ICUPERMITNCT04909762
Paediatric Early Rehabilitation & Mobilisation During InTensive Care (PERMIT) Feasibility
A study testing Early Rehabilitation and Mobilisation (ERM) in people with ICU and Critical Illness, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
19,000 children and young people (CYP)/year are admitted to Paediatric Intensive Care Unit (PICU). The investgators want to see if patients recover quicker if rehabilitation starts early and they are encouraged to get moving whilst still in PICU. This is known as 'early rehabilitation and mobilisation' (ERM). Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- ICU, Critical Illness
- What is being tested?
- Early Rehabilitation and Mobilisation (ERM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2021to Jan 2022
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Steps 1-3:
- The PERMIT champions: health care professionals (HCP) and managers from each PICU who will lead the implementation of the PERMIT intervention. The PERMIT champions could be the PI, the PIC manager, a consultant lead, a physio lead and a senior nurse but this is decided locally.
- HCP: Health care professionals who work within the PICU and could be /are involved in delivering the PERMIT intervention to CYP (i.e. doctors, nurses, allied health professionals, play therapists, psychologists etc.).
- Steps 2-3:
- CYP
- Admitted to a participating PICU. Age 0 to <16 years at time of admission. Likely to remain within PICU on day 3 post admission. Consent by parent/legal guardian.
- Step 3:
- Parents/legal guardians of CYP fulfilling criteria above.
Who cannot join
- Steps 1-3:
- PERMIT champions who decline to participate in the debrief.
- Steps 2-3:
- Local decision by PICU health care professionals not to include CYP.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Women and Children's Hospital PICU
Birmingham, West Midlands, B4 6NH
About this study
Official title: Feasibility of Implementing the Paediatric Early Rehabilitation & Mobilisation During InTensive Care (PERMIT) Intervention
19,000 children and young people (CYP)/year are admitted to Paediatric Intensive Care Unit (PICU). The investgators want to see if patients recover quicker if rehabilitation starts early and they are encouraged to get moving whilst still in PICU. This is known as 'early rehabilitation and mobilisation' (ERM).
PERMIT is an National Institute of Health research/Health Technology Assessment funded programme with four stages:
Read more
- The investgators undertook a national survey of perceptions, a systematic review of the literature and an observational study of ERM over 2 weeks across 14 United Kingdom PICUs
- The investgators worked with professionals and families to develop an ERM manual appropriate for the age and acuity level of the child.
- In the current phase the investgators will try out the ERM manual in 3 PICUs to see if they are useful and then
- Make suggestions about further research.
This protocol outlines the third stage, exploring feasibility and acceptability of implementing the PERMIT intervention in the following Steps:
Step 1: Implementing the PERMIT intervention within 3 PICUs Step 2: Enrolling and delivering PERMIT intervention to CYP in PICU Step 3: Measuring outcomes and assessing impact of PERMIT intervention on CYP and parents.
Over 5 months, the investgatorswill share the ERM manual with 6-15 key staff on 3 PICUs so that they can consider implementation; they will be interviewed weekly. 90 staff will be eligible to complete 3 online questionnaires. If implementation is feasible, the investgators will recruit up 30 children aged 0-16 years in 3 PICUs if parents consent. On ward rounds the PICU team will use the ERM manual to assess acuity and prescribe ERM. the investgators will collect routine data and observe whether prescribed ERM is delivered. After further consent, up to 30 parents can complete questionnaires at PICU discharge and interviews (n=12-15 consenting, approx 3 declining Step 2) within 30 days. 12-15 staff will be interviewed.
Read the detailed description
Purpose and design To design clinical trials to investigate the potential benefits of ERM in critically ill children, it is crucial to understand the feasibility of implementation and opinions of families.
The Stage 3 feasibility study aims to assess the feasibility of the following Steps:
Step 1:
(i) Prepare PICUs to implement the PERMIT intervention. (ii) Assess barriers \& facilitators to implementation.
Step 2:
(iii) Assess enrolment, recruitment and delivery of the PERMIT intervention to CYP.
