Is telephone health coaching a useful population health strategy for supporting older people with multimorbidity? An evaluation of reach, effectiveness and cost-effectiveness using a 'trial within a cohort'.

BACKGROUND: Innovative ways of delivering care are needed to improve outcomes for older people with multimorbidity. Health coaching involves 'a regular series of phone calls between patient and health professional to provide support and encouragement to promote healthy behaviours'. This intervention is promising, but evidence is insufficient to support a wider role in multimorbidity care. We evaluated health coaching in older people with multimorbidity. METHODS: We used the innovative 'Trials within Cohorts' design. A cohort was recruited, and a trial was conducted using a 'patient-centred' consent model. A randomly selected group within the cohort were offered the intervention and were analysed as the intervention group whether they accepted the offer or not. The intervention sought to improve the skills of patients with multimorbidity to deal with a range of long-term conditions, through health coaching, social prescribing and low-intensity support for low mood. RESULTS: We recruited 4377 older people, and 1306 met the eligibility criteria (two or more long-term conditions and moderate 'patient activation'). We selected 504 for health coaching, and 41% consented. More than 80% of consenters received the defined 'dose' of 4+ sessions. In an intention-to-treat analysis, those selected for health coaching did not improve on any outcome (patient activation, quality of life, depression or self-care) compared to usual care. We examined health care utilisation using hospital administrative and self-report data. Patients selected for health coaching demonstrated lower levels of emergency care use, but an increase in the use of planned services and higher overall costs, as well as a quality-adjusted life year (QALY) gain. The incremental cost per QALY was £8049, with a 70-79% probability of being cost-effective at conventional levels of willingness to pay. CONCLUSIONS: Health coaching did not lead to significant benefits on the primary measures of patient-reported outcome. This is likely related to relatively low levels of uptake amongst those selected for the intervention. Demonstrating effectiveness in this design is challenging, as it estimates the effect of being selected for treatment, regardless of whether treatment is adopted. We argue that the treatment effect estimated is appropriate for health coaching, a proactive model relevant to many patients in the community, not just those seeking care. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ( ISRCTN12286422 ).

Patient activation in older people with long-term conditions and multimorbidity: correlates and change in a cohort study in the United Kingdom.

BACKGROUND: Patient Activation is defined as the knowledge, skill, and confidence a patient has in managing their health. Higher levels of patient activation are associated with better self-management, better health outcomes, and lower healthcare costs. Understanding the drivers of patient activation can allow better tailoring of patient support and interventions. There are few data on patient activation in UK patients with long-term conditions. METHODS: A prospective cohort design was used. Questionnaires were mailed to 12,989 patients over the age of 65 years with at least one long-term condition in Salford, UK. They completed the Patient Activation Measure and self-report measures of: depression, health literacy, social support, health-related quality of life, and impact of multimorbidity. We report descriptive data on baseline activation and change over time, and use multivariate regression to model associations with patient activation at baseline and predictors of change in Activation over 6 months. RESULTS: The cohort included 4377 (33.6 %) older people, of whom 4225 were mailed a further questionnaire at 6 months; 3390 returned it complete (80.2 %). At baseline, 15 % self-reported PAM level 1, 16 % level 2, 45 % level 3, and 25 % level 4. Across all patients, depression had the strongest association with patient activation. Other important factors were: older age, being retired, poor health literacy, health-related quality of life, and social support. Total number of self-reported comorbidities and the perceived impact of comorbidities were also important for patients with more than one long-term condition. Patient activation scores were reasonably enduring over time (r = 0.43 between baseline and at six months), although nearly half changed 'levels' of activation over that time. Few variables predicted change in activation over 6 months. CONCLUSIONS: This is the first large scale assessment of patient activation in the UK. Our data may be useful in identifying patients who need support with patient activation, and allow interventions (such as health coaching) to be tailored to better support older patients with long-term conditions who have symptoms of depression, poor social support and impaired health literacy. Further analyses of longitudinal studies will be necessary to better understand the causal relationships between patient activation and variables such as depression.

Evidence from UK Research Ethics Committee members on what makes a good research ethics review, and what can be improved.

The rapid development of vaccines and other innovative medical technologies in response to the COVID-19 pandemic required streamlined and efficient ethics and governance processes. In the UK the Health Research Authority (HRA) oversees and coordinates a number of the relevant research governance processes including the independent ethics review of research projects. The HRA was instrumental in facilitating the rapid review and approval of COVID-19 projects, and following the end of the pandemic, have been keen to integrate new ways of working into the UK Health Departments' Research Ethics Service. In January 2022 the HRA commissioned a public consultation that identified strong public support for alternative ethics review processes. Here we report feedback from 151 current research ethics committee members conducted at three annual training events, where we asked members to critically reflect on their ethics review activities, and to share new ideas or ways of working. The results showed a high regard for good quality discussion among members with diverse experience. Good chairing, organisation, feedback and the opportunity for reflection on ways of working were considered key. Areas for improvement included the consistency of information provided to committees by researchers, and better structuring of discussions by allowing signposting of the key issues that ethics committee members might need to consider.

