Orthopaedic SurgeryHiRisP3NCT03481439
Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication
An observational study of Orthopaedic Surgery and Traumatology, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department. The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopaedic Surgery, Traumatology
- What is being tested?
- Collection of a Pharmaceutical intervention
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2018to 15 Jun 2018
- 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: Adult patient hospitalized in the department of orthopaedic surgery and traumatology on university hospital of Montpellier
Who may be able to join
- Subject aged over 18 years
- Subject hospitalized in the department of orthopaedic surgery and traumatology on university hospital of Montpellier.
Who cannot join
- Vulnerable persons according to French law (pregnant women, adults under guardianship, persons deprived of liberty)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Medication Safety: Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication
The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department.
The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.
Read the detailed description
Pharmaceutical means for clinical pharmacy activities and pharmaceutical analysis are limited. Several methods can be used to increase the efficiency of resources allocated to clinical pharmacy activities. We hypothesize that highlighting patients at risk for iatrogenic drug events (ADEs) by applying a predictive score of ADE could be a way to increase the efficiency of clinician pharmacist interventions.
- Assumption (s) and objective (s) The use of a predictive score of ADE in hospitalized patients in orthopedic surgery would make it possible to prioritize clinical pharmacy actions according to the resources allocated. The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department. The secondary objective is to evaluate its superiority over other predictive models such as the age or the Physical Status Score physical status score used by anesthetists.
- Methodology The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions (NPS) using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.
- Expected results and prospects The usefulness of clinical pharmacy activities is now demonstrated, however an improvement in their efficiency is needed. The prospects are the integration of the risk score in the dispensing assistance software connected to the computerized patient record as well as extending the score to other types of surgery.
- Conditions
- Orthopaedic Surgery, Traumatology
- Being tested
- Collection of a Pharmaceutical intervention
- Keywords
- Pharmacist, Led medication review, Orthopaedic surgery, Traumatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of a Pharmaceutical interventionOther
collection of pharmaceutical interventions carried out by the pharmaceutical team in the care uni in Primary and secondary cohort
| Study group | Role | What they receive |
|---|---|---|
| Primary cohort | Primary cohort : Cohort of patient between January and February 2017 Receives: Other: Collection of a Pharmaceutical intervention | |
| Secondary cohort | Secondary cohort : Cohort of patient between February and March 2018 Receives: Other: Collection of a Pharmaceutical intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major clinical impact pharmaceutical intervention
Occurrence of a major clinical impact pharmaceutical intervention according to the CLEO scale
Measured: 1 day
Secondary outcomes (1)
pharmaceutical intervention
Occurrence of a pharmaceutical intervention
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start13 Feb 2018
- Primary completion13 Mar 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre RENAUDIN, Pharm D, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481439
- Sponsor's protocol ID
- RECHMPL18_0134
- Acronym
- HiRisP3
- Status last verified
- Mar 2018
- First submitted
- 22 Mar 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not determined
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Safety: Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication
- ClinicalTrials.gov ID
- NCT03481439
- Acronym / sponsor ID
- HiRisP3 / RECHMPL18_0134
- Conditions
- Orthopaedic Surgery, Traumatology
- Keywords
- Pharmacist, Led medication review, Orthopaedic surgery, Traumatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 29 Mar 2018 (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.
The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department.
The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.
Detailed description
Pharmaceutical means for clinical pharmacy activities and pharmaceutical analysis are limited. Several methods can be used to increase the efficiency of resources allocated to clinical pharmacy activities. We hypothesize that highlighting patients at risk for iatrogenic drug events (ADEs) by applying a predictive score of ADE could be a way to increase the efficiency of clinician pharmacist interventions.
- Assumption (s) and objective (s) The use of a predictive score of ADE in hospitalized patients in orthopedic surgery would make it possible to prioritize clinical pharmacy actions according to the resources allocated. The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department. The secondary objective is to evaluate its superiority over other predictive models such as the age or the Physical Status Score physical status score used by anesthetists.
- Methodology The study is an prospective, observational, cohort trial. A first step will consist of: (i) a collection of PIs carried out in an orthopedic and traumatological surgery department for 1 month, (ii) a score of the clinical impact of Pharmacist Interventions (NPS) using the Clinical, Econnomic and organisationnal scale by method of consensus and (iii) a statistical analysis. Statistical analysis consists of (i) logistic regression modeling, (ii) performance measurement by discrimination and calibration, and internal validation by resampling. In a second step, external validation using a new sample will be performed.
- Expected results and prospects The usefulness of clinical pharmacy activities is now demonstrated, however an improvement in their efficiency is needed. The prospects are the integration of the risk score in the dispensing assistance software connected to the computerized patient record as well as extending the score to other types of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary cohort | – | Other: Collection of a Pharmaceutical interventionPrimary cohort : Cohort of patient between January and February 2017 |
| Secondary cohort | – | Other: Collection of a Pharmaceutical interventionSecondary cohort : Cohort of patient between February and March 2018 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient hospitalized in the department of orthopaedic surgery and traumatology on university hospital of Montpellier
Key inclusion criteria (2 listed)
- Subject aged over 18 years
- Subject hospitalized in the department of orthopaedic surgery and traumatology on university hospital of Montpellier.
Key exclusion criteria (1 listed)
- Vulnerable persons according to French law (pregnant women, adults under guardianship, persons deprived of liberty)
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 |
|---|---|---|
| Collection of a Pharmaceutical interventioncollection of pharmaceutical interventions carried out by the pharmaceutical team in the care uni in Primary and secondary cohort | Other | Primary cohort, Secondary cohort |
Primary outcome
Major clinical impact pharmaceutical intervention
Time frame: 1 day
Occurrence of a major clinical impact pharmaceutical intervention according to the CLEO scale
1 secondary outcome
pharmaceutical intervention
Time frame: 1 day
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 15 Oct 2018.
- Individual participant dataSharing planned: Undecided. Not determined
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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.
Pierre RENAUDIN, Pharm D study director
University Hospital, Montpellier
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 Orthopaedic Surgery and Traumatology, run by University Hospital, Montpellier 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 2 inclusion and 1 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 15 Oct 2018. 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?
Major clinical impact pharmaceutical intervention (time frame: 1 day). 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 15 Oct 2018.