COPM-Based Goal Setting Strategies in the PICU

Not Applicable

Not yet recruiting

• Conditions: Critical Illness; Pediatric Intensive Care Unit

• Registration Number: NCT07128446
• Lead Sponsor: Samsung Medical Center

Brief Summary

COPM-Based Goal Setting Strategies in the PICU

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-09-20
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Consensus Level for COPM Implementation Criteria in the PICU (Delphi Survey)	From initial Delphi invitation to completion of second round (estimated 2-3 weeks).	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.

Secondary Outcome Measures

Name	Time	Method
Client-Centredness of Goal Setting (C-COGS)	Immediately after pilot intervention completion.	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.
Caregiver Perceived Acceptability and Feasibility of COPM-Based Goal Setting in PICU	Immediately after pilot intervention completion.	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of