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

Primary Purpose

Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
a mail letter, a phone call and a phone call plus mailed letter
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Black Creek Community Health CentreRecruiting
  • Women's College Hospital Family Health Team

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Mailing Letter

Phone call

Mail + Phone call

Control

Arm Description

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.

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.

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.

No intervention will be offered to patients in this arm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of self-reported booking made outside of TOP
Secondary outcomes include the number of self-reported booking made outside of TOP

Full Information

First Posted
April 23, 2019
Last Updated
April 23, 2019
Sponsor
Women's College Hospital
Collaborators
Canadian Institutes of Health Research (CIHR), Diabetes Action Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03927859
Brief Title
Increasing DR Screening Through TOP: Supporting Implementation and Identifying Opportunities for Scale up in Ontario
Acronym
TOP
Official Title
Increasing Diabetic Retinopathy Screening Through the Teleophthalmology Program (TOP): Supporting Implementation and Identifying Opportunities for Scale up in Ontario
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital
Collaborators
Canadian Institutes of Health Research (CIHR), Diabetes Action Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mailing Letter
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Phone call
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mail + Phone call
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be offered to patients in this arm.
Intervention Type
Other
Intervention Name(s)
a mail letter, a phone call and a phone call plus mailed letter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of bookings made through the TOP program
Description
The primary outcome for the study is the number of bookings made through the TOP program
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of self-reported booking made outside of TOP
Description
Secondary outcomes include the number of self-reported booking made outside of TOP
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vess Stamenova, PhD
Phone
416-323-6400
Ext
5112
Email
vess.stamenova@wchospital.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Nike Onabajo, MSc
Phone
4163236400
Ext
5126
Email
nike.onabajo@wchospital.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Brent, MD, FRCSC
Organizational Affiliation
University Health Network, Toronto Western Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Onil Bhattacharyya, MD, PhD
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Desveaux, PhD
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vess Stamenova, PhD
Organizational Affiliation
Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Black Creek Community Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doris Forlemu-Kamwa
Phone
4162498000
Ext
2240
Email
Doris.Forlemu-Kamwa@bcchc.com
Facility Name
Women's College Hospital Family Health Team
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

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

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