Clinical trial NCT02866669: Southeastern Collaboration to Improve Blood Pressure Control
Official title: Collaboration to Improve Blood Pressure in the US Black Belt-addressing the Triple Threat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 1592
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Change in Systolic Blood Pressure Between Baseline and 12 Months
timeFrame: 12 months
measure: Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months
timeFrame: 12 months
measure: Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12)
timeFrame: 12 months
measure: Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12)
timeFrame: 12 months
measure: Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months
timeFrame: between baseline and 6 months
measure: Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months
timeFrame: between 6 months to 12 month
measure: Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months
timeFrame: between baseline to 6 months
measure: Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month
timeFrame: between 6 month to 12 month
measure: Change in Perceived Stress
timeFrame: 12 months
Other outcomes:
measure: Self-reported Stroke
timeFrame: 12 months
measure: Change in Instrumental Support
timeFrame: 12 months
measure: Change in Perceived Emotional Support
timeFrame: 12 months
measure: Change in Social Isolation
timeFrame: 12 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham
state: Alabama
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
References:
citation: 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. 2023 Oct;10(5):2505-2512. doi: 10.1007/s40615-022-01431-2. Epub 2022 Oct 21.
citation: 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.
citation: 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.