HypertensionNCT07228065
Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control
A study testing Provider nudge, Patient nudge and Pharmacist Virtual Visit in people with Hypertension and Primary Care, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The proposed study is an effectiveness-implementation hybrid type II trial designed to evaluate the impact of provider- and patient-directed interventions on FDC use. The trial will test the effectiveness of theory-driven nudges tailored to address provider and patient barriers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Primary Care
- What is being tested?
- Provider nudge, Patient nudge and Pharmacist Virtual Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with documented hypertension diagnosis
- had an elevated ambulatory blood pressure reading during the qualifying visit (systolic >140 mmHg or diastolic >90 mmHg
- have an upcoming scheduled visit
- have an active prescription for 1 blood pressure lowering medication with a fixed-dose combination (FDC) alternative
Who cannot join
- have received a prescription for a FDC in the preceding two years
- reside in a nursing home
- have a documented allergy to any FDC components
- are pregnant
- preferred language is not English or Spanish, defined as documentation in the EHR indicating a primary language other than English or Spanish, or a documented request for an interpreter in a language other than Spanish
- have a diagnosis of heart failure or renal failure, given that antihypertensive management in these populations typically requires disease-specific regimens and more frequent treatment adjustments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pharmacy-led Intervention to Increase the Adoption of Fixed-dose Single Pill Blood Pressure Lowering Medications: Hybrid Effectiveness-Implementation Trial
The proposed study is an effectiveness-implementation hybrid type II trial designed to evaluate the impact of provider- and patient-directed interventions on FDC use. The trial will test the effectiveness of theory-driven nudges tailored to address provider and patient barriers. All interventions will be pharmacist-driven, with pharmacists delivering information via nudges to providers and via nudges or more intensive interventions (i.e., CPA) to patients. Data to evaluate outcomes will be extracted from electronic health records.
- Conditions
- Hypertension, Primary Care
- Being tested
- Provider nudge, Patient nudge, Pharmacist Virtual Visit
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider nudgeBehavioural
Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR)
Patient nudgeBehavioural
Patients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations
Pharmacist Virtual VisitBehavioural
Patients will receive pharmacist counseling and prescribing delivered via virtual encounters after their visit
| Study group | Role | What they receive |
|---|---|---|
| Provider nudge only | Active comparator | Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the EHR. Receives: Behavioral: Provider nudge |
| Provider nudge + Patient nudge | Experimental | In addition to provider nudges (Provider nudge only arm), patients will receive pharmacist delivered nudges (e.g., text messages) 1-7 days before the visit to encourage fixed dose combination medications. Receives: Behavioral: Provider nudge; Behavioral: Patient nudge |
| Provider nudge + Pharmacist Virtual Visit | Experimental | In addition to provider nudges (Provider nudge only arm), patients will receive pharmacist counseling and prescribing delivered via virtual encounters after the visit. Receives: Behavioral: Provider nudge; Behavioral: Pharmacist Virtual Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Data for this outcome will be extracted from electronic health records. The primary effectiveness outcome will be a change in ambulatory systolic blood pressure at 3 months. For patients who do not return within 3 months, their index visit reading will be carried forward.
Measured: 6 months
Secondary outcomes (4)
Change in diastolic blood pressure
Change in diastolic blood pressure from qualifying visit blood pressure reading to the end of the 6-month follow-up, using EHR data
Measured: 6 months
Percentage of patients with well-controlled blood pressure
Percentage of patients who reach blood pressure control defined as <140/90mmHg
Measured: 6 months
PCP level adoption: FDC prescribing; FDC discussion in EHR notes
Percentage of patients whose PCPs prescribe FDC within 6 months; any intensification at 6 months will also be explored; any FDC documentation in the notes
Measured: 6 months
Patient level adoption: FDC adherence (fill)
Percentage of patients who fill their first FDC prescription within 6 months; filling any intensified prescription within 6 months will also be explored.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start7 Aug 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Julie Lauffenburger, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228065
- Sponsor's protocol ID
- 2025P002849
- Other IDs
- 2P30AG064199
- Status last verified
- Aug 2026
- First submitted
- 12 Nov 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacy-led Intervention to Increase the Adoption of Fixed-dose Single Pill Blood Pressure Lowering Medications: Hybrid Effectiveness-Implementation Trial
- ClinicalTrials.gov ID
- NCT07228065
- Acronym / sponsor ID
- 2025P002849
- Conditions
- Hypertension, Primary Care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Wake Forest University Health Sciences
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is an effectiveness-implementation hybrid type II trial designed to evaluate the impact of provider- and patient-directed interventions on FDC use. The trial will test the effectiveness of theory-driven nudges tailored to address provider and patient barriers. All interventions will be pharmacist-driven, with pharmacists delivering information via nudges to providers and via nudges or more intensive interventions (i.e., CPA) to patients. Data to evaluate outcomes will be extracted from electronic health records.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Provider nudge only | Active comparator | Behavioral: Provider nudgePharmacists will deliver targeted nudges to providers through clinical decision support integrated into the EHR. |
| Provider nudge + Patient nudge | Experimental | Behavioral: Provider nudge, Behavioral: Patient nudgeIn addition to provider nudges (Provider nudge only arm), patients will receive pharmacist delivered nudges (e.g., text messages) 1-7 days before the visit to encourage fixed dose combination medications. |
| Provider nudge + Pharmacist Virtual Visit | Experimental | Behavioral: Provider nudge, Behavioral: Pharmacist Virtual VisitIn addition to provider nudges (Provider nudge only arm), patients will receive pharmacist counseling and prescribing delivered via virtual encounters after the visit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with documented hypertension diagnosis
- had an elevated ambulatory blood pressure reading during the qualifying visit (systolic >140 mmHg or diastolic >90 mmHg
- have an upcoming scheduled visit
- have an active prescription for 1 blood pressure lowering medication with a fixed-dose combination (FDC) alternative
Key exclusion criteria (6 listed)
- have received a prescription for a FDC in the preceding two years
- reside in a nursing home
- have a documented allergy to any FDC components
- are pregnant
- preferred language is not English or Spanish, defined as documentation in the EHR indicating a primary language other than English or Spanish, or a documented request for an interpreter in a language other than Spanish
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 |
|---|---|---|
| Provider nudgePharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR) | Behavioural | Provider nudge + Patient nudge, Provider nudge + Pharmacist Virtual Visit, Provider nudge only |
| Patient nudgePatients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations | Behavioural | Provider nudge + Patient nudge |
| Pharmacist Virtual VisitPatients will receive pharmacist counseling and prescribing delivered via virtual encounters after their visit | Behavioural | Provider nudge + Pharmacist Virtual Visit |
Primary outcome
Change in systolic blood pressure
Time frame: 6 months
Data for this outcome will be extracted from electronic health records. The primary effectiveness outcome will be a change in ambulatory systolic blood pressure at 3 months. For patients who do not return within 3 months, their index visit reading will be carried forward.
4 secondary outcomes
Change in diastolic blood pressure
Time frame: 6 months
Percentage of patients with well-controlled blood pressure
Time frame: 6 months
PCP level adoption: FDC prescribing; FDC discussion in EHR notes
Time frame: 6 months
Patient level adoption: FDC adherence (fill)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
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 Provider nudge, Patient nudge and Pharmacist Virtual Visit in people with Hypertension and Primary Care, 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?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in systolic blood pressure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2026.