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

Investigation of Physiotherapy Led ICU Discharge Facilitation Using the REhabilitation After Critical Illness Assisted Discharge Pack (RECAP) Model; a Pilot Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: RECAP; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • St. Vincent'S University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: RECAP; 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.
Active Comparator: Control; Control Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care.	Other: Control; Participants allocated to the control group will receive standard physiotherapy intervention post ICU discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Functional Independence Measure (FIM)	A measure of physical and cognitive function	Assessed at week three to detect change from baseline FIM score as a result of intervention
Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory	A measure of state anxiety	Assessed at week one to detect change from baseline in SAI score as a result of intervention
Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory	A measure of state anxiety	Assessed at week three to detect change from baseline in SAI score as a result of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chelsea Critical Care Physical Assessment Tool (CPAx)	Measure of physical function	Assessed at day one
Patient Rehabilitation Satisfaction Questionnaire	a measure of patient satisfaction with rehabilitation experience	3 weeks post intensive care discharge

Collaborators and Investigators

• Sponsor: Maire Gilmartin
• Collaborators: St Vincent's University Hospital, Ireland; University of Ulster
• Investigators: Principal Investigator: Martina Fitzpatrick, Physiotherapy Manager (Temporary), St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: GilmartinSept2014