Cholesterol Medication Packaging Study
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2012 |
| End Date: | August 2015 |
Evaluate the Efficacy, Perceptions and Cost of an Innovative Cholesterol Packaging
The purpose of the overall study is to improve medication use rates among veterans by
looking at the risk factors of low-density lipoprotein cholesterol (LDL). It will involve
patients who have high LDL-C level (<130mg/dl) and /or may have difficulty taking their
medications based on how often they refilled their medications in the last 12 months.
The investigators will test an innovative adherence packaging relative to usual care. The
primary hypothesis is that veterans who receive the intervention will have greater
improvement in their medication adherence as measured by pill refill at 6 and 12 months of
follow up as compared to the control group.
looking at the risk factors of low-density lipoprotein cholesterol (LDL). It will involve
patients who have high LDL-C level (<130mg/dl) and /or may have difficulty taking their
medications based on how often they refilled their medications in the last 12 months.
The investigators will test an innovative adherence packaging relative to usual care. The
primary hypothesis is that veterans who receive the intervention will have greater
improvement in their medication adherence as measured by pill refill at 6 and 12 months of
follow up as compared to the control group.
A sample of participants with elevated LDL level >130 mg/dl and/or <80% medication position
ratio in the last 12 months (n=250) will be consented. The study sample will consist of both
male and female subjects. Research assistants (RA's) will complete a baseline assessment and
then randomly allocated participants to one of the following two groups:
- MeadWestvaco (MWV) Packaging Intervention. Patients randomized to the intervention
group will receive the MWV medication adherence packaging and adherence education
(Packaging Education.) at baseline from a research pharmacist. The participant will
then receive their prescribed cholesterol medication in the MWV packaging over the next
12 months.
- The Education only Group - Patients randomized to the control group will receive
educational material about LDL reduction at baseline.
The study includes the following contacts with participants.
- Recruitment letter
- Telephone screening
- Baseline consent and interview - In person for all participants [Only Adherence
Packaging Intervention participants will receive baseline discussion and education from
the research pharmacist]
- 6 month outcome assessment follow-up - In person for all participants
- 12 month outcome assessment follow-up - In person for all participants
- 12 month phone interview - Optional recorded qualitative interview for intervention
participants only.
All participants enrolled in study will be followed for 12 months.
The study includes the following contacts with providers
• Baseline consent and explanation of the adherence packaging - In person for all providers
(group style visit)
ratio in the last 12 months (n=250) will be consented. The study sample will consist of both
male and female subjects. Research assistants (RA's) will complete a baseline assessment and
then randomly allocated participants to one of the following two groups:
- MeadWestvaco (MWV) Packaging Intervention. Patients randomized to the intervention
group will receive the MWV medication adherence packaging and adherence education
(Packaging Education.) at baseline from a research pharmacist. The participant will
then receive their prescribed cholesterol medication in the MWV packaging over the next
12 months.
- The Education only Group - Patients randomized to the control group will receive
educational material about LDL reduction at baseline.
The study includes the following contacts with participants.
- Recruitment letter
- Telephone screening
- Baseline consent and interview - In person for all participants [Only Adherence
Packaging Intervention participants will receive baseline discussion and education from
the research pharmacist]
- 6 month outcome assessment follow-up - In person for all participants
- 12 month outcome assessment follow-up - In person for all participants
- 12 month phone interview - Optional recorded qualitative interview for intervention
participants only.
All participants enrolled in study will be followed for 12 months.
The study includes the following contacts with providers
• Baseline consent and explanation of the adherence packaging - In person for all providers
(group style visit)
Inclusion Criteria:
- Enrolled in one of three Durham VA Medical Center (DVAMC) Primary Care clinics for at
least one year
- AT least one visit to a primary care provider at the Raleigh Community Based
Outpatient Clinic (CBOC) or DVAMC associated primary care clinics in the previous 12
months
- Outpatient diagnostic code for hypercholesterolemia
- uncontrolled LDL in the last 12 months and/or poor LDL refill defined as <80%
medication adherence in the last 12 months
- prescribed whole tablets of simvastatin, rosuvastatin or pravastatin
Exclusion Criteria:
- Diagnosis of metastatic cancer.
- Active diagnosis of dementia documented in medical record.
- Active diagnosis of psychosis documented in medical record with admission with last
30days.
- Treated with dialysis
- Hospitalized for a stroke, myocardial infarction, coronary artery revascularization
in past month.
- Severely impaired hearing, speech or sight. (Patients must be able to respond to
phone calls and review adherence literature)
- Participating in another on-going cardio- vascular disease (CVD) risk management
study (i.e., pharmaceutical trial or behavioral intervention)
- Does not have access to a telephone
- Resident in nursing facility that manages patients medications or
- Receiving home health care for extended period (home health service for limited time
period will not exclude, i.e. scheduled surgical procedure not expected to require
care for longer than 30 days)
- Planning to leave the area prior to the anticipated end of participation in the
study.
We found this trial at
2
sites
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