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Effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial protocol.

ABSTRACT: INTRODUCTION:The virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay. METHODS AND ANALYSIS:A consecutive sample of 384 stroke survivor-caregiver dyads will be recruited from four hospitals. An online platform that embraces readily accessible and reliable information will be developed. Participants randomly assigned to the intervention group will receive usual care plus the VMSCC service. The service includes access to a tablet containing 30 videos demonstrating appropriate self-care strategies, communication with a registered nurse monthly through video and telephone calls and regular blood pressure monitoring. Primary outcomes include survivors' SE in self-management and survivors' and caregivers' HRQoL. Secondary outcomes include survivors' performance of self-management behaviours, depression and social participation; and caregivers' coping strategies, satisfaction with caring and depression. Data will be collected at baseline, and at 3 and 6?months after commencing the intervention. Survivors' and caregivers' satisfaction with the service will be assessed at 6-month follow-up. Multivariable regressions and generalised estimating equations model will be conducted. Survivors' emergency admissions and length of hospital stay will be evaluated during the 6-month follow-up period. Cost-effectiveness analysis will be performed on the average total cost incurred. DISCUSSION:The results will inform stakeholders about incorporating the VMSCC service into current stroke rehabilitation service. ETHICS AND DISSEMINATION:This protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2017.660). All participants will provide written informed consent. Results will be disseminated through scientific publications, and presentations at local and international conferences. TRIAL REGISTRATION NUMBER:ChiCTR1800016101; Pre-results.

SUBMITTER: Chau JPC

PROVIDER: S-EPMC6530406 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial protocol.

Chau Janita Pak Chun JPC Lo Suzanne Hoi Shan SHS Lee Vivian Wing Yan VWY Choi Kai Chow KC Shum Edward Wai Ching EWC Hung Zevari Sheung Sheung ZSS Mok Vincent Chung Tong VCT Siow Elaine Kee Chen EKC Ching Jessica Yuet Ling JYL Lam Simon Kwun Yu SKY Yeung Jonas Hon Ming JHM Li Siu Hung SH Lau Alexander Yuk Lun AYL

BMJ open 20190510 5

<h4>Introduction</h4>The virtual multidisciplinary stroke care clinic (VMSCC) is the first nurse-led clinic developed to offer support to community-dwelling stroke survivors and caregivers, and to promote poststroke recovery. This two-arm randomised controlled trial will evaluate its effectiveness on survivors' self-efficacy (SE), survivors' and caregivers' health-related quality of life (HRQoL) and cost-effectiveness on emergency admissions and length of readmission hospital stay.<h4>Methods an ...[more]

PMID: 31079082

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Project description:BackgroundStroke survivors constantly feel helpless and unprepared after discharge from hospitals. More flexible and pragmatic support are needed for their optimized recovery. We examined the effects of a virtual multidisciplinary stroke care clinic on survivors' health and self-management outcomes.MethodsA randomized controlled trial was conducted. Survivors were recruited from 10 hospitals and randomized at 1:1 ratio into the intervention or the control groups. Intervention group participants received the Virtual Multidisciplinary Stroke Care Clinic service (monthly online consultations with a nurse, follow-up phone calls, and access to an online platform). Control group participants received the usual care. Outcomes of self-efficacy (stroke self-efficacy questionnaire; primary), self-management behaviors (Stroke Self-Management Behaviors Performance Scale), social participation (reintegration to normal living index), and depression (Geriatric Depression Scale; secondary) were measured at baseline, and 3 and 6 months after commencing the intervention (post-randomization). A generalized estimating equations model was used to compare the differential changes in outcomes at 3 and 6 months with respect to baseline between 2 groups.ResultsBetween July 2019 and June 2022, 335 eligible participants were enrolled in the study. Participants (intervention group; n=166) showed significantly greater improvements in outcomes of self-efficacy (group-by-time interaction regression coefficient, B=4.60 [95% CI, 0.16 to 9.05]), social participation (B=5.07 [95% CI, 0.61 to 9.53]), and depression (B=-2.33 [95% CI, -4.06 to -0.61]), and no significant improvement in performance of self-management behaviors (B=3.45, [95% CI, -0.87 to 7.77]), compared with the control group (n=169) right after the intervention (6 months after its commencement). Hedges' g effect sizes of the intervention on outcomes: 0.19 to 0.36.ConclusionsThe results provide some positive evidence on the usefulness of the Virtual Multidisciplinary Stroke Care Clinic service. The effect sizes are regarded as small to medium, which may not be of clinical relevance. The baseline levels in outcomes were in favor of the control group, the intervention effects might be overestimated. The service must be tested further to determine its effectiveness.RegistrationURL: https://www.chictr.org.cn; Unique identifier: ChiCTR1800016101.

