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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 (GP-endorsed 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. Discussion:Findings will determine whether IDEAsis feasible and acceptable and will be used to refine the intervention and study procedures. A definitive trial will determine whether IDEAs is a cost-effective intervention to improve DRS uptake and reduce diabetes-related blindness. Trial registration:ClinicalTrials.gov NCT03901898. Registered 3rd April 2019.

SUBMITTER: Riordan F

PROVIDER: S-EPMC7216495 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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

Riordan Fiona F Racine Emmy E Smith Susan M SM Murphy Aileen A Browne John J Kearney Patricia M PM Bradley Colin C James Mark M Murphy Mark M McHugh Sheena M SM

Pilot and feasibility studies 20200512

<h4>Background</h4>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 interv ...[more]

PMID: 32426158

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Project description:ObjectivesDiabetic retinopathy screening (DRS) uptake is suboptimal in many countries with limited evidence available on interventions to enhance DRS uptake in primary care. We investigated the feasibility and preliminary effects of an intervention to improve uptake of Ireland's national DRS programme, Diabetic RetinaScreen, among patients with type 1 or type 2 diabetes.Design/settingWe conducted a cluster randomised pilot trial, embedded process evaluation and cost analysis in general practice, July 2019 to January 2020.ParticipantsEight practices participated in the trial. For the process evaluation, surveys were conducted with 25 staff at intervention practices. Interviews were conducted with nine staff at intervention practices, and 10 patients who received the intervention.InterventionsThe intervention comprised practice reimbursement, an audit of attendance, electronic prompts targeting professionals, General Practice-endorsed patient reminders and a patient information leaflet. Practices were randomly allocated to intervention (n=4) or wait-list control (n=4) (usual care).OutcomesStaff and patient interviews explored their perspectives on the intervention. Patient registration and attendance, including intention to attend, were measured at baseline and 6 months. Microcosting was used to estimate intervention delivery cost.ResultsThe process evaluation identified that enablers of feasibility included practice culture and capacity to protect time, systems to organise care, and staff skills, and workarounds to improve intervention 'fit'. At 6 months, 22/71 (31%) of baseline non-attenders in intervention practices subsequently attended screening compared with 15/87 (17%) in control practices. The total delivery cost across intervention practices (patients=363) was €2509, averaging €627 per practice and €6.91 per audited patient. Continuation criteria supported proceeding to a definitive trial.ConclusionsThe Improving Diabetes Eye screening Attendance intervention is feasible in primary care; however, consideration should be given to how best to facilitate local tailoring. A definitive trial of clinical and cost-effectiveness is required with preliminary results suggesting a positive effect on uptake.Trial registration numberNCT03901898.

Project description:BackgroundOffice work generally consists of high amounts of sedentary behaviour (SB) which has been associated with negative health consequences. We developed the "WorktivIty" mobile app to help office workers reduce their SB through self-monitoring and feedback on sedentary time, prompts to break sedentary time, and educational facts. The aim of this paper is to report the feasibility of delivering the Worktivity intervention to desk-based office workers in the workplace setting and describe methodological considerations for a future trial.MethodsWe conducted a three-arm feasibility cluster randomised controlled pilot study over an 8-week period with full time-desk based employees. Clustered randomisation was to one of three groups: Worktivity mobile app (MA; n = 20), Worktivity mobile app plus SSWD (MA+SSWD; n = 20), or Control (C; n = 16). Feasibility was assessed using measures of recruitment and retention, intervention engagement, intervention delivery, completion rates and usable data, adverse events, and acceptability.ResultsRecruitment of companies to participate in this study was challenging (8% of those contacted), but retention of individual participants within the recruited groups was high (81% C, 90% MA + SSWD, 95% MA). Office workers' engagement with the app was moderate (on average 59%). Intervention delivery was partially compromised due to diminishing user engagement and technical issues related to educational fact delivery. Sufficient amounts of useable data were collected, however either missing or unusable data were observed with activPAL™, with data loss increasing at each follow up time point. No serious adverse events were identified during the study. The majority of participants agreed that the intervention could be implemented within the workplace setting (65% MA; 72% MA + SSWD) but overall satisfaction with the intervention was modest (58% MA; 39% MA + SSWD).ConclusionsThe findings suggest that, in principle, it is feasible to implement a mobile app-based intervention in the workplace setting however the Worktivity intervention requires further technical refinements before moving to effectiveness trials. Challenges relating to the initial recruitment of workplaces and maintaining user engagement with the mHealth intervention over time need to be addressed prior to future large-scale implementation. Further research is needed to identify how best to overcome these challenges.

Project description:BACKGROUND:'Implementation interventions' refer to methods used to enhance the adoption and implementation of clinical interventions such as diabetic retinopathy screening (DRS). DRS is effective, yet uptake is often suboptimal. Despite most routine management taking place in primary care and the central role of health care professionals (HCP) in referring to DRS, few interventions have been developed for primary care. We aimed to develop a multifaceted intervention targeting both professionals and patients to improve DRS uptake as an example of a systematic development process combining theory, stakeholder involvement, and evidence. METHODS:First, we identified target behaviours through an audit in primary care of screening attendance. Second, we interviewed patients (n = 47) and HCP (n = 30), to identify determinants of uptake using the Theoretical Domains Framework, mapping these to behaviour change techniques (BCTs) to develop intervention content. Thirdly, we conducted semi-structured consensus groups with stakeholders, specifically users of the intervention, i.e. patients (n = 15) and HCPs (n = 16), regarding the feasibility, acceptability, and local relevance of selected BCTs and potential delivery modes. We consulted representatives from the national DRS programme to check intervention 'fit' with existing processes. We applied the APEASE criteria (affordability, practicability, effectiveness, acceptability, side effects, and equity) to select the final intervention components, drawing on findings from the previous steps, and a rapid evidence review of operationalised BCT effectiveness. RESULTS:We identified potentially modifiable target behaviours at the patient (consent, attendance) and professional (registration) level. Patient barriers to consent/attendance included confusion between screening and routine eye checks, and fear of a negative result. Enablers included a recommendation from friends/family or professionals and recognising screening importance. Professional barriers to registration included the time to register patients and a lack of readily available information on uptake in their local area/practice. Most operationalised BCTs were acceptable to patients and HCPs while the response to feasibility varied. After considering APEASE, the core intervention, incorporating a range of BCTs, involved audit/feedback, electronic prompts targeting professionals, HCP-endorsed reminders (face-to-face, by phone and letter), and an information leaflet for patients. CONCLUSIONS:Using the example of an intervention to improve DRS uptake, this study illustrates an approach to integrate theory with user involvement. This process highlighted tensions between theory-informed and stakeholder suggestions, and the need to apply the Theoretical Domains Framework (TDF)/BCT structure flexibly. The final intervention draws on the trusted professional-patient relationship, leveraging existing services to enhance implementation of the DRS programme. Intervention feasibility in primary care will be evaluated in a randomised cluster pilot trial.

Project description:Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines.GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial.This pilot study has been developed to support community midwives' implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A cluster design is the gold standard in implementation research as there would be a high risk of contamination if randomisation was at individual midwife level: community midwives usually work in locality-based teams, interact on a daily basis, and share care of pregnant women. The results of the pilot trial will be used to further develop and refine GLOWING prior to a definitive trial to evaluate effectiveness and cost-effectiveness.ISRCTN46869894; retrospectively registered 25th May 2016.

Project description:ObjectivesChildren in China have low levels of physical activity. We developed a school-based behaviour change intervention to increase their physical activity levels. The study aimed to determine the feasibility of undertaking a cluster randomised controlled trial (RCT) in the future. This future cluster RCT will evaluate the effectiveness of the intervention.DesignFeasibility cluster non-RCT design.SettingTwo public schools (one intervention and one control) in Yangzhou, China.ParticipantsChildren aged 10-12 years and their parents.InterventionThe 16-week school-based behaviour change intervention to increase physical activity levels consisted of three components (a) health education (physical education), (b) family involvement and (c) school environment support.Outcomes measuresWe estimated important parameters that are needed to design the future cluster RCT, such as SD of the primary outcome (ie, 7-day steps in children), intracluster correlation coefficient (ICC), recruitment of child-parent dyads, follow-up of children, completion of and time needed for data collection among children and intervention attendance.ResultsSixty-four children and their parents participated in the study (32 per study group). The SD of the primary outcome was 34 519 steps. The ICC was 0.03. The recruitment and follow-up rates were 100%. The completion of data collection was 100% (except for the 7-day steps at baseline-one child lost the step log in the intervention group and two children lost their pedometer in the control group). The time needed to complete the self-reported questionnaire by children was around 15 min per study group, and the measurement of their anthropometric parameters took around 40 min per study group. The intervention attendance was 100%.ConclusionsBased on the promising recruitment, follow-up, completion of and time needed for data collection and intervention attendance, it would be feasible to undertake the future cluster RCT in China.Trial registration numberChiCTR1900026865.

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

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

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