Recruiting men from across the socioeconomic spectrum via GP registers and community outreach to a weight management feasibility randomised controlled trial.

BACKGROUND: Men, particularly those living in disadvantaged areas, are less likely to participate in weight management programmes than women despite similar levels of excess weight. Little is known about how best to recruit men to weight management interventions. This paper describes patient and public involvement in pre-trial decisions relevant to recruitment and aims to report on recruitment to the subsequent men-only weight management feasibility trial, including the: i) acceptability and feasibility of recruitment; and ii) baseline sample characteristics by recruitment strategy. METHODS: Men with BMI ≥30 kg/m2 and/or waist circumference ≥ 40 in. were recruited to the feasibility trial via two strategies; community outreach (venue information stands and word of mouth) and GP letters, targeting disadvantaged areas. Recruitment activities (e.g. letters sent, researcher venue hours) were recorded systematically, and baseline characteristics questionnaire data collated. Qualitative interviews (n = 50) were conducted three months post-recruitment. Analyses and reporting followed a complementary mixed methods approach. RESULTS: 105 men were recruited within four months (community n = 60, GP letter n = 45). Community outreach took 2.3 recruiter hours per participant and GP letters had an opt-in rate of 10.2% (n = 90/879). More men were interested than could be accommodated. Most participants (60%) lived in more disadvantaged areas. Compared to community outreach, men recruited via GP letters were older (mean = 57 vs 48 years); more likely to report an obesity-related co-morbidity (87% vs 44%); and less educated (no formal qualifications, 32% vs 10%, degree educated 11% vs 41%). Recruitment strategies were acceptable, a sensitive approach and trusting relationships with recruiters valued, and the 'catchy' study name drew attention. CONCLUSIONS: Targeted community outreach and GP letters were acceptable strategies that successfully recruited participants to a men-only weight management feasibility trial. Both strategies engaged men from disadvantaged areas, a typically underserved population. Using two recruitment strategies produced samples with different health risk profiles, which could add value to research where either primary or secondary prevention is of interest. Further work is required to examine how these strategies could be implemented and sustained in practice. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03040518 , 2nd February 2017.

Implementing pelvic floor muscle training for women with pelvic organ prolapse: a realist evaluation of different delivery models.

BACKGROUND: Pelvic Floor Muscle Training (PFMT) has been shown to be effective for pelvic organ prolapse in women, but its implementation in routine practice is challenging due to lack of adequate specialist staff. It is important to know if PFMT can be delivered by different staff skill mixes, what barriers and facilitators operate in different contexts, what strategies enable successful implementation and what are the underlying mechanisms of their action. PROPEL intervention was designed to maximise the delivery of effective PFMT in the UK NHS using different staff skill mixes. We conducted a realist evaluation (RE) of this implementation to understand what works, for whom, in what circumstances and why. METHODS: Informed by the Realist and RE-AIM frameworks, the study used a longitudinal, qualitative, multiple case study design. The study took place in five, purposively selected, diverse NHS sites across the UK and proceeded in three phases to identify, test and refine a theory of change. Data collection took place at 4 time points over an 18 month implementation period using focus groups and semi-structured interviews with a range of stakeholders including service leads/managers, senior practitioners, newly trained staff and women receiving care in the new service models. Data were analysed using thematic framework approach adapted to identify Context, Mechanism and Outcome (CMO) configurations of the RE. RESULTS: A heightened awareness of the service need among staff and management was a mechanism for change, particularly in areas where there was a shortage of skilled staff. In contrast, the most established specialist physiotherapist-delivered PFMT service activated feelings of role protection and compromised quality, which restricted the reach of PFMT through alternative models. Staff with some level of prior knowledge in women's health and adequate organisational support were more comfortable and confident in new role. Implementation was seamless when PFMT delivery was incorporated in newly trained staff's role and core work. CONCLUSION: Roll-out of PFMT delivery through different staff skill mixes is possible when it is undertaken by clinicians with an interest in women's health, and carefully implemented ensuring adequate levels of training and ongoing support from specialists, multi-disciplinary teams and management.

Women's experiences of receiving care for pelvic organ prolapse: a qualitative study.

