Improving Quality Based on the Joint Registry

NCT ID: NCT04055103

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Registries Quality Improvement Hip Arthropathy Knee Arthropathy Hospital Performance

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each arm will receive the intervention for 6 months.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Monthly feedback, education and linking hospitals

Intervention Type OTHER

\- 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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PerlaJMarang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Perla Marang-van de Mheen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, South Holland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 35732486 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Main protocol

View Document

Document Type: Study Protocol: Annex 1: Grant Application Form

View Document

Document Type: Study Protocol: Annex 2: Data Delivery Agreement

View Document

Other Identifiers

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VRF2018-001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

G18.140

Identifier Type: -

Identifier Source: org_study_id