Medication AdherenceABMNCT02137551
ABM for ACO Beneficiaries
A study testing ABM in people with Medication Adherence, run by American Pharmacists Association Foundation at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence
- What is being tested?
- ABM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Use of a legal authorized representative
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fry's Pharmacy Care Center
Phoenix, Arizona, 85043
El Rio Community Health Center
Tucson, Arizona, 85745
About this study
Official title: 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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- ABM
- Keywords
- adherence, healthcare costs, appointment based model, accountable care organization
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABMOther
Also called Appointment Based Model
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.
| Study group | Role | What they receive |
|---|---|---|
| ABM Intervention in FQHC | Experimental | Pharmacy technicians within El Rio will implement the ABM Receives: Other: ABM |
| ABM Intervention in a Supermarket Pharmacy | Experimental | Pharmacists within Fry's will implement the ABM Receives: Other: ABM |
| Usual care | No intervention | Patients will refill prescriptions at their usual pharmacy in the customary way. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: At baseline for the one year prior to enrollment, During the 1 year patient care period
Secondary outcomes (1)
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.
Measured: During the Patient Care period (1 year from enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 595 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Pharmacists Association Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsay Kunkle, PharmD, Principal investigator, APhABenjamin Bluml, BPharm, Study director, APhA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137551
- Sponsor's protocol ID
- 012
- Acronym
- ABM
- Status last verified
- Feb 2016
- First submitted
- 2 May 2014
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appointment Based Model (ABM) for Accountable Care Organization (ACO) Beneficiaries
- ClinicalTrials.gov ID
- NCT02137551
- Acronym / sponsor ID
- ABM / 012
- Conditions
- Medication Adherence
- Keywords
- adherence, healthcare costs, appointment based model, accountable care organization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 595 participants (actual)
- Lead sponsor
- American Pharmacists Association FoundationUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABM Intervention in FQHC | Experimental | Other: ABMPharmacy technicians within El Rio will implement the ABM |
| ABM Intervention in a Supermarket Pharmacy | Experimental | Other: ABMPharmacists within Fry's will implement the ABM |
| Usual care | No intervention | –Patients will refill prescriptions at their usual pharmacy in the customary way. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Use of a legal authorized representative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABMAlso: Appointment Based ModelThe 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 | ABM Intervention in FQHC, ABM Intervention in a Supermarket Pharmacy |
Primary outcome
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.
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.
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).
1 secondary outcome
Identified Medication Related Problems
Time frame: During the Patient Care period (1 year from enrollment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Kunkle, PharmD principal investigator
APhA
Benjamin Bluml, BPharm study director
APhA Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABM in people with Medication Adherence, run by American Pharmacists Association Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical costs (time frame: Baseline (for the 1 year prior to the enrollment date), During the Patient Care period (approx. 1 year following enrollment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.