- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901898
Feasibility of an Intervention to Increase Diabetic Retinopathy Screening Attendance
Feasibility of an Implementation Intervention to Increase Attendance at Diabetic Retinopathy Screening: Protocol for a Cluster Randomised Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cork, Ireland
- University College Cork
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (practices):
- Computerised record system
- Practice nurse
Inclusion Criteria (patients)
- 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.
Exclusion Criteria (patients):
• Has retinopathy and are currently under surveillance or receiving treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training, audit, and reminders
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.
|
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.
|
Other: Wait list control
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who intend to contact RetinaScreen
Time Frame: 6 months
|
Patient self-report during phone call from the practice
|
6 months
|
Number of patients who have contacted the national screening programme
Time Frame: 6 months
|
Patient self-report during phone call from the practice
|
6 months
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheena M McHugh, PhD, University College Cork
Publications and helpful links
General 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.
- Lawrenson 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.
- Zhang 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.
- Riordan 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.
- Riordan 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCCork_IDEAs
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
Clinical Trials on Training, audit, and reminders
-
Unity Health TorontoHeart and Stroke Foundation of Canada; Laerdal MedicalCompleted
-
The Hospital for Sick ChildrenUniversity of the Sciences, Techniques and Technologies of Bamako; Global Affairs... and other collaboratorsCompleted
-
Istanbul Medipol University HospitalUnknownObesity | StudentsTurkey
-
United States Naval Medical Center, San DiegoUniversity of Pittsburgh; Walter Reed National Military Medical Center; VA New... and other collaboratorsActive, not recruiting
-
University of ChicagoNorthwestern University; Ann & Robert H Lurie Children's Hospital of Chicago; Howard Brown Health Center and other collaboratorsRecruiting
-
The Hong Kong Polytechnic UniversityCompletedInsomnia, PrimaryHong Kong
-
NYU Langone HealthWithdrawnTobacco Use CessationVietnam
-
Ifakara Health InstituteKEMRI-Wellcome Trust Collaborative Research Program; Swiss Tropical & Public...Unknown
-
University Hospital, LilleNot yet recruitingRenal Insufficiency and Diabetes Mellitus
-
NYU Langone HealthCompletedTobacco Use CessationUnited States