DiabetesNCT03901898
Feasibility of an Intervention to Increase Diabetic Retinopathy Screening Attendance
A study testing Training, audit, and reminders and Intervention after 6 months (wait list) in people with Diabetes and Retinopathy, run by University College Cork at 1 site in Ireland.
Trial summary
The purpose of this study is to test a way to support practices to improve attendance at retinopathy screening among people with diabetes. This new approach will be delivered to staff in general practice and involves: 1) briefing and audit training for practice staff; 2) electronic alerts on patient files to prompt… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Retinopathy
- What is being tested?
- Training, audit, and reminders and Intervention after 6 months (wait list)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteIreland
- Study dates
- 16 Jul 2019to 12 Oct 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Computerised record system
- Practice nurse
- 18 years or over
- Diagnosed diabetes (type 1 or type 2)
- Has been audited as part of the practice-level intervention
- Eligible to attend the national screening programme but has not registered, consented to, and attended the programme.
Who cannot join
- Has retinopathy and are currently under surveillance or receiving treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of an Implementation Intervention to Increase Attendance at Diabetic Retinopathy Screening: Protocol for a Cluster Randomised Pilot Trial
The purpose of this study is to test a way to support practices to improve attendance at retinopathy screening among people with diabetes. This new approach will be delivered to staff in general practice and involves: 1) briefing and audit training for practice staff; 2) electronic alerts on patient files to prompt GPs and nurses to remind patients, 3) face-to-face, phone and letter reminders and a brief information sheet for people with diabetes who have not attended screening, and; 4) payment to practices. The practice will carry out an audit to identify patients who have not attended screening, and re-audit at 6 months to identify any changes in attendance. The study will test this new approach over six months in eight different practices to determine whether it is feasible to deliver in a real-world setting. Four practices will be randomly assigned to receive the new approach straight away (intervention group), while the other four practices will be assigned to the group who wait, deliver care as usual, and roll out the new approach after six months (wait-list-control group). After the new approach has been tested for six months, the research team will use staff questionnaires, and carry out focus groups and interviews with patients and practice staff to learn about their experiences. The time and resources needed to deliver the approach will also be recorded to estimate the cost of delivering the new approach and how feasible it would be to carry out a larger study.
Read the detailed description
Aims and objectives.
The current study will address uncertainties about feasibility, economic evaluation, and the study procedures. The feasibility pilot study is needed to determine whether a larger-scale trial would be viable. Specifically, it will address the questions:
- Are the intervention content, delivery and procedures acceptable to people with diabetes who will receive the intervention, and staff who will deliver the intervention?
- Are the data collection processes, including mode and duration of data collection and outcome measures used, acceptable to staff?
- Is the intervention feasible to deliver in primary care practice, in terms fidelity of delivery and receipt of the intervention?
- Is the study feasible in terms of recruitment and retention procedures and data collection?
- What are the costs associated with the intervention?
Intervention. The intervention involves components which target practice staff (1. brief training 2. electronic prompt, and 3. reimbursement) and components which target patients with type 1 or type 2 diabetes who have not attended screening (1. face-to-face reminder message and information leaflet; 2. phone reminder; 3. GP-endorsed reminder letter and information leaflet). The intervention will be delivered over 6 months. The practice will conduct an audit of their patients with diabetes at baseline and re-audit at 6 months. Only practice staff will access patient files for the purpose of the audit. Only practice staff will have contact with patients during intervention delivery; a member of the practice team will issue the face-to-face, phone and letter reminders.
Methods. IDEAs (Improving Diabetes Eye-screening Attendance) is a cluster randomised feasibility pilot trial, including an embedded process evaluation and economic evaluation. In the current study, general practices will be randomly allocated to intervention or wait-list control groups following stratification by practice size (i.e. single/two-handed or group practice (3 more or GPs). Practices in the wait-list control group will receive the same intervention at 6 months. A multi-method approach will be used to evaluate the trial and study procedures, and to examine the acceptability and feasibility of the intervention from the perspective of practice staff and patients. Quantitative and qualitative data will be collected on intervention delivery, research processes, and implementation outcomes. Data will be collected at the practice, health professional and patient level. Data will be collected by practice staff and study researchers during intervention delivery. An economic evaluation will be conducted to estimate the cost of delivering the intervention in general practice
- Conditions
- Diabetes, Retinopathy
- Being tested
- Training, audit, and reminders, Intervention after 6 months (wait list)
- Keywords
- screening, primary care, general practice, feasibility
- Medical subject headings
- Diabetes Mellitus, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training, audit, and remindersBehavioural
Briefing and training for participating practices, baseline practice audit, addition of electronic prompts to patient records, GP-endorsed patient reminders (in person, phone and letter), and re-audit at 6 months.
