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Korean Model for Post-acute Comprehensive rehabilitation (KOMPACT): The Study Protocol for a Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge.

ABSTRACT: Introduction: Early supported discharge (ESD) is a transitional care model aimed at facilitating post-acute stroke patients' discharge to home. Previous studies have demonstrated that ESD provides equivalent patient and caregiver outcomes with superior cost-effectiveness compared to conventional rehabilitation (CR). This study intends to examine the feasibility of ESD in Korea. Methods and Analysis: This study is designed as a multicenter assessor-blinded, randomized controlled trial. Ninety post-acute stroke patients with mild to moderate disability (modified Rankin Scale 1-3) will be recruited from three university hospitals (30 patients per hospital) in Korea and allocated to either the ESD group or the CR group in a 1:1 ratio. Patients in the ESD group will receive individualized discharge planning and goal setting, a 4-week home-based rehabilitation program, and liaison service to community-based resources by a multidisciplinary team. Patients in the CR group will receive rehabilitation practices according to their current hospital policy. Outcomes: The primary outcome is the Korean version of the modified Barthel Index, and the primary endpoint was post-onset 3 months. Clinical outcomes, patient/caregiver reported outcomes, and socioeconomic outcomes will be measured at baseline, 1 month after discharge, 2 months after discharge, and 3 months after onset. Discussion: The efficacy and cost-effectiveness of ESD can vary according to the healthcare system and sociocultural aspects. To establish ESD as an alternative transitional care model for post-acute stroke patients in Korea, its feasibility needs to be examined in prior. This study will add evidence on the applicability of ESD in Korea. Ethical Considerations: The study protocol was reviewed and approved by the Institutional Review Board of Seoul National University Bundang Hospital (IRB number B-2012/654-308). The study protocol was registered at ClinicalTrials.gov (Identifier NCT04720820). Disseminations will include submission to peer-reviewed journals and presentations at conferences.

SUBMITTER: Chang WK

PROVIDER: S-EPMC8455937 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundGeriatric rehabilitation aims to maintain the functional reserves of older adults in order to optimize social participation and prevent disability. After discharge from inpatient geriatric rehabilitation, patients are at high risk for decreased physical capacity, increased vulnerability, and limitations in mobility. As a result, ageing in place becomes uncertain for a plethora of patients after discharge from geriatric rehabilitation and effective strategies to prevent physical decline are required. Collaboration between different health-care providers is essential to improve continuity of care after discharge from inpatient geriatric rehabilitation. The aim of this study is to evaluate the effectiveness of a multi-professional home-based intervention program (GeRas) to improve functional capacity and social participation in older persons after discharge from inpatient geriatric rehabilitation.MethodsThe study is a multicenter, three-arm, randomized controlled trial with a three-month intervention period. Two hundred and seventy community-dwelling older people receiving inpatient geriatric rehabilitation will be randomized with a 1:1:1 ratio to one of the parallel intervention groups (conventional IG or tablet IG) or the control group (CG). The participants of both IGs will receive a home-based physical exercise program supervised by physical therapists, a nutritional recommendation by a physician, and social counseling by social workers of the health insurance company. The collaboration between the health-care providers and management of participants will be realized within a cloud environment based on a telemedicine platform and supported by multi-professional case conferences. The CG will receive usual care, two short handouts on general health-related topics, and facultative lifestyle counseling with general recommendations for a healthy diet and active ageing. The primary outcomes will be the physical capacity measured by the Short Physical Performance Battery and social participation assessed by the modified Reintegration to Normal Living Index, three months after discharge.DiscussionThe GeRas program is designed to improve the collaboration between health-care providers in the transition from inpatient geriatric rehabilitation to outpatient settings. Compared to usual care, it is expected to improve physical capacity and participation in geriatric patients after discharge from inpatient geriatric rehabilitation.Trial registrationGerman Clinical Trials Register (DRKS00029559). Registered on October 05, 2022.

Project description:BackgroundDelays in patient discharge can not only lead to deterioration, especially among geriatric patients, but also incorporate unnecessary resources at the hospital level. Many of these delays and their negative impact may be preventable by early focused screening to identify patients at risk for transfer to a post-acute care facility. Early interprofessional discharge planning is crucial in order to fit the appropriate individual discharge destination. While prediction of discharge to a post-acute care facility using post-acute care discharge score, the self-care index, and a combination of both has been shown in a single-center pilot study, an external validation is still missing.ObjectiveThis paper outlines the study protocol and methodology currently being used to replicate the previous pilot findings and determine whether the post-acute care discharge score, the self-care index, or the combination of both can reliably identify patients requiring transfer to post-acute care facilities.MethodsThis study will use prospective data involving all phases of the quasi-experimental study "In-HospiTOOL" conducted at 7 Swiss hospitals in urban and rural areas. During an 18-month period, consecutive adult medical patients admitted to the hospitals through the emergency department will be included. We aim to include 6000 patients based on sample size calculation. These data will enable a prospective external validation of the prediction instruments.ResultsWe expect to gain more insight into the predictive capability of the above-mentioned prediction instruments. This approach will allow us to get important information about the generalizability of the three different models. The study was approved by the institutional review board on November 21, 2016, and funded in May 2020. Expected results are planned to be published in spring 2021.ConclusionsThis study will provide evidence on prognostic properties, comparative performance, reliability of scoring, and suitability of the instruments for the screening purpose in order to be able to recommend application in clinical practice.International registered report identifier (irrid)DERR1-10.2196/21447.

