John Green

Background: Sustaining independence is important for older people, but there is insufficient guidance about which community health and care services to implement. Objectives: To synthesise evidence of the effectiveness of community services to sustain independence for older people grouped according to their intervention components, and to examine if frailty moderates the effect. Review design: Systematic review and network meta-analysis. Eligibility criteria: Studies: Randomised controlled trials or cluster-randomised controlled trials. Participants: Older people (mean age 65+) living at home. Interventions: community-based complex interventions for sustaining independence. Comparators: usual care, placebo or another complex intervention. Main outcomes: Living at home, instrumental activities of daily living, personal activities of daily living, care-home placement and service/economic outcomes at 1 year. Data sources: We searched MEDLINE (1946–), Embase (1947–), CINAHL (1972–), PsycINFO (1806–), CENTRAL and trial registries from inception to August 2021, without restrictions, and scanned reference lists. Review methods: Interventions were coded, summarised and grouped. Study populations were classified by frailty. A random-effects network meta-analysis was used. We assessed trial-result risk of bias (Cochrane RoB 2), network meta-analysis inconsistency and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation for network meta-analysis). Results: We included 129 studies (74,946 participants). Nineteen intervention components, including ‘multifactorial-action’ (multidomain assessment and management/individualised care planning), were identified in 63 combinations. The following results were of low certainty unless otherwise stated. For living at home, compared to no intervention/placebo, evidence favoured: multifactorial-action and review with medication-review (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty) multifactorial-action with medication-review (odds ratio 2.55, 95% confidence interval 0.61 to 10.60) cognitive training, medication-review, nutrition and exercise (odds ratio 1.93, 95% confidence interval 0.79 to 4.77) and activities of daily living training, nutrition and exercise (odds ratio 1.79, 95% confidence interval 0.67 to 4.76). Four intervention combinations may reduce living at home. For instrumental activities of daily living, evidence favoured multifactorial-action and review with medication-review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living. For personal activities of daily living, evidence favoured exercise, multifactorial-action and review with medication-review and self-management (standardised mean difference 0.16, 95% confidence interval −0.51 to 0.82). For homecare recipients, evidence favoured the addition of multifactorial-action and review with medication-review (standardised mean difference 0.60, 95% confidence interval 0.32 to 0.88). Care-home placement and service/economic findings were inconclusive. Limitations: High risk of bias in most results and imprecise estimates meant that most evidence was low or very low certainty. Few studies contributed to each comparison, impeding evaluation of inconsistency and frailty. Studies were diverse; findings may not apply to all contexts. Conclusions: Findings for the many intervention combinations evaluated were largely small and uncertain. However, the combinations most likely to sustain independence include multifactorial-action, medication-review and ongoing review of patients. Some combinations may reduce independence. Future work: Further research is required to explore mechanisms of action and interaction with context. Different methods for evidence synthesis may illuminate further. Study registration: This study is registered as PROSPERO CRD42019162195. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR128862) and is published in full in Health Technology Assessment; Vol. 28, No. 48. See the NIHR Funding and Awards website for further award information.

Objective To synthesise evidence of the effectiveness of community based complex interventions, grouped according to their intervention components, to sustain independence for older people. Design Systematic review and network meta-analysis. Data sources Medline, Embase, CINAHL, PsycINFO, CENTRAL, clinicaltrials.gov, and International Clinical Trials Registry Platform from inception to 9 August 2021 and reference lists of included studies. Eligibility criteria Randomised controlled trials or cluster randomised controlled trials with ≥24 weeks’ follow-up studying community based complex interventions for sustaining independence in older people (mean age ≥65 years) living at home, with usual care, placebo, or another complex intervention as comparators. Main outcomes Living at home, activities of daily living (personal/instrumental), care home placement, and service/economic outcomes at 12 months. Data synthesis Interventions were grouped according to a specifically developed typology. Random effects network meta-analysis estimated comparative effects; Cochrane’s revised tool (RoB 2) structured risk of bias assessment. Grading of recommendations assessment, development and evaluation (GRADE) network meta-analysis structured certainty assessment. Results The review included 129 studies (74 946 participants). Nineteen intervention components, including “multifactorial action from individualised care planning” (a process of multidomain assessment and management leading to tailored actions), were identified in 63 combinations. For living at home, compared with no intervention/placebo, evidence favoured multifactorial action from individualised care planning including medication review and regular follow-ups (routine review) (odds ratio 1.22, 95% confidence interval 0.93 to 1.59; moderate certainty); multifactorial action from individualised care planning including medication review without regular follow-ups (2.55, 0.61 to 10.60; low certainty); combined cognitive training, medication review, nutritional support, and exercise (1.93, 0.79 to 4.77; low certainty); and combined activities of daily living training, nutritional support, and exercise (1.79, 0.67 to 4.76; low certainty). Risk screening or the addition of education and self-management strategies to multifactorial action from individualised care planning and routine review with medication review may reduce odds of living at home. For instrumental activities of daily living, evidence favoured multifactorial action from individualised care planning and routine review with medication review (standardised mean difference 0.11, 95% confidence interval 0.00 to 0.21; moderate certainty). Two interventions may reduce instrumental activities of daily living: combined activities of daily living training, aids, and exercise; and combined activities of daily living training, aids, education, exercise, and multifactorial action from individualised care planning and routine review with medication review and self-management strategies. For personal activities of daily living, evidence favoured combined exercise, multifactorial action from individualised care planning, and routine review with medication review and self-management strategies (0.16, −0.51 to 0.82; low certainty). For homecare recipients, evidence favoured addition of multifactorial action from individualised care planning and routine review with medication review (0.60, 0.32 to 0.88; low certainty). High risk of bias and imprecise estimates meant that most evidence was low or very low certainty. Few studies contributed to each comparison, impeding evaluation of inconsistency and frailty. Conclusions The intervention most likely to sustain independence is individualised care planning including medicines optimisation and regular follow-up reviews resulting in multifactorial action. Homecare recipients may particularly benefit from this intervention. Unexpectedly, some combinations may reduce independence. Further research is needed to investigate which combinations of interventions work best for different participants and contexts. Registration PROSPERO CRD42019162195.

Purpose: Persistent pain is common in older people and people living with frailty. Pain or the impact of pain on everyday life is potentially modifiable. We sought to map research evidence and information from randomised controlled trials (RCTs) of pain management programmes and psychological therapies targeting community-dwelling older people, and explore appropriate strategies and interventions for managing or reducing the negative impact of pain for older people, particularly those with frailty. Method: A mapping review of pain management programmes and psychological therapies for community-dwelling older people living with chronic pain. We searched for systematic reviews of randomised controlled trials and for individual randomised controlled trials and extracted data from eligible studies. Results: Searches resulted in 3419 systematic review records and 746 RCT records from which there were 33 eligible interventions identified in 31 eligible RCTs (48 reports). Broad aims of the interventions were to: improve physical, psychological, or social functioning; adjust the effects or sensation of pain psychologically; enhance self-care with self-management skills or knowledge. Common mechanisms of change proposed were self-efficacy enhanced by self-management tasks and skills, using positive psychological skills or refocusing attention to improve responses to pain, and practising physical exercises to improve physiological well-being and reduce restrictions from pain. Content of interventions included: skills training and activity management, education, and physical exercise. Interventions were delivered in person or remotely to individuals or in groups, typically in 1–2 sessions weekly over 5–12 weeks. Conclusion: All the evaluated interventions appeared to show potential to provide some benefits to older people. None of the included studies assessed frailty. However, some of the included interventions appear appropriate for community-dwelling older people living with both frailty and pain.

Background: Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity.Objectives: The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams.Design: This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstream 4); and undertaking a cluster randomised feasibility trial of the intervention [introduced via three facilitated workshops at baseline (with physiotherapist input), 2 weeks (with artist input) and 2 months], with embedded process and health economic evaluations (workstream 5).Setting: The trial was set in 12 residential care homes differing in size, location, ownership and provision in Yorkshire, UK.Participants: The participants were elderly residents, carers, managers and staff of care homes.Intervention: The intervention was MoveMore, designed for the whole home, to encourage and support the movement of residents in their daily routines.Main outcome measures: The main outcome measures related to the feasibility and acceptability of implementing a full-scale trial in terms of recruitment and retention of care homes and residents, intervention delivery, completion and reporting of baseline data and outcomes (including hours of accelerometer wear, hours of sedentary behaviour and hours and type of physical activity), and safety and cost data (workstream 5).Results: Workstream 1 – through a detailed understanding of life in a care home, a needs assessment was produced, and barriers to and facilitators of activity were identified. Key factors included ethos of care; organisation, management and delivery of care; use of space; and the residents’ daily routines. Workstream 2 – 22 (73.3%) out of 30 residents who wore a hip accelerometer had valid data (≥ 8 hours on ≥ 4 days of the week). Workstream 3 – practical mechanisms for increasing physical activity were developed, informed by an advisory group of stakeholders and outputs from workstreams 1 and 2, framed by the process of intervention mapping. Workstream 4 – action groups were convened in four care homes to refine the intervention, leading to further development of implementation strategies. The intervention, MoveMore, is a whole-home intervention involving engagement with a stakeholder group to implement a cyclical process of change to encourage and support the movement of residents in their daily routines. Workstream 5 – 12 care homes and 153 residents were recruited to the cluster randomised feasibility trial. Recruitment in the care homes varied (40–89%). Five care homes were randomised to the intervention and seven were randomised to usual care. Predetermined progression criteria were recruitment of care homes and residents (green); intervention delivery (amber); and data collection and follow-up – 52% of residents provided usable accelerometer data at 9 months (red), > 75% of residents had reported outcomes at 9 months (green, but self-reported resident outcomes were red), 26% loss of residents to follow-up at 9 months [just missing green criterion (no greater than 25%)] and safety concerns (green).Limitations: Observations of residents’ movements were not conducted in private spaces. Working with care home residents to identify appropriate outcome measures was challenging. Take-up of the intervention was suboptimal in some sites. It was not possible to make a reliably informed decision on the most appropriate physical activity end point(s) for future use in a definitive trial.Conclusions: A whole-home intervention was developed that was owned and delivered by staff and was informed by residents and staff. The feasibility of conducting a cluster randomised controlled trial was successfully tested: the target numbers of care homes and residents were recruited, demonstrating that it is possible to recruit care home residents to a cluster randomised trial, although this process was time-consuming and resource heavy. A large data set was collected, which provided a comprehensive picture of the environment, residents and staff in care homes. Extensive quantitative and qualitative work comprehensively explored a neglected area of health and social care research. Completion of ethnographic work in a range of settings enabled the production of an in-depth picture of life in care homes that will be helpful for other researchers considering organisational change in this setting.Future work: The content and delivery of the intervention requires optimisation and the outcome measurement requires further refinement prior to undertaking a full trial evaluation. Consideration could be given to a recommended, simplified, core outcome set, which would facilitate data collection in this population.Trial registration: Current Controlled Trials ISRCTN16076575.Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grant for Applied Research programme and will be published in full inProgramme Grant for Applied Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.

