MedPath

Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

Not Applicable
Completed
Conditions
Coronary Artery Disease
Interventions
Behavioral: Mailed DVD
Behavioral: Motivational Interviewing (MINT)
Registration Number
NCT01651208
Lead Sponsor
University of Miami
Brief Summary

The purpose of this study is to evaluate if the use of a phone based motivational interviewing among minority populations who received a coronary stent can improve adherence to antiplatelet agents from approximately 51% to 66% (15 percentage point increase) at 12 months post stent placement when compared to a mailed educational DVD.

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
452
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
  1. Lack of medical files to document stent placement.
  2. Not receiving informed consent.
  3. Subjects with contraindications for antiplatelet therapy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mailed DVDMailed DVDA 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.
Motivational interviewing (MINT)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.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)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

Secondary Outcome Measures
NameTimeMethod
4-Item Morisky Medication Adherence Scale (MMAS-4)At 12 month post stent placement

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.

Trial Locations

Locations (1)

University of Miami

🇺🇸

Miami, Florida, United States

© Copyright 2025. All Rights Reserved by MedPath