Feasibility of an implementation intervention to increase attendance at diabetic retinopathy screening: protocol for a cluster randomised pilot trial

Abstract

Background: Diabetic retinopathy screening (DRS) leads to the earlier detection of retinopathy and treatment that can prevent or delay the development of diabetes-related blindness. However, uptake continues to be sub-optimal in many countries, including Ireland. Routine management of type 2 diabetes largely takes place in primary care. As such, there may be an opportunity in primary care to introduce interventions to improve DRS uptake. However, few studies test the feasibility of interventions to enhance DRS uptake in this context. Our aim is to investigate the feasibility of an implementation intervention (IDEAs (Improving Diabetes Eye screening Attendance)) delivered in general practice to improve the uptake of the national DRS programme, RetinaScreen. Methods: The IDEAs study is a cluster randomised pilot trial with an embedded process evaluation and economic evaluation. Following stratification by practice size, eight general practices (clusters) will be randomly allocated to intervention (n = 4) or wait-list control groups (n = 4). The intervention will be delivered for 6 months, after which, it will be administered to wait-list control practices. The intervention is multi-faceted and comprises provider-level components (training, audit and feedback, health care professional prompt, reimbursement) and patient-level components (GPendorsed reminder with information leaflet delivered opportunistically face-to-face, and systematically by phone and letter). Patient inclusion criteria are type 1 or type 2 diabetes and DRS programme non-attendance. A multi-method approach will be used to determine screening uptake, evaluate the trial and study procedures and examine the acceptability and feasibility of the intervention from staff and patient perspectives. Quantitative and qualitative data will be collected on intervention uptake and delivery, research processes and outcomes. Data will be collected at the practice, health professional and patient level. A partial economic evaluation will be conducted to estimate the cost of delivering the implementation intervention in general practice. Formal continuation criteria will be used to determine whether IDEAs should progress to a definitive trial.

Development of an intervention to facilitate implementation and uptake of diabetic retinopathy screening

“…Relevant theories which may explain the mechanism of action, include the Health Belief Model [81], Protection Motivation Theory [82], the Theory of Planned Behaviour [83] (patient behaviour), and control theory [84] (professional behaviour), along with macro level theories, Systems Theory, Institutional Theory, and Contingency Theory [85]. These will be explored further through the process evaluation embedded in the feasibility trial of the intervention [86].…”

“…audit and feedback. As part of the pilot trial, practices will record the reason patients did not attend screening [86]. This information, together with qualitative research with patients as part of the process evaluation, will allow us to explore factors which potentially moderate the effect of the intervention (see examples Fig.…”

Factors associated with non-attendance in the Irish national diabetic retinopathy screening programme (INDEAR study report no. 2)

“…A funded study in Ireland, soon to be underway, aims to improve uptake in the national DR screening service by introducing provider and patient-level interventions; provider interventions in the form of training, audit, feedback, and reimbursement and patient interventions in the form of a GP-endorsed reminder, an information leaflet and a phone/letter reminder [ 36 ]. It’s likely that this will increase uptake but to what degree remains to be seen.…”

Feasibility of a multifaceted implementation intervention to improve attendance at diabetic retinopathy screening in primary care in Ireland: a cluster randomised pilot trial

“…27 Predefined continuation criteria were used to decide whether the intervention should progress to a full-scale RCT. 20 Practicability, acceptability and appropriateness Practice recruitment and retention rates were estimated first. We then analysed staff questionnaires generating summary statistics: scale scores were computed as average across items rated by that participant.…”

“…Analysis was both deductive and inductive. Some codes were selected a priori, and themes developed informed by potential moderators as per the logic model, 20 and existing frameworks for different concepts. [29][30][31] Codes were also generated inductively from the data through open coding.…”