required information for SSI benefit application

• Selected OpenMRS as the software vendor to drive the Health Information Exchange due to its extensibility and open-source (license-free) framework (completed) (developed for HIV clinics in Africa)

• Customized OpenMRS to store:– Demographic information– PPD and TB chest x-ray results – Encounter history– County medical record number

• Gathered feedback, monitored OpenMRS usage, and audited compliance at each agency

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Collaboration with WHI• UCLA Wireless Health Institute (WHI)

– Joint effort of medicine, nursing, public health, engineering, computer science, and other social science depts.

– To pursue clinical and economic efficacy of wireless remote intervention in the context of

– Improved patient self-management – Facilitating healthy lifestyle choices and environments that

can positively impact many preventable medical conditions– Improving coordination of health information– Providing low-cost methods of assisting low-income

populations and clinics to conduct health promotion and disease prevention activities

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Improving Access to Effective Contraception by Homeless Women

• 1st Official HCH PBRN study• Focus: Improving access to effective contraception for

homeless women. • Objective: To increase understanding of current knowledge,

practices, and capabilities of HCH practice sites regarding offering contraception to homeless women.

• Methods: Web-based survey of medical directors of the 31 sites of the HCH PBRN

• Team– HCH PBRN Steering Committee– University: Dr.’s Linda Weinreb, Barry Saver, Lillian Gelberg

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Contact Information• Lillian Gelberg, MD, MSPH• Professor of Family Medicine• Professor of Public Health• Department of Family Medicine

– David Geffen School of Medicine at UCLA– 50-071 CHS Box 951683– Los Angeles, CA 90095-1683– 310 794 6092– 310 794 6097 (fax)– LGelberg@mednet.ucla.edu

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EXTRA SLIDES

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Hepatitis B Virus (HBV)

• Hepatitis B is a common and potentially serious blood-borne infection.

• In the US, hepatitis B infection is:– mostly acquired by adults – primarily associated with high-risk behavior including

sexual contact (MSM, multiple sex partners, persons recently diagnosed with STIs) and injection drug use.

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Hepatitis C Virus (HCV)• Hepatitis C is a serious blood-borne infection• Persons infected with hepatitis C:

– are at high-risk for long-term health problems.– are potentially infectious to others

• HCV is a “Hidden” Infection– Few with HCV know they are infected because symptoms from

chronic hepatitis C are uncommon until liver failure manifests. – In addition, few medical facilities routinely screen for viral

hepatitis.• Based on recent work, homeless adults appear to be at high risk for

hepatitis C due to higher rates of injection and other risky drug use.

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Background• NIH’s /IOM national agenda for HBV/ HCV research

– Continued epidemiological monitoring and studies on the specific modes of transmission in minorities, low socioeconomic groups, and injection and intranasal drug users

– Early detection and treatment, along with educational efforts for high-risk and infected persons, are crucial elements of the national health agenda for preventing the spread and consequences of HBV/HCV

IOM, 2010, Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C

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Background

• Homeless– Prevalence of HCV among homeless adults is higher

than in gen pop 27-69% – Yet, know little known about HCV/ HBV among

homeless patients seen by HCHP clinics

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Sampling• Sample Goal

– Adult homeless patients– Recruitment Goal: 50 patients from each of 8 clinics– N = 400

• Sampling– Clients were systematically sampled with a random start– At the beginning of the clinic day, an intake staff person

selected clients from the appointment list or intake roster, for example, by sampling every fifth client

– Clients were screened for eligibility

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Screening: Eligibility Criteria• Age (18 and older)• Federal definition of literal homelessness

– "Literal homelessness" was based on one question about the place where the client had spent the previous night

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Recruitment & Enrollment• Enrollment

– Eligible clients were invited to complete an interview and blood tests for hepatitis B and C infection

– Lead clinicians obtained written informed consent to participate in the study

– Separate consent form authorized subsequent disclosure from the clients’ medical records about whether they returned for their respective test results.

• Recruitment– Lead clinicians continued recruitment over a number of days

until a sample size of 50 clients was completed for their clinic

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Completion Rate• Completion rates

– Varied by site from 92% to 100%• Interviews

– N = 396 completed interviews– 99% completion rate

• Blood draws– N = 387 completed blood draws– 98% completion rate, among those interviewed

• Return for notification of blood test result/post-test counseling, within 90 days– N = 113 – 38% completion rate (38%)

• Among the 300 medical records that were reviewed by the lead clinician

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Hepatitis C Seroprevalence

• Prevalence of Hepatitis C– Ever infected 31%*– Range by site 18%-

48%• “Hidden” Infection

– *Only 16% of the sample already knew they were HCV positive from a previous blood test.

– About half of the HCV infections were “hidden” or unknown to subjects, based on self-report.

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Hepatitis B Seroprevalence• Prevalence of Hepatitis B

• evidence of prior exposure 28%*

• currently infected 1%• Range by site 18%-48%• “Hidden” Infection

– Only 8% knew they were HBV positive from an earlier blood test– Three quarters of the HBV-infected adults were “hidden,” that is, their status was

unknown before our test.

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Data Collection, InitialSeptember, 2003 - July, 2004

• Interview– 20-minutes– Face-to-face– Conducted by the Lead Clinician or their designee

• Blood draw• Compensation

– $10 cash or cash-equivalent incentive for their participation in the interview, blood tests, and pre-test counseling for hepatitis B, and C

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Data Collection, Follow-up• Individual lab results were faxed back to respective

clinics and affixed to each client’s medical chart• Notification and Counseling

– Clients were scheduled for an appointment about two weeks later for notification of blood test results

– Depending on their HBV/HCV test results, returning clients received tailored post-test counseling

– The Task Force provided written pre- and post-test counseling guidelines as a resource for the clinics.

• Medical Record Review– Charts were reviewed within 90 days by Lead Clinician

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Interview• Domains

– Sociodemographic characteristics– Homelessness history– Health insurance status– Detailed medical, psychiatric and HCV-specific history

• Source of Measures– Instrument was adapted from a prior study involving homeless

and other indigent adults• Pilot tested for use with homeless population

– Additional items developed by the HCH task force to address specific concerns of clinic staff

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Blood TestsHCV

ELISA with RIBA confirmation (if signal/cutoff <3.8 per CDC)

HBVPositive hepatitis B surface antigen (marker for acute or chronic infection, HBsAg) or hepatitis B core antibody (marker of exposure that persists for life, anti HBc)

Liver enzymeALT

OTHER (stored blood, future tests)

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Blood Testing• HCV

– HCV antibody (ELISA)– RIBA confirmation if signal to cut-off ratio <3.8 (per

CDC/MMWR)• HBV

– HBV surface antigen– HBV core antibody – HBV surface antibody

• Liver Enzymes– ALT

• Consolidated Laboratory

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Ethical Dilemmas:Clinicians had dual roles

• Clinicians in the HCH health care clinics had dual roles: clinicians and research staff.

• Is it ethical for a clinician to recruit a client into research for which the clinician is also a primary researcher? What about coercion? True informed consent?

– During research interviews, clinicians felt obligated to record any medically relevant data in the client’s chart. How would this affect research guarantees of confidentiality for information shared during the research interview?

• Clients could authorize storage of a blood sample for future (unspecified) research.

– Theoretically, at least, individuals might be identifiable through DNA. How could researchers protect confidentiality of blood samples?

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FOCUS TODAY:PRELIMINARY FINDINGS

• Findings are based on 393 unduplicated subjects with completed interview and blood tests.

• More refined and complete findings will be presented in the near future.

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Demographic ProfileMale 75%

Age: Mean/Median 43years Range 20-72years

Education (median)12 yearsCompleted high school 69%

US Military veteran 16%

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Background•Sexual preference, current

–Heterosexual 90%

–Bisexual 5%

–Gay or Lesbian 5%

•Sexual behavior (ever)

•MSM 7%

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Background

• Prison, ever 37%

• Psychiatric hospitalization, ever 21%

• Transfusion before 1990 9%Blood or blood products

• Frequent heavy drinker 37%(4+ Drinks per occasion past month)

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History of Homelessness• Literally homeless previous night 97% • Age first homeless (since age 18, age 34

mean)

• Cumulative time homeless(since age 18, mean) 4 years

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Access to Health Care

• Today was first trip to clinic 35%• Any medical coverage 31%• Hospital use in prior 12 months

– Outpatient care at hospital 71%

– Used ER & received care from clinician 57%– Inpatient care, stayed overnight 29%

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Drug Use (lifetime)• Crack 63%• Other cocaine 57%• Other stimulants 45%• Heroin 28%

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Injection Drug Use

• Injection drug use ever 28%

• Shared injection drug equipment ever 18%

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Hepatitis C Seroprevalence

• Prevalence of Hepatitis C(ever infected) 31%*

• Rate of “hidden infection” 15%*

• Range: Variation by site 18%-48%

*Only 16% of the sample already knew they were HCV positive from a previous blood test; about half of the HCV infections were “hidden” or unknown to subjects, based on self-report.

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Hepatitis B Seroprevalence• Prevalence of Hepatitis B

• evidence of prior exposure 28%*

• “hidden” infection 20%*• currently infected 1%

• Range by site 18%-48%

*Only 8% knew they were HBV positive from an earlier blood test ---- that is, three quarters of the HBV-infected adults were “hidden”; i.e., their status was unknown before our test.

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Summary: Key Findings

• HCV rates are high in this sample of homeless adults compared to the US general population(31% vs. 1.8% NHANES)– Among those who tested positive for HCV, half did not know

they were infected.

• HBV rates were high compared to the US general population– Among those who tested postiive for HBV, three-quarters did not

know they were infected.

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Preliminary Conclusions• Preliminary findings here and elsewhere suggest that:

– Homeless adults in the US are a high risk group for HBV and HCV infections.

– Most of this infection may be “hidden”– Most of those who are infected have not received medical

attention

• Potential Next Steps:– Implement HBV and HCV screening programs for high risk (or

all?) homeless adults.– Educate homeless adults and medical providers regarding

potential risk for HBV and HCV exposure.