Pharmacist Interventions to Improve Specialty Medication Adherence: Study Protocol for a Randomized Controlled Trial.
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ABSTRACT: Background
The effectiveness of specialty medications in complicated clinical conditions depends on adherence to therapy. However, specialty medications pose unique barriers to adherence.Objective
This study aims to determine whether pharmacist interventions improve specialty medication adherence.Methods
This is a single-center, pragmatic, randomized controlled trial ongoing since 10 May 2019 at an integrated health system specialty pharmacy. This study evaluates usual care compared with usual care plus patient-tailored adherence interventions. Study design and procedures were informed by focus groups with patients and specialty pharmacists. Patients at Vanderbilt Specialty Pharmacy with a proportion of days covered (PDC) < 90% in the previous 4 months are identified by a daily query of the electronic pharmacy database. A pharmacist reviews these patients' electronic health records to identify and exclude ineligible patients. Eligible patients are randomized evenly to the control or intervention arm and stratified by historical clinic nonadherence rates. Patients randomized to the intervention arm undergo a baseline assessment to clarify reasons for nonadherence and subsequently receive patient-tailored interventions based on their specific reasons. Interventions and follow-up are provided at the discretion of the intervening pharmacist. The primary outcome is PDC calculated at 8 months post-enrollment. Enrollment of 438 participants will provide 90% power to detect a 5% difference in PDC between the two arms within each nonadherence risk stratum.Discussion
This trial will evaluate the effect of patient-tailored interventions on specialty medication adherence and will inform how often and why patients are misidentified as nonadherent.Registration
The trial was deemed a quality improvement initiative by the Vanderbilt University Institutional Review Board. It was registered in ClinicalTrials.gov (NCT03709277) on 17 October 2018.
SUBMITTER: Kibbons AM
PROVIDER: S-EPMC7503429 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundLatinos experience disproportionately higher rates of uncontrolled hypertension as compared to Blacks and Whites. While poor adherence is a major contributor to disparities in blood pressure control, data in Latino patients are scant. More importantly, translation of interventions to improve medication adherence in community-based primary care practices, where the majority of Latino patients receive their care is non-existent.MethodsUsing a randomized controlled design, this study evaluates the effectiveness of a culturally tailored, practice-based intervention compared to usual care on medication adherence, among 148 Latino patients with uncontrolled hypertension who are non-adherent to their antihypertensive medications. Bilingual medical assistants trained as Health Coaches deliver the intervention using an electronic medical record system-embedded adherence script. Patients randomized to the intervention group receive patient-centered counseling with a Health Coach to develop individualized self-monitoring strategies to overcome barriers and improve adherence behaviors. Health Coach sessions are held biweekly for the first 3 months (6 sessions total) and then monthly for the remaining 3 months (3 sessions total). Patients randomized to the usual care group receive standard hypertension treatment recommendations as determined by their primary care providers. The primary outcome is the rate of medication adherence at 6 months. The secondary outcome is reduction in systolic and diastolic blood pressure at 6 months.DiscussionIf successful, findings from this study will provide salient information on the translation of culturally tailored, evidence-based interventions targeted at medication adherence and blood pressure control into practice-based settings for this high-risk population.Trial registrationNCT01643473 on 16 July 2012.
| S-EPMC4488119 | biostudies-literature
Project description:Background/objectiveAs pharmacists work to ensure reimbursement for chronic disease management services on the national level, evidence of their impact on important health metrics, such as medication adherence, is needed. However, summative evidence is lacking on the effectiveness of pharmacists to improve medication adherence in older adults. The objective was to assess the effectiveness of pharmacist-led interventions on medication adherence in older adults (65+ years).Design/setting/participantsUsing a systematic review and meta-analytic approach, a comprehensive search of publications in PubMed, Scopus, CINAHL, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Google Scholar was conducted through April 2, 2020 for randomized clinical trials of pharmacist-led interventions to improve medication adherence in older adults. A standardized mean difference effect size (Cohen's d) was calculated for medication adherence in each study. Study effect sizes were pooled using a random-effects model, with effect sizes weighted by inverse of its total variance.MeasurementsMedication adherence using any method of measurement.ResultsAmong 40 unique randomized trials of pharmacist-led interventions with data from 8822 unique patients (mean age, range: 65-85 years), the mean effect size was 0.57 (k = 40; 95% Confidence Interval [CI]: 0.38-0.76). When two outlier studies were excluded from the analysis, the mean effect size reduced to 0.41 (k = 38; 95% CI: 0.27-0.54). A sensitivity analysis of medication adherence outcome by time point resulted in a mean effect size of 0.64 at 3 months (k = 12; 95% CI: 0.32-0.97), 0.30 at 6 months (k = 13; 95% CI: 0.11-0.48), 0.22 at 12 months (k = 12; 95% CI: 0.08-0.37), and 0.36 for outcome time points beyond 12 months (k = 5; 95% CI: 0.02-0.70).ConclusionThis meta-analysis found a significant improvement in medication adherence among older adults receiving pharmacist-led interventions. Implementation of pharmacist-led interventions supported by Medicare reimbursement could ensure older adults' access to effective medication adherence support.
