Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062404) titled 'Development and Evaluation of a "Three-Layer Governance" Implementation Strategy to Overcome Workforce Juniorization Risk in Subacute Rehabilitation Organizations: A Multicenter Prospective-Retrospective Hybrid Cohort Study' on July 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)
Condition:
Condition - All conditions for which patients may be admitted to the post-acute rehabilitation ward
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To overcome the organizational risks associated with the trend towards younger staff in convalescent rehabilitation wards, we will develop a 'three-tier governance' model that integrates AI-powered movement analysis training (Hard), organizational coordination (Soft), and the fostering of psychological safety (Heart). The aim of this study is to verify, using a multi-centre difference-in-differences (DiD) analysis, the effects of this model on the standardization of therapists' skills, the reduction of staff's physical and mental workload, improvements in ward performance indicators (FIM gain and reduction in length of stay), and the reduction of staff turnover.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - [Intervention Group: Hanabatake Hospital]
Duration: Continuous implementation for 12 months starting July 2026.
Content: Introduction of a 'three-tier governance' model.
1. Hard (As needed): Transfer technique feedback using AI video analysis (VP-Ergono) and introduction of KAFO clinical protocols.
2. Soft (Weekly): Integration of clinical reminders into existing weekly brace rounds for organizational coordination.
3. Heart (Weekly): Weekly leader-staff interviews to monitor mental workload and foster psychological safety.
Interventions/Control_2 - [Control Group: Sakurajuji Fukuoka Hospital, Sakurajuji Otemon Hospital, and Sakurajuji Shirokane Rehabilitation Hospital]
Duration: 12 months.
Content: Continuation of conventional education and management systems without the implementation of the three-tier governance model. Note: Sakurajuji Shirokane Rehabilitation Hospital will serve as a complete control group for the initial 12 months, after which it will cross over to the intervention group based on a stepped-wedge design.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - The subjects of this study must meet the following criteria:
1. Patient data: All patients admitted to the convalescent rehabilitation wards of the target facilities and billed for rehabilitation fees during the study period.
2. Staff data: All staff members (e.g., physical therapists, occupational therapists, speech-language-hearing therapists) engaged in clinical practice in the rehabilitation departments of the target facilities during the study period.
Key exclusion criteria - The exclusion criteria are as follows:
1. Data with clear missing values in key metrics required for evaluation (e.g., admission and discharge FIM scores, length of stay, staff experience years).
2. Patient data of those who could not complete the convalescent rehabilitation program due to death, acute exacerbation, or transfer to another ward/hospital.
3. Patients or staff members who explicitly opted out of having their data used for research purposes.
Target Size - 500
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 06 Month 27 Day
Date of IRB - 2026 Year 06 Month 29 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2029 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071033
Disclaimer: Curated by HT Syndication.