Increasing Adherence to Treatment Recommendations Following a Cardiac Event
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Participation in CR
研究概览
简要总结
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.
详细描述
The purpose of this study is to test the feasibility of a pilot intervention to increase adherence behaviors among patients eligible for cardiac rehabilitation (CR). The intervention will include two components. The first component is an educational video shown pre-discharge, at the time referral to CR is made. The video, based on social-cognitive principles, will educate patients about what they can expect during CR using actual CR patients. The second component of the intervention will be a brief, telephone-delivered counseling session to increase motivation to adhere to prescribed CR participation or cardiac medications. The counseling session will use well-established motivational interviewing techniques. Three groups will be formed, with 40 participants each: a control group that receives standard care, experimental group #1 that receives the educational video plus a counseling session that focuses on participating in CR, and experimental group #2 that receives a counseling session that focuses on taking cardiac medications as prescribed.
Given that this is a pilot study and the sample size is relatively small, statistically significant differences are not expected. However, the following hypotheses will be explored:
- Experimental group #1 will differ from the control group in rates of participation in CR.
- Experimental group #2 will differ from the control group and experimental group #1 in adherence to prescribed medications.
Participants will be recruited from patients at Truman Medical Center (TMC) who are eligible for CR. Information is received daily about new patients at TMC who are eligible for CR and who need to be referred. Investigators will provide research team members information about eligible patients who can be approached about study participation. A member of the research team will visit patients in their TMC hospital rooms pre-discharge and ask if they are interested in learning about the study. If they indicate an interest in learning more, a brief summary of the study will be provided (e.g., "The investigators are interested in learning about how health care providers can best talk to patients about treatment recommendations."). Then, the team member will administer a brief cognitive assessment to determine whether the patient is able to complete the study to determine if inclusion criteria are met. If they decline participation, or if they do not correctly answer the first two screening questions, patients will be asked to answer five brief demographic questions and thanked for their time. These five demographic questions will be asked so that investigators may compare the final sample to patients who declined participation to explore for differences that could limit generalizability of findings.
If a patient correctly answers the two screening questions, and continues to be interested in learning more about the study, the research team member will provide the patient with a consent form and TMC's PHI authorization form. Upon completion of the consent form, patients also will be asked to review the pharmacy release form and complete and sign it if they consent to sharing their prescription refill data with investigators. Afterward, the Time 1 (baseline) questionnaire will be administered via interview by the research team member. The interview will take approximately 15 minutes to complete. Upon completion, the research team member will provide the participant with an appointment reminder card and a $10 cash voucher than can be used at the TMC Cash Office. At that time, the team member will schedule the next two interviews to be completed by telephone (i.e., Times 2 and 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Video + MI for CR
This group receives the educational video and an MI session for CR participation.
干预措施: Video + Motivational interview for CR participation (Behavioral)
MI for medication adherence
This group receives an MI session for taking prescribed cardioprotective medications.
干预措施: Motivational interview for medication adherence (Behavioral)
Control group (standard care)
The control group receives standard care while hospitalized.
结局指标
主要结局
Participation in CR
时间窗: Within 2 months of study enrollment
Whether participants attend an orientation session at TMC's CR program
Adherence (Ratio): P2Y12 Platelet Inhibitor
时间窗: Collected at 5 weeks post-discharge
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.
Adherence (Ratio): Beta-Blocker
时间窗: Collected at 5 weeks post-discharge
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.
Adherence (Ratio): Statin
时间窗: Collected at 5 weeks post-discharge
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.
Adherence (Ratio): Angiotensin System Blocker
时间窗: Collected at 5 weeks post-discharge
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.
Number of Participants With Self-reported Medication Adherence: P2Y12 Platelet Inhibitor
时间窗: Interview data at 5 weeks post-discharge
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.
Number of Participants With Self-reported Medication Adherence: Beta-Blocker
时间窗: Interview data at 5 weeks post-discharge
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.
Number of Participants With Self-reported Medication Adherence: Statin
时间窗: Interview data at 5 weeks post-discharge
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.
Number of Participants With Self-reported Medication Adherence: Angiotensin System Blocker
时间窗: Interview data at 5 weeks post-discharge
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.
次要结局
未报告次要终点
研究者
Kymberley Bennett
Associate Professor
University of Missouri, Kansas City