| S-EPMC8595553 | biostudies-literature
Project description:BackgroundAdherence to antiretroviral therapy (ART) is essential for allowing persons living with HIV to live longer, healthier lives. However, a large portion of this population has suboptimal adherence and are not virally suppressed. Conventional interventions aimed at improving ART adherence lack portability and scalability, and improvements in adherence are not often sustained. Mobile health (mHealth) ART interventions offer a low-cost and accessible method of improving adherence, but many have limited functionality and do not offer comprehensive support. The combination of an mHealth intervention with a face-to-face adherence intervention and interactive health coaching feature may offer sufficient support in a manner that is sensitive to resource limitations that are often found in HIV treatment settings. This paper details the protocol of a study designed to evaluate the potential of an enhanced mHealth intervention for improving ART adherence.ObjectiveThe primary objective of this study is to assess the feasibility and acceptability of the Fitbit Plus app enhanced with a face-to-face LifeSteps session (Fitbit Plus condition) for improving ART adherence. In addition, we will determine the preliminary efficacy of the intervention by calculating treatment effect sizes.MethodsThis study will be conducted in 2 phases. The intervention will be developed and piloted with a small group of participants during phase 1. Pilot participants will provide feedback that will be used to refine the intervention for phase 2. In phase 2, a preliminary randomized controlled trial (RCT) comparing Fitbit Plus with a condition that approximates the standard of care (SOC) will be conducted with 60 persons living with HIV. Interviews will be conducted with RCT participants at baseline, and follow-up interviews will be conducted at 1, 3, 6, and 12 months. ART adherence is the primary outcome and will be monitored throughout the study via electronic pill boxes. Effect sizes will be generated using a fractional logit model estimated by generalized estimating equations.ResultsPhase 1 of this trial is complete; data collection for phase 2 is ongoing. Follow-ups with enrolled participants will conclude in January 2020.ConclusionsThis study will contribute to the literature on ART adherence and may produce an efficacious intervention. Owing to a small sample size, there may be insufficient power to detect statistically significant differences between Fitbit Plus and SOC. However, if Fitbit Plus is found to be acceptable and feasible and yields promising effect size estimates, this pilot study could serve as the foundation for a larger, fully powered trial of Fitbit Plus.Trial registrationClinicalTrials.gov NCT02676128; https://clinicaltrials.gov/ct2/show/NCT02676128.International registered report identifier (irrid)DERR1-10.2196/15356.
| S-EPMC6881780 | biostudies-literature
Project description:INTRODUCTION:The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. METHODS AND ANALYSIS:Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. ETHICS AND DISSEMINATION:Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. TRIAL REGISTRATION NUMBER:ACTRN12616000661471; Pre-results.
| S-EPMC5640083 | biostudies-other
Project description:BackgroundNonadherence to antiretroviral therapy (ART) among people living with HIV is a crucial barrier to attaining viral suppression globally. Existing behavioral interventions have successfully increased ART adherence, but typically show only short-term impact that dissipates after the interventions are withdrawn.ObjectiveThis study aims to test the feasibility, acceptability, and preliminary efficacy of a novel intervention that uses SMS text messages and conditional incentives to support ART initiators in establishing pill-taking habits.MethodsA sample of 150 participants aged ≥18 years who have initiated ART in the preceding 3 months will be recruited from Mildmay Uganda in Kampala, Uganda. All (150/150, 100%) participants will be educated on the anchoring strategy and will choose an existing routine to pair with their daily ART adherence from a set of 3 suggested routines: getting dressed in the morning, eating breakfast, or eating dinner. Then, participants will be randomized to receive either usual care (control group: 50/150, 33.3%) or 1 of the 2 interventions delivered over 3 months: daily SMS text message reminders to follow their chosen anchoring plan (messages group; treatment group 1: 50/150, 33.3%) or daily SMS text messages and incentives conditional on taking their ART medication around the time of their chosen anchor (incentives group; treatment group 2: 50/150, 33.3%). Long-term ART adherence will be evaluated for 6 months after the intervention, and survey assessments will be conducted at baseline, 3 months, and 9 months. Outcomes include feasibility and acceptability measures and intervention efficacy outcomes defined by electronically measured mean medication adherence during the intervention and during the 6 months after the intervention, along with a measure of routine ART adherence based on taking medications around the time of participants' anchor during the intervention and during the 6 months after intervention.ResultsAs of February 18, 2022, recruitment was completed. A total of 150 participants were recruited, and data collection is expected to end in December of 2022. Final results are expected to be submitted for publication by April 2023.ConclusionsThis study is the first to use behavioral economics-based interventions in combination with the anchoring strategy to improve long-term ART adherence among treatment initiators. We hypothesize that the combination of SMS text message reminders and incentives will increase participants' use of their anchoring strategy, and thus medication adherence will be better maintained after the intervention ends in our intervention groups relative to the control group that uses only the anchoring strategy. Results of this pilot study will help to refine this combined intervention approach for testing at scale and broaden our understanding of the habit formation process.Trial registrationClinicalTrials.gov NCT05131165; https://clinicaltrials.gov/ct2/show/NCT05131165.International registered report identifier (irrid)DERR1-10.2196/42216.
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Project description:BackgroundPakistan is facing a growing population of people living with human immunodeficiency (HIV). In this randomized controlled trial, we investigate if a pharmacist-led intervention can increase adherence to antiretroviral therapy (ART) for people living with HIV (PLWH).MethodsAdults with HIV, who have been taking ART for more than 3 months were randomly assigned to receive either a pharmacist-led intervention or their usual care. Measures of adherence were collected at 1) baseline 2) just prior to delivery of intervention and 3) 8 weeks later. The primary outcomes were CD4 cell count and self-reported adherence measured with the AIDS Clinical Trial Group (ACTG) questionnaire.ResultsPost-intervention, the intervention group showed a statistically significant increase in CD4 cell counts as compared to the usual care group (p = 0.0054). In addition, adherence improved in the intervention group, with participants being 5.96 times more likely to report having not missed their medication for longer periods of time (p = 0.0086) while participants in the intervention group were 7.74 times more likely to report missing their ART less frequently (p < 0.0001).ConclusionsThe findings support the improvement in ART adherence and HIV management.Trial registrationThe trial is registered with Australian New Zealand Clinical Trials Registry ( ACTRN12618001882213 ). Registered 20 November 2018.
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Project description:Non-adherence to anti-tuberculosis (anti-TB) medication is a major risk factor for poor treatment outcomes. We therefore assessed the effectiveness of medication adherence enhancing interventions in TB patients. We report a systematic review of randomized controlled trials that included either latent tuberculosis infection (LTBI) or active TB patients. Outcomes of interest included adherence rate, completed treatment, defaulted treatment and treatment outcomes. We identified four LTBI and ten active TB studies. In active TB patients, directly observed treatment (DOT) by trained community workers, short messaging service combined with education, counselling, monthly TB vouchers, drug box reminders and combinations of those were found effective. In LTBI patients, shorter regimens and DOT effectively improved treatment completion. Interestingly, DOT showed variable effectiveness, highlighting that implementation, population and setting may play important roles. Since non-adherence factors are patient-specific, personalized interventions are required to enhance the impact of a programme to improve medication adherence in TB patients.
