Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U18HS010548 | U.S. AHRQ Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications.
Heart disease is the leading cause of death for men and women in the United States. For patients with documented coronary artery disease (CAD), anti-platelet agents, beta-blockers and statins have all been shown to improve survival and reduce the frequency of myocardial infarction. Yet, previous research by the Duke CERTs has shown that in a population of over 28,000 patients with documented CAD, only 21% reported consistent use of triple therapy with aspirin, beta-blockers and lipid lowering therapy. These results stimulated the Duke CERTs to devise an intervention to improve adherence to these life-saving medications.
Comparisons: Patients admitted to Duke University Hospital or Southeastern Regional Medical Center (SRMC) with CAD or CAD plus heart failure who agree to participate, will be randomized to an intervention or control arm. The control group will receive usual care, which consists of routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the Duke physician to the community physician. In addition to usual care, the intervention group will receive focused medication counseling in the hospital by the clinical pharmacist-investigator, who will identify and address potential barriers to medication adherence and will reinforce the importance of taking evidence-based medications long term. Discharge medications will be shared with the community pharmacist. The community pharmacist will monitor for problems with adherence and communicate issues back to the patient and the patient's care team.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Usual Care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral education & written tips for remembering medications | Behavioral | Clinical pharmacist will review purpose of medications of interest (beta-blockers, statins, Angiotensin Converting Enzyme Inhibitor (ACEI)/Angiotensin Receptor Blocker (ARB), aspirin, and other anti-platelets) with the subject. A written list of tips for remembering medications will be provided and reviewed. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records | 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 | 6 months |
| Percent of Patients Adherent to Beta-blocker Via Refill Records |
Not provided
Inclusion Criteria:
18 years of age or older
Utilize a pharmacy in Durham, Robeson, Person, Granville, or Vance County, NC
Have coronary artery disease (CAD) documented in the medical record by one of the following:
Plan to have their prescription medications filled and refilled by one of the participating pharmacies
Prescribed aspirin or another antiplatelet, a beta-blocker and statin agent (referred to as triple therapy for this study) at discharge. If a patient has a true contraindication to any of the three medication groups in triple therapy, they will still be eligible for the study
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Judith M. Kramer, MD,MS | Duke University | Principal Investigator |
| Nancy Allen LaPointe, PharmD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16401776 | Background | Newby LK, LaPointe NM, Chen AY, Kramer JM, Hammill BG, DeLong ER, Muhlbaier LH, Califf RM. Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease. Circulation. 2006 Jan 17;113(2):203-12. doi: 10.1161/CIRCULATIONAHA.105.505636. Epub 2006 Jan 9. | |
| 22520532 | Result | Calvert SB, Kramer JM, Anstrom KJ, Kaltenbach LA, Stafford JA, Allen LaPointe NM. Patient-focused intervention to improve long-term adherence to evidence-based medications: a randomized trial. Am Heart J. 2012 Apr;163(4):657-65.e1. doi: 10.1016/j.ahj.2012.01.019. |
Not provided
Not provided
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).
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Outcome (Phone Call at 6 Months) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| pill box | Device | Subject is provided a pill box and briefly instructed on how to use the box. |
|
|
| pocket medication card | Device | Subject is provided with a card that contains space for prescription and non-prescription medications. If desired the clinical pharmacist-investigator will complete the card for the subject. |
|
|
| sharing information with community pharmacist | Behavioral | A fax is sent to the designated community pharmacy at the time of the subject's discharge from the hospital. The fax contains the subject's medications of interest, barriers to medication adherence, and physicians' contact information. |
|
|
| Medication use evaluations by community pharmacist | Behavioral | The community pharmacist will assess use of medications of interest at time of first medication fill and by reviewing the subject's computerized medication profile at the pharmacy. Assessments occur at first visit to pharmacy, 6-weeks, 12-weeks, 18-weeks, and 24-weeks. If there are issues with any medications of interest the subject will be called. If needed, the subject's health care team will be notified. |
|
|
| informing physician if patient has stopped a medication | Behavioral | The community pharmacist or clinical pharmacist-investigator will fax the subject's physician to notify that a medication has been stopped. |
|
|
| Routine discharge counseling | Behavioral | Both groups received routine discharge counseling performed by the patient-care nurse. |
|
|
| Letter to physician/discharge summary | Other | A letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. |
|
|
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 |
| 6 months |
| Percent of Patients Adherent to Statin Via Refill Records | 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 | 6 months |
| Death in Intervention Patients Compared to Usual Care | Number of patients who died in each treatment group prior to the 6 month follow-up time point. | 6 months |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Secondary Outcome (6 Mon Refill Records) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months | 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 | 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. | Posted | Number | percentage of participants | 6 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records | 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 | 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. | Posted | Number | percentage of participants | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Patients Adherent to Beta-blocker Via Refill Records | 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 | 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. | Posted | Number | percentage of patients with PDC >or=75% | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Patients Adherent to Statin Via Refill Records | 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 | 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. | Posted | Number | percentage of patients with >or=75% | 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Death in Intervention Patients Compared to Usual Care | Number of patients who died in each treatment group prior to the 6 month follow-up time point. | Posted | Number | participants | 6 months |
|
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 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. | 0 | 0 | 0 | 0 | ||
| EG001 | Usual Care | 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. | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Calvert, PharmD | Duke University Medical Center | 919-668-7540 | sara.calvert@duke.edu |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D003327 | Coronary Disease |
| D010349 | Patient Compliance |
| D016312 | Treatment Refusal |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| D010595 | Pharmacists |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
| Withdrawal by Subject |
|
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|