Trial Outcomes & Findings for Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease (NCT NCT00323258)
NCT ID: NCT00323258
Last Updated: 2013-01-18
Results Overview
Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist
COMPLETED
NA
143 participants
6 months
2013-01-18
Participant Flow
Patients hospitalized at Duke University Hospital (Durham, NC) were screened for study enrollment from July 5, 2006, through July 2, 2009. To increase enrollment, the study was opened to enrollment at Southeastern Regional Medical Center (Lumberton, NC) on May 27, 2008.
After patients provided written informed consent, the study pharmacist collected baseline demographics, medical history, medication history, potential barriers to medication adherence, pharmacy name, physicians' contact information, and the Beliefs about Medicines Questionnaire (BMQ).
Participant milestones
| Measure |
Intervention Arm
Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.
|
Usual Care
The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.
|
|---|---|---|
|
Primary Outcome (Phone Call at 6 Months)
STARTED
|
71
|
72
|
|
Primary Outcome (Phone Call at 6 Months)
COMPLETED
|
55
|
53
|
|
Primary Outcome (Phone Call at 6 Months)
NOT COMPLETED
|
16
|
19
|
|
Secondary Outcome (6 Mon Refill Records)
STARTED
|
71
|
72
|
|
Secondary Outcome (6 Mon Refill Records)
COMPLETED
|
57
|
58
|
|
Secondary Outcome (6 Mon Refill Records)
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
| Measure |
Intervention Arm
Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.
|
Usual Care
The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.
|
|---|---|---|
|
Primary Outcome (Phone Call at 6 Months)
Death
|
1
|
2
|
|
Primary Outcome (Phone Call at 6 Months)
Lost to Follow-up
|
12
|
11
|
|
Primary Outcome (Phone Call at 6 Months)
Withdrawal by Subject
|
1
|
5
|
|
Primary Outcome (Phone Call at 6 Months)
Died between 180-240 days (call period)
|
2
|
1
|
|
Secondary Outcome (6 Mon Refill Records)
Death
|
1
|
2
|
|
Secondary Outcome (6 Mon Refill Records)
Lost to Follow-up
|
12
|
10
|
|
Secondary Outcome (6 Mon Refill Records)
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=71 Participants
Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.
|
Usual Care
n=72 Participants
The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.0 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Those participants alive and able to speak to pharmacist on 6 month follow up phone call. Missing (n=35)- Could not be reached: 12 intervention and 11 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Died during call period: 2 intervention and 1 usual care, refused to participate in call: 1 intervention and 5 usual care.
Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist
Outcome measures
| Measure |
Intervention
n=55 Participants
Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
|
Usual Care
n=53 Participants
Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
|
|---|---|---|
|
Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months
|
91 percentage of participants
|
94 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.
Percent of patients in each group adherent to beta-blocker and statin for 6 months after discharge as assessed by refill records from the patient's pharmacy
Outcome measures
| Measure |
Intervention
n=57 Participants
Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
|
Usual Care
n=58 Participants
Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
|
|---|---|---|
|
Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records
|
53 percentage of participants
|
38 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.
According to the local pharmacy records, the patient has had a supply of beta-blocker for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account. % adherence = (days of available drug supply in the first 180 days/180)\*100 If % adherence = or \> 75, then adherence = yes
Outcome measures
| Measure |
Intervention
n=57 Participants
Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
|
Usual Care
n=58 Participants
Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
|
|---|---|---|
|
Percent of Patients Adherent to Beta-blocker Via Refill Records
|
71 percentage of patients with PDC >or=75%
|
49 percentage of patients with PDC >or=75%
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.
According to the local pharmacy records, the patient has had a supply of statin for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account. % adherence = (days of available drug supply in the first 180 days/180)\*100 If % adherence = or \> 75, then adherence = yes
Outcome measures
| Measure |
Intervention
n=57 Participants
Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
|
Usual Care
n=58 Participants
Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
|
|---|---|---|
|
Percent of Patients Adherent to Statin Via Refill Records
|
58 percentage of patients with >or=75%
|
49 percentage of patients with >or=75%
|
SECONDARY outcome
Timeframe: 6 monthsNumber of patients who died in each treatment group prior to the 6 month follow-up time point.
Outcome measures
| Measure |
Intervention
n=71 Participants
Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
|
Usual Care
n=72 Participants
Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
|
|---|---|---|
|
Death in Intervention Patients Compared to Usual Care
|
1 participants
|
2 participants
|
Adverse Events
Intervention
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place