Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

• ClinicalTrials.gov Identifier: NCT01651208
• Recruitment Status: Completed
• First Posted: July 26, 2012
• Results First Posted: August 22, 2014
• Last Update Posted: June 9, 2017
• Sponsor: University of Miami
• Collaborator: Humana, Inc
• Information provided by (Responsible Party): Ana M. Palacio, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Behavioral: Motivational Interviewing (MINT); Behavioral: Mailed DVD	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 452 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations
• Study Start Date: January 2010
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: June 2012

Arms and Interventions

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.	Behavioral: Motivational Interviewing (MINT); 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.	Behavioral: Mailed DVD; 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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 4-Item Morisky Medication Adherence Scale (MMAS-4) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

University of Miami

Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

Humana, Inc

Investigators

• Principal Investigator: Ana M Palacio, MD, MPH; University of Miami

More Information

Publications:

Palacio AM, Tamariz LJ, Uribe C, Li H, Salkeld EJ, Hazel-Fernandez L, Carrasquillo O. Can claims-based data be used to recruit black and Hispanic subjects into clinical trials? Health Serv Res. 2012 Apr;47(2):770-82. doi: 10.1111/j.1475-6773.2011.01316.x. Epub 2011 Aug 30.

• Responsible Party: Ana M. Palacio, Associate Professor of Clinical Medicine, University of Miami
• ClinicalTrials.gov Identifier: NCT01651208
• Other Study ID Numbers: 1RC1MD004327 ( U.S. NIH Grant/Contract )
• First Posted: July 26, 2012
• Results First Posted: August 22, 2014
• Last Update Posted: June 9, 2017
• Last Verified: May 2017

Keywords provided by Ana M. Palacio, University of Miami:

Coronary stents; Medication adherence; Antiplatelet medications; Motivational Interviewing

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases