Identifying and Understanding Risk Factors for Instability and Adverse Events Associated With Chest Physiotherapy in Ventilated Children
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      Paediatric intensive care units support the complex medical needs of children with life
      threatening conditions. There are 20000 admissions annually within the United Kingdom and 65%
      require life support through a breathing machine. Chest physiotherapy is considered part of
      routine care for these patients. There is a small amount of evidence providing support for
      the effectiveness of chest physiotherapy however it has been associated with instability and
      adverse events. At present the risks and benefits of chest physiotherapy in ventilated
      children are unknown. It is important to identify which patients are likely to benefit most
      and in which situations chest physiotherapy may present a significant risk.

      Aim: To identify and understand the risk factors for instability and harmful events which may
      occur due to chest physiotherapy in children on intensive care.

      Design/Methods

      Work Package 1

      Phase 1 - An anonymous, electronic survey will be sent to all UK physiotherapists who work in
      paediatric critical care. Information will be collected about physiotherapy practice,
      referrals, and risk factors assessed and monitored.

      Phase 2 - Interviews with 18-27 physiotherapists will take place. The findings from phase 1
      will guide the questions. Phase 2 will provide a more in-depth understanding about
      physiotherapy decision making and management of risks.

      Work Package 2

      This part of the study will quantitatively assess the effects of chest physiotherapy and
      identify risk factors for instability. Routinely collected data from the three intensive care
      units at Great Ormond Street Hospital will be used. No contact with patients/families will be
      required, and no change to care will occur. Data from approximately 1000 patients will be
      collected over one year. Health related measures (e.g. oxygen levels) will be recorded before
      and after chest physiotherapy.
    

Detailed description: 
      Research Questions

        1. What is current chest physiotherapy practice within UK paediatric intensive care units?

        2. How do physiotherapists make decisions regarding provision of chest physiotherapy in UK
           paediatric intensive care units and what other factors influence this decision making?

        3. What do physiotherapists perceive to be risk factors for physiological instability and
           adverse events and how do they manage these?

        4. What is the prevalence of physiological instability and adverse events associated with
           chest physiotherapy in ventilated children?

        5. What are the risk factors/characteristics of children who display instability and/or
           adverse events associated with chest physiotherapy?

        6. What is the long term impact on the child of instability and adverse events associated
           with chest physiotherapy?

      WORK PACKAGE 1

      Phase 1 A descriptive, cross sectional study investigating current chest physiotherapy
      practice in paediatric intensive care units.

      Sample The subject group is physiotherapists working within the 28 NHS PICUs in the UK. Using
      information from a local benchmarking study which investigated physiotherapy staffing levels
      on seven UK PICUs, a total of 33 physiotherapy staff was reported, providing an average of
      four per site. Extrapolating this for the 28 national centres gives an approximate population
      size of 112 physiotherapists.

      Method An electronic survey, created in Smart-survey will be used. The first page of the
      questionnaire will include a covering statement and a link to the more comprehensive
      participant information sheet. The survey includes dichotomous and multiple choice closed
      questions, and open questions where more detail is required. It will be self-administered and
      anonymous.

      Key topics covered include:

        -  Chest physiotherapy techniques used

        -  Chest physiotherapy referral criteria

        -  Decision to treat/not treat processes

        -  Risk factors monitored

        -  Demographic information The survey will be open for eight weeks and a reminder email
           will be sent after four weeks. Consent will be implied if the survey is completed and
           returned.

      Data Analysis The anonymous data will be imported into Excel and descriptive statistics will
      be used including frequency distributions, statistics of central tendency, and dispersion.
      Qualitative data from the open questions will be thematically analysed, as described by Braun
      and Clarke (2006).

      Phase 2 A qualitative study to explore and understand the decision making processes that
      guide delivery of chest physiotherapy, including the perceived risk factors for physiological
      instability and adverse events, and risk management strategies.

      Sample Nine paediatric critical care units have been pre-selected, these are representative
      of all 28 UK NHS PICUs. Up to three physiotherapists will be purposively sampled from each
      centre to ensure a heterogeneous sample in terms of agenda for change banding and years of
      experience. This strategy will generate a sample size of 18-27 and ensure saturation of
      themes.

      Method Semi-structured interviews will be conducted. Eligible participants will be provided
      with appropriate study information and all participants asked to give written consent prior
      to taking part. The interviews will take place at a time and location convenient to the
      participant, outside of their contracted working hours. The interviews will last between
      30-60 minutes. Where possible the interviews will be face to face, however Skype/telephone
      interviews will also be offered. A topic guide for the interviews will be developed using the
      data from phase 1, existing literature, and advice from the steering group. The topic guide
      will be piloted in the first three interviews. The pilot data will be included in the data
      set unless significant revisions to the topic guide are required. The interviews will be
      audio recorded, with permission, and transcribed verbatim. Field notes will be taken to
      provide context and information on non-verbal cues.

      Data Analysis Thematic analysis will be used to analyse the interview transcripts, to
      identify, organise and report themes within the data. The themes will be presented logically
      and meaningfully, evidenced and illustrated with quotes as appropriate. A visual display of
      the findings will also be developed.

      WORK PACKAGE 2 An observational (case-note review) study to assess the variability and
      prevalence of physiological instability and adverse events associated with chest
      physiotherapy, and identify risk factors that predict instability.

      Sample The sampling frame will consist of patients on the three paediatric critical care
      units at a tertiary children's hospital (neonatal, general paediatric, cardiac).

      Subject Recruitment Patients who meet the inclusion criteria will be identified from
      physiotherapy records on a weekly basis by the chief investigator.

      Data Collection This study will involve the collection of four categories of variables:
      primary and secondary outcomes, risk factors/demographics, and general PICU outcomes. These
      are routinely monitored and recorded for all patients on the PICUs. They are retrieved from
      high resolution monitor data (T3) and electronic patient records (EPR). A workspace within
      the digital platform Aridhia will be designed collaboratively with the GOSH Digital Research,
      Informatics and Virtual Environments (DRIVE) team. This will provide a comprehensive and
      secure database to collate, store and analyse the data. The DRIVE team will downloaded the
      de-identified data into the workspace.

      Sample Size and Planned Recruitment Rate The use of digital methods allows a larger sample
      than in previous experimental and retrospective studies. Retrospective data will be collected
      over a 12 month period. An audit of chest physiotherapy across the three PICUs was completed
      over one week. Twenty two patients, accounting for 77 CPT events, were identified who would
      meet the study inclusion criteria. Scaling this up, data collection over a 12 month period
      would provide an approximate sample of 1144 patients and 4000 CPT treatments. Completing the
      data collection over a full year will avoid the impact of seasonal bias on the sample.

      Data Analysis The analysis will be completed using the R Project for Statistical Computing.
      Multilevel analysis will be used to investigate change in the physiological variables and
      allow risk modelling.

      Data Synthesis The findings of both work packages will be synthesised to determine
      similarities and disparities between the perceived risks of physiological instability and
      adverse events associated with CPT and those demonstrated by the objective data. Side by side
      comparison for merged data analysis will be used in a summary table and through visual data
      representation. This will clarify the new knowledge created and areas for service
      improvement.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Children across three intensive care units at a tertiary childrens hospital
      
Keywords: Chest physiotherapy; Paediatric intensive care unit; Physiological instability; Adverse events