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Arthroplasty, Replacement, HipESIPPESNCT05452161

Effects of Preoperative Education, and Follow-up Sessions of Patients With Total Hip and Knee Arthroplasty (ESIPPES)

A study testing Intervention group A and Intervention group B in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The shortening of the length of stay implies rethinking the perioperative management (around the operative period), which precedes and immediately follows the operation, in order to ensure a good preparation of the patient and an adequate postoperative follow-up. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intervention group A and Intervention group B
Could I receive a placebo?
No, everyone receives an active treatment
How many people
163 participants
Where
1 siteSwitzerland
Study dates
18 Jun 2022to 12 Dec 2023
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

  • male and female patients admitted to the CHUV musculoskeletal department during the study period
  • primary total hip replacement or primary total knee replacement
  • a Risk Assessment and Prediction Tool (RAPT) score >6

Who cannot join

  • a RAPT score <6,
  • knee/hip arthroplasty revision surgery
  • inability to give informed consent or answer questionnaires knowledgeably due to language or cognitive impairment as reported in the medical record

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital of Lausanne CHUV - UNIL

    Lausanne, 1011

Other trials in Switzerland

About this study

Official title: Effects of Interdisciplinary Preoperative Preparation, Education, and Follow-up Sessions on Length of Stay in Hospital and Clinical Outcomes of Patients Undergoing Total Hip or Knee Replacement Surgery.

The shortening of the length of stay implies rethinking the perioperative management (around the operative period), which precedes and immediately follows the operation, in order to ensure a good preparation of the patient and an adequate postoperative follow-up.

The aim of this study is to evaluate the effect on the length of stay of adding an individualized preoperative preparation and education session to the current protocol in the musculoskeletal department at the CHUV in patients undergoing total hip or knee replacement surgery.

The implementation of a targeted, low-impact immediate postoperative follow-up could contribute to improving the detection of complications, preventing avoidable readmissions, improving the management of pain and adverse events, supporting the patient and responding to difficulties encountered in the patient's living environment. However, the actual added value for the patient and for the healthcare system has yet to be specified. As patients' needs and resources vary, it would also be useful to better determine the profile of patients for whom a pre- and postoperative session provides significant added value.

Read the detailed description

In Switzerland, in 2017,12.4% of the Swiss population suffered from osteoarthritis. In 2019, the SIRIS hip and knee implant registry recorded 20,077 total hip replacement (THR) and 15,453 total knee replacement (TKR) implants in Switzerland.

The placement of THR and TKR is one of the major activities of the Department of the Musculoskeletal System of the CHUV (DAL-CHUV), with respectively 282 THR and 218 TKR placed in 2019.

The improvement of global practices in prosthetic surgery, the pressure on health costs and the shift to ambulatory care have led to a shortening of the length of stay.

The shortening of the length of stay implies rethinking the perioperative care (around the operative period), which precedes and immediately follows the operation, in order to ensure good preparation of the patient and adequate postoperative follow-up.

Currently, patients of the DAL-CHUV participate in a pre-operative information session (only before the operation) in a group that informs patients about the procedure, its preparation and its implications in general.

Pre-operative management is described in the literature as a multidisciplinary approach to cover all aspects to be taken into consideration in the patient, and thus prepare him/her in an optimal way for the operation and the recovery phase that will follow. Pre-operative or peri-operative rehabilitation is a broader concept of optimized recovery, which involves addressing the entire peri-operative process. Thus, the patient's health status, nutritional status, the operative and immediate postoperative process, pain management, prevention of complications and definition of relevant criteria for return home are all elements to be taken into account in an interdisciplinary manner to optimize the entire perioperative process.

The main objective of the study is to evaluate in patients undergoing total hip (THR) or knee (TKR) replacement surgery whether the addition of an individualized pre- and peri-operative preparation and education session to the existing protocol in the DAL-CHUV, provided by physiotherapists and nursing staff, has an effect on length of stay, hospital indicators, and objective and subjective clinical indicators.

The main hypothesis is that targeted pre- and peri-operative information adapted to the needs of patients would contribute to a decrease in length of stay.

The secondary indicators are readmission rate, discharge destination, postoperative pain, complications, joint function and mobility, anxiety and depression, pain representation, expectations of the prosthesis, satisfaction with care and quality of life. The hypothesis is that these indicators will be improved by the intervention.

The 1st secondary objective of the study is to evaluate in patients operated on for a total hip or knee prosthesis who have benefited from the preparation and education session whether the addition of a remote postoperative follow-up (3 telephone interviews or videoconferences during the 1st postoperative week after discharge) has additional effects on the measured indicators. The hypothesis is that the intervention will provide an additional beneficial effect for these indicators.

The 2nd secondary objective is to identify whether the effect of the pre- and postoperative interventions differs according to the characteristics of the population and the operation (THR or TKR). This secondary analysis will help to better identify the categories of populations for which the proposed peri-operative interventions are useful. The hypothesis is that the effects are dependent on patient characteristics, such as age, education level, or comorbidities for example.

Recruitment was carried out within the DAL-CHUV, based on consultation of the list of patients scheduled for a primary THR or TKR operation, and then consultation of their medical records by the study's scientific collaborator, who is also a collaborating physiotherapist at the CHUV, to verify the inclusion and exclusion criteria.

At the pre-operative information session (PIS), the important points of the study are presented orally and the consent forms of the patients who have made their decision are collected. An individual discussion will take place with those who wish to have more information about the study. The consent form is kept as part of the study files.

Those who wish to have time to reflect after the PIS will be contacted again the following week to find out their decision. They will hand in their approved consent form at the time of the pre-surgical consultation (PSC).

Once their decision is known, patients will be assigned to their group according to the randomization list.

The information of the intervention group A and B (preop and postop) does not imply any additional travel for the patient, there is only additional time dedicated to them during the PSC for the preop (group A and B) and postop (group B). The time for filling in the forms is essentially included in the consultation time (waiting time for the PSC and 6th week control), the hospital stay (day of discharge), as well as at home (2 weeks post-operatively).

The duration of the study per participant is approximately 10 weeks, PSC intervention approximately 3 weeks before the intervention, last follow-up 6 weeks after the intervention during the routine follow-up consultation at DAL-CHUV.

Descriptive statistics will be carried out for all quantitative variables of the study (means and standard deviation or medians and interquartile ranges, frequency, depending on the continuous, ordinal or nominal nature of the data), as well as graphical representations (box plot, histograms, pie chart).

The qualitative data collected will be grouped by theme and their frequency of occurrence will be analyzed (e.g. nature and frequency of occurrence of difficulties at home) For the main analysis, a Student's t test comparing the length of hospitalization between control and intervention groups will be applied. Linear regression models will then be used to adjust the difference between the groups for various potentially confounding factors (e.g. age, comorbidities, etc.). A sample size of N=200 allows for many adjustments to be included, with up to 13 parameters being estimated using the 15 observations per parameter rule.

To assess group differences in post-hospitalization measured values, linear mixed models will be used. This allows for repeated measurements (3 measurements per patient) while adjusting for various confounding factors.

A stratified analysis will be performed to differentiate the effects of the interventions in the various subpopulations of interest (e.g. age, comorbidities...), in order to identify those who particularly benefit from the tested interventions.

Being tested
Control group, Intervention group A, Intervention group B
Keywords
knee, hip, replacement, arthroplasty, patient education, preoperative care, perioperative care, interdisciplinary intervention, physiotherapy, nursing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control groupOther

    All patients follow only the standard care of the department, which includes a preoperative group session of 1h30, with 15 to 30 participants, 6 to 8 weeks before the operation The objectives of these sessions are to inform the patients in a general way about the operation, its preparation and the postoperative process in order to standardize the information received. The content includes general information from the surgeon, explanations related to the course and management of patients by the various professionals (nurse, surgeon, anesthesist, physiotherapist, ergotherapist and liaison-nurse).

  • Intervention group AOther

    The day of the preparatory surgical consultation (CPC), the patient has a 30 minute patient-centered education session by a physiotherapist and a 30 minute patient-centered education session by a nurse. The physiotherapist's session addresses the technical skills to be mastered postoperatively (crutching, stairs, exercises), the course of postoperative rehabilitation, the patient's role in the rehabilitation process, the questions still remaining on this subject and the patient's perspective concerning the rehabilitation (degree and sources of anxiety, expectations of follow-up and results, degree of self-efficacy). The nursing intervention addresses the postoperative pain management, the patient's role in pain management, the care pathway, the organization of the return home and the postoperative follow-up.

  • Intervention group BOther

    In addition to intervention A, patients receive a interdisciplinary intervention of three 10-15 minute phone or video conferences between the patient, a physiotherapist and a nurse.

    The aim of these interviews is to identify the patient's difficulties in the living environment, to detect possible postoperative complications and to provide advice on practical aspects (e.g. ability to perform activities), therapeutic aspects (e.g. exercises to be performed, medication), pain management, interpretation of symptoms and subjective needs (e.g. need for support). Advice on rehabilitation and care is individualized according to the results of the questionnaires administered on the day of the pre-surgical consultation and those administered at discharge, as well as the needs of the moment discussed with the patient. Any suspected complication is reported to the operating physician for appropriate management.

Study groups in NCT05452161
Study groupRoleWhat they receive
Standard careActive comparatorControl group receives the standard care in place in the service, a group information session about knee/hip arthroplasty surgery.
Receives: Other: Control group
Standard care + individualized patient-centered preparation and education sessionExperimentalIntervention group A receives, in addition to standard care, an individualized patient-centered preparation and education session
Receives: Other: Intervention group A
Standard care + individualized patient-centered preparation and education session + remote follow-upExperimentalIntervention group B receives, in addition to standard care and an individualized patient-centered preparation and education session, a remote postoperative follow-up
Receives: Other: Intervention group B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital stay

    Length of hospital stay (days)

    Measured: 2 weeks post-surgery

Secondary outcomes (13)
  1. Readmission rate

    frequency of readmission in percent

    Measured: Consultation 6 weeks post-op

  2. Destination at discharge

    home, rehabilitation center, nursing home for the elderly, other hospital

    Measured: 2 weeks post-surgery

  3. Postoperative pain

    numerical pain scale, minimum score = 0, maximum score = 10, higher score is worse

    Measured: Day of pre-operative surgical consultation, 3 days post-surgery, Control at 2 weeks post-surgery, Medical consultation at 6 weeks post-surgery

  4. Complications

    complication type (thrombosis, pneumonia, infection, others) and rate (percent)

    Measured: 3 days post-surgery, Control at 2 weeks post-surgery, Medical consultation 6 weeks post-surgery

  5. Joint function of hip or knee

    Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (knee and hip), minimum score = 0, maximum score = 96, higher score is worse

    Measured: Day of pre-operative surgical consultation, Control at 2 weeks post-surgery, Medical consultation 6 weeks post-surgery

  6. Joint function of hip

    Hip disability and Osteoarthritis Outcome Score (HOOS-JR), minimum score = 0, maximum score = 100, higher score is worse

    Measured: Day of pre-operative surgical consultation, Control at 2 weeks post-surgery, Medical consultation 6 weeks post-surgery

  7. Joint function of knee

    Knee injury and Osteoarthritis Outcome (KOOS-JR), minimum score = 0, maximum score = 100, higher score is worse

    Measured: Day of pre-operative surgical consultation, Control at 2 weeks post-surgery, Medical consultation 6 weeks post-surgery

  8. Mobility of hip or knee

    Mobility by the degrees of the joint, min score = 0, maximum score = 360, higher score is better

    Measured: Day of pre-operative surgical consultation, Control at 2 weeks post-surgery, Medical consultation 6 weeks post-surgery

  9. Anxiety and Depression

    Hospital Anxiety and Depression scale (HAD), minimum score = 0, maximum score = 21 for anxiety and 21 for depression, higher score is worse

    Measured: Day of pre-operative surgical consultation, 3 days post-surgery, Control at 2 weeks post-surgery, Medical consultation 6 weeks post-surgery

  10. Representation of pain

    Pain Catastrophizing Scale (PCS), minimum score = 0, maximum score = 52, higher score is worse

    Measured: Day of pre-operative surgical consultation, Control at 2 weeks post-surgery, Medical consultation 6 weeks post-surgery

  11. Expectations concerning the prosthesis and subjective function

    Hospital for Special Surgery (HSS) Hip/Knee Replacement Expectations Questionnaires, minimum score = 0, maximum score = 76, higher score means higher expectations

    Measured: Day of pre-operative surgical consultation, 3 days post-surgery

  12. Satisfaction with care

    Questionnaire from the Swiss National Association for Quality Development in Hospitals and Clinics (ANQ), minimum score = 0, maximum score = 5, higher score is worse, no total score, each question is analysed separately

    Measured: Control at 2 weeks post-surgery

  13. Quality of life EuroQol 5 Dimensions (EQ-5D) questionnaire

    Subjective indicators: questionnaire of quality of life EQ-5D, minimum score = 0, maximum score = 100, higher score is better

    Measured: Day of pre-operative surgical consultation and Consultation 6 weeks post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start18 Jun 2022
  3. Primary completion16 Oct 2023
  4. Study completion12 Dec 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective randomized controlled trial, comparing 3 modes of intervention. A single-center study conducted at the Musculoskeletal Department of the University of Lausanne The control group receives the standard care in place in the department, including only a group information session (1/3 of the sample). Intervention group A receives, in addition to a group information session, an individualized preparation and education session (2/3 of the sample). Intervention group B receives, in addition to a group information session, an individualized preparation and education session, and a remote postoperative follow-up (1/2 of group A = 1/3 of the sample). Patients are randomly assigned to their group based on their order of arrival. Hip and knee surgery patients are randomized separately, to keep the same proportions in each of the three groups. Block randomisation will be carried out.
Masking
None (open label)
Enrolment
163 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05452161
Sponsor's protocol ID
ESIPPES
Acronym
ESIPPES
Status last verified
Mar 2024
First submitted
27 Jun 2022
Last updated
12 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weyker PD, Webb CA. Establishing a patient centered, outpatient total joint home recovery program within an integrated healthcare system. Pain Manag. 2020 Jan;10(1):23-41. doi: 10.2217/pmt-2019-0040. Epub 2019 Dec 19.

    PubMed 31852383
  • Feng JE, Novikov D, Anoushiravani AA, Schwarzkopf R. Total knee arthroplasty: improving outcomes with a multidisciplinary approach. J Multidiscip Healthc. 2018 Jan 25;11:63-73. doi: 10.2147/JMDH.S140550. eCollection 2018.

    PubMed 29416347
  • Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.

    PubMed 31663402
  • Carli F, Scheede-Bergdahl C. Prehabilitation to enhance perioperative care. Anesthesiol Clin. 2015 Mar;33(1):17-33. doi: 10.1016/j.anclin.2014.11.002. Epub 2015 Jan 9.

    PubMed 25701926

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group A and Intervention group B in people with Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.

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 12 Mar 2024. 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 Switzerland. 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?

Hospital stay (time frame: 2 weeks post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05452161, which also lists 4 linked publications.

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 12 Mar 2024.

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