COPM-Based Goal Setting Strategies in the PICU

N/ARecruitingNCT07128446

Samsung Medical Center5 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Illness Pediatric Intensive Care Unit

Interventions

Standard physical and occupational therapyOTHER

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.

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: From initial Delphi invitation to completion of second round (estimated 2-3 weeks).

Secondary Outcomes

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.

Time frame: 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.

Time frame: Immediately after pilot intervention completion.

Central Contacts

JEONG-YI KWON, MD, PHD

CONTACT

+821045911039 jeongyi.kwon@samsung.com

Data from ClinicalTrials.gov

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