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

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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