Improving Quality Based on the Joint Registry

Knee Arthropathy Clinical Trial

— IQ Joint  

Official title:

Improving Quality Based on the Joint Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04055103
• Other study ID #: G18.140
• Secondary ID: VRF2018-001
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: October 2021
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Test whether an intervention, consisting of frequently feedback of performance outcomes and education will improve patient care, expressed in better functional outcomes, fewer complications and more quality improving interventions.

Description:

A randomized controlled trial will be conducted where hospitals will be randomized to an early versus late group, stratified by teaching status as this might influence the time available for quality improvement. Randomization will be done using a computer generated randomization table in a 1:1 ratio. During the study only orthopedic surgeons performing THA and TKA will receive monthly feedback by email.

The intervention will consist of the following components:

• Monthly feedback of performance outcomes;

• Education on how to use joint registry data for quality improvement;

• Create awareness by sending monthly feedback about performance; education and by asking what improvement activities have been introduced;

• Hospitals will be linked to hospital with opposite performance outcomes to exchange information and find areas for improvement.

During the trial, the investigators will conduct monthly measurement on intermediate outcomes showing whether the intervention reaches the target group (process evaluation). The following measurements will take place:

• Knowledge among orthopaedic surgeons on their recent performance and how that relates to others;

• Number of quality improvement activities undertaken with the aim to improve the quality of care;

• Planned improvement activities (e.g. record review to figure out why performance is not as good as in other centers) together with who is responsible and by which time;

• Number of people attending the meetings, number of times a specific account has accessed the LROI site to ensure that information has reached the target group;

• Survey among orthopaedic surgeons at the end of the intervention period on knowledge learned and the extent to which they think this is sustainable in daily practice.

In addition, the investigators will compare the outcomes between the early and the late group to test the effectiveness of the intervention, using the appropriate regression techniques. In the second period the investigators will test the sustainability of this approach in daily practice by comparing the outcomes within the early group with the first period, and compare with the late group to test whether outcomes in the sustainability phase are similar as when actively supported.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All Dutch orthopedic clinics where hip- and knee replacement surgery is performed who agree to participate will be randomized.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Hip Arthropathy
• Hospital Performance
• Joint Diseases
• Knee Arthropathy
• Quality Improvement
• Registries

Intervention

Other:
• Monthly feedback, education and linking hospitals
- Give monthly feedback from LROI-data (revision rate & patient reported outcome measures) as well as other outcomes from the participating hospital (length-of-stay, readmission and complications), combined with education on how to use this information for improvement. This will be send monthly by email to the intervention group. Further, hospitals with worse performance for a certain outcome will be linked to hospitals with good performance for this outcome.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival (yes/no)	Patient survival after HA/TKA surgery	1 year follow-up during trial
Primary	1-year revision rate (%)	Number of revisions performed within one year adjusted for patient characteristics	1 year follow-up during trial
Primary	Prolonged length-of stay (yes/no)	Prolonged length-of-stay in the overall upper quartile	1 year follow-up during trial
Primary	Readmission (yes/no)	Readmission within 30 days after discharge	1 year follow-up during trial
Primary	Number of Complications	Number of complications	1 year follow-up during trial
Primary	Composite outcome measure (Textbook Outcome)	Including: Survival; 1-year revision rate; Length-of-Stay and Readmission.	1 year follow-up during trial
Secondary	Number of Quality Improvement Initiatives	Number of quality improvement Initiatives with the aim to improve the quality of care	1 year follow-up during trial