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Completed

NCT Number: NCT05092659

Patient Experience in Bariatric Surgery: Definition of New Indicators

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Intercommunal Créteil

Créteil, 94000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Patient interview

Behavioral

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

Primary outcomes

  1. patient experience of the care pathway

    Time frame: 6 months

    Explain the bariatric surgery care pathway, based on the patient experience

Secondary outcomes

  1. Questionnaire

    Time frame: 3 months

    Construction of a questionnaire based on the common meta-narrative

  2. Number of experiences collected

    Time frame: 3 months

    Number of complete patient experiences collected

  3. Repeat surgeries

    Time frame: 3 months

    Number of repeat surgeries for up to 3 months after surgery

  4. Repeat hospitalizations

    Time frame: 3 months

    Number of repeat hospitalizations for up to 3 months after surgery

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Acronym: CALEX

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2021
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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