Outpatient treatment of Primary Spontaneous Pneumothorax (PSP) compared to usual inpatient management could improve quality of care and represent a more efficient, generalizable and sustainable strategy. This multicenter, cluster-controlled, randomized interventional study with stepped wedge implementation will evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
386
* Chest tube drainage in emergency department (Furhmann drain connected to Heimlich valve), connected to suction system at -5 to -10 cm H2O until bubbling stops * Follow-up imaging at 4 hours (chest X-ray or low-dose CT scan, depending on management practices in the centers) * if the pneumothorax is still very large, or if clinical tolerance is unsatisfactory (dyspnea, unrelieved pain, abnormal vital parameters), the patient should be admitted to hospital * if the lung is in the process of reattachment and a minimal detachment persists, and clinical tolerance is good (assessed on vital parameters, with oxygen saturation above 98%, good hemodynamic stability and pain relieved by analgesics), the patient may be discharged home.
Hospitalisation in a hospital department (pulmonology, thoracic surgery, short-stay emergency unit, critical care, according to the usual pathway of the center in which the patient is included). In-hospital monitoring until complete resolution of pneumothorax and drain removal (average 4-6 days).
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, France
Hôpital Pellegrin - CHU de Bordeaux
Bordeaux, France
CHU de Grenoble - Hôpital Michallon
La Tronche, France
Hôpital Saint Louis - AP-HP
Paris, France
Hôpital Universitaire Pitié Salpétrière AP-HP
Paris, France
Hôpital de la Milétrie - CHU de Poitiers
Poitiers, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Quality of life at 6 months
Evaluate the impact on quality of life (between inclusion, after drain placement, and 6 months) of an ambulatory strategy for the management of large abundance primary spontaneous pneumothorax in the emergency department, compared with usual care, using the Short Form (36) Health Survey (The lower the score the more disability)
Time frame: 6 months
Success rate of the strategy as measured by pulmonary expansion (lung reattachment on X-ray / CT scan) the latest by the investigator who performed the drainage procedure
Time frame: Day 6
Proportion of patients having benefited from an exclusive outpatient management (patients not requiring hospitalisation during the ambulatory approach)
Time frame: Day 6
Assessment of Pain
Pain assessed on a numerical scale (rated from 0 to 10), 0 being the lowest pain and 10 being the maximum pain
Time frame: Day 0, Day 2, Day 4, Day 6 and monthly
Assessment of Dyspnea according to the mMRC classification
mMRC classification (0 to 4), 0 being no discomfort and 4 shortness of breath for simple acts of daily living.
Time frame: Day 0, Day 2, Day 4, Day 6 and monthly
Complication rates (major and minor) in the 2 groups
* Minor (bleeding at insertion site, tube kinking, pain limiting inspiratory movements, subcutaneous emphysema, unsightly scar) * Major (hemothorax due to lesion of the vasculonervous bundle, bubbling (leakage) at the tube insertion site, accidental removal, perforation of an organ (lung, spleen, etc.), local abscess, iatrogenic pneumothorax on tube removal, pulmonary re-expansion edema).
Time frame: Day 2, 4, 6, 1 month and 1 year
Pneumothorax Recurrence Rate
Incidence of recurrence in both groups.
Time frame: at 1 year
Patient satisfaction assessed by SAPS (The Short Assessment of Patient Satisfaction) questionnaire
Time frame: Day 0, 1 month, 6 months and 1 year
Patient preference (coded from 0 to 5): ambulatory/non-ambulatory
Preference will be assessed as follows: Each patient will be asked to code their opinion of outpatient management from 0 to 5, and their opinion of inpatient management from 0 to 5, whatever their randomization group (0 being the worst opinion of the strategy, and 5 a very positive opinion of the strategy).
Time frame: Day 0, 1 month, 6 months and 1 year
Anxiety assessed by the State-Trait Anxiety Inventory (STAI)
Time frame: Day 0, 1 month, 6 months and 1 year.
Quality of life assessed by SF-36 (The Short Form (36) Health Survey)
Time frame: at 1 month and 1 year
Ambulatory strategy implementation criteria : Penetrance
Assesses how widely the device is deployed within a service and whether it is transferable to other contexts. Studied through focus groups with professionals on adoption, institutional changes, and scalability
Time frame: At 1 year
Ambulatory strategy implementation criteria : Acceptability
Represents how patients and healthcare professionals perceive the benefits and limits of the device in care and relationships. Evaluated through semi-structured interviews (patients' experiences) and focus groups (care practices)
Time frame: At 1 year
Ambulatory strategy implementation criteria : Appropriation
Concerns the perceived added value of the device in care management and patient-professional relations. Measured via interviews (perceived value/efficacy) and focus groups (use in ambulatory vs hospital care).
Time frame: At 1 year
Ambulatory strategy implementation criteria : Adoption
Refers to whether professionals and patients integrate or learn new practices with the device. Assessed by interviews on experiences and focus groups on care practices.
Time frame: At 1 year
Ambulatory strategy implementation criteria : Feasibility
Looks at the practical experience of using the device in daily care and the caregiver-patient relationship. Explored in focus groups with healthcare professionals discussing usability and practicality.
Time frame: At 1 year
Ambulatory strategy implementation criteria : Fidelity
Examines whether the device is applied as initially intended, and the perceived quality of its implementation. Assessed through focus groups reflecting on adherence to goals and strategies in care delivery.
Time frame: At 1 year
Ambulatory strategy implementation criteria : Cost of implementation
Considers the economic impact for patients and the health system (direct and indirect costs). Evaluated through quantitative patient data: hospital stays, readmissions, and insurance compensation.
Time frame: At 1 year
Ambulatory strategy implementation criteria : Durability
Relates to maintaining the device over time and integrating it into routine care across hospitals. Evaluated via interviews (patients' risk perception, care continuity) and focus groups (staff reflection on long-term use).
Time frame: At 1 year
Duration of emergency care in the 2 groups
Time frame: 1 year
Estimation of costs associated with each strategy
Total direct and indirect healthcare costs associated with each management strategy.
Time frame: at 1 year
Estimation of the difference in QALYs gained using a mixed model
Time frame: at 1 year
Incremental cost-utility ratio, defined as the difference in costs divided by the difference in utility estimated by the EQ-5D scores obtained by mapping from the SF-36
with a valuation of the scores obtained with the utilities published for the French population
Time frame: at 1 year
Budgetary impact of a national roll-out scenario for the ambulatory care strategy from the perspective of the French Health Insurance
Time frame: at 1 year
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