REhabilitation After Critical Illness Assisted Discharge Pack (RECAP)

NCT02415634 | Completed

• 1 other identifier: GilmartinSept2014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Chelsea Critical Care Physical Assessment Tool (CPAx)

  Assessed at day one

• Patient Rehabilitation Satisfaction Questionnaire

  3 weeks post intensive care discharge

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

RECAP OTHER

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

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maire Gilmartin: lead
• University of Ulster: collaborator
• St Vincent's University Hospital, Ireland: collaborator

Study Sites (1)

St. Vincent's University Hospital

Dublin, Ireland

Location

Related 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.

  PMID: 22386848 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martina Fitzpatrick

  Physiotherapy Manager (Temporary), St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Physiotherapist Critical Care

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 14, 2015
• Study Start: November 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-04

Locations

IE (1)