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Improving Quality Based on the Joint Registry (IQ Joint)

Primary Purpose

Registries, Quality Improvement, Hip Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Monthly feedback, education and linking hospitals
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Registries focused on measuring Total Hip/Knee Arthroplasty;Dutch Arthroplasty Register; Quality Improvement.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Sites / Locations

  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Quality Improvement Initiatives
Number of quality improvement Initiatives with the aim to improve the quality of care

Full Information

First Posted
August 8, 2019
Last Updated
October 26, 2021
Sponsor
Leiden University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04055103
Brief Title
Improving Quality Based on the Joint Registry
Acronym
IQ Joint
Official Title
Improving Quality Based on the Joint Registry
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Registries, Quality Improvement, Hip Arthropathy, Knee Arthropathy, Hospital Performance
Keywords
Total Hip/Knee Arthroplasty;Dutch Arthroplasty Register; Quality Improvement.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each arm will receive the intervention for 6 months.
Masking
Care Provider
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Monthly feedback, education and linking hospitals
Intervention Description
- 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.
Primary Outcome Measure Information:
Title
Survival (yes/no)
Description
Patient survival after HA/TKA surgery
Time Frame
1 year follow-up during trial
Title
1-year revision rate (%)
Description
Number of revisions performed within one year adjusted for patient characteristics
Time Frame
1 year follow-up during trial
Title
Prolonged length-of stay (yes/no)
Description
Prolonged length-of-stay in the overall upper quartile
Time Frame
1 year follow-up during trial
Title
Readmission (yes/no)
Description
Readmission within 30 days after discharge
Time Frame
1 year follow-up during trial
Title
Number of Complications
Description
Number of complications
Time Frame
1 year follow-up during trial
Title
Composite outcome measure (Textbook Outcome)
Description
Including: Survival; 1-year revision rate; Length-of-Stay and Readmission.
Time Frame
1 year follow-up during trial
Secondary Outcome Measure Information:
Title
Number of Quality Improvement Initiatives
Description
Number of quality improvement Initiatives with the aim to improve the quality of care
Time Frame
1 year follow-up during trial

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perla Marang-van de Mheen, Dr.
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is about the performance of hospitals. The individual performance of a hospital will not be announced.
Citations:
PubMed Identifier
35732486
Citation
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.
Results Reference
derived

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Improving Quality Based on the Joint Registry

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