Quality ImprovementNCT04200209
To a Sustainable Quality Policy
A study testing Implementation of a quality indicator feedback mechanism in people with Quality Improvement and Public Health, run by KU Leuven at 1 site in Belgium.
Trial summary
The investigators need stronger feedback loops and a quality monitoring and management system to improve the quality of care in sustainable way. The Chair Sint-Trudo "To a sustainable quality policy" was established to scientifically develop prerequisites for a sustainable quality of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality Improvement, Public Health, Management Systems
- What is being tested?
- Implementation of a quality indicator feedback mechanism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Aug 2020to 1 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted in the hospital for more than one night
Who cannot join
- Patients admitted in the hospital for less than one night
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Implementation and Impact of a Rapid-cycle Quality Indicator Feedback Mechanism on Patients and Professionals: a Case Study of Sint-Trudo Hospital
The investigators need stronger feedback loops and a quality monitoring and management system to improve the quality of care in sustainable way. The Chair Sint-Trudo "To a sustainable quality policy" was established to scientifically develop prerequisites for a sustainable quality of care. In this study protocol, a monocentric mixed-method quasi-experimental study will be used to assess the impact of a rapid-cycle quality indicator feedback mechanism on both patients and professionals.
- Conditions
- Quality Improvement, Public Health, Management Systems
- Being tested
- Implementation of a quality indicator feedback mechanism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a quality indicator feedback mechanismOther
- Audit and feedback: A summary of clinical performance and hospital safety culture over a specified period of time.
- Benchmarking Achievable: benchmarks are calculated from the performance of all members of a peer group and represents a realistic standard of excellence attained by the top performers in that group (i.e. comparing to the top 10% of peers).
- Educational outreach: A trained independent person or investigator will meet with health professionals or managers in their practice setting to provide information (e.g. feedback of quality indicators).
- Action planning: The purpose of action planning is to support quality improvement efforts by identifying opportunities for improvement, strategies and steps to accomplish the work.
| Study group | Role | What they receive |
|---|---|---|
| Hospital | Experimental | Twelve wards of the hospital will be evaluated at the same time. Receives: Other: Implementation of a quality indicator feedback mechanism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
In-hospital mortality rate
Measured: During admission
Patient experiences
Experiences of patients will be measures by a validated questionnaire (Flemisch Patient Experience Questionnaire).
Q: Will you recommend our hospital? (scale min 0 until 10 with 0: not and 10: for sure).
For follow questions the scores are 'disagree', 'somewhat agree', 'largely agree', 'totally agree. The higher the score the better the outcome Q: This information was provided by my GP or by healthcare providers in the hospital.
Q: I understand the information I received about the cost of my stay. Q: I received sufficient information about the causes of my condition or about the possible treatment methods for my condition or about the consequences of my disease.
Q: Nurses or doctors explained things in a way I could understand or treated me with courtesy and respect.
Q: My privacy was respected during conversations with caregivers or during examinations, treatment and care.
Q: Before any treatment my identity was checked. Q: Hospital staff always introduced themselves
Measured: During admission
In-hospital length of stay
Length of stay of each patient in the hospital
Measured: During admission
Adverse events and adverse outcomes
Each adverse event and following adverse outcomes will be measured: urinary tract infections, pressure ulcers, hospital-acquired pneumonia, shock/cardiac arrest, upper-gastrointestinal bleeding, hospital-acquired sepsis, deep venous thrombosis, central nervous system complications, surgical wound infection, pulmonary failure, metabolic derangement, methicillin-resistant Staphylococcus aureus, vancomycin resistant Enterococcus, central line associated bloodstream infections, carbapenemase producing Enterobacteriaceae
Measured: During admission
Failure to rescue rate
The failure to rescue rate for each patient admitted in the hospital will be evaluated
Measured: During admission
Readmission rate
Readmission within 30 days of each patient admitted in the hospital
Measured: 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start15 Aug 2020
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality ImprovementStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Sint-Trudo Hospital
- Responsible party
- Principal investigator, Kris Vanhaecht, KU Leuven
- Investigators
- Kris Vanhaecht, MSc, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200209
- Sponsor's protocol ID
- SQP4ST
- Status last verified
- Feb 2024
- First submitted
- 11 Dec 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation and Impact of a Rapid-cycle Quality Indicator Feedback Mechanism on Patients and Professionals: a Case Study of Sint-Trudo Hospital
- ClinicalTrials.gov ID
- NCT04200209
- Acronym / sponsor ID
- SQP4ST
- Conditions
- Quality Improvement, Public Health, Management Systems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Sint-Trudo Hospital
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Dec 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.
The investigators need stronger feedback loops and a quality monitoring and management system to improve the quality of care in sustainable way. The Chair Sint-Trudo "To a sustainable quality policy" was established to scientifically develop prerequisites for a sustainable quality of care. In this study protocol, a monocentric mixed-method quasi-experimental study will be used to assess the impact of a rapid-cycle quality indicator feedback mechanism on both patients and professionals.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital | Experimental | Other: Implementation of a quality indicator feedback mechanismTwelve wards of the hospital will be evaluated at the same time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted in the hospital for more than one night
Key exclusion criteria (1 listed)
- Patients admitted in the hospital for less than one night
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 |
|---|---|---|
| Implementation of a quality indicator feedback mechanism1. Audit and feedback: A summary of clinical performance and hospital safety culture over a specified period of time. 2. Benchmarking Achievable: benchmarks are calculated from the performance of all members of a peer group and represents a realistic standard of excellence attained by the top performers in that group (i.e. comparing to the top 10% of peers). 3. Educational outreach: A trained independent person or investigator will meet with health professionals or managers in their practice setting to provide information (e.g. feedback of quality indicators). 4. Action planning: The purpose of action planning is to support quality improvement efforts by identifying opportunities for improvement, strategies and steps to accomplish the work. | Other | Hospital |
Primary outcome
Hospital mortality
Time frame: During admission
In-hospital mortality rate
Patient experiences
Time frame: During admission
Experiences of patients will be measures by a validated questionnaire (Flemisch Patient Experience Questionnaire). Q: Will you recommend our hospital? (scale min 0 until 10 with 0: not and 10: for sure). For follow questions the scores are 'disagree', 'somewhat agree', 'largely agree', 'totally agree. The higher the score the better the outcome Q: This information was provided by my GP or by healthcare providers in the hospital. Q: I understand the information I received about the cost of my stay. Q: I received sufficient information about the causes of my condition or about the possible treatment methods for my condition or about the consequences of my disease. Q: Nurses or doctors explained things in a way I could understand or treated me with courtesy and respect. Q: My privacy was respected during conversations with caregivers or during examinations, treatment and care. Q: Before any treatment my identity was checked. Q: Hospital staff always introduced themselves
In-hospital length of stay
Time frame: During admission
Length of stay of each patient in the hospital
Adverse events and adverse outcomes
Time frame: During admission
Each adverse event and following adverse outcomes will be measured: urinary tract infections, pressure ulcers, hospital-acquired pneumonia, shock/cardiac arrest, upper-gastrointestinal bleeding, hospital-acquired sepsis, deep venous thrombosis, central nervous system complications, surgical wound infection, pulmonary failure, metabolic derangement, methicillin-resistant Staphylococcus aureus, vancomycin resistant Enterococcus, central line associated bloodstream infections, carbapenemase producing Enterobacteriaceae
Failure to rescue rate
Time frame: During admission
The failure to rescue rate for each patient admitted in the hospital will be evaluated
Readmission rate
Time frame: 30 days after discharge
Readmission within 30 days of each patient admitted in the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
Related trials for Quality Improvement
Active, not recruiting
AI Ambient Scribe in Psychiatry
Therapeutic Alliance, Empathy
Active, not recruiting
OR Video-Laryngoscope Evaluations
Video Laryngoscopy, Quality Improvement
Recruiting
Study of RRS® HA Long Lasting for Improving Facial Wrinkles and Skin Quality
Photoaged Facial Skin, Photoaging
Active, not recruiting
Enhancing Mental and Physical Health of Women Veterans
Cardiovascular Diseases, Overweight
Active, not recruiting
Respiratory Knowledge Portal Computer and Phone Application to Improve Quality of Mechanical Ventilation by Reducing the Number of Ventilator Associated Events, Injury Created by the Ventilator and Unsafe Setting of Alarms.
Ventilation, ARDS
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.
Kris Vanhaecht, MSc principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of a quality indicator feedback mechanism in people with Quality Improvement and Public Health, run by KU Leuven at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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 Belgium. 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?
Results are not available in the source record.
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?
Hospital mortality (time frame: During admission). 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?
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 7 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.