HypertensionNCT04603560
Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension
A study testing Audit and Feedback and Pharmacist E-Detailing in people with Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This is a three-arm pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Audit and Feedback and Pharmacist E-Detailing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 511 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2021to 8 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Provider Inclusion Criteria:
- Primary care physician
- Practicing in primary care at Massachusetts General Hospital
- Caring for at least 2 patients: (1) aged 18-79, (2) for whom the recent BP history in the last 18 months is above goal, (3) whose most recent BP at an outpatient visit was above goal, and (4) who did not have their hypertension treatment regimens intensified (dose increase, new medication, or medication exchange) at or since that time. The BP goal will be <140/90 for all patients. To accommodate changes in care delivery that occurred during the COVID surge, outpatient visits will include in-office and virtual visits that had vitals recorded in the EHR the same day.
Provider Exclusion Criteria:
- fewer than 100 patients on their primary care panel
- practice less than one session per week
Patient Inclusion Criteria:
- had a blood pressure greater than 140/90 mmHg at 2+ PCP visits in the past 12 months
- treatment was not intensified at any of these visits
Patient Exclusion Criteria:
- excluded from the hypertension registry
- currently pregnant or post-partum 6 months
- receiving hospice care
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This is a three-arm pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness. Study investigators will use EHR data to identify providers of patients whose hypertension treatment was not intensified. Primary care physicians will then be randomized to one of three arms: pharmacist e-detailing, provider dashboards, or no intervention (control). After the intervention, the investigators will conduct virtual interviews with select providers from each arm. A predictive modeling approach will then be used to identify patient and provider characteristics that are associated with inertia and with responsiveness to each intervention.
Read the detailed description
We propose a pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness.
For Aim 1, we will use Electronic Health Record (EHR) data to identify physicians of patients whose hypertension treatment was not intensified despite their having persistently elevated blood pressure. We will then randomize primary care physicians to on of three arms: academic e-detailing, social norming, or no intervention (control).
For Aim 2, we will conduct interviews with select physicians from each arm. We will then identify patient and physician characteristics that are associated with inertia and with responsiveness to each intervention.
- Conditions
- Hypertension
- Being tested
- Audit and Feedback, Pharmacist E-Detailing
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and FeedbackBehavioural
A report of the provider's hypertension control rates compared to benchmark will be displayed using principles of social norming. We will present that provider's hypertension control rates compared to the 90th percentile of their peers.
Pharmacist E-DetailingBehavioural
A pharmacist will review the chart in advance and provide a personalized recommendation for how to intensify the specific patient's antihypertensive regimen based on current guidelines. For example, they might recommend adding an additional medication based on the patient's comorbid conditions and could suggest a starting dose and timeframe for dose escalation.
| Study group | Role | What they receive |
|---|---|---|
| Audit and Feedback | Experimental | A report of the provider's hypertension control rates compared to benchmark will be displayed using principles of social norming. We will present that provider's hypertension control rates compared to the 90th percentile of their peers. Receives: Behavioral: Audit and Feedback |
| Pharmacist E-Detailing | Experimental | A pharmacist will review the chart in advance and provide a personalized recommendation for how to intensify the specific patient's antihypertensive regimen based on current guidelines. For example, they might recommend adding an additional medication based on the patient's comorbid conditions and could suggest a starting dose and timeframe for dose escalation. Receives: Behavioral: Pharmacist E-Detailing |
| Control | No intervention | No intervention will be provided to physicians in the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Intensification
The primary outcome was whether physicians intensified treatment at the target visit. Intensification was defined as adding a new antihypertensive medication or increasing the total daily dose of an existing one. This was measured by identifying all prescriptions for anti-hypertensive medications in the electronic health record (EHR) on the day of the target visit and comparing the medication name and total daily dose to anti-hypertensive medications prescribed prior to the target visit date, following the same procedure used to identify intensification during the eligibility assessment
Measured: During the primary care office visit in which the provider-patient dyad received the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start26 Oct 2021
- Primary completion8 Aug 2022
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a cluster-randomized trial randomized at the provider level. Primary care providers were invited to participate and consented into the study. Patients accrued into the study were study-eligible patients cared for by each enrolled primary care provider. The number of participants listed below includes both patients and providers (466 patients and 45 providers).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Nancy Haff, MD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603560
- Sponsor's protocol ID
- 2020P002897
- Other IDs
- P30AG064199
- Status last verified
- Aug 2024
- First submitted
- 8 Oct 2020
- Last updated
- 21 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haff N, Sreedhara SK, Wood W, Yom-Tov E, Horn DM, Hoover M, Low G, Lauffenburger JC, Chaitoff A, Russo M, Hanken K, Crum KL, Fontanet CP, Choudhry NK. Testing interventions to reduce clinical inertia in the treatment of hypertension: rationale and design of a pragmatic randomized controlled trial. Am Heart J. 2024 Feb;268:18-28. doi: 10.1016/j.ahj.2023.11.005. Epub 2023 Nov 14.
