Clinical Implementation of the Use of Positive Pressure in Chest Drainage
Condition: Pleural Effusion
MeSH terms: Pleural Effusion
Study type: Interventional

Summary: 
      Background: Scientific evidence appoints that the use of non-invasive positive airway
      pressure in pleural effusion drainage patients is associated with a reduction in these
      complications, as well as with other benefits. Objectives: To test the implementation of the
      best evidence-based practices for the use of non-invasive continuous positive airway pressure
      (CPAP) in patients with chest drainage for pleural effusion, by acceptability, reach,
      appropriateness, direct costs, feasibility, fidelity, penetration, and sustainability. In
      addition, to assess the impact of implementing these practices on health-related outcomes of
      patients having their pleural effusion drained through dwelling time of the chest tube,
      hospital stay and others relevant outcomes. Methods: quasi-experimental study with
      pretest-posttest design. Eight hospitals that provide physiotherapeutic care to pleural
      effusion drainage patients will be involved. The study will be developed in three phases. In
      phase I, a audit team will help the local research team to elaborate strategies to cope with
      barriers related to the use of CPAP in patients with pleural effusion and catheter drainage,
      using a interview with the physical therapist, patient history analysis, and interviews with
      the patients. In implementation phase, the results obtained from phase I will be presented to
      physiotherapists to physiotherapists and a discussion will be started on the evidence
      regarding the best practices in the application of CPAP for educational purposes only. In
      phase III, new interviews will be held with the physical therapist and patients and the
      patient histories will be analyzed to assess the impact of the intervention 30 days after
      implementation phase.
    

Detailed description: 
      Design: Effectiveness-implementation hybrid designs, type 3 (primary focus on implementation;
      secondary focus on effectiveness).

      Study setting and Participants: Seven hospitals in Brazil and one in Belgium will be included
      in the study. The investigators will invite physical therapists working in sectors where
      patients with pleural effusion and chest tube are hospitalized and the patients themselves to
      participate in this study.

      Study design: The study will be developed in three phases:

        -  Pre-audit and baseline audit (Phase I)

        -  Transfer of best practices (Phase II)

        -  Post-intervention audit (Phase III) a. Pre-audit and baseline audit phase: the purpose
           of this phase will be to establish the audit team that will discuss the inclusion of
           health professionals and patients in the study. The audit team will be composed of two
           local members selected from researchers, clinical director, administrative director,
           technical director, coordinator, or head of physiotherapy/rehabilitation unit-department
           in each hospital. As a way to increase physical therapists' participation, the audit
           team of each hospital will be responsible for the intervention (Phase II - Transfer
           phase of best practices).

      The audit team will check the current local physiotherapeutic practices in the use of
      Continuous Positive Airway Pressure (CPAP) in patients with pleural effusion drainage
      exclusively based on scientific evidence and evaluation of the feasibility of measuring the
      proposed outcomes. In addition, the team will try to identify the possible barriers to be
      faced in previously scheduled meetings, for example, institutional routines and availability
      of resources. This audit team can help the research team to develop strategies for coping
      with these barriers through a structured interview with physical therapists (including
      questions regarding sociodemographic issues, use of CPAP therapy, physiotherapeutic visits,
      number of visits and physiotherapeutic techniques) as well as with pleural effusion patients
      (including questions on the use of therapies applied by the physical therapist, number of
      daily physiotherapeutic visits, level of tolerance to the use of CPAP, level of satisfaction
      with physical therapy and level of pain) or by another feasible form discussed at the time.
      The collection of information from the physiotherapists, patients and medical records
      simultaneously aims to verify the consistency of the information and the measuring of the
      outcomes prior to the intervention through historical control.

      Audit criteria:

      Previously established criteria listed below:

        1. Increase in: adherence, adoption, appropriateness, fidelity, tolerability of
           non-invasive positive pressure treatment, and level of participant satisfaction with
           treatment.

        2. Reduction in: dwelling time of thoracic tube, length of hospital stay, pulmonary
           complication rate, need for antibiotic therapy, treatment costs, pain level of the
           patient before and immediately after treatment, and adverse effects.

      Baseline evaluation of outcomes and physiotherapeutic practices with CPAP use in patients
      with pleural effusion and chest tube:

      Before the transfer of best practices (Phase II), the outcomes of interest established in the
      audit criteria will be discussed and confirmed by the audit team, and the clinical practices
      used by the physical therapist will be identified through interviews, as well as the
      patients' reports.

      In order to assess the efficiency of the implementation process, medical records of patients
      included in this study will be compared to a historical cohort, i.e. medical records of
      patients with PE that have been hospitalized in the previous 6 months will be retrieved and
      compared.

      The following information will be collected from the patient medical records:

        -  Tolerability of CPAP treatment

        -  Dwelling time of thoracic tube

        -  Length of hospital stay

        -  Presence of pulmonary complication

        -  Use of antibiotics therapy

        -  Estimate of treatment costs (information that can help in the estimation of costs are,
           among others: materials and medicines used, hotel, length of stay)

        -  Presence of adverse effects (aerophagia and pleural or bronchopleural fistula)

        -  Number of physiotherapy sessions

        -  Physiotherapy techniques applied to patients

           b. Transfer phase of best practices: will also be called the intervention phase. This
           phase will present to the physical therapists the results extracted from phase I,
           besides raising a discussion on the best evidence available with mere educational goals.
           For this intervention, educational materials (seminars, posters, and newsletters),
           educational outreach activities (interactive face-to-face instruction, workshops,
           roundtable, and discussion committee), reminders (posters, stickers, and buttons) and
           messages by electronic media will be used, during an event with the same approaches for
           each hospital, i.e. continuing education. All approaches will be carried out as
           homogeneously as possible in all hospital settings to minimize bias.

      A full CPAP kit (Müller Resuscitator, Engesp, Brazil) will be donated to each hospital if it
      is not available onsite. Each kit contains 1 injector, 1 vaporizer, 1 "T" connection, 1
      manual valve, 1 oxygen pressure regulator, 2 face masks for inhalation with inflatable
      cushion, 1 head attachment gear for the mask. In addition, training will be offered on the
      use of the device.

      c. Post-intervention audit phase: all the criteria for inclusion will be maintained in this
      phase and a new interview will be held with the same physical therapists and patients that
      have been involved in phase I. Furthermore, medical records of patients and the historical
      cohort will be analyzed and compared to evaluate the impact of the intervention. This phase
      will take place 30 days after the end of the second phase, based on a recent study13. In
      addition, in another study, it was also suggested that this phase can also be started 30 days
      after the end of the second phase14.

      The new structured interview with the physical therapists will occur only once in each phase
      I and phase III, through a structured form face-to-face or by other communication media, such
      as email, telephone, or any other means that is convenient for the professional. This will
      take place in the hospital, office, home or other place and time at the physical therapist's
      convenience.

      The interview with the patients (who have already received or are receiving physical therapy,
      in order to check what has been done in their physiotherapeutic treatment) will be held by
      means of a structured form, face-to-face or using other communication media, such as e-mail,
      telephone, or any other means that is convenient for the patient. The interview will be
      applied at three different moments. First, within 24 hours after the insertion of chest drain
      in the hospital. Second, between 10 and 12 days after the drainage tube has been inserted
      (please correct if I am wrong) and only for the variables infection and pain level. Third, 30
      days after the drainage. The two latter interviews will take place in the hospital, office,
      home or other place and time at the patient's convenience.
    

Intervention name(s): Continuous Positive Airway Pressure
Intervention type(s): Device
Intervention description(s): Continuous Positive Airway Pressure will be applied three times daily during 7 consecutive days, if the physiotherapist follow the previous training. Each application should during 30 minutes. Pressure should be adjusted in 15 centimeters of water.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Clinical Practice Based on Scientific Evidence; Non-Invasive Positive Airway Pressure; Pleural effusion; Chest drain; Physical therapy