Health Care Appropriateness Assessment and Support Programme at a University Hospital Centre (CHU) in Bordeaux (sPREAdPerti)

Non-appropriateness of care is a common and serious phenomenon that affects healthcare institutions in France. Appropriateness in health care is about adequacy of any type of health care with patient's needs. Relying on structuring innovative tools, the hospital university centre of Bordeaux is implementing a health care appropriateness assessment and support programme ("sPREAd pertinence").

By using a mixed method, the project's main objective is to evaluate programme effectiveness on the improvement of care appropriateness in hospital university centre of Bordeaux. Other assessments are considering impact on: specific care appropriateness indicators, care related adverse events frequency, organizational climate, and work life satisfaction. The economic impact of this program in terms of induced costs and avoided costs will be evaluated. A qualitative approach will be used to identify the programme transferability conditions with a view to produce an Operational Model for the Implementation of Appropriateness at a Healthcare Institution.

Study Overview

• Status: Recruiting
• Conditions: Any Conditions
• Intervention / Treatment: Other: Intervention

Detailed Description

Non-appropriateness of care is a common and serious phenomenon that affects healthcare institutions in France. Appropriateness in health care is about adequacy of any type of health care with patient's needs. It means that a health care is necessary and relevant, given a specific indication, with regard to updated practice recommendations or justifications of experts.

The hospital university centre of Bordeaux is making Health care appropriateness a policy priority. Relying on structuring innovative tools, it is implementing a health care appropriateness assessment and support programme ("sPREAd pertinence"). This programme comprises two parts, one regarding interventional aspects and the other concerning assessments.

sPREAd-Pertinence programme's objectives Project's primary objective is to evaluate programme effectiveness on the improvement of care appropriateness in hospital university centre of Bordeaux.

Project's secondary objectives are :

• to assess impact on specific care appropriateness indicators, care related adverse events frequency, organizational climate and work life satisfaction.
• to evaluate the actual use of GAP.
• to measure the costs of implementing the sPREAD Perti program and to identify the additional costs incurred in comparison with the mobilization and support approach to care appropriateness already existing at the Bordeaux University Hospital;
• to compare the costs of the program with the consequences observed in terms of specific care appropriateness improvement, changes in serious adverse events frequency, organizational work climate and work life satisfaction;
• to estimate, if necessary, in terms of avoided costs, the reduction of serious adverse events frequency.

• to identify, using a qualitative approach:

  • The determinants of programme acceptability and efficiency
  • The appropriation by professionals of the mobilization and support program
  • The impact of the program on professional practices: changes in practices and perceived effectiveness
  • The conditions for programme transferability with a view to producing an Operational Model for the Implementation of Appropriateness at a Healthcare Institution Study design The project is based on a mixed method approach. Study design for the quantitative part is a Stepped-Wedge cluster randomized controlled trial, completed by a control group not receiving the intervention. The clusters are the clinical services of the Bordeaux University Hospital. Up to six volunteer clinical services will be randomly selected to determine the order in which they will start the implementation of the intervention. A control group will be made up of clinical services that meet the inclusion criteria and do not belong to the group of six participating services. The control group will receive the usual support for improving the appropriateness of care.

Qualitative section of the project will analyse the mechanisms of program effectiveness using an exploratory approach based on semi-structured interviews and direct observations of PAG.

Global proportion of patient stays appropriate regarding health cares concerned with feedback indicators available at the start of the trial.

• Study Type: Observational
• Enrollment (Anticipated): 6

Contacts and Locations

• Study Contact: Name: Florence SAILLOUR-GLENISSON, Dr; Phone Number: 05 57 57 46 40; Email: florence.saillour@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • CHU de Bordeaux
    • Contact: Florence SAILLOUR, Dr; Phone Number: 05 57 57 46 40; Email: florence.saillour@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

There are 3 study populations in this trial: - Health care professionals : medical and paramedical staffs - Patients - Hospital stays

Description

Inclusion Criteria:

• Services: services of the non-transversal clinical departments of the Bordeaux University Hospital.
• Health professionals: Medical and paramedical professionals working during the day or night in the participating services for at least one month and at least one day per week.
• Patients: Stays of patients hospitalized at the Bordeaux University Hospital benefiting from care targeted by the automated indicators and made available by the feedback system at the start of the trial.

Exclusion Criteria:

• Services of the transversal and medico-technical departments (Medical Imaging department, Biology and Pathology department, Health Products department, Public Health department and Anesthesia-Intensive care department) and department with specific activity.
• Professionals: planning to be absent during the data collection period.
• Patients: none

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention group; Services of the non-transversal clinical departments of the Bordeaux University Hospital willing to participate to the programme.	Other: Intervention; The program intervention has three focuses : the prioritization of appropriateness indicators, the automation and visualization of the prioritized indicators, and support for practice analysis groups (PAG) based on e-feedback from automated indicators
Control group; Services of the non-transversal clinical departments of the Bordeaux University Hospital not willing to participate to the programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global proportion of patient stays appropriate regarding health cares concerned with feedback indicators available at the start of the trial.	This proportion is calculated by dividing the number of appropriate patient stays for all indicators corresponding to targeted health care by the number of patients who received targeted health care for at least one of the indicators.	Primary outcome is assessed 14 months after the start of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate stays proportion specific to each feedback indicator available at the start of the trial	Appropriate stays proportion specific to each feedback indicator available at the start of the trial is calculated as the number of stays appropriate according to the indicator (numerator) over the number of stays concerned by the indicator (denominator);	two months before and fourteen months after applying the programme in the first cluster.
Incidence density of serious adverse events	Incidence density of serious adverse events measured by a specific data collection in each service using the questionnaires tested in the two France National Surveys on Adverse Events in Healthcare (ENEIS 1 and ENEIS 2);	two months before and fourteen months after applying the programme in the first cluster.
Dimension Scores of the Comet questionnaire	Dimension Scores of the Comet ("Contexte Organisationnel et Managérial en Etablissement de santé" / Organizational and Managerial Context in Healthcare Establishments) questionnaire measuring the Organizational Climate (for each dimension, proportion of professionals giving the answers "completely agree" or "agree");	two months before and fourteen months after applying the programme in the first cluster.
Work life satisfaction	Work life satisfaction score measured by the validated ESVP ("Echelle de Satisfaction globale de Vie Professionnelle" / global professional life satisfaction scale) questionnaire. It consists of 5 items and assesses the overall satisfaction of individuals with their work life. This score is calculated by summing the responses to each of the 5 items. The answers materialize a position on a scale of agreement going from "1" (Not at all in agreement) to "7" (Totally in agreement). The possible range of scores on this scale can thus oscillate from 5 (low satisfaction) to 35 (high satisfaction). The higher the score, the greater the perceived satisfaction with work life.	two months before and fourteen months after applying the programme in the first cluster.

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: (Health care) appropriateness; (Health care) programme assessment; e-feedbacks
• Other Study ID Numbers: CHUBX 2019/65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No