Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS)

Hypertension Clinical Trial

— IMPACTS  

Official title:

Dissemination and Implementation of the SPRINT Study Findings in Underserved Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483662
• Other study ID #: R01HL133790
• Secondary ID: R01HL133790
• Status: Completed
• Phase: N/A
• Start date: June 27, 2018
• Est. completion date: February 15, 2024

Study information

• Verified date: August 2023
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1206
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Behavioral:
• Multicomponent Intervention
The core component of the intervention is protocol-based treatment using the SPRINT BP management algorithm. The following implementation strategies are adaptable components that will be modified to fit specific federally-qualified health center (FQHC) settings: 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
The investigators will provide an up-to-date clinical guideline for hypertension management to providers. A webinar education session on the new American College of Cardiology (ACC)/American Heart Association (AHA) hypertension guideline and findings from the SPRINT trial will be conducted. Otherwise, the investigators will not conduct any active intervention and all control clinics will follow their routine clinic practice in the management of hypertensive patients

Locations

Country	Name	City	State
United States	10 FQHC Primary Care Clinics in Mississippi	Biloxi	Mississippi
United States	26 FQHC Primary Care Clinics in Louisiana	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mean change of systolic BP	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.	Baseline to 18 months
Primary	Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.	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)	Baseline to 18 months
Secondary	Proportion of patients with systolic blood pressure <120 mm Hg	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.	Baseline to 18 months
Secondary	Proportion of patients with systolic blood pressure <130 mm Hg	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.	Baseline to 18 months
Secondary	Proportion of patients with a >30 mm Hg reduction in systolic blood pressure	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.	Baseline to 18 months
Secondary	Difference in mean change of diastolic blood pressure	The difference in mean change of diastolic blood pressure from baseline to 18 months between intervention and control groups will be assessed.	Baseline to 18 months
Secondary	Health-related quality of life (SF-12)	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.	Baseline to 18 months
Secondary	Intensification of treatment (fidelity)	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.	Baseline to 18 months
Secondary	Medication adherence (fidelity)	Patient medication adherence will be assessed by questionnaire. Binary variable: 1=high adherence and 0=low adherence	Baseline to 18 months
Secondary	Self-reported home BP monitoring (fidelity)	Patient home BP monitoring will be assessed by questionnaire. Binary variable: 1=yes and 0=no	Baseline to 18 months
Secondary	Self-reported health education at previous clinic visits (fidelity)	Patient health education at previous clinic visits will be assessed by questionnaire. Binary variable: 1=yes and 0=no.	Baseline to 18 months
Secondary	Satisfaction with antihypertensive medications	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'.	Baseline to 18 months
Secondary	Satisfaction with BP-related care	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'.	Baseline to 18 months
Secondary	Acceptance to intensive BP target by providers in intervention clinics	Survey among providers	Baseline to 18 months
Secondary	Adherence to clinical appointments in the intervention group	Study administrative data	Baseline to 18 months
Secondary	Adherence to health coach session in the intervention group	Study administrative data	Baseline to 18 months