(iv) Monitor safety of the PERMIT intervention and related adverse events.
Step 3:
(v) Measure clinically important outcomes following delivery of the PERMIT intervention.
(vi) Assess parent/legal guardian acceptability of the PERMIT intervention and future trial design.
Recruitment Recruitment for the PERMIT Stage 3 feasibility study will take place on 3 PICUs in United Kingdom National Health Service Trusts: Birmingham's Children's, University hospital Southampton, and King's College hospital In Steps 1-3, the investgators will recruit Health care practitioners and managers within PICU For Steps 2-3 the investgators will recruit Children and Young People (CYP) For Step 3 the investgators will recruit Parents/legal guardians and CYP fulfilling criteria above Screening, recruitment and consent All screening, recruitment and consent will be managed by the Local and Central PERMIT Research Teams: Local PERMIT Research Team: Each of the three participating PICU sites will identify a Principal Investigator, supported by a therapist/nurse. This will form the Local PERMIT Research Team, who will provide local data collection at the sites.
Central PERMIT Research Team: The Chief Investigator and the PERMIT Trial Management Group will form the Central PERMIT Research Team and provide support, oversight and centralised data collection across the sites. The investgators require agreement and consent at a PICU level to prepare the PICU for implementing the PERMIT intervention (step 1) and to deliver the PERMIT intervention to CYP (step 2). PICU-level consent will be provided by the Clinical Lead during the local R\&D trial approval process for the PERMIT feasibility study. This provides consent for the unit to engage in implementing the PERMIT intervention and follow the specified implementation process in the PERMIT intervention manual.
PICU-level approval will also provide permission for the Local PERMIT Research Team to approach PERMIT champions for the weekly debrief and PICU health care professionals for the three brief online surveys, as described below.
Step 1:
Step 1 will assess the feasibility of implementing the preparation phases of the PERMIT intervention in the three PICUs (i.e. phase 1 'build the team', phase 2 'take stock', phase 3 'get buy-in' and phase 4 'get ready').
PERMIT champions: Following Research Ethics Committee and local R\&D approval, the Local PERMIT Research Team at each site will share the protocol and the PERMIT intervention manual with the medical, nursing and therapy leads within their PICU to nominate and 'build the team' of PERMIT champions. The Local PERMIT Research Team will provide the PERMIT champions with an email invitation, participant information sheet, and consent form regarding taking part in the weekly debrief. Consent forms will be completed with a member of the Local PERMIT research team.
PICU health care professionals: The Local PERMIT Research Team at each site will use internal email lists to invite all multidisciplinary PICU health care professionals to complete the first brief online survey. They will send an email invitation after the health care professionals have received education about the PERMIT intervention from the PERMIT champions, but before any patient recruitment starts. The email invitation will have a participant information sheet attached. Both these documents highlight that completion and submission of the survey is an indicator of informed consent. Therefore, no separate consent form will be required.
Completed surveys are automatically submitted via web-based survey tool (SmartSurvey) to the Central PERMIT Research Team for processing and analysis. The Central PERMIT Research Team will monitor survey responses to ensure that relevant health care professional groups and the three PICUs are represented. If required, the Local PERMIT Research Team at each site will send the email invitation again to specific under-represented groups. This will ensure that the investgators have representatives from all three units, from different health care professional groups and from people who have had a variety of experiences.
Step 2:
After phases 1-4 have been implemented, study sites will progress to step 2 which will assess the feasibility of implementing the delivery phases of the PERMIT intervention (i.e. phase 5 'make it work' and phase 6 'keep it going').
PERMIT champions: The weekly debrief with PERMIT champions will continue. PICU health care professionals: The Local PERMIT Research Team at each site will invite all multidisciplinary PICU health care professionals to complete the second brief online survey, following the same process as described for step 1.
CYP: The investgators will display a poster about the PERMIT feasibility study in public areas in each PICU. Basic information about the study, in the form of an awareness leaflet, will be provided to all parents/legal guardians of CYP admitted to PICU during the study period.
In conjunction with patient's clinical team, the local PERMIT Research Team will screen and recruit CYP to receive the PERMIT intervention. They will screen all CYP admitted to each PICU against the study inclusion and exclusion criteria and record the screening and all related decisions in the screening log at each site. They will approach the parents/legal guardians of eligible CYP on day 1 or 2 of admission (where possible). They will explain the study and provide the participant information sheet.
After providing time for parents/legal guardians to read the information and consider the study, the Local PERMIT Research Team will return to ask for consent for the CYP to take part in the study using the consent form. They will discuss the different options for consent. At this point, parents/legal guardians can choose between the following:
Consenting for CYP to receive the PERMIT intervention, with accompanying data collection (specifically, CYP clinical data, PERMIT intervention data and safety monitoring). No additional requirements for parents/legal guardians.
If they consent to the PERMIT intervention, they can also consent to complete additional outcome measurement tools (e.g. related to quality of life, fatigue, pain).
If they consent to the PERMIT intervention and complete additional outcome measurement tools, they can also consent to an optional interview to assess acceptability.
Consent from parents/legal guardians will be obtained by a member of the Local PERMIT Research Team, with copies provided to the parents/ legal guardians and for the medical notes.
The majority of CYP will be unable to provide assent to participate (for example; because of their age (<1 year of age), on pain relief medications, sedated to tolerate interventions). Therefore, the investgators will rely primarily on consent from parents/legal guardians. However, where possible and appropriate, the Local PERMIT Research Team will seek verbal or written assent from the CYP themselves, where consent has first been obtained from their parent/legal guardian. Assent will be recorded on a CYP assent form, which will be completed with a member of the Local PERMIT Research Team with copies provided to parents/legal guardians and for the medical notes.
During the assenting process, the Local PERMIT Research Team will ensure that CYP:
- Understand the purpose and nature of the research.
- Understand what the research involves, its benefits, risks and burdens.
- Understand the alternatives to taking part.
- Are able to retain the information long enough to make an effective decision.
- Are able to make a free choice.
- Are capable of making this particular decision at the time it needs to be made (recognising that their capacity may fluctuate, and they may be capable of making some decisions but not others depending on their complexity).
The Local PERMIT Research Team will employ a 'best interests' approach. Mental capacity will be assumed unless proven otherwise. All members of the Local PERMIT Research Team recruiting CYP into this study will have been trained in Mental Capacity Assessment as part of routine clinical training.
Parents/legal guardians and CYP may request withdrawal from the PERMIT feasibility study at any point, including during step 2 where they have agreed for their child to receive the PERMIT intervention. Reasons for withdrawal will be recorded in the screening logs at each PICU site. At the time of withdrawal the investgators will ascertain if they wish to withdraw from ongoing involvement in the PERMIT intervention or if they wish for all their previously collected data to be removed.
Step 3:
PERMIT champions: The weekly debrief with consenting PERMIT champions will continue.
PICU health care professionals: The Local PERMIT Research Team at each site will invite all multidisciplinary PICU health care professionals to complete the third and final brief online survey, following the same process as described for steps 1-2.
At the end of each of the three brief online surveys, health care professionals will be asked if they would be willing to consider taking part in an interview. If they indicate yes, they will be asked to provide their name and email address. Their name and email address will not be linked to any of their survey responses. Completed surveys - and any names and email addresses provided - are automatically submitted to the Central PERMIT Research Team for processing and analysis.
To recruit health care professionals for the interviews, the investgators will use two approaches: (i) the Central PERMIT Research Team will send an email invitation to survey respondents who agreed to consider taking part in an interview, and (ii) the Local PERMIT Research Team will send the same email invitation asking for participants from specific under-represented groups or groups that the investgators are particularly keen to hear from. This two-pronged approach will ensure that the investgators have representatives in the interviews from all three units, from different health care professional groups and from people who have had a variety of experiences of the PERMIT intervention.
The Participant Information Sheet and consent form will be sent by email to the potential participant by the researcher from the Central PERMIT Research Team. Participants will be asked to complete and return the consent form via email to a secure nhs.net address. Prior to commencing the interview the participant information sheet will be discussed and consent re-affirmed verbally.
Health care professionals responses to the on line survey cannot be withdrawn as they are anonymous. Health care professionals may withdraw their consent to participate during or after an interview. The investgators will ask permission to use any information already provided. If participants do not provide this permission, the investgators will remove all data.
CYP: Throughout step 3, the Local PERMIT Research Team will continue to screen and recruit CYP to receive the PERMIT intervention, as described in step 2.
Parents/legal guardians of CYP receiving the PERMIT intervention: The Local PERMIT Research Team will re- approach parents/legal guardians of the CYP included in step 2 who also agreed to complete additional outcome measurement tools (e.g. related to quality of life, fatigue, pain) and may also have agreed to take part in an interview to assess acceptability.
The Local PERMIT Research Team will re-approach parents/legal guardians of the CYP included in step 2 who only agreed only for their child to receive the PERMIT intervention with accompanying data collection.
- Conditions
- ICU, Critical Illness
- Being tested
- Early Rehabilitation and Mobilisation (ERM)
- Keywords
- PICU, Paediatric, Early mobilisation, Early rehabilitation, Observational
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Rehabilitation and Mobilisation (ERM)Other
Early rehabilitation/mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package. It is provided by health professionals from multiple disciplines and care-givers within intensive care settings.
| Study group | Role | What they receive |
|---|---|---|
| Early rehabilitation and mobilisation | Other | Early rehabilitation/mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package, provided by health care professionals from multiple disciplines and parents/carers within intensive care settings to promote recovery, both physical (e.g. movement, functional activities, ambulation) and non-physical (e.g. speech, play, psychological, cognitive). In adult intensive care, ERM has been shown in clinical trials to improve long term physical functioning and return to independence. It can also shorten the length of ventilation and stay in intensive care and hospital with significant economic benefit. Receives: Other: Early Rehabilitation and Mobilisation (ERM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PICUs implementing PERMIT intervention
The prevalence and scope of ERM will be described as the proportion of PICUs progressing from step 1 (PICU preparation) to step 2 (patient delivery).
Assessment of implementation progress within PICUs (e.g. barriers and facilitators to implementation) PICUs using the weekly debrief with PERMIT champions, the three brief online surveys of PICU health care professionals and the interviews with PICU health care professionals.
Measured: 4 weeks
Proportion of eligible CYP recruited to receive the PERMIT intervention
The proportion of eligible CYP recruited to receive the PEMRIT intervention will be calculated as the number of eligible CYP recruited divided by the total number of eligible CYP at each site.
Measured: 4 weeks
Proportion of completed outcome assessment tools of eligible CYP
Proportion of CYP with 100% completed outcome measurement tools and >50% completed will be recorded at each PICU site.
Measured: 4 weeks
Secondary outcomes (3)
Acceptability of all data collection forms, outcome measurement tools and the PERMIT intervention as a whole
The investigaotrs will use the weekly debrief with PERMIT champions, interviews with PICU health care professionals and interviews with parents/legal guardians to assess acceptability of all data collection forms, outcome measurement tools and the PERMIT intervention as a whole. These data, along with the data from the data collection forms and outcome measurement tools themselves, will also provide the investigaotrs with an indication of the potential impact of the PERMIT intervention on CYP and parents/legal guardians.
Measured: 4 weeks
Number of ERM activities prescribed per CYP following patient acuity screening
The Local PERMIT Research Team will record the number of ERM activities prescribed to CYP follow daily acuity screening daily.
Measured: 4 weeks
Number of ERM activities delivered per CYP
The Local PERMIT Research Team will convert prescribed ERM activity to delivered ERM activity and will calculate this on a daily basis.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionJan 2022 (estimated)
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 ICUStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive Early Rehabilitation and Mobilisation intervention.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust, University Hospital Southampton NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Barnaby Scholefield, Dr, Study chair, Birmingham Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909762
- Sponsor's protocol ID
- ERN_18-1134
- Acronym
- PERMIT
- Status last verified
- Mar 2021
- First submitted
- 11 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Scholefield BR, Menzies JC, McAnuff J, Thompson JY, Manning JC, Feltbower RG, Geary M, Lockley S, Morris KP, Moore D, Pathan N, Kirkham F, Forsyth R, Rapley T. Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study. Health Technol Assess. 2023 Nov;27(27):1-155. doi: 10.3310/HYRW5688.
PubMed 38063184
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Implementing the Paediatric Early Rehabilitation & Mobilisation During InTensive Care (PERMIT) Intervention
- ClinicalTrials.gov ID
- NCT04909762
- Acronym / sponsor ID
- PERMIT / ERN_18-1134
- Conditions
- ICU, Critical Illness
- Keywords
- PICU, Paediatric, Early mobilisation, Early rehabilitation, Observational
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust, University Hospital Southampton NHS Foundation Trust, Birmingham Women's and Children's NHS Foundation Trust
- Study start
- Jun 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 2 Jun 2021 (actual)
- 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.
19,000 children and young people (CYP)/year are admitted to Paediatric Intensive Care Unit (PICU). The investgators want to see if patients recover quicker if rehabilitation starts early and they are encouraged to get moving whilst still in PICU. This is known as 'early rehabilitation and mobilisation' (ERM).
PERMIT is an National Institute of Health research/Health Technology Assessment funded programme with four stages:
- The investgators undertook a national survey of perceptions, a systematic review of the literature and an observational study of ERM over 2 weeks across 14 United Kingdom PICUs
- The investgators worked with professionals and families to develop an ERM manual appropriate for the age and acuity level of the child.
- In the current phase the investgators will try out the ERM manual in 3 PICUs to see if they are useful and then
- Make suggestions about further research.
This protocol outlines the third stage, exploring feasibility and acceptability of implementing the PERMIT intervention in the following Steps:
Step 1: Implementing the PERMIT intervention within 3 PICUs Step 2: Enrolling and delivering PERMIT intervention to CYP in PICU Step 3: Measuring outcomes and assessing impact of PERMIT intervention on CYP and parents.
Over 5 months, the investgatorswill share the ERM manual with 6-15 key staff on 3 PICUs so that they can consider implementation; they will be interviewed weekly. 90 staff will be eligible to complete 3 online questionnaires. If implementation is feasible, the investgators will recruit up 30 children aged 0-16 years in 3 PICUs if parents consent. On ward rounds the PICU team will use the ERM manual to assess acuity and prescribe ERM. the investgators will collect routine data and observe whether prescribed ERM is delivered. After further consent, up to 30 parents can complete questionnaires at PICU discharge and interviews (n=12-15 consenting, approx 3 declining Step 2) within 30 days. 12-15 staff will be interviewed.
Detailed description
Purpose and design To design clinical trials to investigate the potential benefits of ERM in critically ill children, it is crucial to understand the feasibility of implementation and opinions of families.
The Stage 3 feasibility study aims to assess the feasibility of the following Steps:
Step 1:
(i) Prepare PICUs to implement the PERMIT intervention. (ii) Assess barriers \& facilitators to implementation.
Step 2:
(iii) Assess enrolment, recruitment and delivery of the PERMIT intervention to CYP.
(iv) Monitor safety of the PERMIT intervention and related adverse events.
Step 3:
(v) Measure clinically important outcomes following delivery of the PERMIT intervention.
(vi) Assess parent/legal guardian acceptability of the PERMIT intervention and future trial design.
Recruitment Recruitment for the PERMIT Stage 3 feasibility study will take place on 3 PICUs in United Kingdom National Health Service Trusts: Birmingham's Children's, University hospital Southampton, and King's College hospital In Steps 1-3, the investgators will recruit Health care practitioners and managers within PICU For Steps 2-3 the investgators will recruit Children and Young People (CYP) For Step 3 the investgators will recruit Parents/legal guardians and CYP fulfilling criteria above Screening, recruitment and consent All screening, recruitment and consent will be managed by the Local and Central PERMIT Research Teams: Local PERMIT Research Team: Each of the three participating PICU sites will identify a Principal Investigator, supported by a therapist/nurse. This will form the Local PERMIT Research Team, who will provide local data collection at the sites.