Intervention after 6 months (wait list)Behavioural
After 6 months, practices receive the intervention: briefing and training for participating practices, baseline practice audit, addition of electronic prompts to patient records, GP-endorsed patient reminders (in person, phone and letter).
| Study group | Role | What they receive |
|---|---|---|
| Training, audit, and reminders | Experimental | An investigator will deliver a 20-30-minute briefing on intervention delivery to all staff at participating practices, followed by one-on-one audit training (1 hour) with the staff member responsible for conducting the audit. Each practice conducts an audit of their patients with diabetes to identify all people who have not attended retinopathy screening with the national programme. At 6 months, practices conducts a re-audit. Practice staff add electronic alerts to the records of eligible patients, to prompt GPs and nurses to remind patients. Practices are reimbursed at study entry with further payment following intervention cessation based on number of patients audited. Face-to-face verbal reminders are delivered by GPs and practice nurses to eligible patients attending for an appointment during the study period. All eligible patients receive a reminder phone call from a practice nurse and a GP-endorsed reminder letter accompanied by an information leaflet. Receives: Behavioral: Training, audit, and reminders |
| Wait list control | Other | In control practices, the intervention will be delivered after 6 months. For the audit, administrators or practice nurses will use date restricted data extraction from the electronic medical record to capture data for the 12-month period prior to the intervention (study baseline) and 6 months after the study intervention period, during which they will have acted as control practices (follow-up). This will satisfy the baseline data collection prior to the delivery of the intervention to this group on study completion. This approach was chosen as collecting data at baseline (i.e. 6 months before intervention start) would constitute an intervention in those practices; knowledge of non-attenders would lead to a change in usual care as the control group would likely follow up patients immediately. Control practices will receive the same supports and training as intervention practices. Receives: Behavioral: Intervention after 6 months (wait list) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who intend to contact RetinaScreen
Patient self-report during phone call from the practice
Measured: 6 months
Number of patients who have contacted the national screening programme
Patient self-report during phone call from the practice
Measured: 6 months
Number of patients who have attended screening
Number obtained from practice electronic health records. Letter received from the national screening programme on patient record.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start16 Jul 2019
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Four practices will be randomly assigned to the intervention group, while the other four practices will be assigned to the wait list control group. The wait list control group will deliver care as usual, and deliver the intervention after six months.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sheena McHugh, University College Cork
- Investigators
- Sheena M McHugh, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901898
- Sponsor's protocol ID
- UCCork_IDEAs
- Status last verified
- May 2021
- First submitted
- 28 Mar 2019
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tracey ML, McHugh SM, Fitzgerald AP, Buckley CM, Canavan RJ, Kearney PM. Trends in blindness due to diabetic retinopathy among adults aged 18-69years over a decade in Ireland. Diabetes Res Clin Pract. 2016 Nov;121:1-8. doi: 10.1016/j.diabres.2016.08.016. Epub 2016 Aug 30.
PubMed 27612011Lawrenson JG, Graham-Rowe E, Lorencatto F, Burr J, Bunce C, Francis JJ, Aluko P, Rice S, Vale L, Peto T, Presseau J, Ivers N, Grimshaw JM. Interventions to increase attendance for diabetic retinopathy screening. Cochrane Database Syst Rev. 2018 Jan 15;1(1):CD012054. doi: 10.1002/14651858.CD012054.pub2.
PubMed 29333660Zhang X, Norris SL, Saadine J, Chowdhury FM, Horsley T, Kanjilal S, Mangione CM, Buhrmann R. Effectiveness of interventions to promote screening for diabetic retinopathy. Am J Prev Med. 2007 Oct;33(4):318-35. doi: 10.1016/j.amepre.2007.05.002.
PubMed 17888859Riordan F, Murphy A, Dillon C, Browne J, Kearney PM, Smith SM, McHugh SM. Feasibility of a multifaceted implementation intervention to improve attendance at diabetic retinopathy screening in primary care in Ireland: a cluster randomised pilot trial. BMJ Open. 2021 Oct 19;11(10):e051951. doi: 10.1136/bmjopen-2021-051951.
