NCT05452161

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

June 27, 2022

Last Update Submit

March 10, 2024

Conditions

Keywords

kneehipreplacementarthroplastypatient educationpreoperative careperioperative careinterdisciplinary interventionphysiotherapynursing

Outcome Measures

Primary Outcomes (1)

  • Hospital stay

    Length of hospital stay (days)

    2 weeks post-surgery

Secondary Outcomes (13)

  • Readmission rate

    Consultation 6 weeks post-op

  • Destination at discharge

    2 weeks post-surgery

  • Postoperative pain

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

  • Complications

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

  • Joint function of hip or knee

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

  • +8 more secondary outcomes

Study Arms (3)

Standard care

ACTIVE COMPARATOR

Control group receives the standard care in place in the service, a group information session about knee/hip arthroplasty surgery.

Other: Control group

Standard care + individualized patient-centered preparation and education session

EXPERIMENTAL

Intervention group A receives, in addition to standard care, an individualized patient-centered preparation and education session

Other: Intervention group A

Standard care + individualized patient-centered preparation and education session + remote follow-up

EXPERIMENTAL

Intervention group B receives, in addition to standard care and an individualized patient-centered preparation and education session, a remote postoperative follow-up

Other: Intervention group B

Interventions

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).

Standard care

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.

Standard care + individualized patient-centered preparation and education session

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.

Standard care + individualized patient-centered preparation and education session + remote follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Lausanne CHUV - UNIL

Lausanne, 1011, Switzerland

Location

Related Publications (4)

  • 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.

    PMID: 31852383BACKGROUND
  • 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.

    PMID: 29416347BACKGROUND
  • 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.

    PMID: 31663402BACKGROUND
  • 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.

    PMID: 25701926BACKGROUND

Related Links

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Claude Pichonnaz

    Haute Ecole de Santé Vaud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor UAS, Ph.D.

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 11, 2022

Study Start

June 18, 2022

Primary Completion

October 16, 2023

Study Completion

December 12, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations