1. Locally-Employed Study Staff Improve Study Recruitment and Retention: A Community Engagement Strategy in a Predominately Rural South Carolina County
Dana Burshell, mPH, CCRP
Community engagement coordinator
South Carolina clinical & translational research institute
The medical university of south CAROLINA
Thank you, Dr. Magwood. Good afternoon. It is such a pleasure to be here with you today. We would like to share an example of how a community engagement strategy of hiring locally-employed study staff improved study recruitment and retention, making our study possible and successful.

2. background
Inclusion and successful recruitment and retention of under-represented populations in research is essential to minimize health disparities
Recruitment and retention of people of rural populations, especially African Americans, are challenging due to:
Mistrust of researchers
Lack of infrastructure to refer patients to research opportunities
Limited transportation
Perceived absence of personal or societal benefit
As we have discussed today, health disparities are real, destructive and pervasive. It’s been exciting to hear today about the increasing amount of research being conducted to describe and address health disparities.
Inclusion and successful recruitment and retention of under-represented populations in research is an essential component to studying and minimizing health disparities.
However, research shows that recruitment and retention of people in rural communities, especially AAs, are challenging due to mistrust of researchers, lack of infrastructure to refer patients to research opportunities, limited transportation, and perceived absence of personal or societal benefit (Williams 2011).
We will explore some of these challenges and how we addressed them in our study.
Williams IC et. al Recruitment of Rural African Americans for Research Projects: Lessons Learned. South Online J Nurs Res. Apr 1; 11(1): 8.
(Williams 2011)

3. Presentation objectives
Describe the development of a feasibility community-engaged diabetes self-management study in rural Bamberg County, SC
Explain the adaptation of recruitment and retention strategies to increase rural and African American participation
Emphasize the vital role of locally-employed study staff
I plan to
Describe the development of a feasibility community-engaged diabetes self-management intervention in a rural community
Explain the adaptation of recruitment and retention strategies to increase rural and African American participation, and
Emphasize the vital role of locally-employed study staff

4. Bamberg Prioritizes diabetes: A community-engaged effort
Bamberg County is a small, rural area in central South Carolina. Bamberg has limited access to medical care due to a number of factors such as its rural nature, a poverty rate of 29.7%, low average per capita income ($19,136) and transportation challenges.
As of 2012 nearly 15% of residents have diabetes, a rate nearly 1.5 times the national average. African Americans have a 42% higher diabetes prevalence than Caucasians in South Carolina and who comprise 61% of Bamberg County residents. In 2012, the County’s only hospital closed, further exacerbating the need to develop interventions for individuals with diabetes.
The Bamberg Diabetes Coalition initiated this community-driven study by identifying diabetes management as a priority and inviting academic researchers from the Medical University of South Carolina and the University of North Carolina – Chapel Hill to help develop an intervention that would best suit their community’s needs. Through public forums and focus groups hosted by Vorhees College, patients, family members, providers, and community members identified the gap of supporting individuals with diabetes beyond the infrequent hospital and clinical visits. They also stressed the importance of community leader support, locally-employed study staff, and the impact of building and sustaining rapport and trust.
The Regional Medical Center, Orangeburg SC is one the closest hospitals which many Bamberg residents now go even though it is 40 minutes away. The Regional Medical Center has 2 primary clinics in Bamberg County. They joined the consortium as the community hospital partner and regional study management center and provided critical study staff both in Orangeburg and in Bamberg and were the primary recruitment site.
South Carolina Department of Health and Environmental Control Diabetes In Bamberg County, 2012 Fact Sheet.
United States Census Bureau Quickfacts: Bamberg County, South Carolina
Closed in 2012

5. Bamberg diabetes transitional care feasibility study
Community input and feedback were critical to the study design
We developed a randomized-controlled study exploring the feasibility of medical home/community extenders to improve diabetes management
We compared three approaches to diabetes management during a 3- month intervention period:
Community health worker (CHW) in-home intervention
Nurse care coordination via phone
Usual care
Community input and feedback led to a development of the Bamberg Diabetes Transitional Care Feasibility Study which compared three approaches to diabetes management during the 3-month intervention period. Participants were randomized to a
Community health worker (CHW) who provided the intervention at the participant’s home,
Nurse interventionist who provided the intervention via telephone, or
Usual care. 
Community health worker and nurse interventionists worked collaboratively with participants and their families with motivational interviewing and teach-back to identify each individual’s primary health concerns and plan behavior goals to improve diabetes self-management skills.
Outcome assessments included self-reported survey responses about health care behaviors. A1C and vitals were obtained by medical record review.

6. Study team: local residents and participant advocates
Study Personnel
2 Academic Principal Investigators (PI)
1 Hospital PI
1 Community PI / Local Project Manager
1 Project Manager (MUSC)
2 Community Health Workers
2 Nurse Interventionists
1 Bamberg Nurse Liaison
1 Student Volunteer
As suggested, all staff members were from Bamberg or neighboring counties and had personal connections with the Bamberg community. While the MUSC team brought the strengths of an initial study design, the study staff, who had little or no previous research experience, inexhaustibly advocated for their participants which sometimes inadvertently challenged the study design. Through open communication, feedback, and a platform to brainstorm realistic solutions, we addressed the challenges head on.
Pictured here are our 2 community health workers, 2 nurse interventionists, the local project manager, the student volunteer, and the SCTR Principal Investigator.
Helen Sherman – Nurse
Latasha Priester - CHW
Lynn Glenn – Student volunteer and previous nurse practitioner in a Bamberg primary care clinic
Horace Britton – CHW
Melissa Sherman – Coordinator
Dr. Carolyn Jenkins - PI
Mary Brown, – Nurse
And not pictures are Ramona Anderson – tRMC primary care nurse and Samuel Cykert, UNC NC TraCS PI
Study team from left to right: Helen Sherman, RN; Latasha Priester; Lynn Glenn, NP; Horace Britton, MS; Melissa Sherman, MA; Carolyn Jenkins, DrPH, MSN; Mary Brown, BSN
Not pictured: Ramona Anderson, LPN; Dana Burshell, MPH; Samuel Cykert, MD; Randal Davis, MBA

7. Participant inclusion criteria and Recruitment June - December, 2015
Original Criteria
18-75 years
Bamberg County resident
Diabetes diagnosis
Recent hospital admission or ED visit at tRMC*
Patient of participating primary care practices (PCP)
Challenges Encountered
Potential participant pool too small
PCPs refuse to refer patients if assigned to usual care
PCPs serve residents of multiple counties
Final Criteria Changes
Participating PCPs will refer patients from Bamberg or nearby counties
Referred patients randomized to an intervention group
We quickly realized that the originally vetted inclusion criteria would not lead to sufficient recruitment.
We discussed our challenges with the potential primary care practices (PCPs) who said they would be willing and happy to refer patients with uncontrolled diabetes to the study IF and ONLY IF their referrals had the potential to benefit from the study and were not randomized to a usual care group. We accommodated this request and three practices provided referrals.
In response to study staff and practice’s discomfort with limiting participation to their Bamberg County patients, we expanded inclusion criteria to accept patients from other counties.
Study modifications led to a 3-fold increase in recruitment from an average of 4.3 recruits/month in the first 4 months to an average of 12.3 recruits/month in the final 3 months.
Changes to the inclusion criteria and randomization methods significantly impacted the study. Ultimately, two-thirds of recruitments came from PCP referrals which left the study with only 4 participants that completed usual care. Because it is a feasibility study, it was more important to have participants and identify improvements to study design.
* The Regional Medical Center, Orangeburg SC
Study modifications led to a 3-fold increase in recruitment from an average of 4.3 recruits/month in the first 4 months to an average of 12.3 recruits/month in the final 3 months.

8. Retention (June, 2015 – March, 2016)
Original Methods
Administer 8 intervention sessions over 3 months
Monthly telephone surveys assessing health behaviors
Challenges
Inability to meet study deadlines due to multiple life challenges for both participants and staff
Phone access: few active landlines, limited cell minutes
Final Methods
Flexibility in study schedule allowed
Study phone provided if needed
Nine consented participants passively or actively dropped out from the study early on. The study schedule had become overwhelming and unrealistic for most participants who had competing priorities such as balancing caring for multiple family members, their own comorbidities, and multiple jobs with difficult work hours. Also, many participants did not have land lines and had limited cell phone minutes.
Staff advocated for the many participants who wanted to remain in the study but could not meet the study demands. We relaxed the study schedule and allowed a significant amount of flexibility to work with the participant and we provided study cell phones as necessary.
After all modifications were made in December of 2015, there were no additional dropouts during the last 3 months.
Nine consented participants passively or actively withdrew.
After all modifications were made in December, there were no additional dropouts.

9. Participants Participants:
58 participants were consented, 48 completed the study
CHW Group (n=24), Nurse Group (n=20), Usual Care Group (n=4)
Groups and Demographics (n=48)
Average age of 59 (range 21-75), 73% female, 90% African American, 42% married
81% have a high school education or less, 70% make less than $20,000 per year
Horace Britton, community health worker, and 2 participants
In total, 58 participants were consent, 1 was ineligible, 9 dropped out, and 48 completed the study. Of the 48, 24 were in the community health worker group, 20 in the nurse intervention group, and 4 in the usual care group.
The participant’s average age was 59, 73% were female, 90% were African American, and 42% were married.
81% have a high school education or less and 70% make less than $20,000 per year.
(Pictured here is one of the community health workers, Horace Britton, with two of his participants who volunteered to be interviewed for a piece covering the study and used in initial dissemination efforts. The woman echoed many of the experiences of other participants: “Despite all of the things in my life despite that I have to take care of my children and my mother, and I have to work 12-hour shifts that change every day, I have the support of people who make me matter and care and teach me objective things.”
“Despite that I have to take care of my children and my mother, and I have to work 12-hour shifts that change every day, I have the support of people who make me matter and care and teach me.”
- Participant

10. Preliminary Study Outcomes
A1C (CHW Group, n=20; Nurse Group, n=15)
65% of the CHW Group participants and 60% of Nurse Group participants improved their A1C.
On average, A1C decreased 0.93 in the CHW Group and 0.42 in the Nurse Group.
Depression (CHW Group, n = 24; Nurse Group, n=20)
58% of the CHW Group and 60% of the Nurse Group reported fewer depressive symptoms at the end compared to the beginning of the study.
Because there were only 4 in the usual care group due to the changes in the randomization, usual care is not included in these preliminary results. 60% or more participants from both intervention groups improved their A1C, an indicator of diabetes control. On average, the A1C decreased by 0.93 in the community health worker group and decreased by 0.42 in the Nurse Group. (The pre-study A1C for both groups was The post-study A1C average was 8.7 for the CHW Group and 9.32 for the RN Group.)
About 60% of both the community health worker and nurse participants reported fewer depressive symptoms at the end compared to the beginning of the study.
(While 32% of participants reported no depressive symptoms at the beginning of the study, by the end of the study it rose to 64% reporting no depressive symptoms.)
(Cost effectiveness and hospitalization utilization will be analyzed 1-year post study end. The South Carolina Revenue and Fiscal Affairs Office will provide data 2 years prior and 1 year following study for participants and comparison groups.)

11. Conclusions
Conducting a feasibility study and allowing flexibility in the study protocol is essential.
The study succeeded due to the engagement and honest feedback of the community and locally-employed study staff.
Study designs were successfully modified to attract, recruit, and retain rural and African American participants.
Our lessons learned included:
Conducting a feasibility study and allowing flexibility in the study protocol is essential.
We felt the study succeeded due to the engagement and honest feedback of the community and locally-employed study staff.
And we were pleased that we were able to modify the study designs to successfully attract, recruit, and retain rural and African American participants.
Next steps include the continuation of data analysis and dissemination efforts through our partnerships and communities.

12. Acknowledgements Study Team and Co-Authors: Community Partners:
Carolyn Jenkins, DrPH, MSN, RD, LD – SCTR, MUSC
Randal Davis, MBA – SCTR
Melissa Sherman, MA - tRMC
Brian Kendall, MD – tRMC PI
Brenda Williams, MHA, FACHE – tRMC
Kelenne Tuitt, DO, MS – tRMC Bamberg Primary Care
Danette McAlhaney, MD – Bamberg Family Practice
Samuel Cykert, MD – NC TraCS, UNC
Dr. Leroy Davis – Voorhees College
Mayor Blain Crosby of Bamberg
Mayor Gerald Wright of Denmark
Bamberg Diabetes Coalition
Diabetes Initiative of South Carolina
The Regional Medical Center, Orangeburg SC I
Funders
South Carolina Clinical & Translational Research Institute, MUSC
North Carolina Translational & Clinical Sciences Institute, UNC- Chapel Hill
South Carolina Department of Health and Human Services

13. references
Williams IC et. al Recruitment of Rural African Americans for Research Projects: Lessons Learned. South Online J Nurs Res. Apr 1; 11(1): 8.
South Carolina Department of Health and Environmental Control Diabetes In Bamberg County, 2012 Fact Sheet.
United States Census Bureau Quickfacts: Bamberg County, South Carolina