- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02137551
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
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
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Arizona
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Phoenix, Arizona, United States, 85043
- Fry's Pharmacy Care Center
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Tucson, Arizona, United States, 85745
- El Rio Community Health Center
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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:
|
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:
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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)
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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.
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Baseline (for the 1 year prior to the enrollment date), During the Patient Care period (approx. 1 year following enrollment)
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Pharmacy costs
Time Frame: Baseline (at the time of enrollment), During the Patient Care period (approx. 1 year after enrollment)
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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.
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Baseline (at the time of enrollment), During the Patient Care period (approx. 1 year after enrollment)
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Medication adherence
Time Frame: At baseline for the one year prior to enrollment, During the 1 year patient care period
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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).
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At baseline for the one year prior to enrollment, During the 1 year patient care period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identified Medication Related Problems
Time Frame: During the Patient Care period (1 year from enrollment)
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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.
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During the Patient Care period (1 year from enrollment)
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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.
Helpful Links
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
Other Study ID Numbers
- 012
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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