Blood Pressure First Medication Therapy Management

Hypertension Clinical Trial

— BP First  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04275934
• Other study ID #: 020
• Status: Completed
• Start date: February 6, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2023
• Source: American Pharmacists Association Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• Health Management; 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.

Locations

Country	Name	City	State
United States	Woodstock Pharmaceutical & Compounding Center Inc.	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
American Pharmacists Association Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Control	Management of Systolic and Diastolic Blood Pressure Measures	6-months
Primary	Blood Pressure Change	Systolic and Diastolic Blood Pressure Measure Changes	6-months
Secondary	Blood Pressure Medication Adherence	Medication Adherence for Blood Pressure Medications as Measured by Proportion of Days Covered (PDC)	6-months
Secondary	Health Care Utilization of Primary Care Services	Evaluation of Pre- and Post-Intervention Frequency of Primary Health Care Visits	6-months
Secondary	Health Care Utilization of Emergency Department Services	Evaluation of Pre- and Post-Intervention Frequency Emergency Department Visits	6-months
Secondary	Health Care Utilization of Hospital Services	Evaluation of Pre- and Post-Intervention Frequency of Hospital Visits	6-months