NCT04426331

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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
739

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

June 7, 2020

Last Update Submit

June 11, 2020

Conditions

Keywords

voucherinformationhealth behavior

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Uptake of initial appointment

    Within 90 days of the date of screening

Study Arms (3)

No Voucher

NO INTERVENTION

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).

Voucher Without Value Information

EXPERIMENTAL

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

Behavioral: Voucher Without Value Information

Voucher With Value Information

EXPERIMENTAL

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.

Behavioral: Voucher With Value Information

Interventions

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 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, 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."

Voucher With Value Information

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital - Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Related 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.

    PMID: 28549849BACKGROUND

Related Links

MeSH Terms

Conditions

GlaucomaEye DiseasesHealth Behavior

Condition Hierarchy (Ancestors)

Ocular HypertensionBehavior

Study Officials

  • Seema Kacker, PhD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR
  • David S Friedman, MD PhD

    Massachusetts Eye and Ear Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized study: screening events (clusters) randomized to one of three interventions, outcomes from individuals within clusters tracked.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 11, 2020

Study Start

May 5, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations