# Presentation: 202498

## Managing a Clinical Community-Based Research Study:  Comprehensive High Blood Pressure (HBP) Care In Underserved Young Urban Black Men (YBM) 

***Mary C. Roary, MHS***
*Johns Hopkins University**School of Nursing*

## Discussion Topics

- Managing stakeholder expectations
- Understanding study participants
- Implementing a research study
- Mission and goals
- Leadership and study design
- Research team
- Protocol and processes
- Institutional resources
- Results of the YBM HPB Study

## Addressing stakeholders’ expectations throughout the YBM research project has been  critical to its success

- Who is involved in the study?
- Who can be impacted?
- Who will oversee the research?
- What is important to the stakeholders?

**Study**
**Participants**

**Community**

**Staff**

**Students**

**Investigators**

**Institutions**
**(IRB, JHMI)**

## Underserved Young Urban Black Men

- Suffer earliest from severe HBP complications
- Have low rates of continuous HBP care
- Achieve poor control of HBP
- Are vastly under-studied
- Myths suggest that young urban black men are “hard-to-reach” and
- not interested in their health or in participating in research

## YBM Study Participants

- Black men, ages 18-54
- Residing in inner city Baltimore
- Hypertension
- SBP > 140 and/or DBP > 90 mm Hg on > 2 occasions
- Mean of 2nd and 3rd random zero measurements on 2nd eligibility visit > 140 and/or > 90 mm Hg   and
- Able to give verified names, addresses and telephone #s for > 3 contact persons

## Average Blood Pressures of the Men within the Study

| Data Point | Blood Pressure, Mean (SD) |  | Total |
| --- | --- | --- | --- |
|  | More Intensive | Less Intensive |  |
| Baseline

12-Month

24-Month

36-Month* | 147(19)/ 99(14)
(n=157)

136(20)/90(13)
(n=142)

142(19)/87(11)
(n=134)

138(18)/88(12)
(n=125) | 148(21)/99(15)
(n=152)

143(23)/93(16)
(n=122)

143(18)/89(12)
(n=118)

148(24)/94(17)
(n=106) | 147(20)/99(15)
(n=309)

139(21)/92(14)
(n=264)

143(18)/88(12)
(n=252)

142(21)/91(15)
(n=231) |

## YBM’s Mission and Goals are Clear and Specific 

- Enroll 300 inner-city hypertensive black men, with and without controlled Blood Pressures (BP), in a clinical trial comparing a comprehensive Nurse Practitioner/Community Health Worker/MD team intervention to community care to lower BP over 36 months
- Characterize HBP and lifestyle-related co-morbidities at baseline and 36 months
- Examine trends in BP over 36 months
- Document program effectiveness

## Investigators Provide Research Leadership

- Principal Investigator oversees all aspects of the research study and provides intellectual leadership: Martha N. Hill, PhD, RN
- Co-Investigators provide expertise and research guidance
- Lee Bone, MPH, RN	–	Roger Blumenthal, MD
- Gary Gerstenblith, MD	– 	David Levine, MD, ScD
- Wendy Post, MD, MS	–	James Weiss, MD
- Cheryl Dennison, PhD, CRNP	–	Miyong Kim, PhD, RN
- Linda Rose, PhD, RN
- The Co-Investigators come from the Schools of Nursing, Public Health and Medicine

## YBM Randomized Clinical Trial Design

| Less Intensive | More intensive |
| --- | --- |
| Education
Provided list of community HBP care sources
Cardiac Testing: (EKG, ECHO, Carotid Tonometry)
Telephone follow-ups | Access to Care Issues
Individualized NP-CHW-MD Care
NP visits prn < 2-3 months
 ARB Losartan 50 –100 mg (free)
+ HCTZ > 12.5 – 25 mg (free)
Other HBP meds prn
Social Services
Home visits
Transportation |

## The YBM Study Leveraged Existing  Institutional Resources

**Research Infrastructure**
- IRB
- Grants administration
**Human Resources**
- Recruitment
- Payroll & Personnel
**Professional Development**
- Grand Rounds
- Tuition
- Conferences

**Financial Management**
- Pre & Post Award Budgeting
- Monthly monitoring
**Facilities**
- Office and clinical space
- OPD-GCRC
- Equipment
**Research Resources**
- Library
- Patient records
- OPD-GCRC Staff

