Increasing Adherence to Treatment Recommendations Following a Cardiac Event

NCT02327260 | Completed Results

• 1 other identifier: 14-521
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

This project will pilot test an intervention to increase participation rates in cardiac rehabilitation and medication adherence among patients following a cardiovascular event. The intervention will use an educational video shown during referral to cardiac rehabilitation (before hospital discharge), along with a brief, telephone-delivered counseling session to increase motivation to participate in cardiac rehabilitation and take all cardiac medications as prescribed (following hospital discharge). One hundred twenty patients who have experienced a cardiovascular event, and who are eligible for cardiac rehabilitation, will be recruited to participate in the study. Three groups of participants (40 each) will be formed: a control group that receives standard care, a first experimental group that sees the educational video and receives motivational counseling to attend cardiac rehabilitation, and a second experimental group that receives motivational counseling to adhere to their medications as prescribed. It is expected that the experimental group participants will differ from the control group participants in rates of participation in cardiac rehabilitation (experimental group #1) and medication adherence (experimental group #2). If successful, this intervention could be used in hospital settings to increase patients' adherence behaviors.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (9)

• Participation in CR

  Whether participants attend an orientation session at TMC's CR program

  Within 2 months of study enrollment

• Adherence (Ratio): P2Y12 Platelet Inhibitor

  A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.

  Collected at 5 weeks post-discharge

• Adherence (Ratio): Beta-Blocker

  A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.

  Collected at 5 weeks post-discharge

• Adherence (Ratio): Statin

  A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.

  Collected at 5 weeks post-discharge

• Adherence (Ratio): Angiotensin System Blocker

  A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.

  Collected at 5 weeks post-discharge

• Number of Participants With Self-reported Medication Adherence: P2Y12 Platelet Inhibitor

  Participants were asked how many times they filled P2Y12 Platelet Inhibitors since their discharge from TMC. Participants were coded as "adherent" if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as "adherent." Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be "non-adherent." Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent.

  Interview data at 5 weeks post-discharge

• Number of Participants With Self-reported Medication Adherence: Beta-Blocker

  Participants were asked how many times they filled Beta-Blockers since their discharge from TMC. Participants were coded as "adherent" if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as "adherent." Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be "non-adherent." Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent.

  Interview data at 5 weeks post-discharge

• Number of Participants With Self-reported Medication Adherence: Statin

  Participants were asked how many times they filled Statins since their discharge from TMC. Participants were coded as "adherent" if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as "adherent." Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be "non-adherent." Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent.

  Interview data at 5 weeks post-discharge

• Number of Participants With Self-reported Medication Adherence: Angiotensin System Blocker

  Participants were asked how many times they filled Angiotensin System Blockers since their discharge from TMC. Participants were coded as "adherent" if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as "adherent." Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be "non-adherent." Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent.

  Interview data at 5 weeks post-discharge

Study Arms (3)

Video + MI for CR

EXPERIMENTAL

This group receives the educational video and an MI session for CR participation.

Behavioral: Video + Motivational interview for CR participation

MI for medication adherence

EXPERIMENTAL

This group receives an MI session for taking prescribed cardioprotective medications.

Behavioral: Motivational interview for medication adherence

Control group (standard care)

NO INTERVENTION

The control group receives standard care while hospitalized.

Interventions

Video + Motivational interview for CR participation BEHAVIORAL

Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.

Video + MI for CR

Motivational interview for medication adherence BEHAVIORAL

The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.

MI for medication adherence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referral to CR according to the AACVPR/ACCF/AHA guidelines
• English speaking
• At least 18 years of age
• Lack of physical or cognitive impairments that would limit patients' abilities to complete study materials or participate in CR.

You may not qualify if:

• Physical impairment such as debilitating stroke or another medical condition that would limit their ability to complete the study materials or participate in CR
• Patients transferred to an outside facility for revascularization procedures
• Previous participation in this research protocol (i.e. patients can only participate one time)
• Non-English speaking.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (1)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Videotape Recording; Motivational Interviewing

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Kym Bennett
• Organization: University of Missouri, Kansas City

bennettkk@umkc.edu

816-235-6370

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 30, 2014
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2017
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-01

Locations

US (1)