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| ID | Type | Description | Link |
|---|---|---|---|
| VRF2018-001 | Other Grant/Funding Number | Van Rens Foundation |
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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monthly feedback, education and linking hospitals | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perla Marang-van de Mheen, Dr. | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Leiden | South Holland | 2333 ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35732486 | Derived | 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. |
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This is about the performance of hospitals. The individual performance of a hospital will not be announced.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Main protocol | Oct 24, 2018 | Aug 12, 2019 | Prot_SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: Annex 1: Grant Application Form | Mar 1, 2018 | Aug 12, 2019 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Annex 2: Data Delivery Agreement | Oct 24, 2018 | Aug 12, 2019 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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Each arm will receive the intervention for 6 months.
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