Early detection and early intervention program in high-risk patients to avoid invasive long-term ventilation – Prevention of invasive ventilationPRiVENT – Health economic evaluation and process evaluatio

Recruiting

• Conditions: E66.01; E66.02; E10; E11; E12; E13; E14; prolonged weaning, prolonged invasive ventilation, weaning failure; J44; J84

• Registration Number: DRKS00028196
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Inclusion criteria for the health economic evaluation:

- Age = 30
- Invasively ventilated for = 96 h
- Alive 11 days after the day of intubation
- Insured with the statutory health insurance AOK Baden-Württemberg
- No evidence for a degenerative disease that would justify the need for an invasive ventilation

Inclusion criteria for the process evaluation:
INTERVIEWS

- Patients:
All patients who take part in the PRiVENT-study with oral German language skills and who sign the interview consent form

- Relatives:
All relatives of patients who take part in the PRiVENT-study with oral German language skills, aged 18 years or older who give their consent to be interviewed

- Healthcare professionals:
Healthcare professionals working in one of the participating weaning centres or intensive care units of the PRiVENT-study with oral German language skills are considered eligible if they are 18 years or older and agree to the interview

- Stakeholders:
Representatives of health insurance companies, self-help groups and politicians committed to health policy, who have oral German language skills, are 18 years or older and consent to take part in an interview

QUANTITATIVE SURVEYS

- Patients:
All patients who have written or oral German language skills and have themselves given consent to participate in the PRiVENT-study

- Healthcare staff:
All those involved in the care of patients who take part in the PRiVENT-study, i.e. doctors, nurses, respiratory therapists, physiotherapists, etc. working in one of the participating weaning centres or intensive care units, aged 18 years or older, who have written or oral German language skills, and agree to take part in the survey

Exclusion Criteria

All those who do not meet the above inclusion criteria will be excluded.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health economic evaluation: cost savings resulting from the successful PRiVENT-intervention; process evaluation: implementation of the PRiVENT-intervention as a whole and its individual components

Secondary Outcome Measures

Name	Time	Method
Health economic evaluation: The costs associated with the PRiVENT-intervention, direct health care costs of patients with long-term invasive ventilation, patients’ quality of life associated with invasive long-term ventilation as well as with a successful PRiVENT-intervention. Process evaluation: impact on healthcare professionals' job satisfaction and interprofessional collaboration, and PRiVENT patients' decision-making behavior, quality of life, activity levels, and hospital discharge experiences.