A four-stage process for intervention description and guide development of a practice-based intervention: refining the Namaste Care intervention implementation specification for people with advanced dementia prior to a feasibility cluster randomised trial.

BACKGROUND: Some interventions are developed from practice, and implemented before evidence of effect is determined, or the intervention is fully specified. An example is Namaste Care, a multi-component intervention for people with advanced dementia, delivered in care home, community, hospital and hospice settings. This paper describes the development of an intervention description, guide and training package to support implementation of Namaste Care within the context of a feasibility trial. This allows fidelity to be determined within the trial, and for intervention users to understand how similar their implementation is to that which was studied. METHODS: A four-stage approach: a) Collating existing intervention materials and drawing from programme theory developed from a realist review to draft an intervention description. b) Exploring readability, comprehensibility and utility with staff who had not experienced Namaste Care. c) Using modified nominal group techniques with those with Namaste Care experience to refine and prioritise the intervention implementation materials. d) Final refinement with a patient and public involvement panel. RESULTS: Eighteen nursing care home staff, one carer, one volunteer and five members of our public involvement panel were involved across the study steps. A 16-page A4 booklet was designed, with flow charts, graphics and colour coded information to ease navigation through the document. This was supplemented by infographics, and a training package. The guide describes the boundaries of the intervention and how to implement it, whilst retaining the flexible spirit of the Namaste Care intervention. CONCLUSIONS: There is little attention paid to how best to specify complex interventions that have already been organically implemented in practice. This four-stage process may have utility for context specific adaptation or description of existing, but untested, interventions. A robust, agreed, intervention and implementation description should enable a high-quality future trial. If an effect is determined, flexible practice implementation should be enabled through having a clear, evidence-based guide.

Predictors of functional outcome in non-operatively managed Achilles tendon ruptures.

BACKGROUND: Acute Achilles tendon (AT) rupture management remains debatable but non-operative functional regimes are beginning to gain popularity. The aim of this study was to identify predictors of functional outcome in patients with AT ruptures treated non-operatively with an immediate weight bearing functional regime in an orthosis. METHODS: Analysis of prospectively gathered data from a local database of all patients treated non-operatively at our institution with an AT rupture was performed. For inclusion in the study patients required a completed Achilles Tendon Rupture Score (ATRS) at a minimum of 6 months post injury. The ATRS score was correlated against age, gender, time following rupture, duration (8 or 11 weeks) of treatment in a functional orthoses and complications were recorded. RESULTS: 236 patients of average age 49.5 years were included. The mean ATRS on completion of rehabilitation was 74 points. The mean ATRS was significantly lower in the 37 females (65.8) as compared to the 199 males (75.6) (p=0.013). Age inversely affected ATRS with a Pearsons correlation of -0.2. There was no significant difference in the ATRS score when comparing the two different treatment regime durations. There were 12 episodes of VTE and 4 episodes of re-rupture. The ATRS does not change significantly after 6 months following rupture treatment completion. CONCLUSION: Patients with AT ruptures treated non-operatively with a functional rehabilitation regime demonstrate comparable function to other non-surgical regimes with low re-rupture rates. Increasing age and female gender demonstrate inferior functional outcomes. CLINICAL RELEVANCE: Females and increasing age predict poorer functional outcome in acute Achilles tendon ruptures managed in a dynamic full-weight bearing treatment regime.

A group intervention to improve quality of life for people with advanced dementia living in care homes: the Namaste feasibility cluster RCT.

BACKGROUND: People with advanced dementia who live and die in nursing homes experience variable quality of life, care and dying. There is a need to identify appropriate, cost-effective interventions that facilitate high-quality end-of-life care provision. OBJECTIVES: To establish the feasibility and acceptability to staff and family of conducting a cluster randomised controlled trial of the Namaste Care intervention for people with advanced dementia in nursing homes. DESIGN: The study had three phases: (1) realist review and (2) intervention refinement to inform the design of (3) a feasibility cluster randomised controlled trial with a process evaluation and economic analysis. Clusters (nursing homes) were randomised in a 3 : 1 ratio to intervention or control (usual care). The nature of the intervention meant that blinding was not possible. SETTING: Nursing homes in England providing care for people with dementia. PARTICIPANTS: Residents with advanced dementia (assessed as having a Functional Assessment Staging Test score of 6 or 7), their informal carers and nursing home staff. INTERVENTION: Namaste Care is a complex group intervention that provides structured personalised care in a dedicated space, focusing on enhancements to the physical environment, comfort management and sensory engagement. MAIN OUTCOME MEASURES: The two contender primary outcome measures were Comfort Assessment in Dying - End of Life Care in Dementia for quality of dying (dementia) and Quality of Life in Late Stage Dementia for quality of life. The secondary outcomes were as follows: person with dementia, sleep/activity (actigraphy), neuropsychiatric symptoms, agitation and pain; informal carers, satisfaction with care at the end of life; staff members, person-centred care assessment, satisfaction with care at the end of life and readiness for change; and other data - health economic outcomes, medication/service use and intervention activity. RESULTS: Phase 1 (realist review; 86 papers) identified that a key intervention component was the activities enabling the development of moments of connection. In phase 2, refinement of the intervention enabled the production of a user-friendly 16-page A4 booklet. In phase 3, eight nursing homes were recruited. Two homes withdrew before the intervention commenced; four intervention and two control homes completed the study. Residents with advanced dementia (n = 32) were recruited in intervention (n = 18) and control (n = 14) homes. Informal carers (total, n = 12: intervention, n = 5; control, n = 7) and 97 staff from eight sites (intervention, n = 75; control, n = 22) were recruited over a 6-month period. Recruitment is feasible. Completion rates of the primary outcome questionnaires were high at baseline (100%) and at 4 weeks (96.8%). The Quality of Life in Late Stage Dementia was more responsive to change over 24 weeks. Even where economic data were missing, these could be collected in a full trial. The intervention was acceptable; the dose varied depending on the staffing and physical environment of each care home. Staff and informal carers reported changes for the person with dementia in two ways: increased social engagement and greater calm. No adverse events related to the intervention were reported. CONCLUSIONS: A subsequent definitive trial is feasible if there are amendments to the recruitment process, outcome measure choice and intervention specification. FUTURE WORK: In a full trial, consideration is needed of the appropriate outcome measure that is sensitive to different participant responses, and of clear implementation principles for this person-centred intervention in a nursing home context. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14948133. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 6. See the NIHR Journals Library website for further project information.

Namaste Care is a programme of respectful stimulation for nursing home residents who have advanced dementia. It is person-focused and reflects residents' individual likes and interests. It is claimed that Namaste Care improves quality of life for residents, family and staff, and quality of dying for residents, and can be provided without additional cost. This study explored how feasible it would be to conduct a large study in the future to understand the effects of Namaste Care on people with advanced dementia. Our literature review showed that Namaste Care enables people with advanced dementia to have moments of connection with others. We refined some Namaste Care resources through working with care home staff, family and volunteers to create a user-friendly booklet. Eight care homes were recruited to our 6-month trial; four homes were supported to introduce Namaste Care, two continued as usual and two withdrew. In the four intervention homes, residents with advanced dementia received Namaste Care. Staff used standard measures to assess (1) residents' responses and (2) the economic costs and benefits of Namaste Care. Researchers made observation visits. Records of activity in Namaste Care sessions were completed, and interviews were held with staff and family. Residents wore an ActiGraph (Activinsights Ltd, Kimbolton, UK) device that recorded their levels of sleep and activity. The length and frequency of Namaste Care sessions varied. Nursing homes incurred additional costs but could see ways to reduce those. All residents accepted wearing an ActiGraph device. Staff completed the data collection tools; some measures were more informative than others. Data from interviews showed that most people had positive experiences of Namaste Care. The findings support the view that Namaste Care has benefits for people with advanced dementia in nursing homes. We consider that, with some changes, this trial offers a model for a large study to show whether or not Namaste Care could be promoted more widely.

Non-operative functional treatment for acute Achilles tendon ruptures: The Leicester Achilles Management Protocol (LAMP).

OBJECTIVES: The purpose of this study is to present outcomes and objective measures of assessment for acute Achilles tendon (AT) ruptures treated with an eight-week functional dynamic treatment protocol in a VACOped® boot with immediate full weight bearing mobilisation, the Leicester Achilles Management Protocol (LAMP). METHODS: A prospective study of all patients treated with the LAMP with minimum 12-month follow-up was performed. Patients completed the Achilles Tendon Rupture Score (ATRS) and in the latter part of the study, objective measures of the calf muscle girth and heel raise height were obtained. RESULTS: 442 patients were treated with the LAMP. There were nine (2%) re-ruptures in the 442 non-operative treated group of patients throughout the study period. ATRS at twelve months or more were available in 234 patients and objective measures in 77 patients. The mean age was 50 years. The mean ATRS was 75.5 at an average of 23 months post injury. Men had a statistically significant higher ATRS score when compared to women (p < 0.05). There was statistically significant difference in the calf muscle girth and the heel raise height when compared to the uninjured side at 12-months post-injury (p < 0.05). These differences did not correlate with the ATRS (p > 0.05). CONCLUSIONS: The LAMP is a simple yet effective regime for the non-operative treatment of acute AT ruptures, which can be universally adopted without the need for many resources. Compared to other studies, the overall time in the boot is less with low complication rates and similar patient reported outcomes.

Namaste Care in nursing care homes for people with advanced dementia: protocol for a feasibility randomised controlled trial.

INTRODUCTION: Many people living with advanced dementia live and die in nursing care homes. The quality of life, care and dying experienced by these people is variable. Namaste Care is a multisensory programme of care developed for people with advanced dementia. While there is emerging evidence that Namaste Care may be beneficial for people with dementia, there is a need to conduct a feasibility study to establish the optimum way of delivering this complex intervention and whether benefits can be demonstrated in end-of-life care, for individuals and service delivery. The aim of the study is to ascertain the feasibility of conducting a full trial of the Namaste Care intervention. METHODS AND ANALYSIS: A feasibility study, comprising a parallel, two-arm, multicentre cluster controlled randomised trial with embedded process and economic evaluation. Nursing care homes (total of eight) who deliver care to those with advanced dementia will be randomly allocated to intervention (delivered at nursing care home level) or control. Three participant groups will be recruited: residents with advanced dementia, informal carers of a participating resident and nursing care home staff. Data will be collected for 6 months. Feasibility objectives concern the recruitment and sampling of nursing homes, residents, informal carers and staff; the selection and timing of primary (quality of dying and quality of life) and secondary clinical outcome measures (person centredness, symptom presence, agitation, quality of life, resource use and costs and residents' activity monitored using actigraphy). Acceptability, fidelity and sustainability of the intervention will be assessed using semistructured interviews with staff and informal carers. ETHICS AND DISSEMINATION: This protocol has been approved by NHS Wales Research Ethics Committee 5 (ref: 17/WA0378). Dissemination plans include working with a public involvement panel, through a website (http://www.namastetrial.org.uk), social media, academic and practice conferences and via peer reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN14948133; Pre-results.