PubMed 37967641
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Intervention to Reduce Clinical Inertia in the Treatment of Hypertension
- ClinicalTrials.gov ID
- NCT04603560
- Acronym / sponsor ID
- 2020P002897
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Posted 28 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a three-arm pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness. Study investigators will use EHR data to identify providers of patients whose hypertension treatment was not intensified. Primary care physicians will then be randomized to one of three arms: pharmacist e-detailing, provider dashboards, or no intervention (control). After the intervention, the investigators will conduct virtual interviews with select providers from each arm. A predictive modeling approach will then be used to identify patient and provider characteristics that are associated with inertia and with responsiveness to each intervention.
Detailed description
We propose a pragmatic randomized controlled trial to test two interventions targeting clinical inertia in hypertension compared to control, followed by predictive modeling to identify factors that are associated with intervention responsiveness.
For Aim 1, we will use Electronic Health Record (EHR) data to identify physicians of patients whose hypertension treatment was not intensified despite their having persistently elevated blood pressure. We will then randomize primary care physicians to on of three arms: academic e-detailing, social norming, or no intervention (control).
For Aim 2, we will conduct interviews with select physicians from each arm. We will then identify patient and physician characteristics that are associated with inertia and with responsiveness to each intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This was a cluster-randomized trial randomized at the provider level. Primary care providers were invited to participate and consented into the study. Patients accrued into the study were study-eligible patients cared for by each enrolled primary care provider. The number of participants listed below includes both patients and providers (466 patients and 45 providers).
| Arm | Type | Receives |
|---|---|---|
| Audit and Feedback | Experimental | Behavioral: Audit and FeedbackA report of the provider's hypertension control rates compared to benchmark will be displayed using principles of social norming. We will present that provider's hypertension control rates compared to the 90th percentile of their peers. |
| Pharmacist E-Detailing | Experimental | Behavioral: Pharmacist E-DetailingA pharmacist will review the chart in advance and provide a personalized recommendation for how to intensify the specific patient's antihypertensive regimen based on current guidelines. For example, they might recommend adding an additional medication based on the patient's comorbid conditions and could suggest a starting dose and timeframe for dose escalation. |
| Control | No intervention | –No intervention will be provided to physicians in the control arm. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audit and FeedbackA report of the provider's hypertension control rates compared to benchmark will be displayed using principles of social norming. We will present that provider's hypertension control rates compared to the 90th percentile of their peers. | Behavioural | Audit and Feedback |
| Pharmacist E-DetailingA pharmacist will review the chart in advance and provide a personalized recommendation for how to intensify the specific patient's antihypertensive regimen based on current guidelines. For example, they might recommend adding an additional medication based on the patient's comorbid conditions and could suggest a starting dose and timeframe for dose escalation. | Behavioural | Pharmacist E-Detailing |
Primary outcome
Treatment Intensification
Time frame: During the primary care office visit in which the provider-patient dyad received the intervention
The primary outcome was whether physicians intensified treatment at the target visit. Intensification was defined as adding a new antihypertensive medication or increasing the total daily dose of an existing one. This was measured by identifying all prescriptions for anti-hypertensive medications in the electronic health record (EHR) on the day of the target visit and comparing the medication name and total daily dose to anti-hypertensive medications prescribed prior to the target visit date, following the same procedure used to identify intensification during the eligibility assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37967641Haff N, Sreedhara SK, Wood W, Yom-Tov E, Horn DM, Hoover M, Low G, Lauffenburger JC, Chaitoff A, Russo M, Hanken K, Crum KL, Fontanet CP, Choudhry NK. Testing interventions to reduce clinical inertia in the treatment of hypertension: rationale and design of a pragmatic randomized controlled trial. Am Heart J. 2024 Feb;268:18-28. doi: 10.1016/j.ahj.2023.11.005. Epub 2023 Nov 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and Feedback and Pharmacist E-Detailing in people with Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Intensification (time frame: During the primary care office visit in which the provider-patient dyad received the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.