## YBM Staff Resources are Organized to Provide for Clear Guidance and Lines of Authority

**Investigators**

**Assistant Project Director**

**Operational Resources**

**Project Director**

**Financial Management**

**Community Health Worker**

**Data****Manager**

**Nurse Practitioner**

**Clinic Coordinator**

**Research Assistants**

**Principal Investigator**

## YBM’s Research Staff Have Clearly Defined Roles and Responsibilities

- Mary C. Roary - 	Project Director (PD)
- Pamela S. Hall - 	Nurse Practitioner
- Dwyan Y. Monroe - 	Community Health Worker (CHW)
- Sylvia L. Robinson - 	Clinic Coordinator
- LaPricia L. Lewis - 	Data Manager
- Cassia Lewis - 	Senior Research Assistant
- Anthony Weldon - 	Research Assistant
- Jennifer Walker -  	Research Assistant
- Veronica Holland -	Research Assistant
- Dr. Lisa Benz Scott - 	Kellogg Post Doctoral Fellow

## Building the Dedicated, Effective YBM Research Team Required

- Commitment to the study and the participants
- Shared vision and passion
- Commitment  to each other (investigators staff participants)
- Open communication, trust and mutual respect, a family atmosphere
- Perseverance and dedication
- Cross training and education

***PROJECT EXPORT***

## Protocols and Processes Ensured that Day-to-Day Activities Were Effectively Implemented

***Roary’s 12-Step Study Participant Retention Protocol***
- Telephone the participants.
- Send letters to their given addresses.  If wrong address,
- Call contact 1 to obtain current address and repeat steps 1-2;
- Call contact 2 to obtain current address and repeat steps 1-2;
- Call contact 3 to obtain current address and repeat steps 1-2.
- Call any additional contacts obtained at 6, 12, 18, and 24 month follow up if different from baseline contacts and repeat steps 1-2.

## Roary’s 12-Step Participant Retention Protocol (cont'd)

- Call the men’s doctors, if known. If not known,
- Go to most recent emergency department and visit record and search for new contact information.
- Check address on previous study visit and transportation money receipts to see if address is different from earlier address(es).
- Call or go to Motor Vehicles, Vital Statistics, Social Service, Child Protective Services, and Police Department.
- Go to the participant’s address(es) on identification form and money receipts.  If incorrect,
- Go to all contact’s address(es), starting with the most recently identified contacts.

## YBM Tracking and Follow-up (F-U) Rates

|  |     Sample F-U      (N-309) |  | F-U of those Available† |
| --- | --- | --- | --- |
| Contact | N | % |    % |
| 12 month visit | 264 | 85% | 94% |
| 18 month telephone | 253 | 82% | 93% |
| 24 month visit | 252 | 82% | 93% |
| 30 month telephone | 236 | 76% | 90% |
| 36 month visit | 231 | 75% | 93% |

- †	Accounting for deceased (n=8,14,18,26,33), incarcerated (n=16,19,13,15,21), in long-term care facility (n=1,1,1,1,2), moved out-of-state (n=4,4,6,4,5) for 12, 18,24,30, and 36 m follow-up respectively.

## YBM Study Conclusions

- Sustaining BP lowering over time requires engaged patients and a dedicated staff
- Both intervention efficacy and program effectiveness were demonstrated
- A multidisciplinary research program that includes maintaining contact every 6 months facilitates BP lowering over time in a very high risk group
- Participating in a clinical trial with intensive tracking and follow-up was beneficial to both groups

## YBM Study Team Lessons Learned

- Get a clear concept of the purpose and the way things fit into the goals of the study
- Develop excellent organizational skills
- Be flexible with one’s schedule to meet your goals
- Be patient, honest, loyal and dedicated to the study participants and whole team: family
- Put participants interest first
- Have equal respect for each other and be tactful in interacting within the team

## YBM Study Team Successes

- Recruited 309 “Hard to Reach” or as we like to call them” Differently Motivated” Black Men
- Attended and presented at several American Heart Association and International Society of Hypertension in Blacks Conferences
- Participated in community health fairs, festivals, and presentations

- Mentored Students:  Inner City High School to Post Doctorate
- Collaborated with a Community Based Organization to enhance sustain ability of the study findings
- Produced several abstracts, articles, and educational materials