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

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Completed

CT.gov ID

NCT04186611

Collaborator

(none)

Enrollment

Location

Arm

1.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Occupational Therapy Intensive Care	Other: early occupational therapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Ergothérapie précoce Aux Soins Intensifs: faisabilité d'implémentation

Actual Study Start Date :

Oct 14, 2019

Actual Primary Completion Date :

Dec 6, 2019

Actual Study Completion Date :

Dec 6, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Early daily occupational therapy intervention feasability (case report form with questions to ask) [Up to intensive care unit discharge, estimated as an average of 6 days]
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.

Secondary Outcome Measures

Daily occupational therapy intervention description by completion of case report form [Up to intensive care unit discharge, estimated as an average of 6 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire Vaudois	Lausanne	Canton De Vaud	Switzerland	1011

Sponsors and Collaborators

Centre Hospitalier Universitaire Vaudois

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marie-Gabrielle Wick Brasey, Principal Investigator, Centre Hospitalier Universitaire Vaudois

ClinicalTrials.gov Identifier:

NCT04186611

Other Study ID Numbers:

ERGO-PRE-SI_2019-00867

First Posted:

Dec 5, 2019

Last Update Posted:

Feb 25, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 25, 2020