Ignite Creation Date:
2024-05-06 @ 12:58 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03896672
Status:
COMPLETED
Last Update Posted:
2023-07-03
First Post:
2019-03-15
Brief Title:
Clinical Implementation of the Use of Positive Pressure in Chest Drainage
Sponsor:
Universidade Cidade de Sao Paulo
Organization:
Universidade Cidade de Sao Paulo
Study Overview
Official Title:
How To Use Non-Invasive Positive Airway Pressure In Pleural Effusion Drainage Protocol For Implementation Multicentric Scientific Evidence With Audit
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 physiotherapyrehabilitation 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 ie 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 ie 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 therapists 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 patients convenience
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 physiotherapyrehabilitation 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 ie 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 ie 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 therapists 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 patients convenience
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None