NCT02137551

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
595

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

May 2, 2014

Last Update Submit

February 9, 2016

Conditions

Keywords

adherencehealthcare costsappointment based modelaccountable care organization

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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

Secondary Outcomes (1)

  • Identified Medication Related Problems

    During the Patient Care period (1 year from enrollment)

Study Arms (3)

ABM Intervention in FQHC

EXPERIMENTAL

Pharmacy technicians within El Rio will implement the ABM

Other: ABM

ABM Intervention in a Supermarket Pharmacy

EXPERIMENTAL

Pharmacists within Fry's will implement the ABM

Other: ABM

Usual care

NO INTERVENTION

Patients will refill prescriptions at their usual pharmacy in the customary way.

Interventions

ABMOTHER

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.

Also known as: Appointment Based Model
ABM Intervention in FQHCABM Intervention in a Supermarket Pharmacy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Use of a legal authorized representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fry's Pharmacy Care Center

Phoenix, Arizona, 85043, United States

Location

El Rio Community Health Center

Tucson, Arizona, 85745, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Lindsay Kunkle, PharmD

    APhA

    PRINCIPAL INVESTIGATOR
  • Benjamin Bluml, BPharm

    APhA Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2014

First Posted

May 14, 2014

Study Start

August 1, 2014

Primary Completion

November 1, 2015

Study Completion

February 1, 2016

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations