Hypercholesterolemia
Conditions
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)
Interventions
BEHAVIORALpackaging
Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles
Sponsors
Durham VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cholesterol Medication Adherence | 12 months | Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months | Baseline, 6months, 12months | obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period (at baseline, 6 and 12 months) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles | 120 |
| 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. | 120 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 3 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | No longer meets inclusion | 6 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Adherence Packaging Intervention Group | Education Only Group | Total |
|---|---|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 8.9 | 62.9 years STANDARD_DEVIATION 8.6 | 62.6 years STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized African American or Other | 73 participants | 79 participants | 152 participants |
| Race/Ethnicity, Customized Caucasian | 47 participants | 41 participants | 88 participants |
| Region of Enrollment United States | 120 participants | 120 participants | 240 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 109 Participants | 110 Participants | 219 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 120 | 0 / 120 |
| serious Total, serious adverse events | 33 / 120 | 26 / 120 |
Outcome results
Primary
Cholesterol Medication Adherence
Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups
Time frame: 12 months
Population: Data on pill refill could not be obtained for 2 of the education only participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Adherence Packaging Intervention Group | Cholesterol Medication Adherence | .99 adherence proportion |
| Education Only Group | Cholesterol Medication Adherence | .94 adherence proportion |
p-value: 0.3Wilcoxon (Mann-Whitney)
Secondary
Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months
obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period (at baseline, 6 and 12 months)
Time frame: Baseline, 6months, 12months
Population: Cholesterol values could not be obtained for all patients at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adherence Packaging Intervention Group | Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months | Baseline (n=120/119) | 110.1 mg/dL | Standard Deviation 38.8 |
| Adherence Packaging Intervention Group | Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months | 6 months (n=112/115) | 101.1 mg/dL | Standard Deviation 29.4 |
| Adherence Packaging Intervention Group | Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months | 12 months (n=109/115) | 101.3 mg/dL | Standard Deviation 34.3 |
| Education Only Group | Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months | Baseline (n=120/119) | 111.6 mg/dL | Standard Deviation 31.7 |
| Education Only Group | Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months | 6 months (n=112/115) | 105.8 mg/dL | Standard Deviation 32.8 |
| Education Only Group | Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months | 12 months (n=109/115) | 102.9 mg/dL | Standard Deviation 33.1 |
p-value: 0.83995% CI: [-8, 6.5]Mixed Models Analysis