GlaucomaNCT04426331
Vouchers to Increase Uptake of Already Free Eye Care
A study testing Voucher Without Value Information and Voucher With Value Information in people with Glaucoma and Eye Diseases, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Eye Diseases
- What is being tested?
- Voucher Without Value Information and Voucher With Value Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 739 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2017to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hospital - Wilmer Eye Institute
Baltimore, Maryland, 21287
About this study
Official title: Providing Vouchers Redeemable for Already Free Eye Exams To Increase Uptake Among a Low-Income Minority Population: A Randomized Trial
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."
- Conditions
- Glaucoma, Eye Diseases
- Being tested
- Voucher Without Value Information, Voucher With Value Information
- Keywords
- voucher, information, health behavior
- Medical subject headings
- Glaucoma, Eye Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voucher Without Value InformationBehavioural
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 InformationBehavioural
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."
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Voucher With Value Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days of the date of screening
Secondary outcomes (1)
Uptake of initial appointment
Binary indicator for completion of the initially scheduled appointment.
Measured: Within 90 days of the date of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start5 May 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized study: screening events (clusters) randomized to one of three interventions, outcomes from individuals within clusters tracked.
- Masking
- None (open label)
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Seema Kacker, PhD, Principal investigator, Johns Hopkins School of MedicineDavid S Friedman, MD PhD, Principal investigator, Massachusetts Eye and Ear Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426331
- Sponsor's protocol ID
- IRB00054137
- Status last verified
- Jun 2020
- First submitted
- 7 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28549849
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Vouchers Redeemable for Already Free Eye Exams To Increase Uptake Among a Low-Income Minority Population: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04426331
- Acronym / sponsor ID
- IRB00054137
- Conditions
- Glaucoma, Eye Diseases
- Keywords
- voucher, information, health behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 5 May 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cluster randomized study: screening events (clusters) randomized to one of three interventions, outcomes from individuals within clusters tracked.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Voucher Without Value InformationIn addition to receiving the standard approach above, individuals being referred from screening events randomized to "Voucher Without Value Information" received a personal voucher. |
| Voucher With Value Information | Experimental | Behavioral: Voucher With Value InformationIn 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voucher Without Value InformationPatients 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." | Behavioural | Voucher Without Value Information |
| Voucher With Value InformationPatients 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." | Behavioural | Voucher With Value Information |
Primary outcome
Uptake of follow-up appointment
Time frame: Within 90 days of the date of screening
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.
1 secondary outcome
Uptake of initial appointment
Time frame: Within 90 days of the date of screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 28549849Zhao 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.
- Website dedicated to overarching study from which trial participants were drawnLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seema Kacker, PhD principal investigator
Johns Hopkins School of Medicine
David S Friedman, MD PhD principal investigator
Massachusetts Eye and Ear Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voucher Without Value Information and Voucher With Value Information in people with Glaucoma and Eye Diseases, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of follow-up appointment (time frame: Within 90 days of the date of screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04426331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.