Dataset Information

Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing.

ABSTRACT: Many glaucoma patients do not adhere to their medication regimens because they fail to internalize the (health) costs of non-adherence, which may not occur until years or decades later. Behavioural economic theory suggests that adherence rates can be improved by offering patients a near-term benefit. Our proposed strategy is to offer adherence-contingent rebates on medication and check-up costs. This form of value pricing (VP) ensures that rebates are granted only to those most likely to benefit. Moreover, by leveraging loss aversion, rebates are expected to generate a stronger behavioural response than equivalent financial rewards.The main objective of the Study on Incentives for Glaucoma Medication Adherence (SIGMA) is to test the VP approach relative to usual care (UC) in improving medication adherence. SIGMA is a randomized, controlled, open-label, single-centre superiority trial with two parallel arms. A total of 100 non-adherent (Morisky Medication Adherence Scale ?6) glaucoma patients from the Singapore National Eye Centre are block-randomized (blocking factor: single versus multiple medications users) into the VP and UC arms in a 1:1 ratio. The treatment received by VP patients will be strictly identical to that received by UC patients, with the only exception being that VP patients can earn either a 50 % or 25 % rebate on their glaucoma-related healthcare costs conditional on being adherent on at least 90 % or 75 % of days as measured by a medication event monitoring system. Masking the arm allocation will be precluded by the behavioural nature of the intervention but blocking size will not be disclosed to protect concealment. The primary outcome is the mean change from baseline in percentage of adherent days at month 6. A day will be counted as adherent when the patients take all their medication(s) within the appropriate dosing windows.This trial will provide evidence on whether adherence-contingent rebates can improve medication adherence among non-adherent glaucoma patients, and more generally whether this approach represents a promising strategy to cost-effectively improve chronic disease management.NCT02271269 . Registered on 19 October 2014.

SUBMITTER: Bilger M

PROVIDER: S-EPMC4947326 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing.

Bilger Marcel M Wong Tina T TT Howard Kaye L KL Lee Jia Yi JY Toh Ai Nee AN John Geraldine G Lamoureux Ecosse L EL Finkelstein Eric A EA

Trials 20160715 1

<h4>Background</h4>Many glaucoma patients do not adhere to their medication regimens because they fail to internalize the (health) costs of non-adherence, which may not occur until years or decades later. Behavioural economic theory suggests that adherence rates can be improved by offering patients a near-term benefit. Our proposed strategy is to offer adherence-contingent rebates on medication and check-up costs. This form of value pricing (VP) ensures that rebates are granted only to those mos ...[more]

PMID: 27422389

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Project description:PurposeThe majority of patients with glaucoma do not take their medications as prescribed. Estimates of the cost-utility value of adherence to prescribed glaucoma medication are vital to implement potentially effective interventions.DesignCost-utility analysis using Monte Carlo microsimulations incorporating a series of Markov cycles (10 000 iterations per strategy).ParticipantsPatients with glaucoma aged ≥40 years with a full lifetime horizon (up to 60 years).MethodsThe analysis estimated glaucomatous progression on the basis of data from the United Kingdom Glaucoma Treatment Study. Participants with glaucoma entered the model at age 40 years with a mean deviation in the better-seeing eye of -1.4±-1.9 decibels (dB) and -4.3±-3.4 dB in the worse-seeing eye. Participants whose glaucoma worsened each year accumulate -0.8 dB loss compared with -0.1 dB loss for those who remained stable. Data from the Glaucoma Laser Trial and the Tube versus Trabeculectomy Studies were used to assign probabilities of worsening disease among treated patients. Claims data estimating rates of glaucoma medication adherence over 4 years were used to assign probability of adherence. Those with poor adherence were modeled as having outcomes similar to the placebo arm of the clinical trials. As patients' mean deviation deteriorated, they transitioned between health states from mild (≥-6 dB), to moderate (<-6 to ≥-12 dB), to severe glaucoma (<-12 to ≥23 dB), to unilateral (<-20 dB) and bilateral blindness. At each health state, patients incurred the costs of treatment and established health utilities; ultimately, societal costs of low vision and blindness were included.Main outcome measuresCost and quality-adjusted life year (QALY) of glaucoma medication adherence.ResultsBeginning at an initial glaucoma diagnosis at age 40 years, patients proceeded to single-eye blindness as early as 19 years among those who were nonadherent and 23 years for those remaining adherent. Total healthcare costs for adherent patients averaged $62 782 (standard deviation [SD], 34 107), and those for nonadherent patients averaged $52 722 (SD, 38 868). Nonadherent patients had a mean loss of 0.34 QALYs, resulting in a cost-effectiveness ratio of $29 600 per QALY gained.ConclusionAt a conservative willingness to pay of $50 000/QALY, there is room to expand services to improve patient adherence.

Project description:To determine the associations between medical, demographic, socioeconomic, and ocular factors and adherence to topical glaucoma ocular hypotensive therapy.One hundred sixteen patients with ocular hypertension or open-angle glaucoma from 2 tertiary glaucoma services participated in this prospective study. Adherence to ocular hypotensive therapy was measured using an electronic dose monitor (Travatan Dosing Aid, Alcon Laboratories Inc., Fort Worth, TX) and collected data at 3 months after enrollment. We used 3 different definitions of adherence: 1) Definition 1: the proportion of days taking the prescribed number of drops within 3 hours of the prescribed dosing time; 2) Definition 2: the proportion of days taking any drops within 3 hours of the prescribed dosing time; and 3) Definition 3: the proportion of days taking any drops within 6 hours of the prescribed dosing time. Univariate and multivariate models were used to determine the association between the 3 adherence definitions, medical, demographic, socioeconomic, and ocular factors at 3-month follow-up. The main outcome measures for this study were risk factors for poor objective medication adherence.Adherence, using Definition 1, Definition 2, and Definition 3, was 64%, 75%, and 80%, respectively. Age, total number of other eye diseases, and race were significantly associated with full treatment adherence (Definition 1), with race alone significantly predicting 11% of full treatment adherence. For Definition 2, age, income, level of education, and total number of eye diseases were significantly associated with partial adherence (3 h), again race alone significantly predicted 15% of partial adherence (any drops within 3 h). For Definition 3, race, income, level of education, and total number of other eye diseases significantly predicted partial adherence (any drops within 6 h), both race and income predicted 19% of partial treatment adherence. Significant differences for adherence rates between patients of European descent and those of African descent were found for all 3 definitions with those who were less adherent more likely to be of African descent.Electronic dose monitors provide important information regarding adherence to topical ocular hypotensive medications in glaucoma patients. Electronic dose monitors show low adherence in a significant number of participants. Future studies are needed to determine the reasons for these differences in health behaviors related to glaucoma treatment, which should guide treatment of poor adherence with glaucoma therapy.

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.

Project description:PurposeTo assess the accuracy of 5 subjective self-assessment tools (3 adherence measures and 2 psychometric scales) and pharmacy refill data in predicting objective electronically monitored nonadherence.DesignProspective cohort study.ParticipantsGlaucoma patients (> 40 years old, >1 medication with poor self-reported adherence) were recruited from University of Michigan Kellogg Eye Center for a study assessing the impact of a personalized glaucoma coaching program on medication adherence.MethodsParticipants completed an initial assessment including 5 self-assessment tools and a 3-month period of electronic monitoring of glaucoma medication adherence (AdhereTech); pharmacy refill data were obtained. Electronically monitored adherence was calculated monthly as the percentage of doses taken on time. The median of these adherence rates was designated as baseline adherence. Patients with adherence of ≤80% by electronic monitoring were considered nonadherent. Self-assessment tools were scored, and pharmacy refill data were summarized as the proportion of days covered. Correlation between measures of adherence was estimated with Pearson and Spearman correlation coefficients. Receiver operating characteristic curves, including estimation of area under the curve (AUC), sensitivity, specificity, and accuracy were used to compare measures of adherence with respect to predicting electronically monitored nonadherence.Main outcome measuresAccuracy of self-reported and pharmacy refill data adherence measures in predicting electronically monitored nonadherence.ResultsNinety-five patients completed 3 months of electronic monitoring with a median monthly adherence of 74 (± 21%); 53 patients (56%) were nonadherent. Pharmacy refill data were not correlated significantly with electronically monitored medication adherence (r = 0.12; P = 0.2). Of all the measures, a single-item adherence question ("Over the past month, what percentage of your drops do you think you took correctly?") showed the largest correlation with median electronically monitored adherence (r = 0.47; P < 0.0001), largest AUC for predicting nonadherence (AUC = 0.76 [95% confidence interval [CI], 0.66-0.87]), best accuracy (71% [95% CI, 61%-82%]), and good sensitivity (84% [95% CI, 73%-96%]).ConclusionsThe single-item question was the most accurate in predicting electronically monitored nonadherence among participants with poor self-reported adherence. In clinical practice, where alternatives are too resource intensive, this free single-item screening question can help to identify glaucoma patients at risk of poor medication adherence with reasonable accuracy.

Project description:PurposeTo assess the efficacy of the Support, Educate, Empower (SEE) glaucoma coaching program on medication adherence among glaucoma patients with low adherence.DesignUncontrolled intervention study with a pre-post design.ParticipantsGlaucoma patients ≥ age 40, taking ≥1 medication, who self-reported poor adherence were recruited from the University of Michigan Kellogg Eye Center. Adherence was monitored electronically for a 3-month baseline period; participants with median adherence of ≤80% were enrolled in the SEE program.MethodsParticipants' adherence was monitored electronically (AdhereTech, New York, NY) during the 7-month program. Adherence was calculated as the percentage of doses taken on time of those prescribed. The SEE program included (1) automated medication reminders, (2) 3 in-person counseling sessions with a glaucoma coach who had training in motivational interviewing (MI), and (3) 5 phone calls with the same coach for between-session support. The coach used a web-based tool to generate an education plan tailored to the patient's glaucoma diagnosis, test results, and ophthalmologist's recommendations (www.glaucomaeyeguide.org). The tool guided an MI-based conversation between coach and patient to identify barriers to adherence and possible solutions. Descriptive statistics were used to summarize baseline patient characteristics, and differences between those who did and did not complete the SEE program were tested with 2-sample t tests, chi-square tests, and Fisher exact tests. Adherence was compared before and after the SEE program with paired t tests.Main outcome measureChange in electronically monitored medication adherence.ResultsA total of 48 participants were enrolled. The participants were 54% male, 46% white, and on average 64 years of age (standard deviation [SD], 10.8 years), with an average worse-eye mean deviation (MD) of -7.9 dB (SD, 8.8 dB). Those completing the SEE program (n = 39) did not differ significantly from those who dropped out (n = 9) on gender, race, age, MD, or baseline adherence. Medication adherence improved from 59.9% at baseline to 81.3% (P < 0.0001) after completing the SEE program. Ninety-five percent of participants showed an improvement in adherence (mean relative improvement, 21.4%; SD, 16.5%; range, -3.2% to 74.4%; median, 20.1%). Fifty-nine percent of participants showed adherence of >80% on completing the SEE program.ConclusionsThe SEE program participants showed clinically meaningful, statistically significant improvement in glaucoma medication adherence.

Project description:BACKGROUND:Poor adherence to inhaled corticosteroid medications for children with high-risk asthma is both well documented and poorly understood. It has a disproportionate prevalence and impact on children of minority demographics in urban settings. Financial incentives have been shown to be a compelling method to engage those in a high-risk asthma population, but whether adherence can be maintained by offering financial incentives and how these incentives can be used to sustain high adherence are unknown. OBJECTIVE:The aim of this study is to determine the marginal effects of a financial incentive-based intervention on inhaled corticosteroid adherence, health care system use, and costs. METHODS:Participants include children aged 5 to 12 years who have had either at least two hospitalizations or one hospitalization and one emergency department visit for asthma in the year prior to their enrollment (and their caregivers). Participants are given an electronic inhaler sensor in order to track their medication use over a period of 7 months. After a 1-month period of observation, participants are randomized to 1 of 3 arms for a 3-month period. Participants in arm 1 receive daily text message reminders, feedback, and gain-framed, nominal financial incentives; participants in arm 2 receive daily text message reminders and feedback only, and participants in arm 3 receive no reminders, feedback, or incentives. All participants are subsequently observed for an additional 3-month period with no reminders, feedback, or incentives to assess whether any sustained effects are apparent. RESULTS:Study enrollment began in September 2019 with a target sample size of N=125 children. As of June 2020, 61 children have been enrolled. Data collection is estimated to be completed in June 2022, and analyses will be completed by June 2023. CONCLUSIONS:This study will provide data that will help to determine whether a financial incentive-based mobile health intervention for promoting inhaled corticosteroid use can be effective in patients with high-risk asthma over longer periods. TRIAL REGISTRATION:Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16711.

Dataset Information

Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing.

Publications

Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing.

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