REhabilitation After Critical Illness Assisted Discharge Pack (RECAP)

NCT ID: NCT02415634

Last Updated: 2015-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-07-31

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

RECAP

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulster

OTHER

Sponsor Role: collaborator

St Vincent's University Hospital, Ireland

OTHER

Sponsor Role: collaborator

Maire Gilmartin

OTHER

Sponsor Role: lead

Responsible Party

Maire Gilmartin

Senior Physiotherapist Critical Care

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martina Fitzpatrick

Role: PRINCIPAL_INVESTIGATOR

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

Locations

St. Vincent's University Hospital

Dublin, , Ireland

Countries

Ireland

References

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.

Reference Type: BACKGROUND

PMID: 22386848 (View on PubMed)

Other Identifiers

GilmartinSept2014

Identifier Type: -

Identifier Source: org_study_id