Patient Experience in Bariatric Surgery: Definition of New Indicators

Bariatric Surgery Clinical Trial

— CALEX  

Official title:

Patient Experience in Bariatric Surgery: Definition of New Indicators

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092659
• Other study ID #: CALEX
• Secondary ID: 2021-A02161-40
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: March 28, 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Marina VIGNOT
• Phone: 0157022838
• Email: marina.vignot[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Given the growing importance of placing the patient at the heart of care evaluation, the use of patient questionnaires such as Patient Reported Experience Measures (PREMS) or Patient-Reported Outcome Measures (PROMS) has become widespread in recent years. PROMS assess the outcomes of care, whereas PREMS assess the patient's experience of care. However, these tools only imperfectly reflect the patient's experience and only answer specific questions: satisfaction, pain management, waiting times, etc.

Patients undergoing bariatric surgery will undergo major surgery that will have an impact on their subsequent quality of life. Preparing for this surgery is a lengthy process, involving various forms of support: psychological, nutritional, physical activity, and so on. Exploring patients' experiences in depth, based on their account of their care experience, can enable carers to better understand and apprehend this type of journey from a perspective closer to that of the patient.

Description:

Given the growing importance of placing the patient at the heart of care evaluation, the use of patient questionnaires such as Patient Reported Experience Measures (PREMS) or Patient-Reported Outcome Measures (PROMS) has become widespread in recent years. PROMS assess the outcomes of care, whereas PREMS assess the patient's experience of care. However, these tools only imperfectly reflect the patient's experience and only answer specific questions: satisfaction, pain management, waiting times, etc. Other initiatives, such as the patient tracer (https://www.has-sante.fr/jcms/c_2807803/fr/patient-traceur), involve interviewing patients and, where appropriate, their relatives about their care by asking them specific questions about their care, such as the information they have received, the therapeutic workshops they have attended, etc. However, all these attempts to put the patient at the centre of the evaluation of the quality of care are still based on quality questions or indicators defined a priori by healthcare professionals and the health authorities.

Patients undergoing bariatric surgery will undergo major surgery that will have an impact on their subsequent quality of life. Preparing for this surgery is a lengthy process, involving various forms of support: psychological, nutritional, physical activity, and so on. Exploring patients' experiences in depth, based on their account of their care experience, can enable carers to better understand and apprehend this type of journey from a perspective closer to that of the patient.

The narrative inquiry method enables patients' unique experiences to be collected and co-constructed with the help of interviewers. In addition, this qualitative approach focuses not only on the experience of individuals, but also on the social and cultural aspects in which they are embedded, enabling a more global and less reductive approach to the patient experience.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: March 28, 2025
• Est. primary completion date: March 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major patient

• Patient enrolled in a bariatric surgical pathway scheduled.

• First bariatric surgery

Exclusion Criteria:

• Refusal to participate

• Non proficiency in spoken French

• Previous bariatric surgery

• Protected persons (patients under guardianship, pregnant or breastfeeding women, persons deprived of liberty, persons unable to express their non-objection)

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

Behavioral:
• Patient interview
Each patient included will be interviewed 3 times : before surgery, 3 and 6 months after surgery

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient experience of the care pathway	Explain the bariatric surgery care pathway, based on the patient experience	6 months
Secondary	Questionnaire	Construction of a questionnaire based on the common meta-narrative	3 months
Secondary	Number of experiences collected	Number of complete patient experiences collected	3 months
Secondary	Repeat surgeries	Number of repeat surgeries for up to 3 months after surgery	3 months
Secondary	Repeat hospitalizations	Number of repeat hospitalizations for up to 3 months after surgery	3 months