REhabilitation After Critical Illness Assisted Discharge Pack (RECAP)

Critical Illness Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415634
• Other study ID #: GilmartinSept2014
• Status: Completed
• Phase: N/A
• First received: April 6, 2015
• Last updated: November 16, 2015
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2015
• Source: St Vincent's University Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.
• Control
Participants allocated to the control group will receive standard physiotherapy intervention post ICU discharge

Locations

Country	Name	City	State
Ireland	St. Vincent's University Hospital	Dublin

Sponsors (3)

Lead Sponsor	Collaborator
Maire Gilmartin	St Vincent's University Hospital, Ireland, University of Ulster

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Chelsea Critical Care Physical Assessment Tool (CPAx)	Measure of physical function	Assessed at day one	No
Secondary	Patient Rehabilitation Satisfaction Questionnaire	a measure of patient satisfaction with rehabilitation experience	3 weeks post intensive care discharge	No