COPM-Based Goal Setting Strategies in the PICU

Development and Feasibility Evaluation of Canadian Occupational Performance Measure-Based Goal Setting Strategies for Pediatric Intensive Care Unit Patients: A Multi-Phase Mixed-Methods Study

COPM-Based Goal Setting Strategies in the PICU

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Pediatric Intensive Care Unit
• Intervention / Treatment: Other: Standard physical and occupational therapy

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JEONG-YI KWON, MD, PHD; Phone Number: +821045911039; Email: jeongyi.kwon@samsung.com

Study Locations

• South Korea
  • Seoul, South Korea, 06351
    • Not yet recruiting
    • Samsung Medical Center
    • Contact: Youngsub Hwang, Ph.D; Phone Number: +821065292034; Email: asiaargento@naver.com
  • Gangnam-gu
    • Seoul, Gangnam-gu, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
      • Contact: JEONG-YI KWON, Ph.D; Phone Number: +821065292034; Email: jeongyi.kwon@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Phase 1-2 (Delphi Survey - Experts)

• Physicians specializing in pediatrics or physical medicine and rehabilitation, occupational therapists, physical therapists, and nursing staff
• Minimum of 2 years of direct clinical experience in a Pediatric Intensive Care Unit (PICU)

Phase 3 (Pilot Testing - Caregivers & PICU Clinicians)

Caregivers:

• Legal guardian of a child aged 1-18 years admitted to PICU
• ≥24 hours post-admission

PICU clinicians:

- Treating occupational or physical therapist involved in the child's care during PICU admission

Exclusion Criteria:

Phase 1-2 (Delphi Survey - Experts)

• Rehabilitation professionals without prior PICU clinical experience
• Inability to read or respond to Korean-language surveys

Phase 3 (Pilot Testing - Caregivers & PICU Clinicians)

• Caregivers experiencing severe emotional distress, or deemed inappropriate for participation by the treating clinician
• Non-Korean-speaking caregivers
• Refusal or withdrawal of informed consent at any stage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Standard physical and occupational therapy; Participants will receive standard physiacal and occupational therapy as routinely provided in the PICU. The therapy may include activities of daily living training, positioning, range of motion exercises, and caregiver education, according to each patient's condition. No experimental intervention is introduced; the study focuses on evaluating patient-centered outcomes using the Canadian Occupational Performance Measure.

Other: Standard physical and occupational therapy; Participants admitted to the Pediatric Intensive Care Unit (PICU) will receive standard occupational therapy as part of routine clinical care. Interventions will be tailored to each patient's medical status and functional needs and may include activities of daily living (ADL) training, positioning, range of motion exercises, sensory stimulation, and caregiver education. No additional experimental treatment will be introduced for study purposes. The primary focus of the study is to evaluate patient-centered outcomes using the Canadian Occupational Performance Measure (COPM), without altering the standard therapeutic approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consensus Level for COPM Implementation Criteria in the PICU (Delphi Survey)	Level of expert consensus on specific clinical and procedural criteria for implementing COPM-based goal-setting in PICU, measured via a two-round online Delphi survey. Consensus is defined as ≥70% agreement (≥6/10 on a Likert scale) and mean score ≥7 for Likert items, or ≥50% selection for categorical items.	From initial Delphi invitation to completion of second round (estimated 2-3 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client-Centredness of Goal Setting (C-COGS)	C-COGS questionnaire will assess the extent to which client-centred principles are reflected in goal-setting for PICU caregivers. The tool includes 13 items across two subscales: Participation (9 items, max 45 points) and Goal Subscale (up to 24 items). Total scores range from 0-50, with higher scores indicating greater client-centredness.	Immediately after pilot intervention completion.
Caregiver Perceived Acceptability and Feasibility of COPM-Based Goal Setting in PICU	Structured survey developed for this study, based on items from MPOC-20, to assess caregiver perceptions of acceptability, feasibility, and perceived clinical relevance of the COPM-based goal-setting strategy. The survey includes 9 items (7 quantitative on 5-point Likert scale, 2 open-ended for qualitative analysis). Higher scores indicate greater perceived acceptability and feasibility.	Immediately after pilot intervention completion.

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• Hwang Y, Kwon JY, Cho J, Choi J. Individualized Goal Setting for Pediatric Intensive Care Unit-Based Rehabilitation Using the Canadian Occupational Performance Measure. Children (Basel). 2023 May 31;10(6):985. doi: 10.3390/children10060985.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 13, 2025
• First Submitted That Met QC Criteria: August 13, 2025
• First Posted (Actual): August 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Therapeutics; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Occupational Therapy
• Other Study ID Numbers: 2025-08-032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. The dataset includes sensitive clinical information from PICU patients and their caregivers. Due to concerns about patient privacy, potential re-identification risk, and institutional review boardrestrictions, IPD will be used solely for the purposes defined in the approved protocol and will not be made available for external access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No