The cohort multiple randomized controlled trial design was found to be highly susceptible to low statistical power and internal validity biases.

OBJECTIVES: The "cohort multiple randomized controlled trial" (cmRCT) is a recent innovation by which novel interventions are trialed within large longitudinal cohorts of patients to gain efficiencies and align trials more closely to standard clinical practice. The use of cmRCTs is outpacing its methodological understanding, and more appropriate methods for designing and analyzing such trials are urgently needed. STUDY DESIGN AND SETTING: We established the UK Comprehensive Longitudinal Assessment of Salford Integrated Care cohort of 4,377 patients with long-term conditions within which we are conducting a cmRCT ("Proactive Telephone Coaching and Tailored Support") of telephone-based health coaching. RESULTS: We identify some key methodological challenges to the use of the cmRCT in actual practice. Principal are issues around statistical power, sample size, and treatment effect estimation, for which we provide appropriate methods. Sampling procedures commonly applied in conventional RCTs can result in unintentional selection bias. The fixed data collection points that feature in cmRCTs can also threaten validity. CONCLUSION: The cmRCT may offer advantages over conventional trial designs. However, a cmRCT requires appropriate power calculation, sampling, and analysis procedures; else, studies may be underpowered or subject to validity biases. We offer solutions to some of the key issues, but further methodological investigations are needed. Cohort multiple RCT-specific Consolidated Standards of Reporting Trials guidance may be indicated.

Associations of participation in community assets with health-related quality of life and healthcare usage: a cross-sectional study of older people in the community.

BACKGROUND: Community assets are promoted as a way to improve quality of life and reduce healthcare usage. However, the quantitative impact of participation in community assets on these outcomes is not known. METHODS: We examined the association between participation in community assets and health-related quality of life (HRQoL) (EuroQol-5D-5L) and healthcare usage in 3686 individuals aged ≥65 years. We estimated the unadjusted differences in EuroQol-5D-5L scores and healthcare usage between participants and non-participants in community assets and then used multivariate regression to examine scores adjusted for sociodemographic and limiting long-term health conditions. We derived the net benefits of participation using a range of threshold values for a quality-adjusted life year (QALY). RESULTS: 50% of individuals reported participation in community assets. Their EuroQol-5D-5L scores were 0.094 (95% CI 0.077 to 0.111) points higher than non-participants. Controlling for sociodemographic characteristics reduced this differential to 0.081 (95% CI 0.064 to 0.098). Further controlling for limiting long-term conditions reduced this effect to 0.039 (95% CI 0.025 to 0.052). Once we adjusted for sociodemographic and limiting long-term conditions, the reductions in healthcare usage and costs associated with community asset participation were not statistically significant. Based on a threshold value of £20 000 per QALY, the net benefits of participation in community assets were £763 (95% CI £478 to £1048) per participant per year. CONCLUSIONS: Participation in community assets is associated with substantially higher HRQoL but is not associated with lower healthcare costs. The social value of developing community assets is potentially substantial.

Rationale, design and conduct of a comprehensive evaluation of a school-based peer-led anti-smoking intervention in the UK: the ASSIST cluster randomised trial [ISRCTN55572965].

BACKGROUND: To date, no school-based intervention has been proven to be effective in preventing adolescent smoking, despite continuing concern about smoking levels amongst young people in the United Kingdom. Although formal teacher-led smoking prevention interventions are considered unlikely to be effective, peer-led approaches to reducing smoking have been proposed as potentially valuable. METHODS/DESIGN: ASSIST (A Stop Smoking in Schools Trial) is a comprehensive, large-scale evaluation to rigorously test whether peer supporters in Year 8 (age 11-12) can be recruited and trained to effect a reduction in smoking uptake among their fellow students. The evaluation is employing a cluster randomised controlled trial (RCT) design with secondary school as the unit of randomisation, and is being undertaken in 59 schools in South East Wales and the West of England. Embedded within the trial are an economic evaluation of the intervention costs, a process evaluation to provide detailed information on how the intervention was delivered and received, and an analysis of social networks to consider whether such a peer group intervention could work amongst schoolchildren in this age group. Schools were randomised to either continue with normal smoking education (n = 29 schools, 5562 students), or to do so and additionally receive the ASSIST intervention (n = 30 schools, 5481 students). No schools withdrew once the trial had started, and the intervention was successfully implemented in all 30 schools, with excellent participation rates from the peer supporters. The primary outcome is regular (weekly) smoking, validated by salivary cotinine, and this outcome has been obtained for 94.4%, 91.0% and 95.6% of eligible students at baseline, immediate post-intervention, and one-year follow-up respectively. DISCUSSION: Comprehensive evaluations of complex public health interventions of this scale and nature are rare in the United Kingdom. This paper demonstrates the feasibility of conducting cluster RCTs of complex public health interventions in schools, and how the rigour of such designs can be maximised both by thorough implementation of the protocol and by broadening the scope of questions addressed in the trial by including additional evaluative components.