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出境医 / 临床实验 / Increasing DR Screening Through TOP: Supporting Implementation and Identifying Opportunities for Scale up in Ontario (TOP)

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

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.

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.

Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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.

Contacts and Locations

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
Layout table for location information
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
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE July 5, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increasing DR Screening Through TOP: Supporting Implementation and Identifying Opportunities for Scale up in Ontario
Official Title  ICMJE Increasing Diabetic Retinopathy Screening Through the Teleophthalmology Program (TOP): Supporting Implementation and Identifying Opportunities for Scale up in Ontario
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Diabetes Mellitus, Type 1
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: a mail letter, a phone call and a phone call plus mailed letter
  • 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.

    Intervention: Other: a mail letter, a phone call and a phone call plus mailed letter
  • 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.
    Intervention: Other: a mail letter, a phone call and a phone call plus mailed letter
  • No Intervention: Control
    No intervention will be offered to patients in this arm.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927859
Other Study ID Numbers  ICMJE 2018-0068-E
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Women's College Hospital
Study Sponsor  ICMJE Women's College Hospital
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Diabetes Action Canada
Investigators  ICMJE
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
PRS Account Women's College Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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