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Routine data-based quality indicators for the treatment of coxarthrosis and gonarthrosis patients in the ambulatory care sector

Organizational Data

DRKS-ID:
DRKS00027516
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2022-01-25
Last update in DRKS:
2024-01-08
Registration type:
Prospective

Acronym/abbreviation of the study

MobilE-ARTH

URL of the study

https://www.chec-tum.de/mobile-arth

Brief summary in lay language

The current care situation for people with knee or hip osteoarthritis in Germany is characterised by above-average rates of joint replacement surgery. However, in order to reduce the burden on patients and the health care system, joint replacement surgery should only be considered as a last treatment option after other conservative therapies, usually performed in the ambulatory care setting, have proven to be ineffective. Within the project, a set of quality indicators for the ambulatory treatment of knee and hip osteoarthritis will be developed. The quality indicators shall be calculated on the basis of the routinely collected data of the statutory health insurance funds, so that there is no additional documentation effort for the treating physicians. The quality indicators will then be tested in the fourteen existing QuATRo physician networks of the AOK Bavaria. First, the indicators are calculated for the patients of the participating physicians, prepared in the form of feedback reports and sent to the physicians. Subsequently, maximum two facilitated network meetings will be organised in which the feedback reports will serve the physicians as a basis for discussion in order to identify well-functioning aspects of care or to be able to discuss solution concepts for possibly existing factors which are in need of improvement.

Brief summary in scientific language

The aim of the project is to develop, validate and pilot a set of quality indicators for the treatment of gonarthrosis and coxarthrosis, which can be calculated on the basis of the routinely collected data of the statutory health insurance funds. The focus is on the coordination and quality of the ambulatory care prior to a possible implantation of an endoprosthesis. The pilot phase and evaluation of the quality indicator set will take place in the QuATRo physician networks of the AOK Bavaria. The developed quality indicators will be summarised in feedback forms, sent to the physicians and discussed in maximum two facilitated network meetings. With the help of the project, possible barriers to optimal health care for patients with gonarthrosis and coxarthrosis will be identified and multiprofessional care pathways will be developed and subsequently implemented.

Health condition or problem studied

ICD10:
M16 - Coxarthrosis [arthrosis of hip]
ICD10:
M17 - Gonarthrosis [arthrosis of knee]
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
routine data-based feedback on quality indicators for the ambulatory care of patients with gonarthrosis and coxarthrosis; invitation to facilitated network meetings
Arm 2:
standard care

Endpoints

Primary outcome:
use of all suitable ambulatory health services prior to endoprosthetic joint replacement surgery
Secondary outcome:
process indicators which are quantifiable in routine data

Study Design

Purpose:
Other
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
IV
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Other QuATRo-Netzwerke der AOK Bayern Bayern

Recruitment period and number of participants

Planned study start date:
2023-04-01
Actual study start date:
2023-04-19
Planned study completion date:
2025-12-31
Actual Study Completion Date:
No Entry
Target Sample Size:
350
Final Sample Size:
262

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Affiliation to the QuATRo physician networks of the AOK Bavaria (The study population comprises the fourteen QuATRo physician networks of the AOK Bavaria. For the intervention, seven of these physician networks are randomly selected in order to be provided with the feedback reports and invited to the network meetings.)

Exclusion Criteria

none

Addresses

Primary Sponsor

Technische Universität München, Lehrstuhl für Gesundheitsökonomie
Prof. Dr. Leonie Sundmacher
Georg-Brauchle-Ring 60/62
80992 München
Germany
Telephone:
+49 (0) 89 / 289 24464
Fax:
No Entry
Contact per E-Mail
URL:
https://www.sg.tum.de/chec/startseite/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Technische Universität München, Lehrstuhl für Gesundheitsökonomie
Prof. Dr. Leonie Sundmacher
Georg-Brauchle-Ring 60/62
80992 München
Germany
Telephone:
+49 (0) 89 / 289 24464
Fax:
No Entry
Contact per E-Mail
URL:
https://www.sg.tum.de/chec/startseite/

Contact for Public Queries

Technische Universität München, Lehrstuhl für Gesundheitsökonomie
Tobias Bock
Georg-Brauchle-Ring 60/62
80992 München
Germany
Telephone:
+49 (0) 89/289 24471
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Technische Universität München, Lehrstuhl für Gesundheitsökonomie
Prof. Dr. Leonie Sundmacher
Georg-Brauchle-Ring 60/62
80992 München
Germany
Telephone:
+49 (0) 89 / 289 24464
Fax:
No Entry
Contact per E-Mail
URL:
https://www.sg.tum.de/chec/startseite/

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

DLR Projektträger - Bereich Gesundheit - als Projektträger für das Bundesministerium für Bildung und Forschung
Heinrich-Konen-Straße 1
53227 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Fakultät für Medizin der Technischen Universität München
Ismaninger Str. 22
81675 München
Germany
Telephone:
+49-89-41404371
Fax:
+49-89-41404199
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-09-06
Ethics committee number:
566/21 S-NP
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-10-13

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
Routine data are only evaluated within the project consortium and published in aggregated form. Data on study participants and patient data are not published for data protection reasons.

Study protocol and other study documents

Study protocols:
Routine data-based quality indicators for the treatment of gonarthrosis and coxarthrosis patients in the ambulatory care sector – A study protocol for a cluster-randomised pilot trial to evaluate the MobilE-ARTH study.
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry