Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

Coronary Artery Disease Clinical Trial

Official title:

Improving Adherence to Post PCI Antiplatelet Therapy in Minority Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651208
• Other study ID #: 1RC1MD004327
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: June 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Humana Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)	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	12 months after receiving coronary stent
Secondary	4-Item Morisky Medication Adherence Scale (MMAS-4)	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.	At 12 month post stent placement