Clinical trial NCT01744977: Cholesterol Medication Packaging Study
Official title: Evaluate the Efficacy, Perceptions and Cost of an Innovative Cholesterol Packaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2012-12-07
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Cholesterol Medication Adherence
timeFrame: 12 months
Secondary outcomes:
measure: Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months
timeFrame: Baseline, 6months, 12months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Community-based Outpatient Clinic (CBOC- Raleigh)
state: North Carolina
Study officials:
affiliation: Duke University Medical Center/Durham VA Medical Center, Health Services and Development
name: Hayden B Bosworth, PhD
role: PRINCIPAL_INVESTIGATOR
References: