Critical IllnessRECAPNCT02415634
REhabilitation After Critical Illness Assisted Discharge Pack (RECAP)
A study testing RECAP in people with Critical Illness, run by Maire Gilmartin at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- RECAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- RECAP, Control
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECAPOther
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.
ControlOther
Participants allocated to the control group will receive standard physiotherapy intervention post ICU discharge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: RECAP |
| Control | Active comparator | Control Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Functional Independence Measure (FIM)
A measure of physical and cognitive function
Measured: 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
Measured: 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
Measured: 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)
Measure of physical function
Measured: Assessed at day one
Patient Rehabilitation Satisfaction Questionnaire
a measure of patient satisfaction with rehabilitation experience
Measured: 3 weeks post intensive care discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maire Gilmartin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster, St Vincent's University Hospital, Ireland
- Responsible party
- Sponsor-investigator, Maire Gilmartin, St Vincent's University Hospital, Ireland
- Investigators
- Martina Fitzpatrick, Principal investigator, Physiotherapy Manager (Temporary), St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415634
- Sponsor's protocol ID
- GilmartinSept2014
- Acronym
- RECAP
- Status last verified
- Apr 2015
- First submitted
- 6 Apr 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22386848
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02415634
- Acronym / sponsor ID
- RECAP / GilmartinSept2014
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maire GilmartinUniversity, hospital or other
- Collaborators
- University of Ulster, St Vincent's University Hospital, Ireland
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: RECAPIntervention 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 | Active comparator | Other: ControlControl Patients (Controls) will not receive formal (study-related) rehabilitation interventions and will only receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECAPPatients 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. | Other | Intervention |
| ControlParticipants allocated to the control group will receive standard physiotherapy intervention post ICU discharge | Other | Control |
Primary outcome
Change from baseline in Functional Independence Measure (FIM)
Time frame: Assessed at week three to detect change from baseline FIM score as a result of intervention
A measure of physical and cognitive function
Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory
Time frame: Assessed at week one to detect change from baseline in SAI score as a result of intervention
A measure of state anxiety
Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory
Time frame: Assessed at week three to detect change from baseline in SAI score as a result of intervention
A measure of state anxiety
2 secondary outcomes
Chelsea Critical Care Physical Assessment Tool (CPAx)
Time frame: Assessed at day one
Patient Rehabilitation Satisfaction Questionnaire
Time frame: 3 weeks post intensive care discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Background: PubMed 22386848Bench 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Fitzpatrick principal investigator
Physiotherapy Manager (Temporary), St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECAP in people with Critical Illness, run by Maire Gilmartin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Functional Independence Measure (FIM) (time frame: Assessed at week three to detect change from baseline FIM score as a result of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02415634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.