Diabetes Mellitus, Type 2TOPNCT03927859
Increasing DR Screening Through TOP: Supporting Implementation and Identifying Opportunities for Scale up in Ontario
A study testing a mail letter, a phone call and a phone call plus mailed letter in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Women's College Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- What is being tested?
- a mail letter, a phone call and a phone call plus mailed letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Jul 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 1 recruiting
- Recruiting
Black Creek Community Health Centre
Toronto, Ontario, M3M 1A4
Doris Forlemu-Kamwa, 4162498000 ext. 2240, Doris.Forlemu-Kamwa@bcchc.com
- Active, not recruiting
Women's College Hospital Family Health Team
Toronto, Ontario, M5S 1B2
About this study
Official title: Increasing Diabetic Retinopathy Screening Through the Teleophthalmology Program (TOP): Supporting Implementation and Identifying Opportunities for Scale up in Ontario
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.
Read the 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.
- Being tested
- a mail letter, a phone call and a phone call plus mailed letter
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a mail letter, a phone call and a phone call plus mailed letterOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bookings made through the TOP program
The primary outcome for the study is the number of bookings made through the TOP program
Measured: 1 year
Secondary outcomes (1)
Number of self-reported booking made outside of TOP
Secondary outcomes include the number of self-reported booking made outside of TOP
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start5 Jul 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Diabetes Action Canada
- Responsible party
- Sponsor
- Investigators
- Michael H Brent, MD, FRCSC, Principal investigator, University Health Network, Toronto Western HospitalOnil Bhattacharyya, MD, PhD, Principal investigator, Women's College HospitalLaura Desveaux, PhD, Principal investigator, Women's College HospitalVess Stamenova, PhD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927859
- Sponsor's protocol ID
- 2018-0068-E
- Acronym
- TOP
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2019
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36630160
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Diabetic Retinopathy Screening Through the Teleophthalmology Program (TOP): Supporting Implementation and Identifying Opportunities for Scale up in Ontario
- ClinicalTrials.gov ID
- NCT03927859
- Acronym / sponsor ID
- TOP / 2018-0068-E
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Diabetes Action Canada
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mailing Letter | Active comparator | Other: a mail letter, a phone call and a phone call plus mailed letterPatients 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. |
| Phone call | Active comparator | Other: a mail letter, a phone call and a phone call plus mailed letterAdministrative 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. |
| Mail + Phone call | Active comparator | Other: a mail letter, a phone call and a phone call plus mailed letterPatients 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. |
| Control | No intervention | –No intervention will be offered to patients in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a mail letter, a phone call and a phone call plus mailed letterAll 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. | Other | Mail + Phone call, Mailing Letter, Phone call |
Primary outcome
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
1 secondary outcome
Number of self-reported booking made outside of TOP
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
- Derived from this study: PubMed 36630160Stamenova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Brent, MD, FRCSC principal investigator
University Health Network, Toronto Western Hospital
Onil Bhattacharyya, MD, PhD principal investigator
Women's College Hospital
Laura Desveaux, PhD principal investigator
Women's College Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a mail letter, a phone call and a phone call plus mailed letter in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Women's College Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vess Stamenova, PhD (416-323-6400 ext. 5112, vess.stamenova@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of bookings made through the TOP program (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.