Project description:IntroductionThe STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors.Methods and analysisIn a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3-5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention.Ethics and disseminationThe study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017-087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings.Trial registration numberACTRN12617000745347; Pre-results.

Project description:IntroductionStudies show that stroke survivors encounter physical and psychological limitations that restrict their participation in social and community activities. Systematic reviews have yielded inconclusive evidence regarding the effectiveness of different interventions intended to support stroke survivors' social participation. Recent advances in virtual reality technology may offer promising solutions, although the optimal approach to enhance social participation among stroke survivors is yet to be determined. This trial aims to develop and evaluate the effectiveness of a social participation-focused virtual reality (SP-VR) intervention on the physical, psychological and social outcomes of community-dwelling stroke survivors with physical disabilities.Methods and analysisA two-arm randomised, controlled, assessor-blind clinical trial will be conducted with 250 stroke survivor-caregiver dyads recruited from three acute and one rehabilitation hospitals, and three stroke nurse-led clinics. Participants will be survivors of a first or recurrent stroke within 6 months of stroke onset and able to remain in a sitting position without support, and their primary caregivers. Eligible participants will be randomly allocated to receive the SP-VR intervention or usual care which includes conventional physical therapy services. The intervention group will receive a newly developed 6-week novel custom-made SP-VR application comprising two sessions weekly. Three SP-VR modules will cover key aspects of survivors' social health needs, namely functional rehabilitation, social participation, and social interaction and recreation. The primary outcome for stroke survivors is social participation, and secondary outcomes include depressive symptoms, participation self-efficacy, physical function, functional mobility and social support. User satisfaction will be evaluated among both survivors and caregivers. Data will be collected in person at baseline, immediately after, and 3 months postintervention.Ethics and disseminationEthical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Research Ethics Committee (Ref. No.: 2019.676). Study results will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberChiCTR2100050850.

Project description:ObjectiveAdvance directives (ADs) are integral to health care, allowing patients to specify surrogate decision-makers and treatment preferences in case of loss of capacity. The present study sought to identify determinants of ADs among stroke survivors.MethodsIn this cross-sectional study (Care Attitudes and Preferences in Stroke Survivors [CAPriSS]), community-dwelling stroke survivors were surveyed on ADs; validated scales were used to query palliative care knowledge and attitudes towards life-sustaining treatments. Logistic regression was used to determine variables associated with ADs.ResultsAmong 562 community-dwelling stroke survivors who entered the survey after screening questions confirmed eligibility, 421 (74.9%) completed survey components with relevant variables of interest. The median age was 69 years (IQR 58-75 years); 53.7% were male; and 15.0% were Black. Two hundred and fifty-one (59.6%) respondents had ADs. Compared to stroke survivors without ADs, those with ADs were more likely to be older (median age 72 vs. 61 years; p<0.001), White (91.2% vs. 75.9%, p<0.001), and male (58.6% vs. 46.5%, p = 0.015), and reported higher education (p<0.001) and income (p = 0.011). Ninety-eight (23.3%) participants had "never heard of palliative care". Compared to participants without ADs, participants with ADs had higher Palliative Care Knowledge Scale (PaCKS) scores (median 10 [IQR 5-12] vs. 7 [IQR 0-11], p<0.001), and lower scores on the Attitudes Towards Life-Sustaining Treatments Scale (indicating a more negative attitude towards life-sustaining treatments; median 23 [IQR 18-28] vs. 29 [IQR 24-35], p<0.001). Multivariable logistic regression identified age (OR 1.62 per 10 year increase, 95% CI 1.30-2.02; p<0.001), prior advance care planning discussion with a physician (OR 1.73, 95% CI 1.04-2.86; p = 0.034), PaCKS scores (OR 1.06 per 1 point increase, 95% CI 1.01-1.12; p = 0.018), and Attitudes Towards Life-Sustaining Treatments Scale scores (OR 0.91 per 1 point increase, 95% CI 0.88-0.95; p<0.001) as variables independently associated with ADs.ConclusionsAge, prior advance care planning discussion with a physician, palliative care knowledge, and attitudes towards life-sustaining treatments were independently associated with ADs.

Project description:BackgroundGait impairment limiting mobility and restricting activities is common after stroke. Auditory rhythmical cueing (ARC) uses a metronome beat delivered during exercise to train stepping and early work reports gait improvements. This study aimed to establish the feasibility of a full scale multicentre randomised controlled trial to evaluate an ARC gait and balance training programme for use by stroke survivors in the home and outdoors.MethodsA parallel-group observer-blind pilot randomised controlled trial was conducted. Adults within 2 years of stroke with a gait-related mobility impairment were recruited from four NHS stroke services and randomised to an ARC gait and balance training programme (intervention) or the training programme without ARC (control). Both programmes consisted of 3x30 min sessions per week for 6 weeks undertaken at home/nearby outdoor community. One session per week was supervised and the remainder self-managed. Gait and balance performance assessments were undertaken at baseline, 6 and 10 weeks. Key trial outcomes included recruitment and retention rates, programme adherence, assessment data completeness and safety.ResultsBetween November 2018 and February 2020, 59 participants were randomised (intervention n=30, control n=29), mean recruitment rate 4/month. At baseline, 6 weeks and 10 weeks, research assessments were conducted for 59/59 (100%), 47/59 (80%) and 42/59 (71%) participants, respectively. Missing assessments were largely due to discontinuation of data collection from mid-March 2020 because of the UK COVID-19 pandemic lockdown. The proportion of participants with complete data for each individual performance assessment ranged from 100% at baseline to 68% at 10 weeks. In the intervention group, 433/540 (80%) total programme exercise sessions were undertaken, in the control group, 390/522 (75%). Falls were reported by five participants in the intervention group, six in the control group. Three serious adverse events occurred, all unrelated to the study.ConclusionWe believe that a definitive multicentre RCT to evaluate the ARC gait and balance training programme is feasible. Recruitment, programme adherence and safety were all acceptable. Although we consider that the retention rate and assessment data completeness were not sufficient for a future trial, this was largely due to the UK COVID-19 pandemic lockdown.Trial registrationISRCTN, ISRCTN10874601 , Registered on 05/03/2018.

Project description:Background: Lung cancer (LC) care is resource and cost intensive. We launched a Multidisciplinary LC Clinic (MDC), where patients with a new LC diagnosis received concurrent oncology consultation, resulting in improved time to LC assessment and treatment. Here, we evaluate the impact of MDC on health resource utilization, patient and caregiver costs, and secondary patient benefits. Methods: We retrospectively analyzed patients in a rapid assessment clinic with a new LC diagnosis pre-MDC (September 2016-February 2017) and post-MDC implementation (February 2017-December 2018). Data are reported as means; unpaired t-tests and ANOVA were used to assess for significance. We also conducted a cost analysis. Resource utilization, out-of-pocket costs, procedure-related costs, and indirect costs were evaluated from the societal perspective and presented in 2019 Canadian dollars (CAD); multi-way worst/best case and threshold sensitivity analyses were conducted. Results: We reviewed 428 patients (78 traditional model, 350 MDC). Patients in the MDC model required significantly fewer oncology visits from LC diagnosis to first LC treatment (1.62 vs. 2.68, p < 0.001), which was significant for patients with stage 1, 3, and 4 disease. Compared with the traditional model, there was no change in mean biopsies/patient (1.32 traditional vs. 1.17 MDC, p = 0.18) or staging investigations/patient (2.24 traditional vs. 2.02 MDC, p = 0.20). Post-MDC, there was an increase in invasive mediastinal staging for patients with stage 2/3 LC (15.0% vs. 60.0%, p < 0.001). Over 22 months, MDC resulted in savings of CAD 48,389 including CAD 24,167 CAD in direct patient out-of-pocket expenses. For the threshold analyses, MDC was estimated to cost CAD 25,708 per quality-adjusted life year (QALY), considered to be below current willingness to pay thresholds (at CAD 80,000 per QALY). MDC also facilitated oncology assessment for 29 non-LC patients. Conclusions: An MDC led to a reduction in patient visits and direct patient and caregiver costs.

Dataset Information

Effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial protocol.

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Effectiveness and cost-effectiveness of a virtual multidisciplinary stroke care clinic for community-dwelling stroke survivors and caregivers: a randomised controlled trial protocol.

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