Project description:IntroductionVariability in rehabilitation disposition has been proposed as a trauma center quality metric. Benchmarking rehabilitation disposition is limited by a lack of objective measures of functional impairment at discharge. The primary aim of this study was to determine the relative contribution of patient characteristics and hospitalization factors associated with inpatient and outpatient rehabilitation after discharge. The secondary aims were to evaluate the sensitivity of the Functional Status Scale (FSS) score for identifying functional impairments at hospital discharge and track post-discharge recovery.Patients and methodsWe report a planned secondary analysis of a prospective observational study of seriously injured children (<15 years old) enrolled at seven pediatric trauma centers. Functional Status Scale (FSS) score was measured for pre-injury, hospital discharge, and 6-month follow-up timepoints. Multinomial logistic regression identified factors associated with three dispositions: home without rehabilitation services, home with outpatient rehabilitation, and inpatient rehabilitation. Relative weight analysis was used to identify the impact of individual factors associated with inpatient or outpatient rehabilitation disposition.ResultsWe analyzed 427 children with serious injuries. Functional impairment at discharge was present in 103 (24.1%) children, including 43/337 (12.8%) discharged without services, 12/38 (31.6%) discharged with outpatient rehabilitation, and 44/47 (93.6%) discharged to inpatient rehabilitation. In multivariable modeling, variables most contributing to prediction of inpatient rehabilitation were severe initial Glasgow coma scale (GCS), injured body region, and functional impairment at discharge. Severe initial GCS, private insurance, and extremity injury were independently associated with disposition with outpatient rehabilitation. Patients discharged without services or with outpatient rehabilitation most frequently had motor impairments that improved during the next 6 months. Patients discharged to inpatient rehabilitation had impairments in all domains, with many improving within 6 months. A higher proportion of patients discharged to inpatient rehabilitation had residual impairments at follow-up.ConclusionInjury characteristics and discharge impairment were associated with discharge to inpatient rehabilitation. The FSS score identified impairments needing inpatient rehabilitation and characterized improvements after discharge. Less severe impairments needing outpatient rehabilitation were not identified by the FSS score.

Project description:Rehabilitation of patients with chronic obstructive pulmonary disease (COPD) is a key treatment in COPD. However, despite the existing evidence and a strong recommendation from lung associations worldwide, 50% of patients with COPD decline to participate in COPD rehabilitation program and 30-50% drop-out before completion. The main reasons are severe symptoms, inflexible accessibility and necessity for transportation. Currently there are no well-established and evident rehabilitation alternatives. Supervised online screen rehabilitation could be a useful approach to increase accessibility and compliance. The aim of this multicenter RCT study is to compare the potential benefits of a 10-week online COPD rehabilitation program (CORe) with conventional outpatient COPD rehabilitation (CCRe).This study is a randomized assessor- and statistician blinded superiority multicenter trial with two parallel groups, employing 1:1 allocation to the intervention and the comparison group.On the basis of a sample size calculation, 134 patients with severe or very severe COPD and eligible to conventional hospital based outpatient COPD rehabilitation will be included and randomized from eight different hospitals. The CORe intervention group receives group supervised resistance- and endurance training and patient education, 60 min, three times/week for 10 weeks at home via online-screen. The CCRe comparison group receives group based supervised resistance- and endurance training and patient education, 90 min, two times/week for 10 weeks (two hospitals) or 12 weeks (six hospitals) in groups at the local hospital. The primary outcome is change in the 6-min walking distance after 10/12 weeks; the secondary outcomes are changes in 30 s sit-to-stand chair test, physical activity level, symptoms, anxiety and depression symptoms, disease specific and generic quality of life. Primary endpoint is 10/12 weeks from baseline, while secondary endpoints are 22, 36, 62 weeks from baseline assessments.The study will likely contribute to knowledge regarding COPD tele-rehabilitation and to which extent it is more feasible and thereby more efficient than conventional COPD rehabilitation in patients with severe and very severe COPD.Clinicaltrials.gov Identifier: NCT02667171 . Registration data: January 28th 2016.

Project description:BackgroundCardiopulmonary resuscitation (CPR) training rates in the United States are low, highlighting the need to develop CPR educational approaches that are simpler, with broader dissemination potential. The minimum training required to ensure long-term skill retention remains poorly characterized. We compared CPR skill retention among laypersons randomized to training with video-only (VO; no manikin) with those trained with a video self-instruction kit (VSI; with manikin). We hypothesized that VO training would be noninferior to the VSI approach with respect to chest compression (CC) rate.Methods and resultsWe performed a prospective, cluster randomized trial of CPR education for family members of patients with high-risk cardiac conditions on hospital cardiac units, using a multicenter pragmatic design. Eight hospitals were randomized to offer either VO or VSI training before discharge using volunteer trainers. CPR skills were assessed 6 months post training. Mean CC rate among those trained with VO compared with those trained with VSI was assessed with a noninferiority margin set at 8 CC per min; as a secondary outcome, mean differences in CC depth were assessed. From February 2012 to May 2015, 1464 subjects were enrolled and 522 subjects completed a skills assessment. The mean CC rates were 87.7 (VO) CC per min and 89.3 (VSI) CC per min; we concluded noninferiority for VO based on a mean difference of -1.6 (90% confidence interval, -5.2 to 2.1). The mean CC depth was 40.2 mm (VO) and 45.8 mm (VSI) with a mean difference of -5.6 (95% confidence interval, -7.6 to -3.7). Results were similar after multivariate regression adjustment.ConclusionsIn this large, prospective trial of CPR skill retention, VO training yielded a noninferior difference in CC rate compared with VSI training. CC depth was greater in the VSI group. These findings suggest a potential trade-off in efforts for broad dissemination of basic CPR skills; VO training might allow for greater scalability and dissemination, but with a potential reduction in CC depth.Clinical trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT01514656.

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Korean Model for Post-acute Comprehensive rehabilitation (KOMPACT): The Study Protocol for a Pragmatic Multicenter Randomized Controlled Study on Early Supported Discharge.

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