BACKGROUND: Pelvic organ prolapse is a common urogenital condition affecting 41-50% of women over the age of 40. To achieve early diagnosis and appropriate treatment, it is important that care is sensitive to and meets women's needs, throughout their patient journey. This study explored women's experiences of seeking diagnosis and treatment for prolapse and their needs and priorities for improving person-centred care. METHODS: Twenty-two women receiving prolapse care through urogynaecology services across three purposefully selected NHS UK sites took part in three focus groups and four telephone interviews. A topic guide facilitated discussions about women's experiences of prolapse, diagnosis, treatment, follow-up, interactions with healthcare professionals, overall service delivery, and ideals for future services to meet their needs. Data were analysed thematically. RESULTS: Three themes emerged relating to women's experiences of a) Evaluating what is normal b) Hobson's choice of treatment decisions, and c) The trial and error of treatment and technique. Women often delayed seeking help for their symptoms due to lack of awareness, embarrassment and stigma. When presented to GPs, their symptoms were often dismissed and unaddressed until they became more severe. Women reported receiving little or no choice in treatment decisions. Choices were often influenced by health professionals' preferences which were subtly reflected through the framing of the offer. Women's embodied knowledge of their condition and treatment was largely unheeded, resulting in decisions that were inconsistent with women's preferences and needs. Physiotherapy based interventions were reported as helping women regain control over their symptoms and life. A need for greater awareness of prolapse and physiotherapy interventions among women, GPs and consultants was identified alongside greater focus on prevention, early diagnosis and regular follow-up. Greater choice and involvement in treatment decision making was desired. CONCLUSIONS: As prolapse treatment options expand to include more conservative choices, greater awareness and education is needed among women and professionals about these as a first line treatment and preventive measure, alongside a multi-professional team approach to treatment decision making. Women presenting with prolapse symptoms need to be listened to by the health care team, offered better information about treatment choices, and supported to make a decision that is right for them.

PROPEL: implementation of an evidence based pelvic floor muscle training intervention for women with pelvic organ prolapse: a realist evaluation and outcomes study protocol.

BACKGROUND: Pelvic Organ Prolapse (POP) is estimated to affect 41%-50% of women aged over 40. Findings from the multi-centre randomised controlled "Pelvic Organ Prolapse PhysiotherapY" (POPPY) trial showed that individualised pelvic floor muscle training (PFMT) was effective in reducing symptoms of prolapse, improved quality of life and showed clear potential to be cost-effective. However, provision of PFMT for prolapse continues to vary across the UK, with limited numbers of women's health physiotherapists specialising in its delivery. Implementation of this robust evidence from the POPPY trial will require attention to different models of delivery (e.g. staff skill mix) to fit with differing care environments. METHODS: A Realist Evaluation (RE) of implementation and outcomes of PFMT delivery in contrasting NHS settings will be conducted using multiple case study sites. Involving substantial local stakeholder engagement will permit a detailed exploration of how local sites make decisions on how to deliver PFMT and how these lead to service change. The RE will track how implementation is working; identify what influences outcomes; and, guided by the RE-AIM framework, will collect robust outcomes data. This will require mixed methods data collection and analysis. Qualitative data will be collected at four time-points across each site to understand local contexts and decisions regarding options for intervention delivery and to monitor implementation, uptake, adherence and outcomes. Patient outcome data will be collected at baseline, six months and one year follow-up for 120 women. Primary outcome will be the Pelvic Organ Prolapse Symptom Score (POP-SS). An economic evaluation will assess the costs and benefits associated with different delivery models taking account of further health care resource use by the women. Cost data will be combined with the primary outcome in a cost effectiveness analysis, and the EQ-5D-5L data in a cost utility analysis for each of the different models of delivery. DISCUSSION: Study of the implementation of varying models of service delivery of PFMT across contrasting sites combined with outcomes data and a cost effectiveness analysis will provide insight into the implementation and value of different models of PFMT service delivery and the cost benefits to the NHS in the longer term.

Time for You: A process evaluation of the rapid implementation of a multi-level mental health support intervention for frontline workers during the COVID-19 pandemic.

The coronavirus (COVID-19) pandemic had wide-ranging negative impacts on mental health. The pandemic also placed extraordinary strain on frontline workers who were required to continue working and putting themselves at risk to provide essential services at a time when their normal support mechanisms may not have been available. This paper presents an evaluation of the Time for You service, a rapidly developed and implemented intervention aimed at providing frontline workers with quick access to flexible online mental health support. Time for You provided service users with three service options: self-guided online cognitive behavioural therapy (CBT) resources; guided engagement with online CBT resources; 1-1 psychological therapy with trainee sport and exercise psychologists and trainee health psychologists. A process evaluation informed by the Consolidated Framework for Implementation Research considered service fidelity, adaptations, perceived impact, reach, barriers, and facilitators. Interviews with project managers (n = 5), delivery staff (n = 10), and service users (n = 14) explored perceptions of the service implementation and outcomes, supported by data regarding engagement with the online CBT platform (n = 217). Findings indicated that service users valued the flexibility of the service and the speed with which they were able to access support. The support offered by Trainee Psychologists was perceived to be of high quality, and the service was perceived by service users to have improved mental health and wellbeing. The rapid implementation contributed to issues regarding appropriate service user screening that led to trainee psychologists being unable to provide the service users with the support they needed as the presenting issues were outside of trainees' competencies. Overall, the findings suggest that interventions offering flexible, online psychological support to frontline workers can be an effective model for future interventions. Trainee psychologists are also able to play an important role in delivering such services when clear screening processes are in place.

