COPM-Based Goal Setting Strategies in the PICU
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorSamsung Medical Center
About this trial
COPM-Based Goal Setting Strategies in the PICU
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Legal guardian of a child aged 1-18 years admitted to PICU
≥24 hours post-admission
Disqualifiers
Rehabilitation professionals without prior PICU clinical experience
Inability to read or respond to Korean-language surveys
Caregivers experiencing severe emotional distress, or deemed inappropriate for participation by the treating clinician
Non-Korean-speaking caregivers
Trial design
Design model
Single group
Treatments tested in this trial
Standard physical and occupational therapy
Other interventionParticipants 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Standard physical and occupational therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov