RegistriesIQ JointNCT04055103
Improving Quality Based on the Joint Registry
A study testing Monthly feedback, education and linking hospitals in people with Registries and Quality Improvement, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Registries, Quality Improvement, Hip Arthropathy
- What is being tested?
- Monthly feedback, education and linking hospitals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Aug 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All Dutch orthopedic clinics where hip- and knee replacement surgery is performed who agree to participate will be randomized.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
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.
Read the 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.
- Being tested
- Monthly feedback, education and linking hospitals
- Keywords
- Total Hip/Knee Arthroplasty;Dutch Arthroplasty Register; Quality Improvement.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly feedback, education and linking hospitalsOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival (yes/no)
Patient survival after HA/TKA surgery
Measured: 1 year follow-up during trial
1-year revision rate (%)
Number of revisions performed within one year adjusted for patient characteristics
Measured: 1 year follow-up during trial
Prolonged length-of stay (yes/no)
Prolonged length-of-stay in the overall upper quartile
Measured: 1 year follow-up during trial
Readmission (yes/no)
Readmission within 30 days after discharge
Measured: 1 year follow-up during trial
Number of Complications
Number of complications
Measured: 1 year follow-up during trial
Composite outcome measure (Textbook Outcome)
Including: Survival; 1-year revision rate; Length-of-Stay and Readmission.
Measured: 1 year follow-up during trial
Secondary outcomes (1)
Number of Quality Improvement Initiatives
Number of quality improvement Initiatives with the aim to improve the quality of care
Measured: 1 year follow-up during trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Aug 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RegistriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each arm will receive the intervention for 6 months.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PerlaJMarang, Leiden University Medical Center
- Investigators
- Perla Marang-van de Mheen, Dr., Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055103
- Sponsor's protocol ID
- G18.140
- Other IDs
- VRF2018-001
- Acronym
- IQ Joint
- Status last verified
- Oct 2021
- First submitted
- 8 Aug 2019
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is about the performance of hospitals. The individual performance of a hospital will not be announced.
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.
PubMed 35732486
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality Based on the Joint Registry
- ClinicalTrials.gov ID
- NCT04055103
- Acronym / sponsor ID
- IQ Joint / G18.140
- Keywords
- Total Hip/Knee Arthroplasty;Dutch Arthroplasty Register; Quality Improvement.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Each arm will receive the intervention for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Monthly feedback, education and linking hospitalsHalf 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All Dutch orthopedic clinics where hip- and knee replacement surgery is performed who agree to participate will be randomized.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention Group |
Primary outcome
Survival (yes/no)
Time frame: 1 year follow-up during trial
Patient survival after HA/TKA surgery
1-year revision rate (%)
Time frame: 1 year follow-up during trial
Number of revisions performed within one year adjusted for patient characteristics
Prolonged length-of stay (yes/no)
Time frame: 1 year follow-up during trial
Prolonged length-of-stay in the overall upper quartile
Readmission (yes/no)
Time frame: 1 year follow-up during trial
Readmission within 30 days after discharge
Number of Complications
Time frame: 1 year follow-up during trial
Number of complications
Composite outcome measure (Textbook Outcome)
Time frame: 1 year follow-up during trial
Including: Survival; 1-year revision rate; Length-of-Stay and Readmission.
1 secondary outcome
Number of Quality Improvement Initiatives
Time frame: 1 year follow-up during trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Derived from this study: PubMed 35732486van 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.
- Individual participant dataSharing planned: No. This is about the performance of hospitals. The individual performance of a hospital will not be announced.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perla Marang-van de Mheen, Dr. principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly feedback, education and linking hospitals in people with Registries and Quality Improvement, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (yes/no) (time frame: 1 year follow-up during trial). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.