Central PERMIT Research Team: The Chief Investigator and the PERMIT Trial Management Group will form the Central PERMIT Research Team and provide support, oversight and centralised data collection across the sites. The investgators require agreement and consent at a PICU level to prepare the PICU for implementing the PERMIT intervention (step 1) and to deliver the PERMIT intervention to CYP (step 2). PICU-level consent will be provided by the Clinical Lead during the local R\&D trial approval process for the PERMIT feasibility study. This provides consent for the unit to engage in implementing the PERMIT intervention and follow the specified implementation process in the PERMIT intervention manual.
PICU-level approval will also provide permission for the Local PERMIT Research Team to approach PERMIT champions for the weekly debrief and PICU health care professionals for the three brief online surveys, as described below.
Step 1:
Step 1 will assess the feasibility of implementing the preparation phases of the PERMIT intervention in the three PICUs (i.e. phase 1 'build the team', phase 2 'take stock', phase 3 'get buy-in' and phase 4 'get ready').
PERMIT champions: Following Research Ethics Committee and local R\&D approval, the Local PERMIT Research Team at each site will share the protocol and the PERMIT intervention manual with the medical, nursing and therapy leads within their PICU to nominate and 'build the team' of PERMIT champions. The Local PERMIT Research Team will provide the PERMIT champions with an email invitation, participant information sheet, and consent form regarding taking part in the weekly debrief. Consent forms will be completed with a member of the Local PERMIT research team.
PICU health care professionals: The Local PERMIT Research Team at each site will use internal email lists to invite all multidisciplinary PICU health care professionals to complete the first brief online survey. They will send an email invitation after the health care professionals have received education about the PERMIT intervention from the PERMIT champions, but before any patient recruitment starts. The email invitation will have a participant information sheet attached. Both these documents highlight that completion and submission of the survey is an indicator of informed consent. Therefore, no separate consent form will be required.
Completed surveys are automatically submitted via web-based survey tool (SmartSurvey) to the Central PERMIT Research Team for processing and analysis. The Central PERMIT Research Team will monitor survey responses to ensure that relevant health care professional groups and the three PICUs are represented. If required, the Local PERMIT Research Team at each site will send the email invitation again to specific under-represented groups. This will ensure that the investgators have representatives from all three units, from different health care professional groups and from people who have had a variety of experiences.
Step 2:
After phases 1-4 have been implemented, study sites will progress to step 2 which will assess the feasibility of implementing the delivery phases of the PERMIT intervention (i.e. phase 5 'make it work' and phase 6 'keep it going').
PERMIT champions: The weekly debrief with PERMIT champions will continue. PICU health care professionals: The Local PERMIT Research Team at each site will invite all multidisciplinary PICU health care professionals to complete the second brief online survey, following the same process as described for step 1.
CYP: The investgators will display a poster about the PERMIT feasibility study in public areas in each PICU. Basic information about the study, in the form of an awareness leaflet, will be provided to all parents/legal guardians of CYP admitted to PICU during the study period.
In conjunction with patient's clinical team, the local PERMIT Research Team will screen and recruit CYP to receive the PERMIT intervention. They will screen all CYP admitted to each PICU against the study inclusion and exclusion criteria and record the screening and all related decisions in the screening log at each site. They will approach the parents/legal guardians of eligible CYP on day 1 or 2 of admission (where possible). They will explain the study and provide the participant information sheet.
After providing time for parents/legal guardians to read the information and consider the study, the Local PERMIT Research Team will return to ask for consent for the CYP to take part in the study using the consent form. They will discuss the different options for consent. At this point, parents/legal guardians can choose between the following:
Consenting for CYP to receive the PERMIT intervention, with accompanying data collection (specifically, CYP clinical data, PERMIT intervention data and safety monitoring). No additional requirements for parents/legal guardians.
