Orthopedic SurgeryPTHJ-8NCT02771041
Assessment of the Influence of Early Preoperative Consultation on Satisfaction and the Average Length of Stay of Patients Who Underwent Total Hip Arthroplasty
A study testing medical consultation 8 days before surgery in people with Orthopedic Surgery, run by Fondation Hôpital Saint-Joseph.
Trial summary
Arthroplastic hip surgery "fast-track" the subject of increasing interest and reduces the average length of stay and improve patient satisfaction. This fast circuit implemented in many schools uses dedicated inpatient units, preoperative patient education in multidisciplinary groups (including physiotherapists… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery
- What is being tested?
- medical consultation 8 days before surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2015to 1 May 2016
- Phase
- Interventional
- 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
Who may be able to join
- 1. All patients undergoing total hip replacement
Who cannot join
- Patient choosing immediately a supported SSR in postoperative
- Geographical remoteness
- Social isolation
- Medical pathology requiring special monitoring (phlebitis history, coagulation disorders, anticoagulant therapy ...)
- psychiatric pathology
- Patients opting for the protocol "overnight"
About this study
Official title: Prospective Randomized Assessment of the Influence of Early Preoperative Consultation on Satisfaction and the Average Length of Stay of Patients Who Underwent Total Hip Arthroplasty
Arthroplastic hip surgery "fast-track" the subject of increasing interest and reduces the average length of stay and improve patient satisfaction. This fast circuit implemented in many schools uses dedicated inpatient units, preoperative patient education in multidisciplinary groups (including physiotherapists, nurses, rehabilitation doctors and surgeons), an analgesia protocol multimodal and a network dedicated to the outlet (1.2).
The investigators working hypothesis is that the mere realization of a preoperative visit a week before the intervention would reduce the average length of stay for all patients with a target of two nights (instead of 7.5 days currently) (3) to reduce the use of SSR during hospitalization. This consultation would serve to explain to the patient the early course of care, give advice and help to anticipate acts for its release "post-operative" as, for example, contact a physical therapist and a nurse or check to their community pharmacy if their heparin stock is enough and to answer any questions (Appendix 2: early information given to the patient consultation J-8).
The investigators protocol is inspired by the one already in place for outpatient PTH and PTH 1 night but invariably apply to all patients for whom a home is considered output.
Read the detailed description
- Objectives
- Primary Objective Influence of preoperative consultation to "D-8" on the average length of stay of a randomized series multi-operator.
- Secondary objectives
- Evaluation of patient satisfaction and clinical status 2. Evaluation of the analgesic consumption 3. Evaluation of complications
- Population concerned
- Inclusion Criteria All patients undergoing total hip replacement
- Exclusion criteria
- Patient choosing immediately a supported SSR in postoperative 2. Geographical remoteness 3. Social isolation 4. Medical pathology requiring special monitoring (phlebitis history, coagulation disorders, anticoagulant therapy ...) 5. psychiatric pathology 6. Patients opting for the protocol "overnight"
- Methodology and duration of the research This will be a prospective mono-centric multi-operator on the assessment of the management of patients in the surgical practice referred to above.
The inclusion of patients will take place over a period of 12 months, the goal is to include 90 patients (Figure 1).
Justification of Sample Size In 2013, for patients operated in a planned way, and with degenerative osteoarthritis, the length of stay was 7.5 days with a standard deviation of 3 days.
With such a length of stay, a staff of 2 to 45 subjects will detect a difference in length of stay of at least 1.8 days (significance level of 5%, 80% power). Such a difference is reasonably possible with the proposed organizational intervention.
Early preoperative consultation will be proposed to the randomized patient. When the patient is included in the group studied, it will be presented during the preoperative consultation early an information document with advice and guidance for patients to anticipate acts provided for its release "post-operative" (cf. . Appendix 2: patient information delivered early consultation J-8). This consultation will educate patients about what will happen when they leave, specifying concretely how their articulation with the city and the various professionals involved will have been planned and respond to all the issues raised.
Data collection Clinical data will be collected anonymously by an internal orthopedic surgery service for all patients included in the study by the realization of the Oxford hip score before the intervention (J-1), an assessment of pain through verbal validated scale (VAS), of St Joseph satisfaction questionnaire (validated questionnaire Saphora) accompanied by a verbal scale patient discharge and a telephone call 30 days after surgery to achieve again the Oxford hip score, evaluation of pain by VAS and patient satisfaction by simple verbal scale (see Annex 1) (4).
The criteria for hospital discharge are:
- Clinically: clean dressing, no fever, no comorbidity decompensation, EVA <4 with analgesics.
- Biologically: Hemoglobin> 10.
- Functionally: 3 steps climbing ability, ability to walk twenty meters and to go to the bathroom alone.
