Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547762
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Hybrid Approach to Pediatric Rehabilitation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hybrid Approach In-person and Remote to Pediatric Rehabilitation A Look Beyond the Corona Crisis 2019
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 rehabilitation3 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 62019 section 44 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
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 rehabilitation3 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 62019 section 44 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None