Catheter-Related InfectionsNCT03950921
Pilot Testing a Patient Safety Display in the Hospital Setting
A study testing Patient Safety Display in people with Catheter-Related Infections and Pressure Injury, run by University of Michigan at 1 site in United States.
Trial summary
This is a feasibility pilot study to introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. This intervention, the "Patient Safety Display" will be evaluated in one hospital unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections, Pressure Injury
- What is being tested?
- Patient Safety Display
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 20 Sep 2019
- 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
- Hospitalized in specific hospital unit of interest or providers caring for patient in that unit
Who cannot join
- Patients not in unit of interest and providers not caring for patients on that unit
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital, Michigan Medicine
Ann Arbor, Michigan, 48109
About this study
Official title: Improving Risk Detection and Communication to Reduce Hospital-Acquired Conditions
This is a feasibility pilot study to introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. This intervention, the "Patient Safety Display" will be evaluated in one hospital unit.
Read the detailed description
This project will introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. A "Patient Safety Display" will be implemented in half of the patient rooms in one hospital unit. The Patient Safety Display will display catheter and pressure injury data pulled real-time from the electronic medical record onto a tablet mounted at the patient bedside.
This is an intervention-control design study that will be conducted with patients and clinicians at Michigan Medicine. The proposed intervention, the Patient Safety Display, will provide clinicians with key catheter and skin information at the bedside when pertinent clinical decisions are being made.
- Conditions
- Catheter-Related Infections, Pressure Injury
- Being tested
- Patient Safety Display
- Keywords
- Catheter-Related Infections, Pressure Injury, Patient Safety
- Medical subject headings
- Catheter-Related Infections, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Safety DisplayBehavioural
Digital display of catheter and pressure injury information in patient hospital room
| Study group | Role | What they receive |
|---|---|---|
| Patient Safety Display Arm | Experimental | Patient Safety Display in patient room Receives: Behavioral: Patient Safety Display |
| Control Arm | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary catheter awareness
Proportion of physicians and advanced practice providers aware of their patients' indwelling urinary catheters; measured via survey
Measured: 4 months
Central venous catheter awareness
Proportion of physicians and advanced practice providers aware of their patients' central venous catheters; measured via survey
Measured: 4 months
Pressure injury awareness
Proportion of physicians and advanced practice providers aware of their patients' pressure injuries; measured via survey
Measured: 4 months
Secondary outcomes (6)
Urinary catheter usage
Urinary catheter usage rates, as documented in the electronic medical record
Measured: 4 months
CAUTI
Catheter-associated urinary tract infections (CAUTI) rates, as collected for routine National Healthcare Safety Network (NHSN) reporting
Measured: 4 months
Central venous catheter usage
Central venous catheter usage rates, as documented in the electronic medical record
Measured: 4 months
CLABSI
Central-line associated urinary tract infections (CLABSI) rates, as collected for routine NHSN reporting
Measured: 4 months
Pressure injuries
Pressure injury incidence, as documented in the electronic medical record
Measured: 4 months
Pressure injury care
Rates of pressure injury care practices (i.e., wound team consults, specialty bed orders, use of repositioning devices) as reported in the electronic medical record
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start24 Jun 2019
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention-control study design
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Jennifer Meddings, University of Michigan
- Investigators
- Jennifer Meddings, MD, MSc, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950921
- Sponsor's protocol ID
- HUM00106108
- Status last verified
- Oct 2019
- First submitted
- 13 May 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Risk Detection and Communication to Reduce Hospital-Acquired Conditions
- ClinicalTrials.gov ID
- NCT03950921
- Acronym / sponsor ID
- HUM00106108
- Conditions
- Catheter-Related Infections, Pressure Injury
- Keywords
- Catheter-Related Infections, Pressure Injury, Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 15 May 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.
This is a feasibility pilot study to introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. This intervention, the "Patient Safety Display" will be evaluated in one hospital unit.
Detailed description
This project will introduce and evaluate an intervention designed to increase clinician awareness of their patients' urinary catheters, vascular catheters, and pressure injuries. A "Patient Safety Display" will be implemented in half of the patient rooms in one hospital unit. The Patient Safety Display will display catheter and pressure injury data pulled real-time from the electronic medical record onto a tablet mounted at the patient bedside.
This is an intervention-control design study that will be conducted with patients and clinicians at Michigan Medicine. The proposed intervention, the Patient Safety Display, will provide clinicians with key catheter and skin information at the bedside when pertinent clinical decisions are being made.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention-control study design
| Arm | Type | Receives |
|---|---|---|
| Patient Safety Display Arm | Experimental | Behavioral: Patient Safety DisplayPatient Safety Display in patient room |
| Control Arm | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized in specific hospital unit of interest or providers caring for patient in that unit
Key exclusion criteria (1 listed)
- Patients not in unit of interest and providers not caring for patients on that unit
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 |
|---|---|---|
| Patient Safety DisplayDigital display of catheter and pressure injury information in patient hospital room | Behavioural | Patient Safety Display Arm |
Primary outcome
Urinary catheter awareness
Time frame: 4 months
Proportion of physicians and advanced practice providers aware of their patients' indwelling urinary catheters; measured via survey
Central venous catheter awareness
Time frame: 4 months
Proportion of physicians and advanced practice providers aware of their patients' central venous catheters; measured via survey
Pressure injury awareness
Time frame: 4 months
Proportion of physicians and advanced practice providers aware of their patients' pressure injuries; measured via survey
6 secondary outcomes
Urinary catheter usage
Time frame: 4 months
CAUTI
Time frame: 4 months
Central venous catheter usage
Time frame: 4 months
CLABSI
Time frame: 4 months
Pressure injuries
Time frame: 4 months
Pressure injury care
Time frame: 4 months
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 1 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Jennifer Meddings, MD, MSc principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Safety Display in people with Catheter-Related Infections and Pressure Injury, run by University of Michigan at 1 site in United States.
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 1 Nov 2019. 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 United States. 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?
Urinary catheter awareness (time frame: 4 months). The study lists 3 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 1 Nov 2019.