Cardiovascular DiseasePILOT-EBMNCT00323258
Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease
A study testing oral education & written tips for remembering medications, pill box and pocket medication card in people with Cardiovascular Disease, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- oral education & written tips for remembering medications, pill box and pocket medication card
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- A diagnosis of unstable angina or acute myocardial infarction (ST segment elevation or non-ST segment elevation myocardial infarction)
- A cardiac catheterization demonstrating CAD greater than or equal to 50 narrowing of artery)
- Prior angioplasty
Show all 10Show fewer
- Prior coronary artery stent
- Prior coronary artery bypass graft surgery (CABG)
- 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
Who cannot join
- Providers predict an anticipated hospital stay of less than 48 hours
- Patient plans to use a pharmacy outside of Durham, Robeson, Person, Granville, or Vance County, NC
- Patient is unable to give consent (cognitively impaired, does not speak English, or has altered mental status)
- Patient transferred to Cardiothoracic Surgery service for CABG
- Patient has terminal condition and may not survive until 6-month follow-up
- Patient lives in a correctional or long-term care facility
Show all 9Show fewer
- Patient will be unable to participate in follow-up phone call (hearing impaired without caregiver who can help or does not have a phone)
- Patient is a known participant in the Duke Heart Failure Program
- Patient does not agree to use only the one Durham, Robeson, Person, Granville, or Vance County pharmacy throughout the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27704
About this study
Official title: PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications
The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications.
Read the detailed description
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.
- Conditions
- Cardiovascular Disease
- Being tested
- oral education & written tips for remembering medications, pill box, pocket medication card, sharing information with community pharmacist, Medication use evaluations by community pharmacist
- Keywords
- Heart disease, Coronary disease, Patient compliance, Treatment refusal, Pharmacists, Continuity of patient care, Evidence-based medicine, Patient education, Adherence
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Patient Compliance, Treatment Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral education & written tips for remembering medicationsBehavioural
Also called Cue-dose training
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.
pill boxDevice
Also called Pill box organizer, pillbox
Subject is provided a pill box and briefly instructed on how to use the box.
pocket medication cardDevice
Also called Medication List, List of Medications
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 pharmacistBehavioural
Also called increased communication with community pharmacist
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 pharmacistBehavioural
Also called medcation adherence verification
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 medicationBehavioural
Also called Communication with physician about patient's medication use
The community pharmacist or clinical pharmacist-investigator will fax the subject's physician to notify that a medication has been stopped.
Routine discharge counselingBehavioural
Also called Discharge instructions
Both groups received routine discharge counseling performed by the patient-care nurse.
Letter to physician/discharge summaryOther
Also called Communication to physician about hospital course.
A letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
| 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. Receives: Behavioral: Routine discharge counseling; Other: Letter to physician/discharge summary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
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
Measured: 6 months
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
Measured: 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
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Judith M. Kramer, MD,MS, Principal investigator, Duke UniversityNancy Allen LaPointe, PharmD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00323258
- Sponsor's protocol ID
- Pro00005018
- Other IDs
- U18HS010548
- Acronym
- PILOT-EBM
- Status last verified
- May 2012
- First submitted
- 5 May 2006
- Last updated
- 18 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16401776Calvert 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.
PubMed 22520532
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications
- ClinicalTrials.gov ID
- NCT00323258
- Acronym / sponsor ID
- PILOT-EBM / Pro00005018
- Conditions
- Cardiovascular Disease
- Keywords
- Heart disease, Coronary disease, Patient compliance, Treatment refusal, Pharmacists, Continuity of patient care, Evidence-based medicine, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Pfizer, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 May 2006 (estimated)
- Results
- Posted 19 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | 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 summaryPatients 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 | Behavioral: Routine discharge counseling, Other: Letter to physician/discharge summaryThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- Providers predict an anticipated hospital stay of less than 48 hours
- Patient plans to use a pharmacy outside of Durham, Robeson, Person, Granville, or Vance County, NC
- Patient is unable to give consent (cognitively impaired, does not speak English, or has altered mental status)
- Patient transferred to Cardiothoracic Surgery service for CABG
- Patient has terminal condition and may not survive until 6-month follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral education & written tips for remembering medicationsAlso: Cue-dose trainingClinical 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. | Behavioural | Intervention |
| pill boxAlso: Pill box organizer, pillboxSubject is provided a pill box and briefly instructed on how to use the box. | Device | Intervention |
| pocket medication cardAlso: Medication List, List of MedicationsSubject 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. | Device | Intervention |
| sharing information with community pharmacistAlso: increased communication with community pharmacistA 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. | Behavioural | Intervention |
| Medication use evaluations by community pharmacistAlso: medcation adherence verificationThe 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. | Behavioural | Intervention |
| informing physician if patient has stopped a medicationAlso: Communication with physician about patient's medication useThe community pharmacist or clinical pharmacist-investigator will fax the subject's physician to notify that a medication has been stopped. | Behavioural | Intervention |
| Routine discharge counselingAlso: Discharge instructionsBoth groups received routine discharge counseling performed by the patient-care nurse. | Behavioural | Intervention, Usual Care |
| Letter to physician/discharge summaryAlso: Communication to physician about hospital course.A letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. | Other | Intervention, Usual Care |
Primary outcome
Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months
Time frame: 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
4 secondary outcomes
Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records
Time frame: 6 months
Percent of Patients Adherent to Beta-blocker Via Refill Records
Time frame: 6 months
Percent of Patients Adherent to Statin Via Refill Records
Time frame: 6 months
Death in Intervention Patients Compared to Usual Care
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16401776Newby 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.
- Results publication: PubMed 22520532Calvert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith M. Kramer, MD,MS principal investigator
Duke University
Nancy Allen LaPointe, PharmD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral education & written tips for remembering medications, pill box and pocket medication card in people with Cardiovascular Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00323258, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.