Cholesterol Medication Packaging Study (MWV_CAPS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT01744977
First received: December 5, 2012
Last updated: May 6, 2014
Last verified: February 2013
  Purpose

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.


Condition Intervention
Hypercholesterolemia
Behavioral: packaging

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 250
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)
Arms Assigned Interventions
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.
Behavioral: packaging
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.

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)
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744977

Locations
United States, North Carolina
Durham VAMC
Durham, North Carolina, United States, 27701
Raleigh Community-based Outpatient Clinic (CBOC- Raleigh)
Raleigh, North Carolina, United States, 27701
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Hayden B Bosworth, PhD Duke University Medical Center/Durham VA Medical Center, Health Services and Development
  More Information

No publications provided

Responsible Party: Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT01744977     History of Changes
Other Study ID Numbers: 01642
Study First Received: December 5, 2012
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 22, 2014