Clinical trial NCT02271269: Study on Incentives for Glaucoma Medications Adherence
Official title: A Randomized Controlled Trial to Increase Glaucoma Medication Adherence Using Value Pricing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
medication adherence
financial incentives
behavioral economics
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: Singapore National Eye Centre
First posted: 2014-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Glaucoma topical eye medications, when adhered to, are effective at controlling disease progression. Yet evidence shows that many glaucoma patients have incomplete adherence to medications, with disease progression resulting in significant costs to the patient and health system. Through the approach of value pricing, a link can be made between non-adherence and its resulting costs by granting subsidies to adherent patients for their medications and physician visits. This 6-month randomized controlled trial among 100 glaucoma patients from the Singapore National Eye Centre aims to test the extent to which value pricing can improve medication adherence.

Detailed description: By reducing intraocular pressure, glaucoma topical eye medications are effective at controlling disease progression for the majority of patients. Yet evidence shows that many glaucoma patients have incomplete adherence to medications, resulting in significant personal costs in terms of disease progression and visual field loss. The cost to the health system from poor adherence is also substantial as glaucoma surgery is more costly than treatment with topical medication. Behavioural economics theory suggests that adherence rates can be improved by providing a clearer link between non-adherence and the resulting costs thereof. In the proposed study, this link is made by granting subsidies to adherent patients for their medications and physician visits, whereas those who are not sufficiently adherent would not receive the subsidy and thus pay a higher rate for their treatment.

These subsidies provide a financial incentive for patients to take their medicines as prescribed, and because prescription refills and visits occur regularly, also provide a tangible and near-term cost resulting from non-adherence. The investigators refer to this approach as value pricing as subsidies are allocated to medications that have not only been shown to be clinically effective but that are also effectively used by the patient. In efforts to increase adherence among glaucoma patients in Singapore, the investigators propose to conduct a 6-month proof-of-concept randomized controlled trial among 100 participants from the Singapore National Eye Centre (SNEC) to test the extent to which value pricing can improve medication adherence. As Singapore's population continues to age and a larger share of the population requires daily medications to treat chronic diseases, such innovative solutions are needed to ensure not only that patients take their medications as prescribed and receive the full benefit of their treatment but also that Government subsidies are allocated effectively so that to ensure the sustainability of the health system.

Specific Aim and hypothesis tested:

Aim: Test whether adding Value Pricing (VP) to Usual Care (UC) can improve medication adherence over a 6-month period.

Hypothesis: VP patients will show greater adherence rates at 6 months compared to those receiving only UC.

Eligibility criteria: Inclusion Criteria:

* Singaporean citizens or permanent residents
* Conversant in English or Mandarin
* Taking at least one glaucoma eye drop medication
* Shown to be non-adherent based on a value of 6 or less on the Modified Medication Adherence Scale (MMAS)

Exclusion Criteria:

* Significant comorbid conditions preventing application of medications without assistance
* Stage 4 (advanced) or Stage 5 (end stage) glaucoma according to the Glaucoma Staging System

Primary outcomes:
measure: Monthly dose-rate adherence percentage
timeFrame: Month 6
Secondary outcomes:
measure: Dose-rate adherence percentage
timeFrame: Months 1 - 6
measure: Proportion meeting 90% dose-rate adherence percentage
timeFrame: Months 3 & 6
measure: Proportion meeting 75% dose-rate adherence percentage
timeFrame: Months 3 & 6
measure: Intraocular Pressure
timeFrame: Baseline & Month 6
measure: EQ-5D-5L
timeFrame: Baseline & Month 6
measure: Glaucoma Quality of Life (GQL-15)
timeFrame: Baseline & Month 6
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Center
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Marcel Bilger, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Bilger M, Wong TT, Howard KL, Lee JY, Toh AN, John G, Lamoureux EL, Finkelstein EA. Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing. Trials. 2016 Jul 15;17(1):316. doi: 10.1186/s13063-016-1459-1.