PubMed 34667010Riordan F, Racine E, Smith SM, Murphy A, Browne J, Kearney PM, Bradley C, James M, Murphy M, McHugh SM. Feasibility of an implementation intervention to increase attendance at diabetic retinopathy screening: protocol for a cluster randomised pilot trial. Pilot Feasibility Stud. 2020 May 12;6:64. doi: 10.1186/s40814-020-00608-y. eCollection 2020.
PubMed 32426158
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Implementation Intervention to Increase Attendance at Diabetic Retinopathy Screening: Protocol for a Cluster Randomised Pilot Trial
- ClinicalTrials.gov ID
- NCT03901898
- Acronym / sponsor ID
- UCCork_IDEAs
- Conditions
- Diabetes, Retinopathy
- Keywords
- screening, primary care, general practice, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 3 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.
The purpose of this study is to test a way to support practices to improve attendance at retinopathy screening among people with diabetes. This new approach will be delivered to staff in general practice and involves: 1) briefing and audit training for practice staff; 2) electronic alerts on patient files to prompt GPs and nurses to remind patients, 3) face-to-face, phone and letter reminders and a brief information sheet for people with diabetes who have not attended screening, and; 4) payment to practices. The practice will carry out an audit to identify patients who have not attended screening, and re-audit at 6 months to identify any changes in attendance. The study will test this new approach over six months in eight different practices to determine whether it is feasible to deliver in a real-world setting. Four practices will be randomly assigned to receive the new approach straight away (intervention group), while the other four practices will be assigned to the group who wait, deliver care as usual, and roll out the new approach after six months (wait-list-control group). After the new approach has been tested for six months, the research team will use staff questionnaires, and carry out focus groups and interviews with patients and practice staff to learn about their experiences. The time and resources needed to deliver the approach will also be recorded to estimate the cost of delivering the new approach and how feasible it would be to carry out a larger study.
Detailed description
Aims and objectives.
The current study will address uncertainties about feasibility, economic evaluation, and the study procedures. The feasibility pilot study is needed to determine whether a larger-scale trial would be viable. Specifically, it will address the questions:
- Are the intervention content, delivery and procedures acceptable to people with diabetes who will receive the intervention, and staff who will deliver the intervention?
- Are the data collection processes, including mode and duration of data collection and outcome measures used, acceptable to staff?
- Is the intervention feasible to deliver in primary care practice, in terms fidelity of delivery and receipt of the intervention?
- Is the study feasible in terms of recruitment and retention procedures and data collection?
- What are the costs associated with the intervention?
Intervention. The intervention involves components which target practice staff (1. brief training 2. electronic prompt, and 3. reimbursement) and components which target patients with type 1 or type 2 diabetes who have not attended screening (1. face-to-face reminder message and information leaflet; 2. phone reminder; 3. GP-endorsed reminder letter and information leaflet). The intervention will be delivered over 6 months. The practice will conduct an audit of their patients with diabetes at baseline and re-audit at 6 months. Only practice staff will access patient files for the purpose of the audit. Only practice staff will have contact with patients during intervention delivery; a member of the practice team will issue the face-to-face, phone and letter reminders.
Methods. IDEAs (Improving Diabetes Eye-screening Attendance) is a cluster randomised feasibility pilot trial, including an embedded process evaluation and economic evaluation. In the current study, general practices will be randomly allocated to intervention or wait-list control groups following stratification by practice size (i.e. single/two-handed or group practice (3 more or GPs). Practices in the wait-list control group will receive the same intervention at 6 months. A multi-method approach will be used to evaluate the trial and study procedures, and to examine the acceptability and feasibility of the intervention from the perspective of practice staff and patients. Quantitative and qualitative data will be collected on intervention delivery, research processes, and implementation outcomes. Data will be collected at the practice, health professional and patient level. Data will be collected by practice staff and study researchers during intervention delivery. An economic evaluation will be conducted to estimate the cost of delivering the intervention in general practice
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Four practices will be randomly assigned to the intervention group, while the other four practices will be assigned to the wait list control group. The wait list control group will deliver care as usual, and deliver the intervention after six months.
