Improving Quality Based on the Joint Registry (IQ Joint)

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthropathy; Quality Improvement; Hip Arthropathy; Registries; Hospital Performance
• Intervention / Treatment: Other: Monthly feedback, education and linking hospitals

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Leiden University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival (yes/no)	Patient survival after HA/TKA surgery	1 year follow-up during trial
1-year revision rate (%)	Number of revisions performed within one year adjusted for patient characteristics	1 year follow-up during trial
Prolonged length-of stay (yes/no)	Prolonged length-of-stay in the overall upper quartile	1 year follow-up during trial
Readmission (yes/no)	Readmission within 30 days after discharge	1 year follow-up during trial
Number of Complications	Number of complications	1 year follow-up during trial
Composite outcome measure (Textbook Outcome)	Including: Survival; 1-year revision rate; Length-of-Stay and Readmission.	1 year follow-up during trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Investigators: Principal Investigator: Perla Marang-van de Mheen, Dr., Leiden University Medical Center

Publications and helpful links

General Publications

• van Schie P, van Bodegom-Vos L, Zijdeman TM, Nelissen RGHH, Marang-van de Mheen PJ; IQ Joint study group. Effectiveness of a multifaceted quality improvement intervention to improve patient outcomes after total hip and knee arthroplasty: a registry nested cluster randomised controlled trial. BMJ Qual Saf. 2023 Jan;32(1):34-46. doi: 10.1136/bmjqs-2021-014472. Epub 2022 Jun 22.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (ACTUAL): August 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Total Hip/Knee Arthroplasty;Dutch Arthroplasty Register; Quality Improvement.
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: G18.140; VRF2018-001 (OTHER_GRANT: Van Rens Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is about the performance of hospitals. The individual performance of a hospital will not be announced.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No