- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01651208
Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Other aims are: 1) Improve the self reported adherence of antiplatelet medications 2) Identify specific barriers for the use of post PCI anti-platelet therapy among minority populations enrolled in Humana by administering a short survey at the baseline recruitment call and at the 12 month follow up call, 3) identify predictors of never filling an anti-platelet therapy prescription post PCIS.
Inclusion criteria:
We will include black or Hispanic patients having coronary stenting using the following codes for bare metal or drug eluting stents: ICD-9 procedure codes (36.06) or (36.07), MS-DRG codes 247-249 or CPT codes 92980, 92981, C1984 G0290, G0291. The identification period will last approximately 10 months.
Primary Outcome: Medication Possession ratio as a dichotomous variable (appropriate/not appropriate adherence) and as a continuous variable
Secondary outcomes:
Self reported adherence by 4- item Morisky Medication Adherence Scale (MMAS-4) Barriers to appropriate adherence Predictors of adherence
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- We will identify prospectively all subjects who undergo coronary stenting using the following codes for bare metal or drug eluting stents: ICD-9 procedure codes (36.06) or (36.07), MS-DRG codes 247-249 or CPT codes 92980, 92981, C1984 G0290, G0291
- We will select subjects identified as Black or Hispanics by a validated algorithm that uses the Medicare race code, geocoding techniques and the Spanish Surname list.
Exclusion Criteria:
- Lack of medical files to document stent placement.
- Not receiving informed consent.
- Subjects with contraindications for antiplatelet therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivational interviewing (MINT)
The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent.
All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.
MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
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We will hire a Latino and an AA nurse to deliver the interventions and will match their race/ethnicity with that of the subject. Past experience suggests that at 4-7 calls per subjects each lasting about 30-45 minutes, a nurse can carry a caseload of about 125-150 subject (we propose 125 per nurse) Each telephone encounter will have a patient centered approach having the following basic structure and goals: a)Establishing a connection and reinforcing autonomy b)Empathizing with ambivalence and rolling with resistance.c)Coach the subject towards expressions of commitment. |
Active Comparator: Mailed DVD
A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention.
The DVD will also address many questions and concerns patients have after stent placement.
The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
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The DVD will have a documentary format that will engage subjects as the portrayed real patients relate their struggles and successes, that will entertain and ultimately motivate subjects to succeed in a similar way as the role models in the video.
That personal connection will activate patients to address their own adherence issues and will show real life ways to deal with the health behaviors recommended post PCIS.
Key concepts regarding adherence to medications and other behaviors will be imbedded in the story telling.
The DVD will also feature a humanistic perspective of a cardiologist talking about his concerns for his patients that do not adhere to the antiplatelet therapy, the difficulties that his patients face, and the merit of the success stories he witnesses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)
Time Frame: 12 months after receiving coronary stent
|
Medication Possession ratio (MPR) is a continuous multiple interval measure of medication availability.
This is a validated method of estimating medication adherence .
The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill.We will use the previously validated cutpoint of MPR>=.80 to define the binary outcome of Appropriate Adherence
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12 months after receiving coronary stent
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
4-Item Morisky Medication Adherence Scale (MMAS-4)
Time Frame: At 12 month post stent placement
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The Morisky 4-Item Medication Adherence Scale (MMAS-4) is a self-reported measure of medication-taking behavior.
Available in 33 languages, it addresses barriers to medication-taking.
Each question can be answer as Yes or No for a range of 0-4 points.
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At 12 month post stent placement
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana M Palacio, MD, MPH, University of Miami
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1RC1MD004327 (U.S. NIH Grant/Contract)
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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