| Arm | Type | Receives |
|---|---|---|
| Training, audit, and reminders | Experimental | Behavioral: Training, audit, and remindersAn investigator will deliver a 20-30-minute briefing on intervention delivery to all staff at participating practices, followed by one-on-one audit training (1 hour) with the staff member responsible for conducting the audit. Each practice conducts an audit of their patients with diabetes to identify all people who have not attended retinopathy screening with the national programme. At 6 months, practices conducts a re-audit. Practice staff add electronic alerts to the records of eligible patients, to prompt GPs and nurses to remind patients. Practices are reimbursed at study entry with further payment following intervention cessation based on number of patients audited. Face-to-face verbal reminders are delivered by GPs and practice nurses to eligible patients attending for an appointment during the study period. All eligible patients receive a reminder phone call from a practice nurse and a GP-endorsed reminder letter accompanied by an information leaflet. |
| Wait list control | Other | Behavioral: Intervention after 6 months (wait list)In control practices, the intervention will be delivered after 6 months. For the audit, administrators or practice nurses will use date restricted data extraction from the electronic medical record to capture data for the 12-month period prior to the intervention (study baseline) and 6 months after the study intervention period, during which they will have acted as control practices (follow-up). This will satisfy the baseline data collection prior to the delivery of the intervention to this group on study completion. This approach was chosen as collecting data at baseline (i.e. 6 months before intervention start) would constitute an intervention in those practices; knowledge of non-attenders would lead to a change in usual care as the control group would likely follow up patients immediately. Control practices will receive the same supports and training as intervention practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Computerised record system
- Practice nurse
- 18 years or over
- Diagnosed diabetes (type 1 or type 2)
- Has been audited as part of the practice-level intervention
Key exclusion criteria (1 listed)
- Has retinopathy and are currently under surveillance or receiving treatment
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 |
|---|---|---|
| Training, audit, and remindersBriefing and training for participating practices, baseline practice audit, addition of electronic prompts to patient records, GP-endorsed patient reminders (in person, phone and letter), and re-audit at 6 months. | Behavioural | Training, audit, and reminders |
| Intervention after 6 months (wait list)After 6 months, practices receive the intervention: briefing and training for participating practices, baseline practice audit, addition of electronic prompts to patient records, GP-endorsed patient reminders (in person, phone and letter). | Behavioural | Wait list control |
Primary outcome
Number of patients who intend to contact RetinaScreen
Time frame: 6 months
Patient self-report during phone call from the practice
Number of patients who have contacted the national screening programme
Time frame: 6 months
Patient self-report during phone call from the practice
Number of patients who have attended screening
Time frame: 6 months
Number obtained from practice electronic health records. Letter received from the national screening programme on patient record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 27612011Tracey ML, McHugh SM, Fitzgerald AP, Buckley CM, Canavan RJ, Kearney PM. Trends in blindness due to diabetic retinopathy among adults aged 18-69years over a decade in Ireland. Diabetes Res Clin Pract. 2016 Nov;121:1-8. doi: 10.1016/j.diabres.2016.08.016. Epub 2016 Aug 30.
- Background: PubMed 29333660Lawrenson JG, Graham-Rowe E, Lorencatto F, Burr J, Bunce C, Francis JJ, Aluko P, Rice S, Vale L, Peto T, Presseau J, Ivers N, Grimshaw JM. Interventions to increase attendance for diabetic retinopathy screening. Cochrane Database Syst Rev. 2018 Jan 15;1(1):CD012054. doi: 10.1002/14651858.CD012054.pub2.
- Background: PubMed 17888859Zhang X, Norris SL, Saadine J, Chowdhury FM, Horsley T, Kanjilal S, Mangione CM, Buhrmann R. Effectiveness of interventions to promote screening for diabetic retinopathy. Am J Prev Med. 2007 Oct;33(4):318-35. doi: 10.1016/j.amepre.2007.05.002.
- Derived from this study: PubMed 34667010Riordan F, Murphy A, Dillon C, Browne J, Kearney PM, Smith SM, McHugh SM. Feasibility of a multifaceted implementation intervention to improve attendance at diabetic retinopathy screening in primary care in Ireland: a cluster randomised pilot trial. BMJ Open. 2021 Oct 19;11(10):e051951. doi: 10.1136/bmjopen-2021-051951.
- Derived from this study: PubMed 32426158Riordan F, Racine E, Smith SM, Murphy A, Browne J, Kearney PM, Bradley C, James M, Murphy M, McHugh SM. Feasibility of an implementation intervention to increase attendance at diabetic retinopathy screening: protocol for a cluster randomised pilot trial. Pilot Feasibility Stud. 2020 May 12;6:64. doi: 10.1186/s40814-020-00608-y. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Sheena M McHugh, PhD principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training, audit, and reminders and Intervention after 6 months (wait list) in people with Diabetes and Retinopathy, run by University College Cork at 1 site in Ireland.
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 6 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: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who intend to contact RetinaScreen (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT03901898, which also lists 5 linked publications.
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 11 May 2021.