Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS)
- Conditions
- Blood PressureHypertension
- Interventions
- Behavioral: Multicomponent InterventionBehavioral: Enhanced Usual Care
- Registration Number
- NCT03483662
- Lead Sponsor
- Tulane University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1206
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multicomponent Intervention 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 Enhanced Usual Care Enhanced Usual Care Webinar education session for providers on the new ACC/AHA hypertensive clinical guideline and the SPRINT study findings
- Primary Outcome Measures
Name Time Method Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention. 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 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 Outcome Measures
Name Time Method Proportion of patients with systolic blood pressure <130 mm Hg Baseline to 18 months The differences in the proportion of patients with systolic blood pressure \<130 mm Hg between the intervention and control groups at 18 months will be assessed.
Acceptance to intensive BP target by providers in intervention clinics Baseline to 18 months Survey among providers
Adherence to clinical appointments in the intervention group Baseline to 18 months Study administrative data
Intensification of treatment (fidelity) Baseline to 18 months Survey data and electronic health record data will be used to assess whether providers add new antihypertensive medications or titrate existing medications. Intensification of antihypertension treatment is a binary outcome variable, with 1 representing the initiation of a new medication or an increase in the current medication dosage, and 0 representing no change in medication.
Self-reported health education at previous clinic visits (fidelity) Baseline to 18 months Patient health education at previous clinic visits will be assessed by questionnaire. Binary variable: 1=yes and 0=no.
Difference in mean change of diastolic blood pressure Baseline to 18 months The difference in mean change of diastolic blood pressure from baseline to 18 months between intervention and control groups will be assessed.
Proportion of patients with systolic blood pressure <120 mm Hg Baseline to 18 months The differences in the proportion of patients with systolic blood pressure \<120 mm Hg between the intervention and control groups at 18 months will be assessed.
Health-related quality of life (SF-12) Baseline to 18 months Health-related quality of life will be assessed using the 12-Item Short Form Survey (SF-12). Physical component summary (PCS-12) and mental component summary (MCS-12) scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Medication adherence (fidelity) Baseline to 18 months Patient medication adherence will be assessed by questionnaire. Binary variable: 1=high adherence and 0=low adherence
Self-reported home BP monitoring (fidelity) Baseline to 18 months Patient home BP monitoring will be assessed by questionnaire. Binary variable: 1=yes and 0=no
Proportion of patients with a >30 mm Hg reduction in systolic blood pressure Baseline to 18 months The differences in the proportion of patients with a \>30 mm Hg reduction in systolic blood pressure between the intervention and control groups at 18 months will be assessed.
Satisfaction with antihypertensive medications Baseline to 18 months The satisfaction of patients with antihypertensive medications was assessed at baseline and follow-up visits using the question, 'How satisfied are you with antihypertensive medications you have received?' There are five possible answers: 'very satisfied,' 'satisfied,' 'neutral,' 'dissatisfied,' and 'very dissatisfied'.
Satisfaction with BP-related care Baseline to 18 months The satisfaction of patients with BP-related care was assessed at baseline and follow-up visits using the question, 'How satisfied are you with the care you have received for your blood pressure?' There are five possible answers: 'very satisfied,' 'satisfied,' 'neutral,' 'dissatisfied,' and 'very dissatisfied'.
Adherence to health coach session in the intervention group Baseline to 18 months Study administrative data
Trial Locations
- Locations (2)
26 FQHC Primary Care Clinics in Louisiana
🇺🇸New Orleans, Louisiana, United States
10 FQHC Primary Care Clinics in Mississippi
🇺🇸Biloxi, Mississippi, United States