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Post-surgical Patient Experience: Definition of New Indicators (CALEX)

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ClinicalTrials.gov Identifier: NCT05092659
Recruitment Status : Not yet recruiting
First Posted : October 25, 2021
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Brief Summary:
The success of a surgical intervention is evaluated by different indicators: survival, functional after-effects, regression of the clinical signs that led to the intervention, rate of re-operation or re-hospitalization, etc. However, the success of an intervention and, more generally, the quality of care are complex notions that include several aspects: technical, human, narrative, relational, ethical and systemic aspects. Thus, quantitative criteria are very useful and reliable indicators, but they must be integrated into a more global vision. In particular, quality of care is not perceived in the same way by caregivers, patients and their families. The integration of the patient experience in the design and implementation of quality indicators opens new perspectives for reflection and action. For example, patient-tracer questionnaires, which make it possible to evaluate the patient's experience after the fact, have been developed by the High Authority for Health (HAS) and are now part of the quality indicators in hospitals. Some studies have adopted a qualitative approach to collect the patient's experience after surgery. However, there is currently no questionnaire based on the patient's experience evaluating the success of a surgical procedure. The objective of this work will be to report meta-narratives based on patients' experiences and in a second step to build a quality questionnaire of the surgical pathway focused on patients' needs.

Condition or disease Intervention/treatment Phase
General Surgery Behavioral: Patient interview Not Applicable

Detailed Description:
The success of a surgical intervention is evaluated by different indicators: survival, functional after-effects, regression of the clinical signs that led to the intervention, rate of re-operation or re-hospitalization, etc. However, the success of an intervention and, more generally, the quality of care are complex notions that include several aspects: technical, human, narrative, relational, ethical and systemic aspects. Thus, quantitative criteria are very useful and reliable indicators, but they must be integrated into a more global vision. In particular, quality of care is not perceived in the same way by caregivers, patients and their families. The integration of the patient experience in the design and implementation of quality indicators opens new perspectives for reflection and action. For example, patient-tracer questionnaires, which make it possible to evaluate the patient's experience after the fact, have been developed by the High Authority for Health (HAS) and are part of the quality indicators in hospitals. Some studies have adopted a qualitative approach to collect the patient's experience after surgery. However, there is currently no questionnaire based on the patient's experience evaluating the success of a surgical procedure. The objective of this work will be to report meta-narratives based on patients' experiences and in a second step to build a quality questionnaire of the surgical pathway focused on patients' needs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Post-surgical Patient Experience: Definition of New Indicators
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Arm Intervention/treatment
patient interviews
Patient enrolled in a carcinological (group 1), bariatric (group 2) or non-bariatric non-carcinological (group 3) surgical pathway scheduled for visceral surgery.
Behavioral: Patient interview
Each patient included will be interviewed between 2 and 6 times in the 3 months following surgery in order to narrate his or her care pathway




Primary Outcome Measures :
  1. patient experience of the care pathway [ Time Frame: 3 months ]
    report of the patient experience based on at least 3 interviews


Secondary Outcome Measures :
  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

  4. Repeat hospitalizations [ Time Frame: 3 months ]
    Number of repeat hospitalizations for up to 3 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major patient
  • Patient enrolled in a carcinological (group 1), bariatric (group 2) or non-bariatric non-carcinological (group 3) surgical pathway scheduled for visceral surgery.

Exclusion Criteria:

  • Refusal to participate
  • Non proficiency in spoken French
  • Protected persons (patients under guardianship, pregnant or breastfeeding women, persons deprived of liberty, persons unable to express their non-objection)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05092659


Contacts
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Contact: Andréa LAZZATI 0145175000 ext +33 Andrea.lazzati@chicreteil.fr
Contact: Camille JUNG 0145175000 ext +33 camille.jung@chicreteil.fr

Locations
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France
Centre Hospitalier Intercommunal Créteil
Créteil, France, 94000
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT05092659    
Other Study ID Numbers: CALEX
2021-A02161-40 ( Other Identifier: ID-RCB )
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No