| S-EPMC7214451 | biostudies-literature
Project description:Multiple studies demonstrate poor adherence to medication regimens prescribed for chronic illnesses, including osteoporosis, but few interventions have been proven to enhance adherence. We examined the effectiveness of a telephone-based counseling program rooted in motivational interviewing to improve adherence to a medication regimen for osteoporosis.We conducted a 1-year randomized controlled clinical trial. Participants were recruited from a large pharmacy benefits program for Medicare beneficiaries. All potentially eligible individuals had been newly prescribed a medication for osteoporosis. Consenting participants were randomized to a program of telephone-based counseling (n = 1046) using a motivational interviewing framework or a control group (n = 1041) that received mailed educational materials. Medication regimen adherence was the primary outcome compared across treatment arms and was measured as the median (interquartile range) medication possession ratio, calculated as the ratio of days with filled prescriptions to total days of follow-up.The groups were balanced at baseline, with a mean age of 78 years; 93.8% were female. In an intention-to-treat analysis, median adherence was 49% (interquartile range, 7%-88%) in the intervention arm and 41% (2%-86%) in the control arm (P = .07, Kruskal-Wallis test). There were no differences in self-reported fractures.In this randomized controlled trial, we did not find a statistically significant improvement in adherence to an osteoporosis medication regimen using a telephonic motivational interviewing intervention.
| S-EPMC3905804 | biostudies-literature
Project description:Behavioral intervention effectiveness in randomized controlled trials requires fidelity to the protocol. Fidelity assessment tools tailored to the intervention may strengthen intervention research.The aim of this study was to describe the assessment of fidelity to the structured intervention protocol in an examination of a nurse-delivered telephone intervention designed to improve medication adherence.Fidelity assessment included random selection and review of approximately 10% of the audiorecorded intervention sessions, stratified by interventionist and intervention session. Audiotapes were reviewed along with field notes for percentage of agreement, addressing whether key components were covered during the sessions. Visual analog scales were used to provide summary scores (0 = low to 5 = high) of interaction characteristics of the interventionists and participants with respect to engagement, demeanor, listening skills, attentiveness, and openness.Four nurse interventionists delivered 871 structured intervention sessions to 113 participants. Three trained graduate student researchers assessed 131 intervention sessions. The mean percentage of agreement was 92.0% (±10.5%), meeting the criteria of 90% congruence with the intervention protocol. The mean interventionist interaction summary score was 4.5 ± 0.4, and the mean participant interaction summary score was 4.5 ± 0.4.Overall, the interventionists successfully delivered the structured intervention content, with some variability in both the percentage of agreement and quality of interaction scores. Ongoing assessment aids in ensuring fidelity to study protocol and having reliable study results.
| S-EPMC3138209 | biostudies-literature
Project description:BackgroundMobile health technologies have the potential to improve the reach and delivery of interventions for promoting long-term secondary prevention of coronary heart disease.ObjectiveThis study aims to determine the effectiveness of an SMS text messaging intervention (Text4HeartII) for improving adherence to medication and lifestyle changes over and above usual care in people with coronary heart disease at 24 and 52 weeks.MethodsA two-arm, parallel, randomized controlled trial was conducted in New Zealand. Participants with a recent acute coronary syndrome were randomized to receive usual cardiac services alone (control, n=153) or a 24-week SMS text message program for supporting self-management plus usual cardiac services (n=153). The primary outcome was adherence to medication at 24 weeks, defined as a medication possession ratio of 80% or more for aspirin, statin, and antihypertensive therapy. Secondary outcomes included medication possession ratio at 52 weeks, self-reported medication adherence, adherence to healthy lifestyle behaviors, and health-related quality of life at 24 and 52 weeks.ResultsParticipants were predominantly male (113/306, 80.3%) and European New Zealanders (210/306, 68.6%), with a mean age of 61 years (SD 11 years). Groups were comparable at baseline. National hospitalization and pharmacy dispensing records were available for all participants; 92% (282/306, 92.1%) of participants completed a 24-week questionnaire and 95.1% (291/306) of participants completed a 52-week questionnaire. Adherence with 3 medication classes were lower in the intervention group than in the control group (87/153, 56.8% vs 105/153, 68.6%, odds ratio 0.60, 95% CI 0.38-0.96; P=.03) and 52 weeks (104/153, 67.9% vs 83/153, 54.2%; odds ratio 0.56, 95% CI 0.35-0.89; P=.01). Self-reported medication adherence scores showed the same trend at 52 weeks (mean difference 0.3; 95% CI 0.01-0.59; P=.04). Moreover, self-reported adherence to health-related behaviors was similar between groups.ConclusionsText4HeartII did not improve dispensed medication or adherence to a favorable lifestyle over and above usual care. This finding contrasts with previous studies and highlights that the benefits of text interventions may depend on the context in which they are used.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000422426; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370398.International registered report identifier (irrid)RR2-10.1186/s13063-018-2468-z.
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