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REhabilitation After Critical Illness Assisted Discharge Pack (RECAP) (RECAP)

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
RECAP
Control
Sponsored by
Maire Gilmartin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted to ICU >4 days
  • Indication for physiotherapy referral in ICU
  • Indication for follow up physiotherapy on discharge from the ICU
  • Age>18 years
  • RASS score 0 at time of consent

Exclusion Criteria:

  • ICU length of stay >14 days
  • Patients with a multi-disciplinary team based work-up in advance of a planned ICU admission (e.g. Liver transplant)
  • Pregnant mothers
  • Palliation
  • Expected discharge to another hospital
  • Unable to understand English
  • Patients who have direct access to condition specific MDT follow up (e.g. Stroke, Neurology)
  • Psychiatric Disease
  • Unstable Cardiac Disease
  • Where physiotherapy treatment is limited or maximal functional capacity is capped for duration of study (e.g. Non Weight Bearing status due to orthopaedic limitation x 12 weeks.
  • Patients who are unable to give consent

Sites / Locations

  • St. Vincent's University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Intervention Participants in the experimental group will receive usual care plus the RECAP with ICU therapist follow up after ICU discharge. This will be provided for a period of 3 weeks after intensive care unit discharge.

Control Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.

Outcomes

Primary Outcome Measures

Change from baseline in Functional Independence Measure (FIM)
A measure of physical and cognitive function
Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory
A measure of state anxiety
Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory
A measure of state anxiety

Secondary Outcome Measures

Chelsea Critical Care Physical Assessment Tool (CPAx)
Measure of physical function
Patient Rehabilitation Satisfaction Questionnaire
a measure of patient satisfaction with rehabilitation experience

Full Information

First Posted
April 6, 2015
Last Updated
November 16, 2015
Sponsor
Maire Gilmartin
Collaborators
University of Ulster, St Vincent's University Hospital, Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT02415634
Brief Title
REhabilitation After Critical Illness Assisted Discharge Pack (RECAP)
Acronym
RECAP
Official Title
Investigation of Physiotherapy Led ICU Discharge Facilitation Using the REhabilitation After Critical Illness Assisted Discharge Pack (RECAP) Model; a Pilot Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maire Gilmartin
Collaborators
University of Ulster, St Vincent's University Hospital, Ireland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The complexity of critical illness can result in both physical and psychological consequences for survivors, which can extend past the intensive unit care stay and after hospital discharge. A need for information and empowerment in the recovery process are highlighted for developing treatment strategies. It is suggested that there is a relationship between physical problems and psychological symptoms, but this has not been researched. This pilot study aims to test the effectiveness of a physiotherapy directed Rehabilitation after Critical illness Assisted discharge Pack (RECAP) on the physical and psychological function of patients recovering from critical illness in the first three weeks post discharge from ICU to the general ward area. The study will rely on a randomized controlled clinical trial design, with patients assigned to either a "usual care" control group vs. the treatment group. It is expected that engaging patients in their rehabilitation plan will focus physiotherapy treatment and improve physical recovery. It is hypothesized that the RECAP will reassure, support and empower patients to directly affect their psychological recovery in the first three weeks after critical illness.
Detailed Description
The process of recovering from critical illness is complex. The physical and psychological consequences of surviving critical illness can extend past the intensive unit care stay and after hospital discharge. For a critically ill patient, their first transition is being discharged from intensive care to a general ward and is one of the most stressful transitions they experience. They are required to adjust both physically and psychologically as they begin an uncertain journey to recovery. Research on the patient experience has identified vulnerability, hopelessness, fear of the unknown and anxiety as key features of this transition. A need for information and empowerment in the recovery process are highlighted for developing treatment strategies. It is suggested that there is a relationship between physical problems and psychological symptoms but this has not been researched. There is also limited evidence to guide clinicians in treatment strategy choice for these patients. This pilot study aims to test the effectiveness of a physiotherapy directed Rehabilitation after Critical illness Assisted discharge Pack (RECAP) on the physical and psychological function of patients recovering from critical illness in the first three weeks post discharge from the ICU to the general ward area. The study will rely on a randomized controlled clinical trial design, with patients assigned to either a "usual care" control group vs. the treatment group. Individuals in the treatment group will receive "usual care" plus a RECAP pack at ICU discharge with once weekly follow up with an ICU physiotherapist. The intervention group will receive the RECAP plus standard physiotherapy for the first three weeks after intensive care stay and the control group will receive standard physiotherapy alone. Outcome measures used will be the Functional Independence Measure (FIM) and State Anxiety Inventory (SAI). Secondary Outcome measures will include the Chelsea Critical Care Physical Assessment Tool (CPAx) and a 5 question patient satisfaction questionnaire. Outcome measures will be taken at ICU discharge, at one week post ICU discharge and at three weeks after ICU discharge to determine physical and psychological recovery, along with evaluating overall study feasibility. It is expected that engaging patients in their rehabilitation plan will focus physiotherapy treatment and improve physical recovery. It is hypothesized that the RECAP will reassure, support and empower patients to directly affect their psychological recovery in the first three weeks after critical illness. The User Centred Critical Care Discharge Information Pack (UCCDIP) and instructions, designed by Bench and Day (2012), will be used as a component of the RECAP. These are being used with the authors permission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention Participants in the experimental group will receive usual care plus the RECAP with ICU therapist follow up after ICU discharge. This will be provided for a period of 3 weeks after intensive care unit discharge.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.
Intervention Type
Other
Intervention Name(s)
RECAP
Intervention Description
Patients will receive an information pack at ICU discharge called the RECAP. This pack will include Part 1: A critical care discharge summary (UCCDIP) (Bench and Day, 2012) Part 2: A rehabilitation goal setting care plan Part 3: A patient communication forum Part 4: Useful supports and contact information Part 5: Tailored exercise programme The patient will have a consultation with the ICU physiotherapist before ICU discharge once weekly thereafter for 3 weeks . The focus of the session will be to discuss goal attainment and associated challenges. The ICU therapist will meet once weekly with the patient's primary physiotherapist to provide clinical support if necessary, in determining the patient's needs post critical care.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Participants allocated to the control group will receive standard physiotherapy intervention post ICU discharge
Primary Outcome Measure Information:
Title
Change from baseline in Functional Independence Measure (FIM)
Description
A measure of physical and cognitive function
Time Frame
Assessed at week three to detect change from baseline FIM score as a result of intervention
Title
Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory
Description
A measure of state anxiety
Time Frame
Assessed at week one to detect change from baseline in SAI score as a result of intervention
Title
Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory
Description
A measure of state anxiety
Time Frame
Assessed at week three to detect change from baseline in SAI score as a result of intervention
Secondary Outcome Measure Information:
Title
Chelsea Critical Care Physical Assessment Tool (CPAx)
Description
Measure of physical function
Time Frame
Assessed at day one
Title
Patient Rehabilitation Satisfaction Questionnaire
Description
a measure of patient satisfaction with rehabilitation experience
Time Frame
3 weeks post intensive care discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted to ICU >4 days Indication for physiotherapy referral in ICU Indication for follow up physiotherapy on discharge from the ICU Age>18 years RASS score 0 at time of consent Exclusion Criteria: ICU length of stay >14 days Patients with a multi-disciplinary team based work-up in advance of a planned ICU admission (e.g. Liver transplant) Pregnant mothers Palliation Expected discharge to another hospital Unable to understand English Patients who have direct access to condition specific MDT follow up (e.g. Stroke, Neurology) Psychiatric Disease Unstable Cardiac Disease Where physiotherapy treatment is limited or maximal functional capacity is capped for duration of study (e.g. Non Weight Bearing status due to orthopaedic limitation x 12 weeks. Patients who are unable to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Fitzpatrick
Organizational Affiliation
Physiotherapy Manager (Temporary), St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22386848
Citation
Bench SD, Day TL, Griffiths P. Developing user centred critical care discharge information to support early critical illness rehabilitation using the Medical Research Council's complex interventions framework. Intensive Crit Care Nurs. 2012 Apr;28(2):123-31. doi: 10.1016/j.iccn.2012.02.002. Epub 2012 Mar 3.
Results Reference
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REhabilitation After Critical Illness Assisted Discharge Pack (RECAP)

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