Study of the Lived Experience of Patients With Prosthetic Joint Infection, Their Families, and Healthcare Professionals. Development of a Therapeutic Education Program for Patient Care (TEP).

NCT07409402 | Not Yet Recruiting

• 2 other identifiers: APHP2510972025-A01667-42
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The PROTHEE-QUALI study (Qualitative study of the lived experience of patients with prosthetic joint infection, their accompanying persons and health professionals and construction of a therapeutic education program for management: qualitative study) is categorized as non-interventional qualitative research. In France, a prosthetic joint infection (PJI) is diagnosed in approximately 3000 patients per year. This complication is severe and results in major consequences for the patient, such as prolonged or repeated hospitalization, pain, anxiety, and a transient or permanent loss of autonomy, sometimes resulting in disability, or even amputation or joint resection. PJI management is complex, necessitating a multidisciplinary approach combining surgical treatment and prolonged antibiotic therapy (lasting from 6 to 12 weeks to several months). The PROTHEE-QUALI project was designed to create this essential tool by collecting and crossing the perspectives of the affected patients, their accompanying persons, and the healthcare professionals involved. The general objective of the project is the structuring of a TPE program destined for patients with PJI, aiming to improve their management and support. This includes assistance with adherence to and better tolerance of antibiotic treatments, pain management, physical rehabilitation, psycho-social care, providing information on the infection and its evolution, and adapting hygiene measures. The primary objective is the exploration of the lived experience of patients with PJI, their accompanying persons, and the health professionals (nurses, physiotherapists, psychologists, and pharmacists) taking care of them in real-life settings. The secondary objective is the structuring of a TPE program based on the crossed perspectives of patients, their accompanying persons, and health professionals concerning the issue of PJI. PROTHEE-QUALI is an 18-month prospective multicenter qualitative study. It uses the IPSE qualitative research method ("Inductive process to analyze the structure of lived experience"). The design involves two main phases: Phase 1 focuses on exploring the experience through individual interviews (patients and accompanying persons) and focus groups (health professionals) to extract a structure of experience; Phase 2 involves the validation and elaboration of the TPE program proposal through feedback from new focus groups. The sampling technique used is non-probabilistic and intentional, known as "purposive sampling" with maximum variation, seeking exemplary situations and rich, diversified accounts rather than statistical representativeness. Involved Structures The research is promoted by the Assistance Publique - Hôpitaux de Paris (AP-HP), with the Délégation à la Recherche Clinique et à l'Innovation (DRCI) ensuring the promoter's missions by delegation. The study is funded by a grant from GIRCI APRESO Convergence 2024. The research is multicentric, involving three investigating centers which are Complex Osteoarticular Infection Reference Centers (CRIOACs) in the Île de France region:

• The CRIOAC of the Groupe Hospitalier Diaconesses Croix Saint-Simon.
• The CRIOAC Lariboisière Saint Louis.
• The CRIOAC Cochin. The qualitative and methodological team includes members of the INSERM U1153, Statistic and epidemiologic research center Sorbonne Paris Cité. The monitoring of the research is overseen by a Clinical Research Unit (URC).

Conditions

Prosthetic Joint Infection

Keywords

Prosthetic joint infection; Lived experience; Qualitative research; Therapeutic patient education; IPSE method

Outcome Measures

Primary Outcomes (1)

• Structure of the lived experience of prosthetic joint infection

  Qualitative description of the lived experience of prosthetic joint infection among patients, accompanying persons, and healthcare professionals, based on semi-structured individual interviews and focus groups, and analyzed using the IPSE qualitative method (Inductive Process to Analyze the Structure of Lived Experience) Unit of Measure : Emergent experiential categories and axes of experience derived from qualitative analysis

  From inclusion to completion of Phase 1 data analysis (approximately 9 months)

Secondary Outcomes (1)

• Structuring of a Therapeutic Patient Education (TPE) program for prosthetic joint infection

  From Phase 2 focus groups to completion of final qualitative analysis (approximately 3 months)

Study Arms (1)

Interview with participant

Semi-structured, open-ended individual or group interview with a researcher, with an average duration of 1 hour

Other: Exploration of the lived experience of patients with prosthetic joint infection (PJI), their families, and healthcare professionals

Interventions

Exploration of the lived experience of patients with prosthetic joint infection (PJI), their families, and healthcare professionals OTHER

Organization of individual interviews and group meetings to collect information about the lived experiences of patients, their families, and the healthcare professionals who support them. This data collection will be based on questionnaires and recorded interviews, which will be transcribed verbatim and then analyzed by IPSEA researchers.

Interview with participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients managed in the CRIOAC unit, who underwent surgery for prosthetic joint infection more than one month and less than one year ago and were treated with antibiotic therapy. Relatives or friends designated by the patient, who accompanied them throughout their care, from diagnosis, during and after hospitalisation, at least until the end of the antibiotic therapy. Healthcare professionals (nurses, physiotherapist, psychologists, pharmacists) working for at least one year in the CRIOAC unit.

You may qualify if:

• Patients :
• Age ≥ 18 years
• Have undergone surgery \> 1 month and \< 1 year ago for a hip, knee, or shoulder prosthetic implant, and are currently receiving or have received prolonged antibiotic therapy (≥ 6 weeks)
• Patients had to agree to sign a consent form to participate in the study.
• Patient companions :
• Age ≥ 18 years
• Close relative or friend designated by the patient, who has accompanied them throughout their care journey, from diagnosis, during and after hospitalization, at least until the end of antibiotic treatment
• Not opposed to participating in the study
• Healthcare professionals :
• Practicing for ≥ 1 year in a CRIOAC (Reference Center for Osteoarticular Infections)
• Role: nurse, physiotherapist, psychologist, pharmacist
• Not opposed to participating in the study

You may not qualify if:

• Patients :
• Do not have proficiency in the French language
• Patients with advanced cognitive disorders
• Patients with severe depression
• Patient companions :
• Do not have proficiency in the French language
• Patients with advanced cognitive disorders
• Patients with severe depression
• Healthcare professionals :
• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre de Références des Infections-Ostéo Articulaires Complexes CRIOAC

Paris, France, 75020, France

Location

MeSH Terms

Interventions

Health Personnel

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• ZOE DAVENNE

  GH Diaconesses Croix Saint Simon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZOE DAVENNE

CONTACT

+33 1 44 64 16 09; zdavenne@hopital-dcss.org

David LEBEAUX, Pr

CONTACT

+33 01 49 95 69 56; david.lebeaux@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 13, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): September 2, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)