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Vouchers to Increase Uptake of Already Free Eye Care

Primary Purpose

Glaucoma, Eye Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Voucher Without Value Information

Voucher With Value Information

About this trial

This is an interventional health services research trial for Glaucoma focused on measuring voucher, information, health behavior

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Referred for follow-up at a Screening to Prevent Glaucoma (SToP) study screening event (overarching observational study from which trial sample was drawn). SToP participants were referred for follow-up for any of the following conditions: (1) VA worse than 20/40 in at least 1 eye despite autorefraction; (2) signs of retinal abnormalities on fundus photography; (3) uninterpretable fundus photography; (4) cup-to-disc ratio (CDR) greater than or equal to 0.9, and/or CDR between 0.7 and 0.9 with visual field defects or history of glaucoma; and (5) IOP of 23 mm Hg or greater.

Exclusion Criteria:

SToP participants who were not referred at the time of screening but later contacted after review of fundus photography
SToP participants who were referred for follow-up but stated at the time of counseling that they were already under the care of an eye doctor

Sites / Locations

Johns Hopkins Hospital - Wilmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

No Voucher

Voucher Without Value Information

Voucher With Value Information

Arm Description

Individuals being referred from screening events randomized to "no intervention" received the standard approach to offering free follow-up examinations (patient education, standard counseling, appointment information packet, reminder phone calls).

In addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher Without Value Information" received a personal voucher.

In addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher With Value Information" received a personal voucher, which differed from the voucher in the second arm since it included a statement of value.

Outcomes

Primary Outcome Measures

Uptake of follow-up appointment

The primary endpoint was attending a follow-up appointment, either on the initially scheduled or on a rescheduled date within 90 days of the date of screening. Individuals who did not meet this endpoint either stated that they were not interested in follow-up at the screening event itself, cancelled or did not show for their appointments on 3 occasions, stated that they were not interested in follow-up when study staff attempted to reschedule, or did not show for an appointment and could not be reached for rescheduling after 3 attempts.

Secondary Outcome Measures

Uptake of initial appointment

Binary indicator for completion of the initially scheduled appointment.

Full Information

NCT ID

NCT04426331

First Posted

June 7, 2020

Last Updated

June 11, 2020

Sponsor

Johns Hopkins University

Collaborators

Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT04426331

Brief Title

Vouchers to Increase Uptake of Already Free Eye Care

Official Title

Providing Vouchers Redeemable for Already Free Eye Exams To Increase Uptake Among a Low-Income Minority Population: A Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

May 5, 2017 (Actual)

Primary Completion Date

January 1, 2019 (Actual)

Study Completion Date

January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study was intended to test if reframing an offer for a free follow-up eye examination could increase uptake within ongoing community-based screening program for low-income and minority populations in Baltimore City. This study evaluated the effect of offering participants a physical voucher they were told was redeemable for free follow-up, relative to simply telling participants that the follow-up appointment would be free of charge. The investigators assessed two forms of vouchers, one with estimated value information, and one without. The underlying hypothesis was that reframing these already free offers would increase uptake by increasing perceived offer value and increasing a sense of regret from not taking advantage of a "good deal."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Eye Diseases

Keywords

voucher, information, health behavior

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Cluster randomized study: screening events (clusters) randomized to one of three interventions, outcomes from individuals within clusters tracked.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

739 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No Voucher

Arm Type

No Intervention

Arm Description

Arm Title

Voucher Without Value Information

Arm Type

Experimental

Arm Description

In addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher Without Value Information" received a personal voucher.

Arm Title

Voucher With Value Information

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Voucher Without Value Information

Intervention Description

Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital. The voucher included the patient's name, the screener's name, and an expiration date 90 days from the date of screening. These participants were told: "I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. So, with this voucher, both the exam and the glasses will be completely free."

Intervention Type

Behavioral

Intervention Name(s)

Voucher With Value Information

Intervention Description

Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital, which would normally cost $250. The voucher included the patient's name, the screener's name, an expiration date 90 days from the date of screening, and a statement about the $250 voucher value. These participants were told: "I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. These services normally cost about $250, but with this voucher, both the exam and the glasses will be completely free."

Primary Outcome Measure Information:

Title

Uptake of follow-up appointment

Description

Time Frame

Within 90 days of the date of screening

Secondary Outcome Measure Information:

Title

Uptake of initial appointment

Description

Binary indicator for completion of the initially scheduled appointment.

Time Frame

Within 90 days of the date of screening

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Referred for follow-up at a Screening to Prevent Glaucoma (SToP) study screening event (overarching observational study from which trial sample was drawn). SToP participants were referred for follow-up for any of the following conditions: (1) VA worse than 20/40 in at least 1 eye despite autorefraction; (2) signs of retinal abnormalities on fundus photography; (3) uninterpretable fundus photography; (4) cup-to-disc ratio (CDR) greater than or equal to 0.9, and/or CDR between 0.7 and 0.9 with visual field defects or history of glaucoma; and (5) IOP of 23 mm Hg or greater. Exclusion Criteria: SToP participants who were not referred at the time of screening but later contacted after review of fundus photography SToP participants who were referred for follow-up but stated at the time of counseling that they were already under the care of an eye doctor

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seema Kacker, PhD

Organizational Affiliation

Johns Hopkins School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David S Friedman, MD PhD

Organizational Affiliation

Massachusetts Eye and Ear Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Hospital - Wilmer Eye Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28549849

Citation

Zhao D, Guallar E, Gajwani P, Swenor B, Crews J, Saaddine J, Mudie L, Varadaraj V, Friedman DS; SToP Glaucoma Study Group. Optimizing Glaucoma Screening in High-Risk Population: Design and 1-Year Findings of the Screening to Prevent (SToP) Glaucoma Study. Am J Ophthalmol. 2017 Aug;180:18-28. doi: 10.1016/j.ajo.2017.05.017. Epub 2017 May 24.

Results Reference

background

Links:

URL

https://www.stopglaucomajhu.org/

Description

Website dedicated to overarching study from which trial participants were drawn

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Vouchers to Increase Uptake of Already Free Eye Care

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