Hybrid Approach to Pediatric Rehabilitation

NCT ID: NCT06547762

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-16
• Study Completion Date: 2025-12-01

Brief Summary

Children and youth recovering from acquired injuries typically receive therapy via in-patient or outpatient rehabilitation (OPR). Families from peripheral areas often face significant time and financial burdens to access treatment. Over the past decade, evidence supporting the effectiveness of remote (online) rehabilitation has increased.

Objectives: 1. Identify facilitators and barriers to hybrid service adoption. 2. Develop a hybrid telerehabilitation program for youth that is at least equivalent (non-inferior) to conventional, in-person therapy. 3. Compare hybrid rehabilitation to in-person rehabilitation at two centers in Israel in terms of: Adherence to therapy, Therapeutic alliance, Perceived quality of care (families and therapists), Functional effectiveness (measured by pre-post change in the Pediatric Evaluation of Disability Inventory, PEDI), Cost-effectiveness (including training requirements, physical space requirements, and costs); 4. Provide best practice recommendations for hybrid rehabilitation in children.

Research Methods: Focus Groups: Experts will develop a two-month hybrid program for approximately 200 children in OPR, commencing one month after in-person rehabilitation.

Evaluation Metrics: Therapy adherence, therapeutic alliance, and perceived quality of care will be assessed monthly and compared to in-person treatment. Insights will inform best practice guidelines for hybrid telerehabilitation.

Data Collection: Thematic Analysis: Analyzing focus group information. Comparative Metrics: Comparing measures of adherence, therapeutic alliance, and perceived quality of care between hybrid and in-person programs.

Difference-in-Difference Approach: Assessing functional differences between in-person and remote therapy.

Cost Analysis: Estimating direct and indirect costs per child for in-person versus remote rehabilitation.

Detailed Description

Scientific background: Children and youth recovering from acquired injuries receive therapy via in-patient or outpatient rehabilitation (OPR). Families from the periphery are required to invest time and money to get treatment. In the last decade, evidence for the effectiveness of remote (online) rehabilitation has grown. During the first four months of the COVID-19 pandemic, remote rehabilitation services were provided at Sheba and Alyn Medical Centers with demonstrated feasibility and satisfaction. Nevertheless, most rehabilitation services returned to in-person treatment. Objectives: To develop, implement and evaluate hybrid OPR for youth including a) identification of facilitators and barriers to hybrid service adoption; b) development of a hybrid telerehabilitation program for youth that is at least equivalent (non-inferior) to conventional, in-person therapy; c) compare hybrid rehabilitation to in-person rehabilitation at two rehabilitation centers in Israel in terms of (1) adherence to therapy, (2) therapeutic alliance and (3) perceived quality of care (families and therapists), (4) functional effectiveness as measured by pre-post change in the PEDI, (5) cost-effectiveness of hybrid therapy (by comparing financial versus effectiveness outcomes) in the healthcare system (hospitals, health maintenance organizations), including training requirements, physical space requirements and cost. d) provide best practice recommendations for hybrid rehabilitation in children.

Working hypotheses: 1) Carrying out research at two major rehabilitation centers will enable identification of target populations for hybrid rehabilitation programs, assessment of the required resources and provision of solutions to identified barriers; 2) families and caregivers will express positive attitudes toward hybrid rehabilitation.3) the hybrid program will be cost-effective in terms of direct and indirect costs.

Research Methods: Focus groups of experts will develop a two-month hybrid program offered to all children (~200) in OPR commencing one month after in-person rehabilitation. Therapy adherence, therapeutic alliance and perceived quality of care will be examined monthly and compared to in-person treatment. Insight will be used to formulate best practice guidelines for hybrid telerehabilitation.

Data Collection: Thematic analysis will be used to analyze focus groups information. Data on measures of adherence, therapeutic alliance and perceived quality of care will be compared between hybrid and in-person programs. A difference-in-difference approach will assess differences in function between in-person and remote therapy. Cost estimates will compare direct and indirect services per child for in-person versus remote rehabilitation.

Importance of research: This study will be among the first to examine implementation of a hybrid program as recommended by the Ministry of Health (MOH) 'Remote Medicine' (6/2019, section 4.4). Utilizing the demonstrated benefits and infrastructure developed for remote rehabilitation during Corona pandemic , this research will help to uphold a basic principle in the State Health Insurance Law - ensuring accessible and quality health services throughout the country.

Possible recommendations for policy makers: Best practices for hybrid rehabilitation programs will enable policy makers to make quality rehabilitation services more accessible nationwide.

Conditions

Cerebral Palsy; Traumatic Brain Injury; Orthopedic Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hybrid rehabilitation

Children will receive one day of remote rehabilitation. All other days children will receive therapy at hospital

Group Type: EXPERIMENTAL

Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis

Intervention Type: OTHER

Hybrid rehabilitation. Out patients will receive one day a week of remote therapy and the remaining (1-4 days) in person at rehabilitation hospital

Interventions

Hybrid approach (in-person and remote) to pediatric rehabilitation: A look beyond the COVID-19 crisis

Hybrid rehabilitation. Out patients will receive one day a week of remote therapy and the remaining (1-4 days) in person at rehabilitation hospital

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children with physical disability
• Children receiving treatment via the out patient department
• Children who receive more than one day of treatment a week.
• Children who are able to follow instructions
• Families who can interact with a computer and other technologies

Exclusion Criteria

• Children who are visually impaired
• Children who are hearing impaired
• Children who receive hydrotherapy every day of their rehabilitation program

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: collaborator

Alyn Pediatric & Adolescent Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Naomi Gefen

PI, PARC ALYN; Deputy Director General

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alyn Pediatric and Adolescent Rehabilitation Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

063-22

Identifier Type: -

Identifier Source: org_study_id