Health TrialsbyHealthPanel

Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control

ConditionsHypertensionPrimary Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBrigham and Women's Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Provider nudge

    Behavioral

    Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR)

  • Patient nudge

    Behavioral

    Patients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations

  • Pharmacist Virtual Visit

    Behavioral

    Patients will receive pharmacist counseling and prescribing delivered via virtual encounters after their visit

Treatment groups

720 Participants
are divided into 3 treatment groups
Group A: Provider nudge onlyActive comparator 1 intervention
Group B: Provider nudge + Patient nudgeExperimental treatment 2 interventions
Group C: Provider nudge + Pharmacist Virtual VisitExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months

Secondary outcomes

1

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

Time frame
6 months
2

Percentage of patients with well-controlled blood pressure

Percentage of patients who reach blood pressure control defined as \<140/90mmHg

Time frame
6 months
3

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

Time frame
6 months
4

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.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Wake Forest University Health Sciences

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: