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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04055103
Other study ID # G18.140
Secondary ID VRF2018-001
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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