Getting evidence into clinical practice: protocol for evaluation of the implementation of a home-based cardiac rehabilitation programme for patients with heart failure

INTRODUCTION: Cardiac rehabilitation (CR) improves health-related quality of life and reduces hospital admissions. However, patients with heart failure (HF) often fail to attend centre-based CR programmes. Novel ways of delivering healthcare, such as home-based CR programmes, may improve uptake of CR. Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is a new, effective and cost-effective home-based CR programme for people with HF. The aim of this prospective mixed-method implementation evaluation study is to assess the implementation of the REACH-HF CR programme in the UK National Health Service (NHS). The specific objectives are to (1) explore NHS staff perceptions of the barriers and facilitators to the implementation of REACH-HF, (2) assess the quality of delivery of the programme in real-life clinical settings, (3) consider the nature of any adaptation(s) made and how they might impact on intervention effectiveness and (4) compare real-world patient outcomes to those seen in a prior clinical trial. METHODS AND ANALYSIS: REACH-HF will be rolled out in four NHS CR centres across the UK. Three healthcare professionals from each site will be trained to deliver the 12-week programme. In-depth qualitative interviews and focus groups will be conducted with approximately 24 NHS professionals involved in delivering or commissioning the programme. Consultations for 48 patients (12 per site) will be audio recorded and scored using an intervention fidelity checklist. Outcomes routinely recorded in the National Audit of Cardiac Rehabilitation will be analysed and compared with outcomes from a recent randomised controlled trial: the Minnesota Living with HF Questionnaire and exercise capacity (Incremental Shuttle Walk Test). Qualitative research findings will be mapped onto the Normalisation Process Theory framework and presented in the form of a narrative synthesis. Results of the study will inform national roll-out of REACH-HF. ETHICS AND DISSEMINATION: The study (IRAS 261723) has received ethics approval from the South Central (Hampshire B) Research Ethics Committee (19/SC/0304). Written informed consent will be obtained from all health professionals and patients participating in the study. The research team will ensure that the study is conducted in accordance with the Declaration of Helsinki, the Data Protection Act 2018, General Data Protection Regulations and in accordance with the Research Governance Framework for Health and Social Care (2005). Findings will be published in scientific peer-reviewed journals and presented at local, national and international meetings to publicise and explain the research methods and findings to key audiences to facilitate the further uptake of the REACH-HF intervention. TRIAL REGISTRATION: ISRCTN86234930

A pragmatic effectiveness-implementation study comparing trial evidence with routinely collected outcome data for patients receiving the REACH-HF home-based cardiac rehabilitation programme

BACKGROUND: Cardiac rehabilitation for heart failure continues to be greatly underused worldwide despite being a Class I recommendation in international clinical guidelines and uptake is low in women and patients with mental health comorbidities. METHODS: Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) programme was implemented in four UK National Health Service early adopter sites ('Beacon Sites') between June 2019 and June 2020. Implementation and patient-reported outcome data were collected across sites as part of the National Audit of Cardiac Rehabilitation. The change in key outcomes before and after the supervised period of REACH-HF intervention across the Beacon Sites was assessed and compared to those of the intervention arm of the REACH-HF multicentre trial. RESULTS: Compared to the REACH-HF multicentre trial, patients treated at the Beacon Site were more likely to be female (33.8% vs 22.9%), older (75.6 vs 70.1), had a more severe classification of heart failure (26.5% vs 17.7%), had poorer baseline health-related quality of life (MLHFQ score 36.1 vs 31.4), were more depressed (HADS score 6.4 vs 4.1) and anxious (HADS score 7.2 vs 4.7), and had lower exercise capacity (ISWT distance 190 m vs 274.7 m). There appeared to be a substantial heterogeneity in the implementation process across the four Beacon Sites as evidenced by the variation in levels of patient recruitment, operationalisation of the REACH-HF intervention and patient outcomes. Overall lower improvements in patient-reported outcomes at the Beacon Sites compared to the trial may reflect differences in the population studied (having higher morbidity at baseline) as well as the marked challenges in intervention delivery during the COVID-19 pandemic. CONCLUSION: The results of this study illustrate the challenges in consistently implementing an intervention (shown to be clinically effective and cost-effective in a multicentre trial) into real-world practice, especially in the midst of a global pandemic. Further research is needed to establish the real-world effectiveness of the REACH-HF intervention in different populations

White Paper: Open Digital Health – accelerating transparent and scalable health promotion and treatment

In this White Paper, we outline recommendations from the perspective of health psychology and behavioural science, addressing three research gaps: (1) What methods in the health psychology research toolkit can be best used for developing and evaluating digital health tools? (2) What are the most feasible strategies to reuse digital health tools across populations and settings? (3) What are the main advantages and challenges of sharing (openly publishing) data, code, intervention content and design features of digital health tools? We provide actionable suggestions for researchers joining the continuously growing Open Digital Health movement, poised to revolutionise health psychology research and practice in the coming years. This White Paper is positioned in the current context of the COVID-19 pandemic, exploring how digital health tools have rapidly gained popularity in 2020-2022, when world-wide health promotion and treatment efforts rapidly shifted from face-to-face to remote delivery. This statement is written by the Directors of the not-for-profit Open Digital Health initiative (n = 6), Experts attending the European Health Psychology Society Synergy Expert Meeting (n = 17), and the initiative consultant, following a two-day meeting (19-20th August 2021).Peer reviewe

“It helps me to stay on the right path, rather than give in”: Mixed-method process evaluation of the ImpulsePal app-based intervention for weight management

Background Empirical research indicates that impulsive processes that operate below conscious monitoring can undermine peoples’ attempts to change behaviour patterns, especially those that have become habitual. This may, therefore, be a serious challenge for those trying to lose weight. A novel smartphone app-based intervention (ImpulsePal) offers practical strategies to manage impulsive urges to facilitate reductions in the consumption of energy-dense processed food and overeating. Aim This process evaluation of ImpulsePal aimed to explore what was delivered/received and used, mechanisms of action, and potential contextual factors impacting intervention engagement and outcomes. Methods A mixed-methods process evaluation, with composite analysis of the quantitative (app usage statistics) and qualitative data (semi-structured interviews), was conducted alongside a feasibility randomised controlled trial with individuals with a body mass index of at least 25 kg/m 2 who wanted to lose weight. Results Of 58 participants receiving ImpulsePal, 56 had successfully shared app usage statistics, and 36 (62%) were interviewed. Although usage statistics indicated reductions in the use of some features, interviews indicated that participants were still using app-recommended strategies without requiring them to open ImpulsPal. Overall, interviews highlighted that participants valued having access to in-the-moment support, felt more aware of their own eating behaviour and influences on it, and felt an increased ability to avoid and reconceptualise, in-the-moment temptations. Conclusion This process evaluation offers support for a logic model suggesting that impulse management, using ImpulsePal, can promote healthier eating among those motivated to lose weight. It also highlights the necessity of using multimodal methods to explore the delivery and use of digital interventions

Barriers and facilitators to implementation of a home-based cardiac rehabilitation programme for patients with heart failure in the NHS : a mixed-methods study

OBJECTIVES: This study aimed to identify barriers to, and facilitators of, implementation of the Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) programme within existing cardiac rehabilitation services, and develop and refine the REACH-HF Service Delivery Guide (an implementation guide cocreated with healthcare professionals). REACH-HF is an effective and cost-effective 12-week home-based cardiac rehabilitation programme for patients with heart failure. SETTING/PARTICIPANTS: In 2019, four early adopter 'Beacon Sites' were set up to deliver REACH-HF to 200 patients. In 2020, 5 online REACH-HF training events were attended by 85 healthcare professionals from 45 National Health Service (NHS) teams across the UK and Ireland. DESIGN: Our mixed-methods study used in-depth semi-structured interviews and an online survey. Interviews were conducted with staff trained specifically for the Beacon Site project, identified by opportunity and snowball sampling. The online survey was later offered to subsequent NHS staff who took part in the online REACH-HF training. Normalisation Process Theory was used as a theoretical framework to guide data collection/analysis. RESULTS: Seventeen healthcare professionals working at the Beacon Sites were interviewed and 17 survey responses were received (20% response rate). The identified barriers and enablers included, among many, a lack of resources/commissioning, having interest in heart failure and working closely with the clinical heart failure team. Different implementation contexts (urban/rural), timing (during the COVID-19 pandemic) and factors outside the healthcare team/system (quality of the REACH-HF training) were observed to negatively or positively impact the implementation process. CONCLUSIONS: The findings are highly relevant to healthcare professionals involved in planning, delivering and commissioning of cardiac rehabilitation for patients with heart failure. The study's main output, a refined version of the REACH-HF Service Delivery Guide, can guide the implementation process (eg, designing new care pathways) and provide practical solutions to overcoming common implementation barriers (eg, through early identification of implementation champions)

White Paper: Open Digital Health–accelerating transparent and scalable health promotion and treatment

In this White Paper, we outline recommendations from the perspective of health psychology and behavioural science, addressing three research gaps: (1) What methods in the health psychology research toolkit can be best used for developing and evaluating digital health tools? (2) What are the most feasible strategies to reuse digital health tools across populations and settings? (3) What are the main advantages and challenges of sharing (openly publishing) data, code, intervention content and design features of digital health tools? We provide actionable suggestions for researchers joining the continuously growing Open Digital Health movement, poised to revolutionise health psychology research and practice in the coming years. This White Paper is positioned in the current context of the COVID-19 pandemic, exploring how digital health tools have rapidly gained popularity in 2020–2022, when world-wide health promotion and treatment efforts rapidly shifted from face-to-face to remote delivery. This statement is written by the Directors of the not-for-profit Open Digital Health initiative (n = 6), Experts attending the European Health Psychology Society Synergy Expert Meeting (n = 17), and the initiative consultant, following a two-day meeting (19–20th August 2021)