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

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00323258
First received: May 5, 2006
Last updated: January 11, 2013
Last verified: May 2012
Results First Received: March 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
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.


Participant Flow for 2 periods

Period 1:   Primary Outcome (Phone Call at 6 Months)
    Intervention Arm     Usual Care  
STARTED     71     72  
COMPLETED     55     53  
NOT COMPLETED     16     19  
Death                 1                 2  
Lost to Follow-up                 12                 11  
Withdrawal by Subject                 1                 5  
Died between 180-240 days (call period)                 2                 1  

Period 2:   Secondary Outcome (6 Mon Refill Records)
    Intervention Arm     Usual Care  
STARTED     71     72  
COMPLETED     57     58  
NOT COMPLETED     14     14  
Death                 1                 2  
Lost to Follow-up                 12                 10  
Withdrawal by Subject                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
    Intervention Arm     Usual Care     Total  
Number of Participants  
[units: participants]
  71     72     143  
Age  
[units: years]
Median ( Inter-Quartile Range )
  63  
  ( 54 to 71 )  
  62  
  ( 52 to 70 )  
  62  
  ( 53 to 70 )  
Age  
[units: years]
Mean ± Standard Deviation
  63.0  ± 11.5     61.5  ± 12.0     62.3  ± 11.7  
Gender  
[units: participants]
     
Female     24     28     52  
Male     47     44     91  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records   [ Time Frame: 6 months ]

3.  Secondary:   Percent of Patients Adherent to Beta-blocker Via Refill Records   [ Time Frame: 6 months ]

4.  Secondary:   Percent of Patients Adherent to Statin Via Refill Records   [ Time Frame: 6 months ]

5.  Secondary:   Death in Intervention Patients Compared to Usual Care   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: sara.calvert@duke.edu


Publications of Results:
Other Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00323258     History of Changes
Other Study ID Numbers: Pro00005018, U18HS10548
Study First Received: May 5, 2006
Results First Received: March 19, 2012
Last Updated: January 11, 2013
Health Authority: United States: Institutional Review Board