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Completed

NCT Number: NCT03901898

Feasibility of an Intervention to Increase Diabetic Retinopathy Screening Attendance

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Cork

Cork, Ireland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Number of patients who intend to contact RetinaScreen

    Time frame: 6 months

    Patient self-report during phone call from the practice

  2. Number of patients who have contacted the national screening programme

    Time frame: 6 months

    Patient self-report during phone call from the practice

  3. 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.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

Feasibility of an Implementation Intervention to Increase Attendance at Diabetic Retinopathy Screening: Protocol for a Cluster Randomised Pilot Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2019
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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