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The American Journal of Managed Care September 2017
Guideline Concordance of New Statin Prescriptions: Who Got a Statin?
Thomas Cascino, MD; Marzieh Vali, MS, BS; Rita Redberg, MD, MSc; Dawn M. Bravata, MD; John Boscardin, PhD; Elnaz Eilkhani, MPH; and Salomeh Keyhani, MD, MPH
Provider-Owned Insurers
David H. Howard, PhD, and Erin Trish, PhD
The Effect of Narrow Network Plans on Out-of-Pocket Cost
Emily Meredith Gillen, PhD; Kristen Hassmiller Lich, PhD; Laurel Clayton Trantham, PhD; Morris Weinberger, PhD; Pam Silberman, JD, DrPh; and Mark Holmes, PhD
In-Gap Discounts in Medicare Part D and Specialty Drug Use
Jeah Jung, PhD; Wendy Yi Xu, PhD; and Chelim Cheong, PhD
Racial and Ethnic Differences in Hip Fracture Outcomes in Men
Lucy H. Liu, MD, MPH; Malini Chandra, MS, MBA; Joel R. Gonzalez, MPH, MPP; and Joan C. Lo, MD
Integrating Behavioral Health Under an ACO Global Budget: Barriers and Progress in Oregon
Jason Kroening-Roché, MD, MPH; Jennifer D. Hall, MPH; David C. Cameron, BA; Ruth Rowland, MA; and Deborah J. Cohen, PhD
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Evaluation of a Packaging Approach to Improve Cholesterol Medication Adherence
Hayden B. Bosworth, PhD; Jamie N. Brown, PharmD, BCPS; Susanne Danus, BS; Linda L. Sanders, MPH; Felicia McCant, MSSW; Leah L. Zullig, PhD; and Maren K. Olsen, PhD
Against the Current: Back-Transfer as a Mechanism for Rural Regionalization
Leah F. Nelson, MD, MS; Karisa K. Harland, PhD, MPH; Dan M. Shane, PhD; Azeemuddin Ahmed, MD, MBA; and Nicholas M. Mohr, MD, MS
Association Between FDA Black Box Warnings and Medicare Formulary Coverage Changes
Sanket S. Dhruva, MD, MHS; Pinar Karaca-Mandic, PhD; Nilay D. Shah, PhD; Daniel L. Shaw, BA; and Joseph S. Ross, MD, MHS

Evaluation of a Packaging Approach to Improve Cholesterol Medication Adherence

Hayden B. Bosworth, PhD; Jamie N. Brown, PharmD, BCPS; Susanne Danus, BS; Linda L. Sanders, MPH; Felicia McCant, MSSW; Leah L. Zullig, PhD; and Maren K. Olsen, PhD
A 7.6% improvement in 12-month cholesterol refill was observed among US military veterans randomized to an adherence blister packaging intervention versus an education-only intervention.
ABSTRACT

Objectives:
Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease, a leading cause of death in the United States. Our goal was to evaluate a simple, scalable, and affordable medication packaging method for improving cholesterol medication adherence and subsequently lowering LDL-C levels. 

Study Design: Mixed-method study.

Methods: This mixed-method study involved US military veterans with LDL-C levels greater than 130 mg/dL and/or less than 80% refill adherence of cholesterol-lowering medication in the last 12 months; they were randomized to an education-only (control) group or an adherence packaging intervention group. Adherence packaging group participants’ statin medication was provided in special blister packaging labeled for daily use that included written reminder prompts. Outcomes included 12-month cholesterol medication possession ratio (MPR) for medication refills; baseline, 6-, and 12-month self-reported cholesterol medication use; LDL-C and high-density lipoprotein cholesterol (HDL-C) levels; and total cholesterol changes over 12 months. Qualitative evaluation of the intervention is presented as well. 

Results: We enrolled 240 individuals (120 intervention, 120 control). Overall, 54.2% of the adherence packaging intervention group was adherent per MPR over 12 months compared with 46.6% of the education-only group (difference = 7.6%; 95% confidence interval, –5% to 20%; P ≤.24). Both arms reported improvements in self-reported cholesterol adherence at 12 months, and decreases in LDL-C, HDL-C, and total cholesterol were observed, but differences in change between arms were not statistically significant. Qualitatively, patients reported high levels of satisfaction with the blister package. 

Conclusions: In a sample of US veterans, prefilled calendared blister packaging provided an inexpensive method for improving cholesterol medication adherence.

Am J Manag Care. 2017;23(9):e280-e286
Takeaway Points
  • Overall, 54.2% of the adherence packaging intervention group was adherent per medication possession ratio over 12 months compared with 46.6% of the education-only intervention (difference = 7.6%; 95% confidence interval, –5% to 20%; P ≤.24).
  • The potential impact of a relatively inexpensive and highly scalable method for improving adherence should be further considered.
  • Packaging interventions provide a mechanism for patients to self-monitor medication consumption and provide a method for remembering whether a given dose has been consumed.
  • In a sample of US veterans, pre-filled calendared blister packaging provided an inexpensive method for improving cholesterol medication adherence.
Elevated low-density lipoprotein cholesterol (LDL-C) is a major modifiable risk factor for cardiovascular disease (CVD).1 Because of the health implications of hyperlipidemia, developing strategies to reduce LDL-C is critical. CMS established a quality goal for Medicare Part D members who are prescribed statin medications for hyperlipidemia: filling their prescriptions often enough to cover 80% or more of the time they are supposed to be taking the medication.2 The Department of Veterans Affairs (VA) healthcare system has adopted a similar guideline for pill refill quality.3 Unfortunately, many veterans do not achieve preferred LDL-C levels.4 

One strategy to promote better medication adherence is calendared blister packaging. It may make taking medication more convenient for patients by eliminating issues associated with traveling with medication and with forgetting whether medications have been taken on a particular day.5,6 Additionally, this packaging approach may streamline health professionals’ monitoring of patients’ statin medication adherence. A patient’s provider, caregiver, and/or pharmacy staff could examine a patient’s blister packaging and straightforwardly assess whether and when a patient has taken their medication. 

We sought to evaluate the efficacy and clinical effectiveness of a relatively inexpensive prescription medication calendared blister packaging approach. We hypothesized that this packaging would improve medication refill rates relative to a control group receiving only cholesterol education. 

METHODS

Study Overview

The study included users of the VA healthcare system at risk for CVD, defined as having an LDL-C level greater than 130 mg/dL and/or having less than 80% cholesterol medication refill in the previous 12 months.7 

Sponsorship was provided by a grant from WestRock/MeadWestvaco and the study was approved by the Durham VA Medical Center Institutional Review Board (clinicaltrials.gov registration number: NCT01744977).

Sample Identification and Eligibility Criteria

To be eligible for study inclusion, patients had to meet all of the following criteria: enrolled in 1 of 3 primary care clinics affiliated with the Durham VA Medical Center for at least 1 year; had at least 1 visit to their primary care provider in the previous 12 months; had an outpatient diagnostic code for hypercholesterolemia; had uncontrolled LDL-C in the last 12 months (average >130 mg/dL) and/or poor cholesterol medication refill history, defined as lower than 80% medication adherence in the last 12 months; and be prescribed 20- or 40-mg daily doses of simvastatin, rosuvastatin, or pravastatin. The study statistician identified patients meeting initial inclusion criteria and randomly sampled potential participants for additional screening and study recruitment. 

Recruitment and Randomization Procedure

Patient recruitment took place between February 2013 and April 2014. Based on appointment information in the electronic health record, study staff identified participants who had an upcoming medical appointment scheduled in the next 2 to 3 weeks. An introductory recruitment letter, signed by the patient’s primary care provider, was sent to potential participants. Approximately 1 week after the introductory letter was mailed, study staff called potential participants to determine whether they met eligibility criteria. For interested and eligible patients, an in-person interview was scheduled. Patients were sent reminder letters up to 3 weeks prior to their scheduled 6- and 12-month follow-up appointments. During the initial in-person interview, patients were presented with full details of the study and provided written informed consent. 

The statistician completed the study randomization prior to the study. Once a patient consented and completed the baseline assessment, the research assistant randomized the patient to 1 of the 2 groups: 1) education-only or 2) adherence packaging intervention. A blocked randomization technique was used to ensure rolling balance between study arms. To prevent contamination, research assistants were blinded to block size. A centralized computer process that integrated into the tracking database determined randomization assignments. The study flow is described in the Figure.

Baseline Patient Assessment and Follow-up Contacts 

Participants completed assessments at the baseline, 6-month, and 12-month visits, plus during 1 optional qualitative, a telephone-based interview at the conclusion of the study. During the patient assessments, laboratory values (ie, lipids) were obtained. Participants also underwent an in-person baseline interview, which collected each patient’s age, race, medical history, self-reported statin medication adherence, health beliefs and knowledge, and understanding about CVD risk. Additionally, during the 12-month visit, 30 of those randomized to the intervention arm were asked about perceptions of the study packaging. In addition to reviewing VA medical records for adverse events, patients were asked about such events at each follow-up visit. 