If they consent to the PERMIT intervention, they can also consent to complete additional outcome measurement tools (e.g. related to quality of life, fatigue, pain).
If they consent to the PERMIT intervention and complete additional outcome measurement tools, they can also consent to an optional interview to assess acceptability.
Consent from parents/legal guardians will be obtained by a member of the Local PERMIT Research Team, with copies provided to the parents/ legal guardians and for the medical notes.
The majority of CYP will be unable to provide assent to participate (for example; because of their age (<1 year of age), on pain relief medications, sedated to tolerate interventions). Therefore, the investgators will rely primarily on consent from parents/legal guardians. However, where possible and appropriate, the Local PERMIT Research Team will seek verbal or written assent from the CYP themselves, where consent has first been obtained from their parent/legal guardian. Assent will be recorded on a CYP assent form, which will be completed with a member of the Local PERMIT Research Team with copies provided to parents/legal guardians and for the medical notes.
During the assenting process, the Local PERMIT Research Team will ensure that CYP:
- Understand the purpose and nature of the research.
- Understand what the research involves, its benefits, risks and burdens.
- Understand the alternatives to taking part.
- Are able to retain the information long enough to make an effective decision.
- Are able to make a free choice.
- Are capable of making this particular decision at the time it needs to be made (recognising that their capacity may fluctuate, and they may be capable of making some decisions but not others depending on their complexity).
The Local PERMIT Research Team will employ a 'best interests' approach. Mental capacity will be assumed unless proven otherwise. All members of the Local PERMIT Research Team recruiting CYP into this study will have been trained in Mental Capacity Assessment as part of routine clinical training.
Parents/legal guardians and CYP may request withdrawal from the PERMIT feasibility study at any point, including during step 2 where they have agreed for their child to receive the PERMIT intervention. Reasons for withdrawal will be recorded in the screening logs at each PICU site. At the time of withdrawal the investgators will ascertain if they wish to withdraw from ongoing involvement in the PERMIT intervention or if they wish for all their previously collected data to be removed.
Step 3:
PERMIT champions: The weekly debrief with consenting PERMIT champions will continue.
PICU health care professionals: The Local PERMIT Research Team at each site will invite all multidisciplinary PICU health care professionals to complete the third and final brief online survey, following the same process as described for steps 1-2.
At the end of each of the three brief online surveys, health care professionals will be asked if they would be willing to consider taking part in an interview. If they indicate yes, they will be asked to provide their name and email address. Their name and email address will not be linked to any of their survey responses. Completed surveys - and any names and email addresses provided - are automatically submitted to the Central PERMIT Research Team for processing and analysis.
To recruit health care professionals for the interviews, the investgators will use two approaches: (i) the Central PERMIT Research Team will send an email invitation to survey respondents who agreed to consider taking part in an interview, and (ii) the Local PERMIT Research Team will send the same email invitation asking for participants from specific under-represented groups or groups that the investgators are particularly keen to hear from. This two-pronged approach will ensure that the investgators have representatives in the interviews from all three units, from different health care professional groups and from people who have had a variety of experiences of the PERMIT intervention.
The Participant Information Sheet and consent form will be sent by email to the potential participant by the researcher from the Central PERMIT Research Team. Participants will be asked to complete and return the consent form via email to a secure nhs.net address. Prior to commencing the interview the participant information sheet will be discussed and consent re-affirmed verbally.
Health care professionals responses to the on line survey cannot be withdrawn as they are anonymous. Health care professionals may withdraw their consent to participate during or after an interview. The investgators will ask permission to use any information already provided. If participants do not provide this permission, the investgators will remove all data.
CYP: Throughout step 3, the Local PERMIT Research Team will continue to screen and recruit CYP to receive the PERMIT intervention, as described in step 2.