The assessment criteria will be used:
Primary endpoint:
- Average length of stay
Criterion of secondary judgments:
- Score Oxford Hip before and after the intervention
- Patient satisfaction (verbal scale: 0 to 10) before and after the intervention
- St. Joseph Satisfaction Questionnaire (validated questionnaire Saphora)
- Evaluation of pain by VAS before and after the intervention
- Morbidity and mortality randomization: Randomization in the 2 groups (usual care without consultation with J-8 versus consultation with J-8) will be carried by the patient. The patient list will be balanced by randomly alternating blocks. orthopedic service personnel will not be notified in advance of schedule to avoid a bias in the management of patients with the service.
Data processing :
For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data.
Statistical analysis :
To find and test differences, univariate analyzes will use the test t-Student for continuous variables and the chi of 2 for categorical variables or their nonparametric equivalents. The significance level was set at p <0.05. If imbalance groups, a multivariate model is developed
- Conditions
- Orthopedic Surgery
- Being tested
- medical consultation 8 days before surgery
- Keywords
- Hip prothesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical consultation 8 days before surgeryProcedure or surgery
This consultation would serve to explain to the patient the early course of care, give advice and help to anticipate acts for its release "post-operative" as, for example, contact a physical therapist and a nurse or check to their community pharmacy if their heparin stock is enough and to answer any questions.
| Study group | Role | What they receive |
|---|---|---|
| Group with D-8 medical consultation | Experimental | A medical consultation 8 days before surgery would serve to explain to the patient the early course of care, give advice and help to anticipate acts for its release "post-operative" as, for example, contact a physical therapist and a nurse or check to their community pharmacy if their heparin stock is enough and to answer any questions. Receives: Procedure: medical consultation 8 days before surgery |
| Group without D-8 medical consultation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average length of stay
Measured: After surgery at Day 1
Secondary outcomes (6)
OXFORD Score for Hip
Measured: Before and after surgery at Day -1 then Day 1
Patient satisfaction (verbal scale: 0 to 10)
Patient satisfaction (verbal scale: 0 to 10)
Measured: Before and after surgery at Day -1 then Day 1
St. Joseph Satisfaction
St. Joseph Satisfaction Questionnaire (validated questionnaire Saphora)
Measured: After surgery when leaving the hospital, in average in the 3 Days
Evaluation of pain by VAS
Evaluation of pain by VAS before and after the intervention
Measured: Before and after surgery at Day -1 then Day 1
Morbidity
Measured: In the week after surgery
Mortality
Measured: In the week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start23 Sep 2015
- Primary completion1 May 2016
- Study completion1 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume RIOUALLON, MD, Principal investigator, Groupe Hospitalier Paris Saint-Joseph (FRANCE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771041
- Sponsor's protocol ID
- PTH J-8
- Acronym
- PTHJ-8
- Status last verified
- May 2016
- First submitted
- 9 May 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Assessment of the Influence of Early Preoperative Consultation on Satisfaction and the Average Length of Stay of Patients Who Underwent Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02771041
- Acronym / sponsor ID
- PTHJ-8 / PTH J-8
- Conditions
- Orthopedic Surgery
- Keywords
- Hip prothesis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 23 Sep 2015 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- 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.
Arthroplastic hip surgery "fast-track" the subject of increasing interest and reduces the average length of stay and improve patient satisfaction. This fast circuit implemented in many schools uses dedicated inpatient units, preoperative patient education in multidisciplinary groups (including physiotherapists, nurses, rehabilitation doctors and surgeons), an analgesia protocol multimodal and a network dedicated to the outlet (1.2).
The investigators working hypothesis is that the mere realization of a preoperative visit a week before the intervention would reduce the average length of stay for all patients with a target of two nights (instead of 7.5 days currently) (3) to reduce the use of SSR during hospitalization. This consultation would serve to explain to the patient the early course of care, give advice and help to anticipate acts for its release "post-operative" as, for example, contact a physical therapist and a nurse or check to their community pharmacy if their heparin stock is enough and to answer any questions (Appendix 2: early information given to the patient consultation J-8).
The investigators protocol is inspired by the one already in place for outpatient PTH and PTH 1 night but invariably apply to all patients for whom a home is considered output.
Detailed description
- Objectives
- Primary Objective Influence of preoperative consultation to "D-8" on the average length of stay of a randomized series multi-operator.
- Secondary objectives
- Evaluation of patient satisfaction and clinical status 2. Evaluation of the analgesic consumption 3. Evaluation of complications
- Population concerned
- Inclusion Criteria All patients undergoing total hip replacement
- Exclusion criteria
- Patient choosing immediately a supported SSR in postoperative 2. Geographical remoteness 3. Social isolation 4. Medical pathology requiring special monitoring (phlebitis history, coagulation disorders, anticoagulant therapy ...) 5. psychiatric pathology 6. Patients opting for the protocol "overnight"
- Methodology and duration of the research This will be a prospective mono-centric multi-operator on the assessment of the management of patients in the surgical practice referred to above.
The inclusion of patients will take place over a period of 12 months, the goal is to include 90 patients (Figure 1).
Justification of Sample Size In 2013, for patients operated in a planned way, and with degenerative osteoarthritis, the length of stay was 7.5 days with a standard deviation of 3 days.
With such a length of stay, a staff of 2 to 45 subjects will detect a difference in length of stay of at least 1.8 days (significance level of 5%, 80% power). Such a difference is reasonably possible with the proposed organizational intervention.
Early preoperative consultation will be proposed to the randomized patient. When the patient is included in the group studied, it will be presented during the preoperative consultation early an information document with advice and guidance for patients to anticipate acts provided for its release "post-operative" (cf. . Appendix 2: patient information delivered early consultation J-8). This consultation will educate patients about what will happen when they leave, specifying concretely how their articulation with the city and the various professionals involved will have been planned and respond to all the issues raised.
Data collection Clinical data will be collected anonymously by an internal orthopedic surgery service for all patients included in the study by the realization of the Oxford hip score before the intervention (J-1), an assessment of pain through verbal validated scale (VAS), of St Joseph satisfaction questionnaire (validated questionnaire Saphora) accompanied by a verbal scale patient discharge and a telephone call 30 days after surgery to achieve again the Oxford hip score, evaluation of pain by VAS and patient satisfaction by simple verbal scale (see Annex 1) (4).
The criteria for hospital discharge are:
- Clinically: clean dressing, no fever, no comorbidity decompensation, EVA <4 with analgesics.
- Biologically: Hemoglobin> 10.
- Functionally: 3 steps climbing ability, ability to walk twenty meters and to go to the bathroom alone.
The assessment criteria will be used:
Primary endpoint:
- Average length of stay
Criterion of secondary judgments:
- Score Oxford Hip before and after the intervention
- Patient satisfaction (verbal scale: 0 to 10) before and after the intervention
- St. Joseph Satisfaction Questionnaire (validated questionnaire Saphora)
- Evaluation of pain by VAS before and after the intervention
- Morbidity and mortality randomization: Randomization in the 2 groups (usual care without consultation with J-8 versus consultation with J-8) will be carried by the patient. The patient list will be balanced by randomly alternating blocks. orthopedic service personnel will not be notified in advance of schedule to avoid a bias in the management of patients with the service.
Data processing :
For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data.
Statistical analysis :
To find and test differences, univariate analyzes will use the test t-Student for continuous variables and the chi of 2 for categorical variables or their nonparametric equivalents. The significance level was set at p <0.05. If imbalance groups, a multivariate model is developed
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with D-8 medical consultation | Experimental | Procedure: medical consultation 8 days before surgeryA medical consultation 8 days before surgery would serve to explain to the patient the early course of care, give advice and help to anticipate acts for its release "post-operative" as, for example, contact a physical therapist and a nurse or check to their community pharmacy if their heparin stock is enough and to answer any questions. |
| Group without D-8 medical consultation | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All patients undergoing total hip replacement
Key exclusion criteria (6 listed)
- Patient choosing immediately a supported SSR in postoperative
- Geographical remoteness
- Social isolation
- Medical pathology requiring special monitoring (phlebitis history, coagulation disorders, anticoagulant therapy ...)
- psychiatric pathology
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 |
|---|---|---|
| medical consultation 8 days before surgeryThis consultation would serve to explain to the patient the early course of care, give advice and help to anticipate acts for its release "post-operative" as, for example, contact a physical therapist and a nurse or check to their community pharmacy if their heparin stock is enough and to answer any questions. | Procedure or surgery | Group with D-8 medical consultation |
Primary outcome
Average length of stay
Time frame: After surgery at Day 1
6 secondary outcomes
OXFORD Score for Hip
Time frame: Before and after surgery at Day -1 then Day 1
Patient satisfaction (verbal scale: 0 to 10)
Time frame: Before and after surgery at Day -1 then Day 1
St. Joseph Satisfaction
Time frame: After surgery when leaving the hospital, in average in the 3 Days
Evaluation of pain by VAS
Time frame: Before and after surgery at Day -1 then Day 1
Morbidity
Time frame: In the week after surgery
Mortality
Time frame: In the week after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
Guillaume RIOUALLON, MD principal investigator
Groupe Hospitalier Paris Saint-Joseph (FRANCE)
Questions about this trial
What is this clinical trial studying?
A study testing medical consultation 8 days before surgery in people with Orthopedic Surgery, run by Fondation Hôpital Saint-Joseph.
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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Average length of stay (time frame: After surgery at Day 1). 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 23 Feb 2017.