Study on Incentives for Glaucoma Medications Adherence

NCT ID: NCT02271269

Last Updated: 2017-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care (UC)

Patients receiving Usual Care for Glaucoma comprising:

* Education on effective glaucoma treatment
* Routine check-ups with an ophthalmologist and prescription of glaucoma eye drops
* Glaucoma counselling \[Can be recommended by ophthalmologist for non-adherent patients\] covering:

* Glaucoma risk factors and symptoms
* Management and treatment
* Medications and optimal dosage windows
* Risks of medication non-adherence
* Formulation of a dosing schedule that compliments each patient's lifestyle

Group Type NO_INTERVENTION

No interventions assigned to this group

Value Pricing (VP)

Patient receiving Usual Care for Glaucoma and given the opportunity to receive Value Pricing Subsidies.

Group Type EXPERIMENTAL

Value Pricing Subsidies

Intervention Type BEHAVIORAL

* Usual care for glaucoma
* Subsidies granted to adherent patients for their glaucoma medications and physician visits, lowering the costs of treatment and providing a financial incentive for patients to take their medicines as prescribed.
* Subsidy (25 / 50%) granted based on meeting dose-rate adherence percentage targets (75 / 90%) at the month 3 and 6 assessment points.

Interventions

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Value Pricing Subsidies

* Usual care for glaucoma
* Subsidies granted to adherent patients for their glaucoma medications and physician visits, lowering the costs of treatment and providing a financial incentive for patients to take their medicines as prescribed.
* Subsidy (25 / 50%) granted based on meeting dose-rate adherence percentage targets (75 / 90%) at the month 3 and 6 assessment points.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore National Eye Centre

OTHER_GOV

Sponsor Role collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role lead

Responsible Party

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Marcel Bilger

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcel Bilger, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke-NUS Graduate Medical School

Locations

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Singapore National Eye Center

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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Elliott RA, Shinogle JA, Peele P, Bhosle M, Hughes DA. Understanding medication compliance and persistence from an economics perspective. Value Health. 2008 Jul-Aug;11(4):600-10. doi: 10.1111/j.1524-4733.2007.00304.x. Epub 2008 Jan 8.

Reference Type BACKGROUND
PMID: 18194403 (View on PubMed)

Chapman GB, Brewer NT, Coups EJ, Brownlee S, Leventhal H, Leventhal EA. Value for the future and preventive health behavior. J Exp Psychol Appl. 2001 Sep;7(3):235-50.

Reference Type BACKGROUND
PMID: 11676102 (View on PubMed)

van Dulmen S, Sluijs E, van Dijk L, de Ridder D, Heerdink R, Bensing J. Patient adherence to medical treatment: a review of reviews. BMC Health Serv Res. 2007 Apr 17;7:55. doi: 10.1186/1472-6963-7-55.

Reference Type BACKGROUND
PMID: 17439645 (View on PubMed)

Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3.

Reference Type BACKGROUND
PMID: 18425859 (View on PubMed)

Giuffrida A, Torgerson DJ. Should we pay the patient? Review of financial incentives to enhance patient compliance. BMJ. 1997 Sep 20;315(7110):703-7. doi: 10.1136/bmj.315.7110.703.

Reference Type BACKGROUND
PMID: 9314754 (View on PubMed)

DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004 Mar;42(3):200-9. doi: 10.1097/01.mlr.0000114908.90348.f9.

Reference Type BACKGROUND
PMID: 15076819 (View on PubMed)

Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.

Reference Type BACKGROUND
PMID: 19102784 (View on PubMed)

Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.

Reference Type BACKGROUND
PMID: 18453793 (View on PubMed)

Mills RP, Budenz DL, Lee PP, Noecker RJ, Walt JG, Siegartel LR, Evans SJ, Doyle JJ. Categorizing the stage of glaucoma from pre-diagnosis to end-stage disease. Am J Ophthalmol. 2006 Jan;141(1):24-30. doi: 10.1016/j.ajo.2005.07.044.

Reference Type BACKGROUND
PMID: 16386972 (View on PubMed)

Horne R, Weinman J. Patients' beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999 Dec;47(6):555-67. doi: 10.1016/s0022-3999(99)00057-4.

Reference Type BACKGROUND
PMID: 10661603 (View on PubMed)

Tsai JC, McClure CA, Ramos SE, Schlundt DG, Pichert JW. Compliance barriers in glaucoma: a systematic classification. J Glaucoma. 2003 Oct;12(5):393-8. doi: 10.1097/00061198-200310000-00001.

Reference Type BACKGROUND
PMID: 14520147 (View on PubMed)

Bilger M, Wong TT, Lee JY, Howard KL, Bundoc FG, Lamoureux EL, Finkelstein EA. Using Adherence-Contingent Rebates on Chronic Disease Treatment Costs to Promote Medication Adherence: Results from a Randomized Controlled Trial. Appl Health Econ Health Policy. 2019 Dec;17(6):841-855. doi: 10.1007/s40258-019-00497-0.

Reference Type DERIVED
PMID: 31317511 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27422389 (View on PubMed)

Other Identifiers

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HSRNIG12nov007

Identifier Type: -

Identifier Source: org_study_id

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