- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04275934
Blood Pressure First Medication Therapy Management (BP First)
February 18, 2023 updated by: American Pharmacists Association Foundation
Evaluation of the Impact of Self-insured Employer Implementation of an Innovative Care Model Utilizing Pharmacist-delivered MTM Services for Health Plan Beneficiaries With High Blood Pressure
The primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Univariate comparisons of the baseline/pre-intervention outcomes to the post-intervention outcomes will be performed on outcomes in order to determine how the intervention affects each.
For continuous outcomes data the univariate comparisons of the pre-treatment and post-intervention outcomes will be performed using related samples t-test comparisons.
For categorical outcomes data, comparisons of pre-intervention to post-intervention time frames will be performed using McNemar tests.
Study Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Woodstock, Georgia, United States, 30188
- Woodstock Pharmaceutical & Compounding Center Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Beneficiaries of self-insured employer who may benefit from patient-centered, team-based care that supports blood pressure control.
Description
Inclusion Criteria:
- All health plan beneficiaries 18 years-of-age and older
- Have filled at least one blood pressure medication in the last three months,
- Have a known hypertension diagnosis or have an uncontrolled blood pressure
Exclusion Criteria:
- Not an adult
- Not a health plan beneficiary of the self-insured employer
- Not ambulatory and able to work or participate in care visits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cohort
This project will evaluate the impact of self-insured employers implementing an innovative care model utilizing pharmacist-delivered MTM services for health plan beneficiaries with high blood pressure.
|
Pharmacists will work with the patient/study subject, referred to as the participant hereafter, and the participant's other health care providers to manage their blood pressure, making recommendations for medication and lifestyle adjustments as needed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure Control
Time Frame: 6-months
|
Management of Systolic and Diastolic Blood Pressure Measures
|
6-months
|
|
Blood Pressure Change
Time Frame: 6-months
|
Systolic and Diastolic Blood Pressure Measure Changes
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure Medication Adherence
Time Frame: 6-months
|
Medication Adherence for Blood Pressure Medications as Measured by Proportion of Days Covered (PDC)
|
6-months
|
|
Health Care Utilization of Primary Care Services
Time Frame: 6-months
|
Evaluation of Pre- and Post-Intervention Frequency of Primary Health Care Visits
|
6-months
|
|
Health Care Utilization of Emergency Department Services
Time Frame: 6-months
|
Evaluation of Pre- and Post-Intervention Frequency Emergency Department Visits
|
6-months
|
|
Health Care Utilization of Hospital Services
Time Frame: 6-months
|
Evaluation of Pre- and Post-Intervention Frequency of Hospital Visits
|
6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Benjamin M Bluml, RPh, APhA Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2020
Primary Completion (Actual)
July 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
February 14, 2020
First Submitted That Met QC Criteria
February 17, 2020
First Posted (Actual)
February 19, 2020
Study Record Updates
Last Update Posted (Estimate)
February 21, 2023
Last Update Submitted That Met QC Criteria
February 18, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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