NCT04055103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

August 8, 2019

Last Update Submit

October 26, 2021

Conditions

Keywords

Total Hip/Knee Arthroplasty;Dutch Arthroplasty Register; Quality Improvement.

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Number of Quality Improvement Initiatives

    1 year follow-up during trial

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

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.

Interventions

\- 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.

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Perla Marang-van de Mheen, Dr.

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Each arm will receive the intervention for 6 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 13, 2019

Study Start

August 1, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

This is about the performance of hospitals. The individual performance of a hospital will not be announced.

Locations