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Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease (PILOT-EBM)

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ClinicalTrials.gov Identifier: NCT00323258
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : April 19, 2012
Last Update Posted : January 18, 2013
Sponsor:
Collaborators:
Pfizer
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Condition Cardiovascular Disease
Interventions Behavioral: oral education & written tips for remembering medications
Device: pill box
Device: pocket medication card
Behavioral: sharing information with community pharmacist
Behavioral: Medication use evaluations by community pharmacist
Behavioral: informing physician if patient has stopped a medication
Behavioral: Routine discharge counseling
Other: Letter to physician/discharge summary
Enrollment 143
Recruitment Details 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.
Pre-assignment Details 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).
Arm/Group Title Intervention Arm Usual Care
Hide Arm/Group Description

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.

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.

Period Title: Primary Outcome (Phone Call at 6 Months)
Started 71 72
Completed 55 53
Not Completed 16 19
Reason Not Completed
Death             1             2
Lost to Follow-up             12             11
Withdrawal by Subject             1             5
Died between 180-240 days (call period)             2             1
Period Title: Secondary Outcome (6 Mon Refill Records)
Started 71 72
Completed 57 58
Not Completed 14 14
Reason Not Completed
Death             1             2
Lost to Follow-up             12             10
Withdrawal by Subject             1             2
Arm/Group Title Intervention Arm Usual Care Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 71 72 143
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 71 participants 72 participants 143 participants
63
(54 to 71)
62
(52 to 70)
62
(53 to 70)
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 71 participants 72 participants 143 participants
63.0  (11.5) 61.5  (12.0) 62.3  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 72 participants 143 participants
Female
24
  33.8%
28
  38.9%
52
  36.4%
Male
47
  66.2%
44
  61.1%
91
  63.6%
1.Primary Outcome
Title Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months
Hide Description 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
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 55 53
Measure Type: Number
Unit of Measure: percentage of participants
91 94
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Usual Care
Comments Sample size of 286 patients(143 patients per group).Based on an estimated absolute improvement in medication adherence of 15% in the intervention group (eg, 85% in the intervention group, 70% in the control group), a 2-sided test with α level of .05, a 15% dropout rate, and power of 0.80.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalence analysis. Null hypothesis: The will be no difference in proportion of participants adherent to triple therapy in the “treatment” arm compared to those who receive “usual care.”
Statistical Test of Hypothesis P-Value .50
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records
Hide Description 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
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 57 58
Measure Type: Number
Unit of Measure: percentage of participants
53 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Usual Care
Comments Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are >/= 75% adherent to combined beta-blocker and statin therapy in the “treatment” arm compared to those who receive “usual care.”
Statistical Test of Hypothesis P-Value =0.11
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Percent of Patients Adherent to Beta-blocker Via Refill Records
Hide Description

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

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 57 58
Measure Type: Number
Unit of Measure: percentage of patients with PDC >or=75%
71 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Usual Care
Comments Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are >/= 75% adherent to beta-blockers in the “treatment” arm compared to those who receive “usual care.”
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Percent of Patients Adherent to Statin Via Refill Records
Hide Description

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

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 57 58
Measure Type: Number
Unit of Measure: percentage of patients with >or=75%
58 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Usual Care
Comments Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are >/= 75% adherent to statins in the “treatment” arm compared to those who receive “usual care.”
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Death in Intervention Patients Compared to Usual Care
Hide Description Number of patients who died in each treatment group prior to the 6 month follow-up time point.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 71 72
Measure Type: Number
Unit of Measure: participants
1 2
Time Frame [Not Specified]
Adverse Event Reporting Description This was a behavioral and educational intervention. It was minimal risk and all patients (both groups) were taking the same medication classes. Adverse Events were not collected for this study. Death was not considered an event but collected only as a reason for not being available for follow-up with a participant.
 
Arm/Group Title Intervention Usual Care
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sara Calvert, PharmD
Organization: Duke University Medical Center
Phone: 919-668-7540
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00323258     History of Changes
Other Study ID Numbers: Pro00005018
U18HS010548 ( U.S. AHRQ Grant/Contract )
First Submitted: May 5, 2006
First Posted: May 9, 2006
Results First Submitted: March 19, 2012
Results First Posted: April 19, 2012
Last Update Posted: January 18, 2013