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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927859
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Diabetes Action Canada
Information provided by (Responsible Party):
Women's College Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Other: a mail letter, a phone call and a phone call plus mailed letter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Increasing Diabetic Retinopathy Screening Through the Teleophthalmology Program (TOP): Supporting Implementation and Identifying Opportunities for Scale up in Ontario
Actual Study Start Date : July 5, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: 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.


Active Comparator: 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.

Other: 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.


Active Comparator: 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.
Other: 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.


No Intervention: Control
No intervention will be offered to patients in this arm.



Primary Outcome Measures :
  1. Number of bookings made through the TOP program [ Time Frame: 1 year ]
    The primary outcome for the study is the number of bookings made through the TOP program


Secondary Outcome Measures :
  1. Number of self-reported booking made outside of TOP [ Time Frame: 1 year ]
    Secondary outcomes include the number of self-reported booking made outside of TOP



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927859


Contacts
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Contact: Vess Stamenova, PhD 416-323-6400 ext 5112 vess.stamenova@wchospital.ca
Contact: Nike Onabajo, MSc 4163236400 ext 5126 nike.onabajo@wchospital.ca

Locations
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Canada, Ontario
Black Creek Community Health Centre Recruiting
Toronto, Ontario, Canada, M3M 1A4
Contact: Doris Forlemu-Kamwa    4162498000 ext 2240    Doris.Forlemu-Kamwa@bcchc.com   
Women's College Hospital Family Health Team Active, not recruiting
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
Canadian Institutes of Health Research (CIHR)
Diabetes Action Canada
Investigators
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Principal Investigator: 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
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Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT03927859    
Other Study ID Numbers: 2018-0068-E
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases