ABM for ACO Beneficiaries

Medication Adherence Clinical Trial

— ABM  

Official title:

Appointment Based Model (ABM) for Accountable Care Organization (ACO) Beneficiaries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137551
• Other study ID #: 012
• Status: Completed
• Phase: N/A
• First received: May 2, 2014
• Last updated: February 9, 2016
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: American Pharmacists Association Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate how engaging ACO beneficiaries in the appointment based model for one year impacts medication adherence and healthcare costs compared to usual care.

Description:

The American Pharmacists Association (APhA) Foundation has partnered with a federally qualified health center (FQHC), a supermarket community pharmacy, and an accountable care organization (ACO) to participate in this ABM for ACO Beneficiaries initiative. The FQHC, El Rio Community Health Center pharmacy, and supermarket pharmacy, Fry's Pharmacy, will serve as implementing pharmacy study sites and will implement the ABM for beneficiaries of the ACO who utilize their pharmacies for medication refill services. The ABM involves synchronizing all medications to come due on the same day of the month and the individual receives a pre-appointment phone call from the pharmacy staff to review medications and identify any changes. The ACO will provide medical and claims data on enrolled subjects as well as a control group for the intervention population. The APhA Foundation will aggregate intervention, prescription fill, and economic data from the 3 partners in an effort to evaluate the impact of the ABM on healthcare costs and medication adherence. The APhA Foundation has an a priori intent to publish the project results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Individuals eligible to be enrolled in the study include those who:

• Are beneficiaries of the partnering ACO;

• Are receiving medical care at El Rio and have been since before May 1, 2013;

• Are taking 2 or more medications that are refilled on 30, 60, or 90 day schedules;

• Speak English or Spanish;

• Are at least 18 years of age; and

• Are not institutionalized (i.e., residents of nursing homes, psychiatric institutions, or prisons).

Exclusion Criteria:

• Use of a legal authorized representative

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Other:
• ABM
The ABM involves synchronizing all medications to come due on the same say of the month and the individual receives a pre-appointment phone call from the pharmacy staff to review medications and identify any changes.

Locations

Country	Name	City	State
United States	Fry's Pharmacy Care Center	Phoenix	Arizona
United States	El Rio Community Health Center	Tucson	Arizona

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	Medical costs	Total medical costs will be collected at baseline for the year prior to enrollment and at the end of the one-year study period for the intervention year.	Baseline (for the 1 year prior to the enrollment date), During the Patient Care period (approx. 1 year following enrollment)	No
Primary	Pharmacy costs	Pharmacy costs will be collected at baseline for the year prior to enrollment and at the end of the one-year study period for the intervention year.	Baseline (at the time of enrollment), During the Patient Care period (approx. 1 year after enrollment)	No
Primary	Medication adherence	Proportion of days covered will be calculated to determine medication adherence. Data will be collected on a quarterly basis (every 3 months beginning at enrollment).	At baseline for the one year prior to enrollment, During the 1 year patient care period	No
Secondary	Identified Medication Related Problems	Information regarding the type of medication related problem identified at each intervention point will be reported to the sponsor on a quarterly basis and during the Patient Care period.	During the Patient Care period (1 year from enrollment)	No

External Links

•   APhA Foundation ABM Work