Adherence Packaging Intervention Arm

Adherence packaging participants’ medications were provided in a special packaging, the WestRock/MeadWestVaco Corporations’ prefilled Dosepak Express with Optilock Technology, which contained standard dose statins. The calendar blister packaging medication flow (ie, prescription fill and refill process) is described in a prior publication.7 Prepackaged calendar blister packages of 20- or 40-mg tablets of simvastatin, pravastatin, or rosuvastatin were provided to participants in accordance with their existing prescription. If patients were taking a half-tablet of statin medication prior to study enrollment, the investigational drug pharmacy service kept the participant’s current dose but provided it in a whole tablet. Over the course of the study, the study staff did not change patients’ medications; however, as part of their usual care, a participant’s primary care provider may have adjusted medications during the course of the study. In this instance, the calendar blister package contents would change accordingly. Each package was labeled with the preapproved cholesterol education material, and the medication name and dose were labeled for each batch of medication received into pharmacy. 

When an adherence packaging participant presented to pharmacy services, they received a 3-month supply of their standard-dose cholesterol medication in the calendar blister package. Following the baseline assessment, adherence packaging patients reported to the VA study pharmacy for their first medication fill, and the pharmacist: 1) counseled the patient on the appropriate use of the calendar blister package (how to open it and use the calendar feature), 2) reviewed the counseling points for statins included on the package, and 3) reviewed how to obtain subsequent refills. Each medication fill for enrolled patients was labeled by pharmacy staff, checked for accuracy, and dispensed by a registered licensed pharmacist. 

Participants in the adherence packaging group were contacted for an optional telephone-based qualitative interview within 30 days after their final in-person interview. The objective of the qualitative interview was to evaluate participants’ perception of the study packaging and evaluate the successes and challenges of the program.

Education-Only Arm 

The health education-only (control) group received primary care and management of LDL-C according to the discretion of their regular primary care provider. These patients received generic educational information on LDL-C reduction and had no contact with the research pharmacist. Additionally, the control group received written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed. At follow-up study appointments, patients were provided with further educational material addressing issues of hyperlipidemia. 

Using a health education group as a control enabled an assessment of the cost benefit of the intervention and is comparable with care typically provided in a traditional VA primary care clinic setting. Patients in the education-only arm did not receive their medication in the special packaging. Veterans randomized to the education group did not have any changes to the way they received their cholesterol medication from the study staff, but healthcare providers made changes as they would ordinarily do, for any medical reasons that arose. Individuals in the education arm typically received a 3-month supply, but they used the standard VA mechanism for refills (centralized mail, not the local VA pharmacy). 

Compensation

Participants were paid $20 for participation in each interview (eg, baseline, 6-month, 12-month outcome, and qualitative). Therefore, individuals could receive a maximum compensation of $80. 

Measures

Using a single-item measure, participants were asked to describe their household’s current financial situation.7 A binary measure was created. Patients who reported cutting back on their expenditures or having difficulty paying bills were coded as having inadequate financial status.

Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine (REALM) test.8 Low health literacy was defined as a REALM score up to and including 8th grade (≤60 score) versus 9th grade or higher (≥61 score).9

Outcomes and Statistical Methodology

The primary analysis examined whether veterans who received the intervention had greater cholesterol medication adherence as measured by medication possession ratio (MPR) at 12 months of follow-up compared with the education group. MPR was calculated as the days supplied divided by the days in the calculation period (ie, 365 days). A Wilcoxon Rank Sum test was used to compare median MPR between the 2 groups. MPR as a continuous measure had a ceiling effect at 1 and spikes in the data distribution at 0.25, 0.50, and 0.75. For this reason, we created a dichotomous categorical variable using MPR at 12 months (adherent [MPR ≥99%] vs nonadherent [MPR <99%]). A c2 test was used to compare adherence between the 2 groups.10 

The secondary clinical outcome measures were LDL-C, total cholesterol, and high-density lipoprotein cholesterol (HDL-C) levels obtained from a nonfasting lipid profile. We also measured self-reported medication adherence, specifically to lipid-lowering medications, using a valid, reliable measure.11 Secondary analyses evaluated whether veterans who received the adherence packaging intervention had improved LDL and total cholesterol levels, as well as self-reported cholesterol medication adherence, compared with the education-only group, over 12 months of follow-up. 

 
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