Early Occupational Therapy in Intensive Care: Feasibility of Implementation (ERGO-PRE-SI)

Ergothérapie précoce Aux Soins Intensifs: faisabilité d'implémentation

The objective of the study is to assess the feasibility of early daily occupational therapy intervention within an interdisciplinary team in an intensive care unit of a Swiss university hospital.

Study Overview

• Status: Completed
• Conditions: Intensive Care; Occupational Therapy
• Intervention / Treatment: Other: early occupational therapy

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton De Vaud
    • Lausanne, Canton De Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 18 years old.
• Hospitalized at SMIA for at least 48 hours.
• Stable patient: hemodynamically stabilized patient (norepinephrine dose < 15 mcg/min iv), respiratory (P/F ratio > 150) and neurological (Glasgow Coma Scale > 8).

Exclusion Criteria:

• contraindication to occupational therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Early daily occupational therapy intervention; A daily occupational therapy intervention is performed with the patients included. The intervention will consist of assessment as well as early positioning and/or rehabilitation in activities of daily living.

Other: early occupational therapy; The intervention will be the one usually carried out but earlier and on a daily basis. It will consist of the initial assessment and then positioning and/or carrying out activities of daily living. The daily duration of the intervention will be about 45 minutes to 1 hour. The overall duration of the intervention will be determined according to the objectives and will be at most equal to the time of stay in the intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early daily occupational therapy intervention feasability (case report form with questions to ask)	Assess the feasibility of providing early daily occupational therapy interventions in the Adult Intensive Medicine Service of the Centre Hospitalier Universitaire Vaudois within the current interdisciplinary team. Every day, the occupational therapist complete a case report form which say if the intervention can be realise or not in order to find the feasability of a daily early occupationnal therapy intervention. The feasability is mesure every day for each participant until they leave the intensive care unit. the feasibility assessment contains several elements, including the possibility or not of carrying out the intervention, but also the safety aspect with the collection of possible adverse events.	Up to intensive care unit discharge, estimated as an average of 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily occupational therapy intervention description by completion of case report form	Describe the content of the occupational therapy intervention in intensive care unit. Occupational therapists complete a form for each intervention (daily) regarding the type of intervention they have performed with the participants (positioning, daily activities, etc.) until the end of the intervention, when the patient leaves the intensive care unit.	Up to intensive care unit discharge, estimated as an average of 6 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): December 6, 2019

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 23, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ERGO-PRE-SI_2019-00867

Drug and device information, study documents

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