Care home (CH) residents are mainly inactive, leading to increased dependency and low mood. Strategies to improve activity are required. Cluster randomised controlled feasibility trial with embedded process and health economic evaluations. Twelve residential CHs in Yorkshire, United Kingdom, were randomised to the MoveMore intervention plus usual care (UC) (n = 5) or UC only (n = 7). Permanent residents aged ≥65 years. MoveMore: a whole home intervention involving all CH staff designed to encourage and support increase in movement of residents. Feasibility objectives relating to recruitment, intervention delivery, data collection and follow-up and safety concerns informed the feasibility of progression to a definitive trial. Data collection at baseline, 3, 6 and 9 months included: participants’ physical function and mobility, perceived health, mood, quality of life, cognitive impairment questionnaires; accelerometry; safety data; intervention implementation. 300 residents were screened; 153 were registered (62 MoveMore; 91 UC). Average cluster size: MoveMore: 12.4 CHs; UC: 13.0 CHs. There were no CH/resident withdrawals. Forty (26.1%) participants were unavailable for follow-up: 28 died (12 MoveMore; 16 UC); 12 moved from the CH. Staff informant/proxy data collection for participants was >80%; data collection from participants was <75%; at 9 months, 65.6% of residents provided valid accelerometer data; two CHs fully, two partially and one failed to implement the intervention. There were no safety concerns. Recruiting CHs and residents was feasible. Intervention implementation and data collection methods need refinement before a definitive trial. There were no safety concerns.

Background Delirium is a distressing, common and serious condition in older people in hospital. Evidence suggests that it could be prevented in about one-third of patients using multicomponent interventions targeting delirium risk factors, but these interventions are not yet routinely available in the NHS. Objective The objective was to improve delirium prevention for older people admitted to the NHS. Design Project 1 comprised case studies employing qualitative methods (observation, interviews, workshops) in three NHS hospitals to develop the Prevention of Delirium system of care. Project 2 comprised case studies using mixed methods in five NHS hospitals to test the Prevention of Delirium implementation, feasibility and acceptability, and to modify the Prevention of Delirium system of care. Project 3 comprised a multicentre, cluster randomised, controlled, pragmatic feasibility study in eight hospitals, with embedded economic evaluation, to investigate the potential clinical effectiveness and cost-effectiveness of the Prevention of Delirium system of care, compared with standard care, among older patients admitted to hospital for emergency care. The primary objectives related to gathering information to design a definitive trial. Criteria for progression to a definitive trial were as follows: a minimum of six wards (75%) completing the Prevention of Delirium manual milestone checklist and an overall recruitment rate of at least 10% of the potential recruitment pool. Setting This study was set in NHS general hospitals. Participants In project 1, participants were staff, volunteers, and patient and carer representatives. In project 2, participants were staff, volunteers, patients and carers. In project 3, participants were older patients admitted to elderly care and orthopaedic trauma wards. Intervention The developed intervention (i.e. the Prevention of Delirium system of care). Main outcome measures For the feasibility study (project 3), the primary outcome measure was the Confusion Assessment Method. The secondary outcome measures were the Nottingham Extended Activities of Daily Living scale, the Clinical Anxiety Scale and the Geriatric Depression Scale Short Form. Results Project 1: understanding of delirium prevention was poor. Drawing on evidence, and working with ward teams, we developed the Prevention of Delirium system of care, which targeted 10 delirium risk factors. This multicomponent intervention incorporated systems and mechanisms to introduce and embed delirium prevention into routine ward practices. Project 2: five out of six wards implemented or partially implemented the Prevention of Delirium intervention. A prominent role for hospital volunteers was intended, but most wards were unable to recruit or sustain the numbers needed. We identified four conditions necessary to implement and deliver the Prevention of Delirium intervention: (1) commitment of senior nurse, (2) a named person to drive implementation forward, (3) dedicated time (1 day per week) of an experienced nurse to lead implementation and (4) adequate ward staffing levels. Overall, the intervention was acceptable to staff, volunteers, patients and carers, and did not increase nursing staff workload. In the light of these findings, the Prevention of Delirium system of care was modified for use in project 3. Project 3: 16 wards in eight hospitals (two wards per hospital) were recruited. Out of 4449 patients screened, 3274 (73.6%) were eligible and 713 were registered, resulting in a recruitment rate of 16.0%. Thirty-three (4.6%) participants withdrew. The screened and registered participants were similar, but some between-treatment group imbalances were noted among those registered to the trial. All eight wards allocated to the intervention group completed the Prevention of Delirium manual milestone checklist and delivered the Prevention of Delirium intervention (median time 18.6 weeks for implementation). Overall, fidelity to the intervention was assessed as being high in two wards, medium in five wards and low in one ward. Of the expected 5645 Confusion Assessment Method delirium assessments, 5065 (89.7%) were completed during the first 10 days of admission. The rates of return of the patient-reported questionnaire booklets were 98.0% at baseline, 81.8% at 30 days and 70.5% at 3 months. The return rate of the EuroQol-5 Dimensions questionnaire was 98.6% at baseline, 77.5% at 1 month and 65.3% at 3 months (94–98% fully completed). The completion rate of the resource use questionnaire was lower (48.7%). The number of people with new-onset delirium at 10 days was 24 (7.0%) in the Prevention of Delirium group and 33 (8.9%) in the control group. Multilevel logistic regression analysis showed that participants in the Prevention of Delirium group had non-significant lower odds of developing delirium (odds ratio 0.68, 95% confidence interval 0.37 to 1.26; p = 0.2225). The average cost of the Prevention of Delirium intervention was estimated as £10.98 per patient and the mean costs for the Prevention of Delirium and usual-care groups were £5332 and £4412, respectively, with negligible between-group differences in quality-adjusted life-years. There was conflicting evidence from the trial- and model-based analyses relating to the cost-effectiveness of the Prevention of Delirium intervention. Given this, and in view of issues with the data (e.g. high levels of missingness), the results from the economic evaluation are highly uncertain. The criteria for continuation to a future definitive randomised controlled trial were met. Such a trial would need to recruit 5200 patients in 26 hospital clusters (200 patients per cluster). Conclusions The Prevention of Delirium system of care was successfully developed, and a multicentre feasibility study showed that the intervention is capable of implementation and delivery in routine care, with acceptable intervention fidelity and preliminary estimate of...

Objective: to provide a preliminary estimate of the effectiveness of the prevention of delirium (POD) system of care in reducing incident delirium in acute hospital wards and gather data for a future definitive randomised controlled trial. Design: cluster randomised and controlled feasibility trial. Setting: sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales. Participants: patients 65 years and over admitted to participating wards during the trial period. Interventions: participating wards were randomly assigned to either the POD programme or usual care, determined by existing local policies and practices. The POD programme is a manualised multicomponent delirium prevention intervention that targets 10 risk factors for delirium. The intervention wards underwent a 6-month implementation period before trial recruitment commenced. Main outcome measure incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10 days post consent. Results: out of 4449, 3274 patients admitted to the wards were eligible. In total, 714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew. Adherence to the intervention was classified as at least medium for seven wards. Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37–1.26); P = 0.2225). Conclusions: based on these findings, a definitive trial is achievable and would need to recruit 5220 patients in 26 two-ward hospital clusters. Trial registration: ISRCTN01187372. Registered 13 March 2014.

Background: Delirium is a frequent complication of hospital admission among older people. Multicomponent interventions which can reduce incident delirium by ≈one-third are recommended by the National Institute of Health and Care Excellence. Currently, a standardised delirium prevention system of care suitable for adoption in the UK National Health Service does not exist. The Prevention of Delirium (POD) system of care is a theory informed, multicomponent intervention and systematic implementation process which includes a role for hospital volunteers. We report POD implementation and delivery processes in NHS hospital wards, as part of a feasibility study. Methods: A comparative case study design and participatory, multi-method evaluation was performed with sequential six month preparatory and six month delivery stages. Six wards in five hospitals in Northern England were recruited. Methods included: facilitated workshops; observation of POD preparatory activities; qualitative interviews with staff; collection of ward organisational and patient profiles; and structured observation of staff workload. Results: POD implementation and delivery was fully accomplished in four wards. On these wards, implementation strategies informed by Normalization Process Theory operated synergistically and cumulatively. An interactive staff training programme on delirium and practices that might prevent it among those at risk, facilitated purposeful POD engagement. Observation of practice juxtaposed to action on delirium preventive interventions created tension for change, legitimating new ways of organising work around it. Establishing systems, processes and documentation to make POD workable in the ward setting, enhanced staff ownership. ‘Negotiated experimentation’ to involve staff in creating, appraising and modifying systems and practices, helped integrate the POD care system in ward routines. Activating these change mechanisms required a particular form of leadership: pro-active ‘steer’, and senior ward ‘facilitator’ to extend ‘reach’ to the staff group. Organisational discontinuity (i.e. ward re-location and re-modelling) disrupted and extended POD implementation; staff shortages adversely affected staff capacity to invest in POD. Findings resulted in the development of ‘site readiness’ criteria without which implementation of this complex intervention was unlikely to occur. Conclusions: POD implementation and delivery is feasible in NHS wards, but a necessary context for success is ‘site readiness.’

Delirium occurs commonly in older adults and is associated with adverse outcomes. Multicentre clinical trials evaluating interventions to prevent delirium are needed. The Confusion Assessment Method (CAM) is a validated instrument for delirium detection. We hypothesised it would be possible for a large feasibility study to train a large number of research assistants, with varying experience levels, to conduct CAM assessments reliably in multiple hospital sites. A standardised training programme was followed, incorporating structured training at a central location and at study sites. CAM practice sessions on both delirious and non-delirious patients by research assistants were conducted and, thereafter, there was ongoing inter-rater reliability assessment on the CAM between research assistant pairs at study sites. The setting was eight acute care hospitals in England and Wales. Participants were research assistants working on a multicentre feasibility study of delirium prevention. The measurement used was the Confusion Assessment Method. Thirty-seven research assistants were trained in CAM assessment and 33 returned training logs. The logs showed there was 100% overall agreement between research assistant pairs on 295 CAM assessments, of which 263 (89.2%) were negative for delirium and 32 (10.8%) were positive. In the course of the feasibility study, research assistants successfully completed 5065 (89.7%) of the 5645 expected CAM assessments, with minimal missing data. Using the training methods described in this study, it is possible to achieve high quality delirium assessments for large numbers of patients with little missing data across geographically dispersed sites in multicentre studies. The standardisation of multisite delirium assessments is an important contribution to research methodology, and provides a much-needed advance for the field. ISRCT ISRCTN01187372 . Registered 13 March 2014.

There are more than a quarter of a million individuals aged ≥ 65 years who are resident in care homes in England and Wales. Care home residents have high levels of cognitive impairment, physical disability, multimorbidity and polypharmacy. Research is needed to ensure there are robust, evidence-based interventions to improve the quality of life of this frail group. However, there is a paucity of research studies in this area. Recruiting care homes and their residents to research is challenging. A feasibility, cluster randomised controlled trial was undertaken as part of a research programme to identify ways to develop and test methods to enhance the physical activity of care home residents. This paper describes two methods of recruiting care homes to the trial and draws out learning to inform future studies. Eligible care homes met the following criteria: they were within a defined geographical area in the north of England; provided residential care for adults ≥ 65 years of age; had not previously been involved in the research programme; were not taking part in a conflicting study; were not recorded on the Care Quality Commission website as ‘inadequate’ or ‘requiring improvements’ in any area; and had ≥ 10 beds. Care homes were identified by a ‘systematic approach’ using the Care Quality Commission website database of care homes or a ‘targeted approach’ via a network of research-ready care homes. A standardised method was used to recruit care homes including eligibility screening; invitation letters; telephone contact; visits; formal letter of agreement. In the systematic approach, 377 care homes were screened, 230 (61%) were initially eligible and invited to participate, 11 were recruited (recruitment rate (RR) 4.8%). In the targeted approach, 15 care homes were invited to participate, two were recruited (RR 13.3%). Overall, 245 care homes were approached and 13 recruited (RR 5.3%). A variety of care homes were recruited to the trial in terms of size, location, ownership and care provision. Systematic recruitment of care homes to the study was time-consuming and resource-heavy but led to a variety of care homes being recruited. The targeted approach led to a higher recruitment rate. ISRCTN registry, ISRCTN16076575 . Registered on 25 June 2015.