PROMoting Quality - Intersectoral use of Patient Reported Outcome Measures to increase patient-relevant outcome quality

Not Applicable

• Conditions: M16; M17; Coxarthrosis [arthrosis of hip]; Gonarthrosis [arthrosis of knee]

• Registration Number: DRKS00019916
• Lead Sponsor: Fachgebiet Management im GesundheitswesenTechnische Universität Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-26
• Study Completion: 2021-12-31
• Results First Posted: 2023-03-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6871

Inclusion Criteria

Eligible for this study are all patients with primary elective TKR/THR above the age of 18 having a scheduled surgery between October 2019 and October 2020 and having direct or indirect access to an e-mail account.

Exclusion Criteria

Exclusion criteria for participation are emergencies (e.g., femoral fracture), patients with ASA classification 4-6 (4 - patient with life-threatening disease, 5 - moribund patient who is unlikely to survive without surgery, 6 - deceased patient with confirmed brain death, or organ donor), and patients younger than 18 years. Additionally, patients without direct or indirect access to an e-mail account are excluded from the study due to practical reasons. E-mail addresses from relatives are accepted. All patients who deny participation will not be included in the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is to investigate cost efficiency, thus the optimization of outcome quality compared to the resource utilization of the designed intervention. Outcome quality is defined as a composite measure of PROMs and clinical outcome measures. Utilized resources are direct and follow-up health care cost of the procedures and cost of implementing the designed intervention.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include the improvement of functionality of the patient reflected by the KOOS-PS/HOOS-PS, of medium to long-term health-related quality of life evaluated by the EQ-5D-5L, of pain in knee, hip and lower back, of satisfaction with treatment outcome and of clinical outcome measures like post-operative revision and reoperation rates. Furthermore, these analyses will be repeated with subgroups, built by age, sex, baseline PROM scores, etc.