Clinical trial NCT03483662: Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS)
Official title: Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Keywords: hypertension
blood pressure
medication adherence
lifestyle modification
blood pressure control
implementation
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-03-30
Enrollment: 1206
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.
* High risk for CVD, defined as history of CVD (myocardial infarction, stroke or heart failure), chronic kidney disease (CKD, estimate glomerular filtration rate (eGFR) \<60 ml/min/1.73m2), diabetes, estimated 10-year global CVD risk ≥10%, or age ≥65 years.

Exclusion Criteria for Study Participants:

* Not able to understand English
* Pregnant women, women planning to become pregnant in the next 18 months, 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.
* 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.

Primary outcomes:
measure: Difference in mean change of systolic BP
timeFrame: Baseline to 18 months
measure: Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: Proportion of patients with systolic blood pressure <120 mm Hg
timeFrame: Baseline to 18 months
measure: Proportion of patients with systolic blood pressure <130 mm Hg
timeFrame: Baseline to 18 months
measure: Proportion of patients with a >30 mm Hg reduction in systolic blood pressure
timeFrame: Baseline to 18 months
measure: Difference in mean change of diastolic blood pressure
timeFrame: Baseline to 18 months
measure: Health-related quality of life (SF-12)
timeFrame: Baseline to 18 months
measure: Intensification of treatment (fidelity)
timeFrame: Baseline to 18 months
measure: Medication adherence (fidelity)
timeFrame: Baseline to 18 months
measure: Self-reported home BP monitoring (fidelity)
timeFrame: Baseline to 18 months
measure: Self-reported health education at previous clinic visits (fidelity)
timeFrame: Baseline to 18 months
measure: Satisfaction with antihypertensive medications
timeFrame: Baseline to 18 months
measure: Satisfaction with BP-related care
timeFrame: Baseline to 18 months
measure: Acceptance to intensive BP target by providers in intervention clinics
timeFrame: Baseline to 18 months
measure: Adherence to clinical appointments in the intervention group
timeFrame: Baseline to 18 months
measure: Adherence to health coach session in the intervention group
timeFrame: Baseline to 18 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: 26 FQHC Primary Care Clinics in Louisiana
state: Louisiana
city: Biloxi
country: United States
facility: 10 FQHC Primary Care Clinics in Mississippi
state: Mississippi
Study officials:
affiliation: Tulane University
name: Jiang He, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University
name: Marie A Krousel-Wood, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mills KT, Peacock E, Chen J, Zimmerman A, He H, Cyprian A, Davis G, Fuqua SR, Gilliam DS, Greer A, Gray-Winfrey L, Williams S, Wiltz GM, Winfrey KL, Whelton PK, Krousel-Wood M, He J. Experiences and Beliefs of Low-Income Patients With Hypertension in Louisiana and Mississippi During the COVID-19 Pandemic. J Am Heart Assoc. 2021 Feb 2;10(3):e018510. doi: 10.1161/JAHA.120.018510. Epub 2020 Dec 3.
citation: Mills KT, Peacock E, Chen J, Zimmerman A, Brooks K, He H, Cyprian A, Davis G, Fuqua SR, Greer A, Gray-Winfrey L, Williams S, Wiltz GM, Winfrey KL, Whelton PK, Krousel-Wood M, He J. Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial. Am Heart J. 2020 Dec;230:13-24. doi: 10.1016/j.ahj.2020.08.009. Epub 2020 Aug 19.