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

NCT03927859 | Unknown

• 1 other identifier: 2018-0068-E
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Number of bookings made through the TOP program

  The primary outcome for the study is the number of bookings made through the TOP program

  1 year

Secondary Outcomes (1)

• Number of self-reported booking made outside of TOP

  1 year

Study Arms (4)

Mailing Letter

ACTIVE COMPARATOR

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.

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

Phone call

ACTIVE COMPARATOR

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.

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

Mail + Phone call

ACTIVE COMPARATOR

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.

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

Control

NO INTERVENTION

No intervention will be offered to patients in this arm.

Interventions

a mail letter, a phone call and a phone call plus mailed letter 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; Mailing Letter; Phone call

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's College Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Diabetes Action Canada: collaborator

Study Sites (2)

Black Creek Community Health Centre

Toronto, Ontario, M3M 1A4, Canada

RECRUITING

Women's College Hospital Family Health Team

Toronto, Ontario, M5S 1B2, Canada

ACTIVE NOT RECRUITING

Related Publications (1)

• 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.

  PMID: 36630160 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michael H Brent, MD, FRCSC

  University Health Network, Toronto Western Hospital

  PRINCIPAL INVESTIGATOR

• Onil Bhattacharyya, MD, PhD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

• Laura Desveaux, PhD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

• Vess Stamenova, PhD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vess Stamenova, PhD

CONTACT

416-323-6400; vess.stamenova@wchospital.ca

Nike Onabajo, MSc

CONTACT

4163236400; nike.onabajo@wchospital.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a Multiphase Optimization Strategy (MOST) trial. All patients will be randomized to one of 4 (or 3 for one of the sites) intervention conditions in a fractional factorial design.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: July 5, 2018
• Primary Completion: June 30, 2019
• Study Completion: August 30, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

CA (2)