Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tulane University
- Enrollment
- 1,272
- Locations
- 2
- Primary Endpoint
- Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.
Study Overview
Brief Summary
The IMPACTS study utilizes an effectiveness-implementation hybrid type 2 design to achieve two primary goals simultaneously: 1). to test the effectiveness of a multifaceted implementation strategy for intensive BP control among underserved hypertensive patients at high risk for CVD, and 2). to assess the implementation outcomes of the multifaceted implementation strategy in patients and providers.
Detailed Description
Recently, the Systolic Blood Pressure Intervention Trial (SPRINT) reported that more intensive blood pressure (BP) treatment (target systolic BP<120 mm Hg) reduced major cardiovascular disease (CVD) by about 25% and all-cause mortality by about 27% compared to standard BP treatment (target systolic BP<140 mm Hg) among hypertensive patients aged ≥50 years. SPRINT clearly answered the question - Will lowering BP more than the currently recommended goal further reduce the risk of CVD and mortality? The next important question is how to implement a more intensive BP treatment program in real-world clinical practice, especially in underserved patients. The IMPACTS trial is an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multicomponent intervention program for more intensive BP treatment and the feasibility and fidelity of implementing the program in underserved patients with hypertension in Louisiana and Mississippi. The Consolidated Framework for Implementation Research has been used to guide the development of the multicomponent intervention, including dissemination of SPRINT study findings among patients, providers and policymakers; team-based collaborative care using a stepped-care protocol adapted from the SPRINT intensive-treatment algorithm, BP audit and feedback, and home BP monitoring; and health coaching on antihypertensive medication adherence and lifestyle modification. The investigators will collaborate with 36 federally qualified health center clinics that serve low-income populations in Louisiana and Mississippi to recruit 1,260 trial participants and conduct the IMPACTS trial. The primary clinical outcome is the difference in mean change of systolic BP from baseline to 18 months. The fidelity of the intervention, measured by intensification of treatment by providers and adherence to medications in patients, will be the primary implementation outcome. This study will generate urgently needed data on effective and adoptable intervention strategies aimed at eliminating health disparities and reducing the BP-related disease burden in underserved populations in the US.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligibility Criteria for Clinics:
- •Affiliated with participating FQHCs and not sharing providers or nurses/pharmacists with other clinics.
- •Predominantly managing underserved populations with health disparities (ethnic minorities, low-income groups, and residents of rural areas and inner cities).
- •Having electronic medical record systems.
- •Serving >200 hypertension patients (ICD-10-CM I10-I15) during the previous year.
- •Not participating in other hypertension control programs.
- •Inclusion Criteria for Study Participants:
- •Men or women aged ≥40 years who receive primary care from the participating FQHC clinics.
- •Systolic BP ≥140 mmHg at two screening visits for those not taking antihypertensive medication or systolic BP ≥ 130 mmHg at two screening visits for those taking antihypertensive medications.
Exclusion Criteria
- •for Study Participants:
- •Not able to understand English
- •Pregnant women, women planning to become pregnant in the next 18 months, women of childbearing potential and not practicing birth control, and persons who cannot give informed consent.
- •Plans to change to a primary healthcare provider outside of the FQHC clinic during the next 18 months.
- •Diagnosis of end-stage renal disease, defined as dialysis or transplantation.
- •Individuals unlikely to complete the study, such as those who plan to move out the study area during the next 18 months, temporary migrant workers, and homeless persons.
- •Patients with immediate family members who are staff at their FQHC clinic.
Arms & Interventions
Multicomponent Intervention
Protocol-based treatment using the SPRINT stepped-care intensive BP management algorithm, dissemination of SPRINT study findings among provider-teams, patients, and administrators, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification
Intervention: Multicomponent Intervention (Behavioral)
Enhanced Usual Care
Webinar education session for providers on the new ACC/AHA hypertensive clinical guideline and the SPRINT study findings
Intervention: Enhanced Usual Care (Behavioral)
Outcomes
Primary Outcomes
Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.
Time Frame: Baseline to 18 months
A fidelity summary score includes adherence to antihypertensive medications, initiation or intensification of treatment, home BP monitoring, and health education over the intervention period. The fidelity summary score ranges from 0 (worst) to 4 (best)
Difference in mean change of systolic BP
Time Frame: Baseline to 18 months
The primary outcome is the difference in mean change of systolic blood pressure from baseline to 18 months between intervention and control groups. Blood pressure will be measured 3 times each at two baseline, one 6-month, one 12-month, and two termination visits according to a standard protocol.
Secondary Outcomes
- Adherence to health coach session in the intervention group(Baseline to 18 months)
- Proportion of patients with systolic blood pressure <130 mm Hg(Baseline to 18 months)
- Acceptance to intensive BP target by providers in intervention clinics(Baseline to 18 months)
- Adherence to clinical appointments in the intervention group(Baseline to 18 months)
- Intensification of treatment (fidelity)(Baseline to 18 months)
- Self-reported health education at previous clinic visits (fidelity)(Baseline to 18 months)
- Difference in mean change of diastolic blood pressure(Baseline to 18 months)
- Proportion of patients with systolic blood pressure <120 mm Hg(Baseline to 18 months)
- Health-related quality of life (SF-12)(Baseline to 18 months)
- Medication adherence (fidelity)(Baseline to 18 months)
- Self-reported home BP monitoring (fidelity)(Baseline to 18 months)
- Proportion of patients with a >30 mm Hg reduction in systolic blood pressure(Baseline to 18 months)
- Satisfaction with antihypertensive medications(Baseline to 18 months)
- Satisfaction with BP-related care(Baseline to 18 months)
Investigators
Jiang He, MD, PhD
Professor and Director
Tulane University