Parents/legal guardians of CYP receiving the PERMIT intervention: The Local PERMIT Research Team will re- approach parents/legal guardians of the CYP included in step 2 who also agreed to complete additional outcome measurement tools (e.g. related to quality of life, fatigue, pain) and may also have agreed to take part in an interview to assess acceptability.
The Local PERMIT Research Team will re-approach parents/legal guardians of the CYP included in step 2 who only agreed only for their child to receive the PERMIT intervention with accompanying data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive Early Rehabilitation and Mobilisation intervention.
| Arm | Type | Receives |
|---|---|---|
| Early rehabilitation and mobilisation | Other | Other: Early Rehabilitation and Mobilisation (ERM)Early rehabilitation/mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package, provided by health care professionals from multiple disciplines and parents/carers within intensive care settings to promote recovery, both physical (e.g. movement, functional activities, ambulation) and non-physical (e.g. speech, play, psychological, cognitive). In adult intensive care, ERM has been shown in clinical trials to improve long term physical functioning and return to independence. It can also shorten the length of ventilation and stay in intensive care and hospital with significant economic benefit. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Steps 1-3:
- The PERMIT champions: health care professionals (HCP) and managers from each PICU who will lead the implementation of the PERMIT intervention. The PERMIT champions could be the PI, the PIC manager, a consultant lead, a physio lead and a senior nurse but this is decided locally.
- HCP: Health care professionals who work within the PICU and could be /are involved in delivering the PERMIT intervention to CYP (i.e. doctors, nurses, allied health professionals, play therapists, psychologists etc.).
- Steps 2-3:
- CYP
Key exclusion criteria (4 listed)
- Steps 1-3:
- PERMIT champions who decline to participate in the debrief.
- Steps 2-3:
- Local decision by PICU health care professionals not to include CYP.
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 |
|---|---|---|
| Early Rehabilitation and Mobilisation (ERM)Early rehabilitation/mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package. It is provided by health professionals from multiple disciplines and care-givers within intensive care settings. | Other | Early rehabilitation and mobilisation |
Primary outcome
Number of PICUs implementing PERMIT intervention
Time frame: 4 weeks
The prevalence and scope of ERM will be described as the proportion of PICUs progressing from step 1 (PICU preparation) to step 2 (patient delivery). Assessment of implementation progress within PICUs (e.g. barriers and facilitators to implementation) PICUs using the weekly debrief with PERMIT champions, the three brief online surveys of PICU health care professionals and the interviews with PICU health care professionals.
Proportion of eligible CYP recruited to receive the PERMIT intervention
Time frame: 4 weeks
The proportion of eligible CYP recruited to receive the PEMRIT intervention will be calculated as the number of eligible CYP recruited divided by the total number of eligible CYP at each site.
Proportion of completed outcome assessment tools of eligible CYP
Time frame: 4 weeks
Proportion of CYP with 100% completed outcome measurement tools and >50% completed will be recorded at each PICU site.
3 secondary outcomes
Acceptability of all data collection forms, outcome measurement tools and the PERMIT intervention as a whole
Time frame: 4 weeks
Number of ERM activities prescribed per CYP following patient acuity screening
Time frame: 4 weeks
Number of ERM activities delivered per CYP
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 38063184Scholefield BR, Menzies JC, McAnuff J, Thompson JY, Manning JC, Feltbower RG, Geary M, Lockley S, Morris KP, Moore D, Pathan N, Kirkham F, Forsyth R, Rapley T. Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study. Health Technol Assess. 2023 Nov;27(27):1-155. doi: 10.3310/HYRW5688.
Related trials for ICU
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effect of Rutin and Vitamin C on Outcomes in Adults With Sepsis Admitted to the Intensive Care Unit
Sepsis
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
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.
Barnaby Scholefield, Dr study chair
Birmingham Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Rehabilitation and Mobilisation (ERM) in people with ICU and Critical Illness, run by University of Birmingham at 1 site in United Kingdom.
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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barnaby Scholefield, Dr (00441213339684, b.scholefield@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of PICUs implementing PERMIT intervention (time frame: 4 weeks). 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 NCT04909762, 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 2 Jun 2021.