Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial

Background: Unplanned hospital presentations may occur post-stroke due to inadequate preparation for transitioning from hospital to home. The Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) trial was designed to test the effectiveness of receiving a 12-week, self-management intervention, comprising personalised goal setting with a clinician and aligned educational/motivational electronic messages. Primary outcome is as follows: self-reported unplanned hospital presentations (emergency department/admission) within 90-day post-randomisation. We present the statistical analysis plan for this trial. Methods/design: Participants are randomised 1:1 in variable block sizes, with stratification balancing by age and level of baseline disability. The sample size was 890 participants, calculated to detect a 10% absolute reduction in the proportion of participants reporting unplanned hospital presentations/admissions, with 80% power and 5% significance level (two sided). Recruitment will end in December 2023 when funding is expended, and the sample size achieved will be used. Logistic regression, adjusted for the stratification variables, will be used to determine the effectiveness of the intervention on the primary outcome. Secondary outcomes will be evaluated using appropriate regression models. The primary outcome analysis will be based on intention to treat. A p-value ≤ 0.05 will indicate statistical significance. An independent Data Safety and Monitoring Committee has routinely reviewed the progress and safety of the trial. Conclusions: This statistical analysis plan ensures transparency in reporting the trial outcomes. ReCAPS trial will provide novel evidence on the effectiveness of a digital health support package post-stroke. Trial registration: ClinicalTrials.gov ACTRN12618001468213. Registered on August 31, 2018. SAP version 1.13 (October 12 2023) Protocol version 1.12 (October 12, 2022) SAP revisions Ni

Acute stroke patients not meeting their nutrition requirements: investigating nutrition within the enriched environment

Background & aims: Malnutrition is common after stroke. We investigated the impact of environmental enrichment strategies on dietary intake and rates of malnutrition in an acute stroke unit. Methods: We performed a before-after study. In standard care, meals were delivered to participants’ rooms whilst in the enriched environment, communal meals with assistance were offered and nutritional intake reminders were placed at the patient bedside. Nutrition supplementation was provided to both groups if indicated. Breakfast and lunch meals were directly observed while remaining intake was calculated using food charts. Nutrition requirements were calculated for energy (ratio method), protein (1 g/kg) and proportion of requirements met. Malnutrition was assessed using the Subjective Global Assessment and body weight. ANCOVA adjusting for stroke severity was used to determine between group differences. Stepwise multivariable logistic regression was performed to assess predictors of nutritional outcomes, adjusting for intervention group, demographic, clinical and baseline nutritional factors. Results: Neither standard care (n = 30, age 76.0yrs ± SD12.8) nor enriched environment (n = 30, age 76.7yrs ± SD12.1, p = 0.84) met daily requirements for energy (70.7% ± SD16.8 vs. 70.7% ± SD17.3, p = 0.94) or protein intake (73.2% ± SD18.6 vs. 69.8% ± SD17.3, p = 0.70). Mean body weight dropped: standard care 0.92 kg ± SD2.47 vs. enriched 0.64 kg ± SD3.12 (p = 0.53) and malnutrition increased: standard care 3.3%–26.6% vs. enriched 6.6%–13.3% (p = 0.07). Predictors of malnutrition on discharge in logistic regression models were: length of stay (p < 0.01) and protein (p < 0.01) or energy intake (p = 0.02). Conclusions: Acute stroke patients were not meeting nutritional requirements and losing body weight. The enriched environment showed no effect on nutritional intake. Malnutrition was associated with lower energy and protein intakes and increased length of stay

The impact of environmental enrichment in an acute stroke unit on how and when patients undertake activities

Objectives: To explore the effect of environmental enrichment within an acute stroke unit on how and when patients undertake activities, and the amount of staff assistance provided, compared with a control environment (no enrichment). Design: This is a substudy of a controlled before-after observational study. Setting: The study was conducted in an Australian acute stroke unit. Participants: The study included stroke patients admitted to (1) control and (2) environmental enrichment period. Intervention: The control group received standard therapy and nursing care, which was delivered one-on-one in the participants' bedroom or a communal gym. The enriched group received stimulating resources and communal areas for mealtimes, socializing and group activities. Furthermore, participants and families were encouraged to increase patient activity outside therapy hours. Main measures: Behavioral mapping was performed every 10 minutes between 7.30 a.m. and 7.30 p.m. on weekdays and weekends to estimate activity levels. We compared activity levels during specified time periods, nature of activities observed and amount of staff assistance provided during patient activities across both groups. Results: Higher activity levels in the enriched group (n = 30, mean age 76.7 +/- 12.1) occurred during periods of scheduled communal activity (P < 0.001), weekday non-scheduled activity (P = 0.007) and weekends (P = 0.018) when compared to the control group (n = 30, mean age 76.0 +/- 12.8), but no differences were observed on weekdays after 5 p.m. (P = 0.324). The enriched group spent more time on upper limb (P < 0.001), communal socializing (P < 0.001), listening (P = 0.007) and iPad activities (P = 0.002). No difference in total staff assistance during activities was observed (P = 0.055). Conclusion: Communal activities and environmental resources were important contributors to greater activity within the enriched acute stroke unit

Qualitative investigation of the perceptions and experiences of nursing and allied health professionals involved in the implementation of an enriched environment in an Australian acute stroke unit

An enriched environment embedded in an acute stroke unit can increase activity levels of patients who had stroke, with changes sustained 6 months post-implementation. The objective of this study was to understand perceptions and experiences of nursing and allied health professionals involved in implementing an enriched environment in an acute stroke unit.A descriptive qualitative approach.An acute stroke unit in a regional Australian hospital.We purposively recruited three allied health and seven nursing professionals involved in the delivery of the enriched environment. Face-to-face, semistructured interviews were conducted 8 weeks post-completion of the enriched environment study. One independent researcher completed all interviews. Voice-recorded interviews were transcribed verbatim and analysed by three researchers using a thematic approach to identify main themes.Three themes were identified. First, staff perceived that 'the road to recovery had started' for patients. An enriched environment was described to shift the focus to recovery in the acute setting, which was experienced through increased patient activity, greater psychological well-being and empowering patients and families. Second, 'it takes a team' to successfully create an enriched environment. Integral to building the team were positive interdisciplinary team dynamics and education. The impact of the enriched environment on workload was diversely experienced by staff. Third, 'keeping it going' was perceived to be challenging. Staff reflected that changing work routines was difficult. Contextual factors such as a supportive physical environment and variety in individual enrichment opportunities were indicated to enhance implementation. Key to sustaining change was consistency in staff and use of change management strategies.Investigating staff perceptions and experiences of an enrichment model in an acute stroke unit highlighted the need for effective teamwork. To facilitate staff in their new work practice, careful selection of change management strategies are critical to support clinical translation of an enriched environment.ANZCTN12614000679684; Results

Assessment and selection for rehabilitation following acute stroke: a prospective cohort study in Queensland, Australia

To describe current practice and investigate factors associated with selection for rehabilitation following acute stroke.Prospective observational cohort study.Seven public hospitals in Queensland, Australia.Consecutive patients surviving acute stroke.Rehabilitation selection processes are assessment for rehabilitation needs, referral for rehabilitation and receipt of rehabilitation. Functional impairment following stroke is modified Rankin Scale (mRS).We recruited 504 patients, median age 73 years (interquartile range (IQR) = 62-82), between July 2016 and January 2017. Of these, 90% (454/504) were assessed for rehabilitation needs, 76% (381/504) referred for rehabilitation, and 72% (363/504) received any rehabilitation. There was significant variation in all rehabilitation selection processes across sites ( P

Dose and setting of rehabilitation received after stroke in Queensland, Australia: a prospective cohort study

The aims of this study were to describe patterns and dose of rehabilitation received following stroke and to investigate their relationship with outcomes.This was a prospective observational cohort study.A total of seven public hospitals and all subsequent rehabilitation services in Queensland, Australia, participated in the study.Participants were consecutive patients surviving acute stroke between July 2016 and January 2017.We tracked rehabilitation for six months following stroke and obtained 90- to 180-day outcomes from the Australian Stroke Clinical Registry.Dose of rehabilitation - time in therapy by physiotherapy, occupational therapy and speech pathology; modified Rankin Scale (mRS)- premorbid, acute care discharge and 90- to 180-day follow-up.We recruited 504 patients, of whom 337 (median age = 73 years, 41% female) received 643 episodes of rehabilitation in 83 different services. Initial rehabilitation was predominantly inpatient (260/337, 77%) versus community-based (77/337, 21%). Therapy time was greater within inpatient services (median = 29 hours) compared to community-based (6 hours) or transition care (16 hours). Median (Quartile 1, Quartile 3) six-month cumulative therapy time was 73 hours (40, 130) when rehabilitation commenced in stroke units and continued in inpatient rehabilitation units; 43 hours (23, 78) when commenced in inpatient rehabilitation units; and 5 hours (2, 9) with only community rehabilitation. In 317 of 504 (63%) with follow-up data, improvement in mRS was most likely with inpatient rehabilitation (OR = 3.6, 95% CI = 1.7-7.7), lower with community rehabilitation (OR = 1.6, 95% CI = 0.7-3.8) compared to no rehabilitation, after adjustment for baseline factors.Amount of therapy varied widely between rehabilitation pathways. Amount of therapy and chance of improvement in function were highest with inpatient rehabilitation

Embedding an enriched environment in an acute stroke unit increases activity in people with stroke: a controlled before-after pilot study

Objectives: To determine whether an enriched environment embedded in an acute stroke unit could increase activity levels in acute stroke patients and reduce adverse events