Increasing lay-people's intentions to initiate CPR in out of hospital cardiac arrest: Results of a mixed-methods 'before and after' pilot study of a behavioural text-message intervention (BICeP).

Background: Prompt, effective cardio-pulmonary resuscitation (CPR) increases survival in out-of-hospital cardiac arrest. However, CPR is often not provided, even by people with training. Low confidence, perceptions of risks and high emotion can prevent initiation of CPR. Behaviour-change techniques may be helpful in increasing CPR rates. Aim: To pilot a text-message behavioural intervention designed to increase intentions to initiate CPR, explore participant responses and pilot methods for future randomised controlled trial of effectiveness. Methods: A 'before and after' pilot study plus qualitative interviews was undertaken. Participants were lay-people who had undertaken CPR training in previous 2 years.Participants were sent an intervention, comprising 35 text-messages containing 14 behaviour-change techniques, to their mobile phone over 4-6 weeks.Primary outcome: intentions to initiate CPR assessed in response to 4 different scenarios.Secondary outcomes: theory-based determinants of intention (attitudes, subjective norms, perceived behavioural control and self-efficacy) and self-rated competence. Results: 20 participants (6 female, 14 male), aged 20-84 provided baseline data. 17 received the full suite of 35 text messages.15 provided follow-up data. Intentions to perform CPR in scenarios where CPR was indicated were high at baseline and increased (18.1 ± 3.2-19.5 ± 1.8/21) after the intervention, as did self-efficacy and self-rated competency. Self-efficacy, attitudes, perceived behavioural control and subjective norms were positively correlated with intentions. Qualitative data suggest the intervention was perceived as useful. Additional options for delivery format and pace were suggested. Conclusions: Pilot-testing suggests a text-message intervention delivered after CPR training is acceptable and may be helpful in increasing/maintaining intentions to perform CPR.

Game of Stones: feasibility randomised controlled trial of how to engage men with obesity in text message and incentive interventions for weight loss.

OBJECTIVES: To examine the acceptability and feasibility of narrative text messages with or without financial incentives to support weight loss for men. DESIGN: Individually randomised three-arm feasibility trial with 12 months' follow-up. SETTING: Two sites in Scotland with high levels of disadvantage according to Scottish Index for Multiple Deprivation (SIMD). PARTICIPANTS: Men with obesity (n=105) recruited through community outreach and general practitioner registers. INTERVENTIONS: Participants randomised to: (A) narrative text messages plus financial incentive for 12 months (short message service (SMS)+I), (B) narrative text messages for 12 months (SMS only), or (C) waiting list control. OUTCOMES: Acceptability and feasibility of recruitment, retention, intervention components and trial procedures assessed by analysing quantitative and qualitative data at 3, 6 and 12 months. RESULTS: 105 men were recruited, 60% from more disadvantaged areas (SIMD quintiles 1 or 2). Retention at 12 months was 74%. Fewer SMS+I participants (64%) completed 12-month assessments compared with SMS only (79%) and control (83%). Narrative texts were acceptable to many men, but some reported negative reactions. No evidence emerged that level of disadvantage was related to acceptability of narrative texts. Eleven SMS+I participants (31%) successfully met or partially met weight loss targets. The cost of the incentive per participant was £81.94 (95% CI £34.59 to £129.30). Incentives were acceptable, but improving health was reported as the key motivator for weight loss. All groups lost weight (SMS+I: -2.51 kg (SD=4.94); SMS only: -1.29 kg (SD=5.03); control: -0.86 kg (SD=5.64) at 12 months). CONCLUSIONS: This three-arm weight management feasibility trial recruited and retained men from across the socioeconomic spectrum, with the majority from areas of disadvantage, was broadly acceptable to most participants and feasible to deliver. TRIAL REGISTRATION NUMBER: NCT03040518.

Evaluation of a Digital Consultation and Self-Care Advice Tool in Primary Care: A Multi-Methods Study.

Digital services are often regarded as a solution to the growing demands on primary care services. Provision of a tool offering advice to support self-management as well as the ability to digitally consult with a General Practitioner (GP) has the potential to alleviate some of the pressure on primary care. This paper reports on a Phase II, 6-month evaluation of eConsult, a web-based triage and consultation system that was piloted across 11 GP practices across Scotland. Through a multi-method approach the evaluation explored eConsult use across practices, exposing both barriers and facilitators to its adoption. Findings suggest that expectations that eConsult would offer an additional and alternative method of accessing GP services were largely met. However, there is less certainty that it has fulfilled expectations of promoting self-help. In addition, low uptake meant that evaluation of current effectiveness was difficult for practices to quantify. The presence of an eConsult champion(s) within the practice was seen to be a significant factor in ensuring successful integration of the tool. A lack of patient and staff engagement, insufficient support and lack of protocols around processes were seen as barriers to its success.