An interventional study of Multicomponent Intervention and Enhanced Usual Care in Hypertension and Blood Pressure, sponsored by Tulane University. Completed at 2 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Tulane University · Not applicable, Interventional, and Treatment
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 1,272 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Tulane University is the lead sponsor of 96 studies on the registry; 23 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligibility Criteria for Clinics:
Inclusion Criteria for Study Participants:
Exclusion Criteria for Study Participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: Multicomponent Intervention
Webinar education session for providers on the new ACC/AHA hypertensive clinical guideline and the SPRINT study findings
Behavioral: Enhanced Usual Care
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.
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
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.
Time frame: Baseline to 18 months
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)
Time frame: Baseline to 18 months
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.
Time frame: Baseline to 18 months
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.
Time frame: Baseline to 18 months
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.
Time frame: Baseline to 18 months
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.
Time frame: Baseline to 18 months
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.
Time frame: Baseline to 18 months
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.
Time frame: Baseline to 18 months
Medication adherence (fidelity)
Patient medication adherence will be assessed by questionnaire. Binary variable: 1=high adherence and 0=low adherence
Time frame: Baseline to 18 months
Self-reported home BP monitoring (fidelity)
Patient home BP monitoring will be assessed by questionnaire. Binary variable: 1=yes and 0=no
Time frame: Baseline to 18 months
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.
Time frame: Baseline to 18 months
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'.
Time frame: Baseline to 18 months
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'.
Time frame: Baseline to 18 months
Acceptance to intensive BP target by providers in intervention clinics
Survey among providers
Time frame: Baseline to 18 months
Adherence to clinical appointments in the intervention group
Study administrative data
Time frame: Baseline to 18 months
Adherence to health coach session in the intervention group
Study administrative data
Time frame: Baseline to 18 months
Plan to share: Yes — The study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository. The study data will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." At the completion of the project, the investigators will make all intervention materials and procedure manuals available to the public according to the approved plan for making data and materials available to the scientific community, lay public, and the NIH.
Supporting information: Study protocol
Time frame: The data sets will be submitted to the study NHLBI study Program Official no later than 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first.
Access criteria: The investigators will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.
Ran from Jun 2018 to primary completion in Feb 2024, 67 months.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 67 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Tulane University