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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04426331
Other study ID # IRB00054137
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2017
Est. completion date January 1, 2019

Study information

Verified date June 2020
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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."


Recruitment information / eligibility

Status Completed
Enrollment 739
Est. completion date January 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Voucher Without Value Information
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."
Voucher With Value Information
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."

Locations

Country Name City State
United States Johns Hopkins Hospital - Wilmer Eye Institute Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 90 days of the date of screening
Secondary Uptake of initial appointment Binary indicator for completion of the initially scheduled appointment. Within 90 days of the date of screening
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