Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care

<p>Abstract</p> <p>Background</p> <p>Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers' and participants' experiences of its implementation and to inform future strategies to maximise recruitment and retention.</p> <p>Methods</p> <p>In total 48 general practices and 903 patients were recruited from three different areas of Ireland to a RCT of an intervention designed to optimise secondary prevention of coronary heart disease. The recruitment process involved telephoning practices, posting information, visiting practices, identifying potential participants, posting invitations and obtaining consent. Retention involved patients attending reviews and responding to questionnaires and practices facilitating data collection.</p> <p>Results</p> <p>We achieved high retention rates for practices (100%) and for patients (85%) over an 18-month intervention period. Pilot work, knowledge of the setting, awareness of change in staff and organisation amongst participant sites, rapid responses to queries and acknowledgement of practitioners' contributions were identified as being important. Minor variations in protocol and research support helped to meet varied, complex and changing individual needs of practitioners and patients and encouraged retention in the trial. A collaborative relationship between researcher and practice staff which required time to develop was perceived as vital for both recruitment and retention.</p> <p>Conclusion</p> <p>Recruiting and retaining the numbers of practices and patients estimated as required to provide findings with adequate power contributes to increased confidence in the validity and generalisability of RCT results. A continuous dynamic process of monitoring progress within trials and tailoring strategies to particular circumstances, whilst not compromising trial protocols, should allow maximal recruitment and retention.</p> <p>Trial registration</p> <p>ISRCTN24081411</p

How to specify healthcare process improvements collaboratively using rapid, remote consensus-building: a framework and a case study of its application

Abstract: Background: Practical methods for facilitating process improvement are needed to support high quality, safe care. How best to specify (identify and define) process improvements – the changes that need to be made in a healthcare process – remains a key question. Methods for doing so collaboratively, rapidly and remotely offer much potential, but are under-developed. We propose an approach for engaging diverse stakeholders remotely in a consensus-building exercise to help specify improvements in a healthcare process, and we illustrate the approach in a case study. Methods: Organised in a five-step framework, our proposed approach is informed by a participatory ethos, crowdsourcing and consensus-building methods: (1) define scope and objective of the process improvement; (2) produce a draft or prototype of the proposed process improvement specification; (3) identify participant recruitment strategy; (4) design and conduct a remote consensus-building exercise; (5) produce a final specification of the process improvement in light of learning from the exercise. We tested the approach in a case study that sought to specify process improvements for the management of obstetric emergencies during the COVID-19 pandemic. We used a brief video showing a process for managing a post-partum haemorrhage in women with COVID-19 to elicit recommendations on how the process could be improved. Two Delphi rounds were then conducted to reach consensus. Results: We gathered views from 105 participants, with a background in maternity care (n = 36), infection prevention and control (n = 17), or human factors (n = 52). The participants initially generated 818 recommendations for how to improve the process illustrated in the video, which we synthesised into a set of 22 recommendations. The consensus-building exercise yielded a final set of 16 recommendations. These were used to inform the specification of process improvements for managing the obstetric emergency and develop supporting resources, including an updated video. Conclusions: The proposed methodological approach enabled the expertise and ingenuity of diverse stakeholders to be captured and mobilised to specify process improvements in an area of pressing service need. This approach has the potential to address current challenges in process improvement, but will require further evaluation

Functional Imagery Training versus Motivational Interviewing for Weight Loss: A randomised controlled trial of brief individual interventions for overweight and obesity

Objective: Functional Imagery Training (FIT) is a new brief motivational intervention based on the Elaborated Intrusion theory of desire. FIT trains the habitual use of personalised, affective, goal-directed mental imagery to plan behaviours, anticipate obstacles, and mentally try out solutions from previous successes. It is delivered in the client-centred style of Motivational Interviewing (MI). We tested the impact of FIT on weight loss, compared with time- and contact-matched MI. Design: We recruited 141 adults with BMI (kg/m²) ≥25, via a community newspaper, to a single-centre randomised controlled trial. Participants were allocated to one of two active interventions: FIT or MI. Primary data collection and analyses were conducted by researchers blind to interventions. All participants received two sessions of their allocated intervention; the first face-to-face (1 h), the second by phone (maximum 45 min). Booster calls of up to 15 min were provided every 2 weeks for 3 months, then once-monthly until 6 months. Maximum contact time was 4 h of individual consultation. Participants were assessed at Baseline, at the end of the intervention phase (6 months), and again 12 months post-baseline. Main outcome measures: Weight (kg) and waist circumference (WC, cm) reductions at 6 and 12 months. Results: FIT participants (N = 59) lost 4.11 kg and 7.02 cm of WC, compared to.74 kg and 2.72 cm in the MI group (N = 55) at 6 months (weight mean difference (WMD) = 3.37 kg, p <.001, 95% CI [−5.2, −2.1], waist-circumference mean difference (WCMD) = 4.3 cm, p <.001, 95% CI [−6.3,−2.6]). Between-group differences were maintained and increased at month 12: FIT participants lost 6.44 kg (W) and 9.1 cm (WC) compared to the MI who lost.67 kg and 2.46 cm (WMD = 5.77 kg, p <.001, 95% CI [−7.5, −4.4], WCMD = 6.64 cm, p <.001, 95% CI [−7.5, −4.4]). Conclusion: FIT is a theoretically informed motivational intervention which offers substantial benefits for weight loss and maintenance of weight reduction, compared with MI alone, despite including no lifestyle education or advice.</p