Increasing Adherence to Treatment Recommendations Following a Cardiac Event
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | November 2016 |
| Contact: | Kymberley Bennett, Ph.D. |
| Email: | bennettkk@umkc.edu |
| Phone: | 816-235-6370 |
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.
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.
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).
Upon completion of the Time 1 questionnaire, the team member will complete a form with the
participant's basic information and provide it to the CR nurse. In turn, the CR nurse will
assign the participant to one of the three study groups. Before recruitment begins, a
statistician will create a random number table with group assignments stratified by race and
heart failure diagnosis. The random number table will be used to create sealed envelopes
with randomization information for each study participant. The envelopes will be
sequentially numbered and provided to the CR nurse before recruitment. Upon receiving a form
from a team member, she will open the next sealed envelope to reveal into which group the
participant is assigned. She will note the envelope number and group assignment on the form.
Then, the form will be provided to the research team for secure storage.
Participants will be randomly assigned to one of three groups:
A control group that receives standard care. Standard care includes a visit by the CR nurse
pre-discharge to refer the patient to CR. This referral session includes a discussion of
heart health, CR benefits and outcomes, and literature about prescribed medications. If
possible, the CR orientation appointment is scheduled with patients. If it is not possible
to schedule the orientation session at the referral, CR staff members call the patient a few
days after discharge to schedule an appointment. Reminder calls are made by CR staff members
a few days before scheduled appointments. The pharmacist also visits all patients after the
CR referral is made to review prescribed medications. Follow-up phone calls are made 2-3
days after discharge by the pharmacy team to answer any medication questions and
trouble-shoot any problems.
Experimental group #1: This group will receive standard care (detailed above), and it will
be shown the educational video on an iPad by the CR nurse during referral. The educational
video will be based on social-cognitive principles, with the goal of educating prospective
CR patients about what happens during CR. The video will be approximately nine minutes long,
and will feature testimonials by real CR patients. In addition, this group will be called by
a trained counselor approximately one week after discharge. During this call, the counselor
will conduct a brief counseling session, using motivational interviewing (MI) techniques,
that focuses on increasing motivation to participate in CR. During this session, the
counselor will help the participant identify barriers and benefits to participating in CR,
thereby increasing internal motivation to participate. The counseling session will take
approximately 10 minutes.
Experimental group #2: This group will receive standard care (detailed above), plus a
counseling session that focuses on medical adherence. Specifically, the counselor will
conduct a session on improving internal motivation to adhere to the cardiac medications
prescribed by the pharmacist. The session will take approximately 10 minutes.
As stated above, the CR nurse will note the participant's randomization on the information
sheet, and this information will be shared with the other research team members after the
participant is discharged from the hospital. This information will be shared with team
members prior to the Time 2 phone call (because group membership needs to be determined
before the call is made to plan for which, if any, counseling session will be completed).
All participants will take part in the Time 1 interview (see above), as well as telephone
interviews at Time 2 (approximately one week post-discharge; immediately prior to the
counseling session provided to the experimental groups) and Time 3 (approximately five weeks
post-discharge). The Time 2 interview will take approximately 20 minutes and the Time 3
interview will take approximately 30 minutes.
Therefore, the control group will take part in a 15-minute Time 1 in-person interview, a
20-minute Time 2 telephone interview, and a 30-minute Time 3 telephone interview.
Experimental group #1 will take part in a 15-minute Time 1 in-person interview, a 20-minute
Time 2 telephone interview, a 10 minute counseling session immediately following the Time 2
interview, and a 30-minute Time 3 telephone interview. Experimental group #3 will take part
in a 15-minute Time 1 in-person interview, a 20-minute Time 2 telephone interview, a
10-minute counseling session immediately following the Time 2 interview, and a 30-minute
Time 3 telephone interview.
The Time 1 (baseline) interview measures the following constructs/contains the following
scales:
- Demographic questions
- Confidence and motivation to change behaviors
- Knowledge about cardiac rehabilitation
- Patient Health Questionnaire (PHQ-9)
- Perceived Stress Scale (PSS)
- Subjective health status (adapted from BRFSS)
- Cardiac self-blame
The Time 2 (1-week post-discharge) interview measures the following constructs/contains the
following scales:
- Confidence and motivation to change behaviors
- Medication Adherence Self-Efficacy
- Treatment Self-Regulation Questionnaire
- Knowledge about cardiac rehabilitation
- Knowledge about cardioprotective medications
- Patient Health Questionnaire (PHQ-9)
- Perceived Stress Scale (PSS)
- Subjective health status (adapted from BRFSS)
- Medical Care Questionnaire
- Medication Adherence
- Feedback about educational video (not for control/experimental group #2)
The Time 3 (5-weeks post-discharge) interview measures the following constructs/contains the
following scales:
- Confidence and motivation to change behaviors
- Medication Adherence Self-Efficacy
- Treatment Self-Regulation Questionnaire
- Knowledge about cardiac rehabilitation
- Knowledge about cardioprotective medications
- Patient Health Questionnaire (PHQ-9)
- Perceived Stress Scale (PSS)
- Subjective health status (adapted from BRFSS)
- Medical Care Questionnaire
- Medication Adherence
- Ratings of the counseling session (not for control group)
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).
Upon completion of the Time 1 questionnaire, the team member will complete a form with the
participant's basic information and provide it to the CR nurse. In turn, the CR nurse will
assign the participant to one of the three study groups. Before recruitment begins, a
statistician will create a random number table with group assignments stratified by race and
heart failure diagnosis. The random number table will be used to create sealed envelopes
with randomization information for each study participant. The envelopes will be
sequentially numbered and provided to the CR nurse before recruitment. Upon receiving a form
from a team member, she will open the next sealed envelope to reveal into which group the
participant is assigned. She will note the envelope number and group assignment on the form.
Then, the form will be provided to the research team for secure storage.
Participants will be randomly assigned to one of three groups:
A control group that receives standard care. Standard care includes a visit by the CR nurse
pre-discharge to refer the patient to CR. This referral session includes a discussion of
heart health, CR benefits and outcomes, and literature about prescribed medications. If
possible, the CR orientation appointment is scheduled with patients. If it is not possible
to schedule the orientation session at the referral, CR staff members call the patient a few
days after discharge to schedule an appointment. Reminder calls are made by CR staff members
a few days before scheduled appointments. The pharmacist also visits all patients after the
CR referral is made to review prescribed medications. Follow-up phone calls are made 2-3
days after discharge by the pharmacy team to answer any medication questions and
trouble-shoot any problems.
Experimental group #1: This group will receive standard care (detailed above), and it will
be shown the educational video on an iPad by the CR nurse during referral. The educational
video will be based on social-cognitive principles, with the goal of educating prospective
CR patients about what happens during CR. The video will be approximately nine minutes long,
and will feature testimonials by real CR patients. In addition, this group will be called by
a trained counselor approximately one week after discharge. During this call, the counselor
will conduct a brief counseling session, using motivational interviewing (MI) techniques,
that focuses on increasing motivation to participate in CR. During this session, the
counselor will help the participant identify barriers and benefits to participating in CR,
thereby increasing internal motivation to participate. The counseling session will take
approximately 10 minutes.
Experimental group #2: This group will receive standard care (detailed above), plus a
counseling session that focuses on medical adherence. Specifically, the counselor will
conduct a session on improving internal motivation to adhere to the cardiac medications
prescribed by the pharmacist. The session will take approximately 10 minutes.
As stated above, the CR nurse will note the participant's randomization on the information
sheet, and this information will be shared with the other research team members after the
participant is discharged from the hospital. This information will be shared with team
members prior to the Time 2 phone call (because group membership needs to be determined
before the call is made to plan for which, if any, counseling session will be completed).
All participants will take part in the Time 1 interview (see above), as well as telephone
interviews at Time 2 (approximately one week post-discharge; immediately prior to the
counseling session provided to the experimental groups) and Time 3 (approximately five weeks
post-discharge). The Time 2 interview will take approximately 20 minutes and the Time 3
interview will take approximately 30 minutes.
Therefore, the control group will take part in a 15-minute Time 1 in-person interview, a
20-minute Time 2 telephone interview, and a 30-minute Time 3 telephone interview.
Experimental group #1 will take part in a 15-minute Time 1 in-person interview, a 20-minute
Time 2 telephone interview, a 10 minute counseling session immediately following the Time 2
interview, and a 30-minute Time 3 telephone interview. Experimental group #3 will take part
in a 15-minute Time 1 in-person interview, a 20-minute Time 2 telephone interview, a
10-minute counseling session immediately following the Time 2 interview, and a 30-minute
Time 3 telephone interview.
The Time 1 (baseline) interview measures the following constructs/contains the following
scales:
- Demographic questions
- Confidence and motivation to change behaviors
- Knowledge about cardiac rehabilitation
- Patient Health Questionnaire (PHQ-9)
- Perceived Stress Scale (PSS)
- Subjective health status (adapted from BRFSS)
- Cardiac self-blame
The Time 2 (1-week post-discharge) interview measures the following constructs/contains the
following scales:
- Confidence and motivation to change behaviors
- Medication Adherence Self-Efficacy
- Treatment Self-Regulation Questionnaire
- Knowledge about cardiac rehabilitation
- Knowledge about cardioprotective medications
- Patient Health Questionnaire (PHQ-9)
- Perceived Stress Scale (PSS)
- Subjective health status (adapted from BRFSS)
- Medical Care Questionnaire
- Medication Adherence
- Feedback about educational video (not for control/experimental group #2)
The Time 3 (5-weeks post-discharge) interview measures the following constructs/contains the
following scales:
- Confidence and motivation to change behaviors
- Medication Adherence Self-Efficacy
- Treatment Self-Regulation Questionnaire
- Knowledge about cardiac rehabilitation
- Knowledge about cardioprotective medications
- Patient Health Questionnaire (PHQ-9)
- Perceived Stress Scale (PSS)
- Subjective health status (adapted from BRFSS)
- Medical Care Questionnaire
- Medication Adherence
- Ratings of the counseling session (not for control group)
Inclusion Criteria:
1. Referral to CR according to the AACVPR/ACCF/AHA guidelines
2. English speaking
3. At least 18 years of age
4. Lack of physical or cognitive impairments that would limit patients' abilities to
complete study materials or participate in CR.
Exclusion Criteria:
1. Physical impairment such as debilitating stroke or another medical condition that
would limit their ability to complete the study materials or participate in CR
2. Patients transferred to an outside facility for revascularization procedures
3. Previous participation in this research protocol (i.e. patients can only participate
one time)
4. Non-English speaking.
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Truman Medical Center Located in the heart of downtown Kansas City, TMC Hospital Hill is...
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