Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease (PILOT-EBM)
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| 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
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
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
| 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 ] |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| 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 |
|---|
| No text entered. |
Results Point of Contact:
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 |