ABM for ACO Beneficiaries (ABM)

February 9, 2016 updated by: American Pharmacists Association Foundation

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

595

Phase

  • Not Applicable

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

    • Arizona
      • Phoenix, Arizona, United States, 85043
        • Fry's Pharmacy Care Center
      • Tucson, Arizona, United States, 85745
        • El Rio Community Health Center

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

Description

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 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

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ABM Intervention in FQHC
Pharmacy technicians within El Rio will implement the 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.
Other Names:
  • Appointment Based Model
EXPERIMENTAL: ABM Intervention in a Supermarket Pharmacy
Pharmacists within Fry's will implement the 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.
Other Names:
  • Appointment Based Model
NO_INTERVENTION: Usual care
Patients will refill prescriptions at their usual pharmacy in the customary way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical costs
Time Frame: Baseline (for the 1 year prior to the enrollment date), During the Patient Care period (approx. 1 year following enrollment)
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)
Pharmacy costs
Time Frame: Baseline (at the time of enrollment), During the Patient Care period (approx. 1 year after enrollment)
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)
Medication adherence
Time Frame: At baseline for the one year prior to enrollment, During the 1 year patient care period
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identified Medication Related Problems
Time Frame: During the Patient Care period (1 year from enrollment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lindsay Kunkle, PharmD, APhA
  • Study Director: Benjamin Bluml, BPharm, APhA Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

August 1, 2014

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

May 2, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (ESTIMATE)

May 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

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.

Clinical Trials on Medication Adherence

Clinical Trials on ABM

3
Subscribe