Feasibility of an Intervention to Increase Diabetic Retinopathy Screening Attendance

NCT03901898 | Completed DMC

• 1 other identifier: UCCork_IDEAs
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Diabetes; Retinopathy

Keywords

screening; primary care; general practice; feasibility

Outcome Measures

Primary Outcomes (3)

• Number of patients who intend to contact RetinaScreen

  Patient self-report during phone call from the practice

  6 months

• Number of patients who have contacted the national screening programme

  Patient self-report during phone call from the practice

  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.

  6 months

Study Arms (2)

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.

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.

Behavioral: Intervention after 6 months (wait list)

Interventions

Training, audit, and reminders BEHAVIORAL

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.

Training, audit, and reminders

Intervention after 6 months (wait list) BEHAVIORAL

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).

Wait list control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Computerised record system
• Practice nurse
• 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.

You may not qualify if:

• Has retinopathy and are currently under surveillance or receiving treatment

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

University College Cork

Cork, Ireland

Location

Related Publications (5)

• 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.

  PMID: 27612011 BACKGROUND

• 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.

  PMID: 29333660 BACKGROUND

• 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.

  PMID: 17888859 BACKGROUND

• 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.

  PMID: 34667010 DERIVED

• 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.

  PMID: 32426158 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Retinal Diseases

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Sheena M McHugh, PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 3, 2019
• Study Start: July 16, 2019
• Primary Completion: October 12, 2020
• Study Completion: October 12, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)