How To Use Non-Invasive Positive Airway Pressure In Pleural Effusion Drainage: Protocol For Implementation Multicentric Scientific Evidence With Audit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Rate of appropriateness of the treatment according to previous professional training
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for professionals:
- •Graduated physical therapists working in the sectors where patients with PE and chest drainage are hospitalized.
- •Inclusion Criteria for patients:
- •18 years or older
- •with pleural effusion diagnosed by the physician
- •undergo to chest drainage less than 24 hours earlier
排除标准
- •for professionals:
- •Physical therapists taking internships in these hospitals and physical therapists who fail to participate in at least one phase of the study will be excluded.
- •Exclusion Criteria for patients:
- •contraindications for the use of CPAP (such as drowsiness, restlessness, treatment refusal, hemodynamic instability, systolic blood pressure <90 mmHg, facial trauma, ineffective cough or swallowing impairment, vomiting, upper gastrointestinal bleeding, acute myocardial infarction in the past 48 hours or bullous emphysema).
结局指标
主要结局
Rate of appropriateness of the treatment according to previous professional training
时间窗: through study completion, an average of 1 years
Appropriateness will be evaluated through the perception of physical therapist about the adequacy of the use of CPAP for the treatment of patients with PE drained in the hospital environment.
Rate of sustainability of professional training
时间窗: through study completion, an average of 1 years
Sustainability will be assessed by the Level of Institutionalization scales for health promotion programs proposed by Goodman et al.
Rate of adherence to treatment by patients and by professionals
时间窗: through study completion, an average of 1 years
Adherence will be assessed by the level of satisfaction of the treatment with CPAP use among the participants (patients and professionals).
Treatment direct costs
时间窗: through study completion, an average of 1 years
Treatment costs will be estimated based on the informed daily hospital fees, antibiotics use, physiotherapy session, equipment and accessories for the use of CPAP during the hospitalization period of each patient.
Penetration of professional training
时间窗: through study completion, an average of 1 years
Service access the integration of the use of CPAP in the treatment of chest drained for pleural effusion within the hospital service and its subsystems will be assessed by the following operation: Total number of people with any contact with the service during the year (number of eligible persons who use a service), divided by Total eligible persons at some point during the year (total number of persons eligible for the service)14. This penetration (annual penetration) is the most used in research because it is very easy to perform
Rate of treatment feasibility
时间窗: through study completion, an average of 1 years
Feasibility will be evaluated through the success or unsuccess of the use of noninvasive positive pressure in the treatment of drainage drainage within the hospital environment. Successful viability will be determined if there is a decrease in adverse effects, pulmonary complications, and need for antibiotics, and increased tolerance of CPAP use.
次要结局
- Chest drainage duration(through study completion, an average of 1 years)
- Hospitalization duration(through study completion, an average of 1 years)
- Rate of need for antibiotics therapy(through study completion, an average of 1 years)
- Level of tolerance of noninvasive positive pressure use(through study completion, an average of 1 years)
- Rate of pulmonary complications(through study completion, an average of 1 years)
- Pain level of the patient: visual analog scale(through study completion, an average of 1 years)
- Rate of adverse effects(through study completion, an average of 1 years)
研究者
Adriana Claudia Lunardi
Principal Investigator
Universidade Cidade de Sao Paulo