Cholesterol Medication Packaging Study (MWV_CAPS)
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Evaluate the Efficacy, Perceptions and Cost of an Innovative Cholesterol Packaging|
- Change in cholesterol medication adherence [ Time Frame: Baseline, 6 and 12 months ] [ Designated as safety issue: No ]PIll refill will be obtained at baseline, 6 and 12 months to review change in cholesterol medication adherence over the 12 month period
- Change in LDL cholesterol level [ Time Frame: baseline, 6 and 12 months ] [ Designated as safety issue: No ]obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Adherence Packaging Intervention Group
[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.
Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles
No Intervention: Education Only Group
Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed. The 6-month interval was selected to maintain contact with patients.
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)
- 6 month phone interview - recorded qualitative interview for providers with intervention participants only.
- 12 month phone interview - recorded qualitative interview for providers with intervention participants only.
Participation in this aspect of the study by providers does not preclude them for participating in other research studies during the same time period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744977
|United States, North Carolina|
|Durham, North Carolina, United States, 27701|
|Raleigh Community-based Outpatient Clinic (CBOC- Raleigh)|
|Raleigh, North Carolina, United States, 27701|
|Principal Investigator:||Hayden B Bosworth, PhD||Duke University Medical Center/Durham VA Medical Center, Health Services and Development|