Increasing DR Screening Through TOP: Supporting Implementation and Identifying Opportunities for Scale up in Ontario

NCT ID: NCT03927859

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-05
• Study Completion Date: 2019-08-30

Brief Summary

It is recommended that people with diabetes have their eyes screened for retinopathy every 1-2 years. Retinopathy can lead to visual impairment and blindness, but early detection through regular retinal screening can help to prevent this. Many Ontarians with diabetes have not been receiving regular screening. One possible way to get more people screened for retinopathy involves tele-retinal screening using teleophthalmology (TOP), where patients can have their eyes screened in their local clinic or a site nearby. In this project, we are testing 3 patient interventions: mailing a letter, phone call or an option to bundle their screening with other diabetic care services (e.g. foot care exam) and examine the impact of these various interventions alone or in combination with each other.

Detailed Description

Currently in Ontario, about a third of patients with diabetes, or more than 400,000 individuals, have not had their screening done within the last two years. The rates are even lower if you examine screening rates within the last year. Within Ontario, the highest rates of unscreened individuals live in the Greater Toronto Area (Toronto Central Local Health Integration Network (LHIN), Central LHIN and Central West LHIN). Despite the recommendation for patients to be screened every year, currently only about 5% of patients in TCLHIN and CLHIN have been screened within the last year based on a preparatory analysis for this study.

It is, therefore, important to identify which intervention strategies, or combination of strategies, will be most effective in improving screening rates in Ontario. While many studies have examined the effects of various strategies individually, for this project we aim to use several interventions that have been identified in the past as being effective and examine the effects of these interventions alone or in combination.

The approach we are taking in this study is the Multiphase Optimization Strategy (MOST). This study design approach consists of three stages: a screening phase, a refining phase and a confirming phase.

During the screening phase, several intervention approaches are evaluated alone or in combination with each other in order to assess which intervention(s) have the greatest potential for impact on the selected outcome. During the refining phase of MOST, the selected components are fine-tuned and issues such as optimal levels of each component are investigated. During the confirming phase, the selected components are delivered at optimal levels and the intervention showing greatest promise is evaluated through a standard randomized controlled trial.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mailing Letter

Patients assigned to this arm, in which a letter is mailed out will receive 2 pamphlets in the mail. One pamphlet described the teleophthalmology program and the other pamphlet was designed by the Canadian Association of Ophthalmologists and describes what DR is and why screening is important. The letter will also contain contact information about the closest TOP to the area of the PCP practice.

Group Type: ACTIVE_COMPARATOR

a mail letter, a phone call and a phone call plus mailed letter

Intervention Type: OTHER

All patients will be administered an intervention that will contain one or more of 3 possible interventions (a mail letter, a phone call and a mail plus phone call). Some patients will also be assigned into a condition where none of the interventions will be present.

Patients at Black Creek CHC will only be offered a phone or a phone plus incentive intervention or a no intervention.

Phone call

Administrative staff on site of each practice will contact all patients assigned to this arm by a phone call.

The patient will be informed that they are calling from the family health practice that the patient belongs to. The reason for the call will be that the patient has been identified as somebody who is likely overdue for a screening test. Patients will be asked if they have had a screening test done recently, and if not, they will be offered an appointment. Patients that refuse an appointment, will be politely probed for reasons and attempts will be made to provide them with information on potential solutions to these barriers (e.g. patients working 9-5 on weekdays will be informed that they can access TOP on evenings). The call will also be used as an opportunity to inform patients about the importance of screening.Three attempts will be made to reach each patient. Only a single voicemail message will be left, when the possibility is available.

Group Type: ACTIVE_COMPARATOR

a mail letter, a phone call and a phone call plus mailed letter

Intervention Type: OTHER

All patients will be administered an intervention that will contain one or more of 3 possible interventions (a mail letter, a phone call and a mail plus phone call). Some patients will also be assigned into a condition where none of the interventions will be present.

Patients at Black Creek CHC will only be offered a phone or a phone plus incentive intervention or a no intervention.

Mail + Phone call

Patients assigned to this arm will first have letters mailed out to them (identical to the ones mailed out in the letter only arm). A week later, the letter will be followed up by a phone call as per the phone only arm. Patients will be asked if they have already booked, and if not, will be provided with information about the program as per the phone call script in the phone only arm.

Group Type: ACTIVE_COMPARATOR

a mail letter, a phone call and a phone call plus mailed letter

Intervention Type: OTHER

All patients will be administered an intervention that will contain one or more of 3 possible interventions (a mail letter, a phone call and a mail plus phone call). Some patients will also be assigned into a condition where none of the interventions will be present.

Patients at Black Creek CHC will only be offered a phone or a phone plus incentive intervention or a no intervention.

Control

No intervention will be offered to patients in this arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

a mail letter, a phone call and a phone call plus mailed letter

All patients will be administered an intervention that will contain one or more of 3 possible interventions (a mail letter, a phone call and a mail plus phone call). Some patients will also be assigned into a condition where none of the interventions will be present.

Patients at Black Creek CHC will only be offered a phone or a phone plus incentive intervention or a no intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Only patients diagnosed with Type I or Type II Diabetes with no evidence in their medical records of a screening within the last 2 years will be included in the study and only individuals 18 years of age or older will be included.

Exclusion Criteria

Patients screened within the last year. In addition, individuals who cannot speak English will be excluded from the study to minimize additional workload placed on administrative staff.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Diabetes Action Canada

UNKNOWN

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Brent, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto Western Hospital

Onil Bhattacharyya, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Laura Desveaux, PhD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Vess Stamenova, PhD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

Black Creek Community Health Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Women's College Hospital Family Health Team

Toronto, Ontario, Canada

Site Status: ACTIVE_NOT_RECRUITING

Countries

Canada

Central Contacts

Vess Stamenova, PhD

Role: CONTACT

vess.stamenova@wchospital.ca

416-323-6400 ext. 5112

Nike Onabajo, MSc

Role: CONTACT

nike.onabajo@wchospital.ca

4163236400 ext. 5126

Facility Contacts

Doris Forlemu-Kamwa

Role: primary

Doris.Forlemu-Kamwa@bcchc.com

4162498000 ext. 2240

References

Stamenova V, Nguyen M, Onabajo N, Merritt R, Sutakovic O, Mossman K, Wong I, Ives-Baine L, Bhatia RS, Brent MH, Bhattacharyya O. Mailed Letter Versus Phone Call to Increase Diabetic-Related Retinopathy Screening Engagement by Patients in a Team-Based Primary Care Practice: Prospective, Single-Masked, Randomized Trial. J Med Internet Res. 2023 Jan 11;25:e37867. doi: 10.2196/37867.

Reference Type: DERIVED

PMID: 36630160 (View on PubMed)

Other Identifiers

2018-0068-E

Identifier Type: -

Identifier Source: org_study_id