Any ConditionssPREAdPertiNCT04908501
Health Care Appropriateness Assessment and Support Programme at a University Hospital Centre (CHU) in Bordeaux
An observational study of Any Conditions, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Conditions
- What is being tested?
- Intervention
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 7 Oct 2021to 19 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are 3 study populations in this trial: - Health care professionals : medical and paramedical staffs - Patients - Hospital stays
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Any Conditions
- Being tested
- Intervention
- Keywords
- (Health care) appropriateness, (Health care) programme assessment, e-feedbacks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Services of the non-transversal clinical departments of the Bordeaux University Hospital willing to participate to the programme. Receives: Other: Intervention | |
| Control group | Services of the non-transversal clinical departments of the Bordeaux University Hospital not willing to participate to the programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Primary outcome is assessed 14 months after the start of the intervention
Secondary outcomes (4)
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);
Measured: 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);
Measured: 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");
Measured: 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.
Measured: two months before and fourteen months after applying the programme in the first cluster.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start7 Oct 2021
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any ConditionsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908501
- Sponsor's protocol ID
- CHUBX 2019/65
- Acronym
- sPREAdPerti
- Status last verified
- Mar 2026
- First submitted
- 7 May 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Appropriateness Assessment and Support Programme at a University Hospital Centre (CHU) in Bordeaux
- ClinicalTrials.gov ID
- NCT04908501
- Acronym / sponsor ID
- sPREAdPerti / CHUBX 2019/65
- Conditions
- Any Conditions
- Keywords
- (Health care) appropriateness, (Health care) programme assessment, e-feedbacks
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Other: InterventionServices of the non-transversal clinical departments of the Bordeaux University Hospital willing to participate to the programme. |
| Control group | – | –Services of the non-transversal clinical departments of the Bordeaux University Hospital not willing to participate to the programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are 3 study populations in this trial: - Health care professionals : medical and paramedical staffs - Patients - Hospital stays
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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 | Other | Intervention group |
Primary outcome
Global proportion of patient stays appropriate regarding health cares concerned with feedback indicators available at the start of the trial.
Time frame: Primary outcome is assessed 14 months after the start of the intervention
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.
4 secondary outcomes
Appropriate stays proportion specific to each feedback indicator available at the start of the trial
Time frame: two months before and fourteen months after applying the programme in the first cluster.
Incidence density of serious adverse events
Time frame: two months before and fourteen months after applying the programme in the first cluster.
Dimension Scores of the Comet questionnaire
Time frame: two months before and fourteen months after applying the programme in the first cluster.
Work life satisfaction
Time frame: two months before and fourteen months after applying the programme in the first cluster.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Any Conditions
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
RecruitingPhase 1/2
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases
Leptomeningeal Metastasis
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingPhase 4
A Novel Two-Step Dosing Induction Strategy (The Propofol Challenge Test) to Minimize Propofol Injection Pain
Any Patient Under General Anesthesia With Propofol Induction
Active, not recruitingPhase 3
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Any Conditions, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global proportion of patient stays appropriate regarding health cares concerned with feedback indicators available at the start of the trial. (time frame: Primary outcome is assessed 14 months after the start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.