Improving Quality Based on the Joint Registry (IQ Joint)
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|ClinicalTrials.gov Identifier: NCT04055103|
Recruitment Status : Completed
First Posted : August 13, 2019
Last Update Posted : October 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Registries Quality Improvement Hip Arthropathy Knee Arthropathy Hospital Performance||Other: Monthly feedback, education and linking hospitals||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Each arm will receive the intervention for 6 months.|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Improving Quality Based on the Joint Registry|
|Actual Study Start Date :||August 1, 2019|
|Actual Primary Completion Date :||May 31, 2021|
|Actual Study Completion Date :||May 31, 2021|
Active Comparator: Intervention Group
Half of the participating hospitals will be in the intervention group for the first 6 months. The intervention will switch to the control group after the 6 months.
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.
No Intervention: Control Group
Half of the participating hospitals will be in the control group for the first 6 months. The control group will undergo the intervention in the second 6 months.
- Survival (yes/no) [ Time Frame: 1 year follow-up during trial ]Patient survival after HA/TKA surgery
- 1-year revision rate (%) [ Time Frame: 1 year follow-up during trial ]Number of revisions performed within one year adjusted for patient characteristics
- Prolonged length-of stay (yes/no) [ Time Frame: 1 year follow-up during trial ]Prolonged length-of-stay in the overall upper quartile
- Readmission (yes/no) [ Time Frame: 1 year follow-up during trial ]Readmission within 30 days after discharge
- Number of Complications [ Time Frame: 1 year follow-up during trial ]Number of complications
- Composite outcome measure (Textbook Outcome) [ Time Frame: 1 year follow-up during trial ]Including: Survival; 1-year revision rate; Length-of-Stay and Readmission.
- Number of Quality Improvement Initiatives [ Time Frame: 1 year follow-up during trial ]Number of quality improvement Initiatives with the aim to improve the quality of care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055103
|Leiden University Medical Center|
|Leiden, Zuid-Holland, Netherlands, 2333 ZA|
|Principal Investigator:||Perla Marang-van de Mheen, Dr.||Leiden University Medical Center|