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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
Sponsor:
Information provided by (Responsible Party):
PerlaJMarang, Leiden University Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Registries Quality Improvement Hip Arthropathy Knee Arthropathy Hospital Performance Other: Monthly feedback, education and linking hospitals Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Survival (yes/no) [ Time Frame: 1 year follow-up during trial ]
    Patient survival after HA/TKA surgery

  2. 1-year revision rate (%) [ Time Frame: 1 year follow-up during trial ]
    Number of revisions performed within one year adjusted for patient characteristics

  3. Prolonged length-of stay (yes/no) [ Time Frame: 1 year follow-up during trial ]
    Prolonged length-of-stay in the overall upper quartile

  4. Readmission (yes/no) [ Time Frame: 1 year follow-up during trial ]
    Readmission within 30 days after discharge

  5. Number of Complications [ Time Frame: 1 year follow-up during trial ]
    Number of complications

  6. Composite outcome measure (Textbook Outcome) [ Time Frame: 1 year follow-up during trial ]
    Including: Survival; 1-year revision rate; Length-of-Stay and Readmission.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Netherlands
Leiden University Medical Center
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Sponsors and Collaborators
Leiden University Medical Center
Investigators
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Principal Investigator: Perla Marang-van de Mheen, Dr. Leiden University Medical Center
  Study Documents (Full-Text)

Documents provided by PerlaJMarang, Leiden University Medical Center:
Study Protocol and Statistical Analysis Plan: Main protocol  [PDF] October 24, 2018
Study Protocol: Annex 1: Grant Application Form  [PDF] March 1, 2018
Study Protocol: Annex 2: Data Delivery Agreement  [PDF] October 24, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PerlaJMarang, Associate Professor, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT04055103    
Other Study ID Numbers: G18.140
VRF2018-001 ( Other Grant/Funding Number: Van Rens Foundation )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is about the performance of hospitals. The individual performance of a hospital will not be announced.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PerlaJMarang, Leiden University Medical Center:
Total Hip/Knee Arthroplasty;Dutch Arthroplasty Register; Quality Improvement.
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases