Southeastern Collaboration to Improve Blood Pressure Control

• ClinicalTrials.gov Identifier: NCT02866669
• Recruitment Status: Completed
• First Posted: August 15, 2016
• Last Update Posted: April 28, 2021
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Andrea Cherrington, MD, University of Alabama at Birmingham

Study Description

Brief Summary:

The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt".

In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions.

Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care.

The study's 4 arms are:

1. Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care
2. Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques
3. Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
4. Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: Practice Facilitation; Behavioral: Peer Coach; Behavioral: Enhanced usual care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1592 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Collaboration to Improve Blood Pressure in the US Black Belt-addressing the Triple Threat
• Actual Study Start Date: May 3, 2017
• Actual Primary Completion Date: February 28, 2021
• Actual Study Completion Date: February 28, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Enhanced usual care; Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.	Behavioral: Enhanced usual care; Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.
Experimental: Practice facilitation; Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction	Behavioral: Practice Facilitation; ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction; Behavioral: Enhanced usual care; Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.
Experimental: Peer coach; Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.	Behavioral: Peer Coach; Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.; Other Name: Taking Control of Your Health; Behavioral: Enhanced usual care; Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.
Experimental: Peer coach and Practice facilitation; Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months.	Behavioral: Practice Facilitation; ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction; Behavioral: Peer Coach; Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.; Other Name: Taking Control of Your Health; Behavioral: Enhanced usual care; Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.

Outcome Measures

Primary Outcome Measures :

1. change in blood pressure control control at 12 months [ Time Frame: baseline and 12 months ]
   change in BP control between baseline and follow-up between practices in any of the intervention arms and the enhanced usual care arm

Secondary Outcome Measures :

1. change in systolic blood pressure at 12 months [ Time Frame: baseline and 12 months ]
   change in systolic blood pressure at 12 months
2. change in satisfaction using the patient assessment of chronic illness care" [ Time Frame: Baseline, 12 months ]
   change in satisfaction measured using self report scale "patient assessment of chronic illness care"
3. change in satisfaction using the Chronic Illness Resources Survey [ Time Frame: Baseline, 12 months ]
   change in satisfaction measured using self report scale "Chronic Illness Resources Survey"
4. change in health related quality of life [ Time Frame: Baseline, 12 months ]
   change in health related quality of life measured using self report scale Short form-12
5. change in depressive symptoms [ Time Frame: Baseline, 12 months ]
   change in depressive symptoms measured using self report scale 8 item Patient Health Questionnaire
6. change in perceived stress [ Time Frame: Baseline, 12 months ]
   change in perceived stress measured using self report scale 4 item Perceived stress scale
7. change in social support [ Time Frame: Baseline, 12 months ]
   change in social support measured using self report scale "Patient-reported outcomes measurement information system (PROMIS) Social functioning scale"
8. change in hypertension knowledge [ Time Frame: Baseline, 12 months ]
   change in hypertension knowledge measured using self report scale "Hypertension Knowledge and attitudes"
9. change in patient activation measured [ Time Frame: Baseline, 12 months ]
   change in patient activation measured using self report scale 4 item patient activation measure
10. change in medication adherence [ Time Frame: Baseline, 12 months ]
    change in medication adherence measured using self report scale "4-item medication adherence scale"

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• African American adults aged 19-85 years
• Uncontrolled HTN, defined as BP >140/90 mm Hg at the time of study enrollment
• Black Belt resident
• English speaking
• Willing to work with a peer coach
• Willing to sign informed consent

Exclusion Criteria:

• Plans to move out of the area within the next two years
• Advanced illness with limited life expectancy
• Pregnant or plans to get pregnant in the next year
• Advanced chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73 m2)
• Unwillingness to work with a peer coach or to sign informed consent

Contacts and Locations

Locations

United States, Alabama

University of Alabama At Birmingham

Birmingham, Alabama, United States, 35205

United States, North Carolina

UNC Chapel Hill

Chapel Hill, North Carolina, United States, 37599

East Carolina University

Greenville, North Carolina, United States, 27834

Sponsors and Collaborators

University of Alabama at Birmingham

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cummings DM, Adams A, Patil S, Cherrington A, Halladay JR, Oparil S, Soroka O, Ringel JB, Safford MM. Treatment Intensity, Prescribing Patterns, and Blood Pressure Control in Rural Black Patients with Uncontrolled Hypertension. J Racial Ethn Health Disparities. 2022 Oct 21. doi: 10.1007/s40615-022-01431-2. Online ahead of print.

Finch AJ, Ringel JB, Dargar S, Halladay J, Cene C, Cherrington A, Cummings D, Safford MM. Greater Social Functioning Associated With Lower Depressive Symptomatology Among Black Belt African Americans Enrolled in the Southeastern Collaboration to Improve Blood Pressure Control Study. Prim Care Companion CNS Disord. 2022 Feb 3;24(1):21m02988. doi: 10.4088/PCC.21m02988.

Sutton KF, Richman EL, Rees JR, Pugh-Nicholson LL, Craft MM, Peaden SH, Mackey M, Halladay JR; Southeastern Collaboration to Improve Blood Pressure Writing Group. Successful Trial of Practice Facilitation for Plan, Do, Study, Act Quality Improvement. J Am Board Fam Med. 2021 Sep-Oct;34(5):991-1002. doi: 10.3122/jabfm.2021.05.210140.

• Responsible Party: Andrea Cherrington, MD, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT02866669
• Other Study ID Numbers: X160722009
• First Posted: August 15, 2016
• Last Update Posted: April 28, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases