NursingNCT05744180
A Study of Workflow-Integrated Artificial Intelligence for RPM Enrollment
A study testing Interventional in people with Nursing, run by Mayo Clinic at 1 site in United States.
Trial summary
The objective of this study is to evaluate effectiveness, usability and clinical utility of the remote patient monitoring (RPM) "fit" score when choosing patients to enter the RPM Program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing
- What is being tested?
- Interventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2023to 16 Jan 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study participants will be nurses who are part of the RPM care team that cares for adult patients ≥18 years.
- A patient's data will be included in the analysis if the patient is ≥18 years old and receives care from a participating nurse.
- Patient data will only be collected if permitted (based on the use of the Minnesota Research Authorization Retrieval Tool).
- Patients who will be considered for this study will be assessed based on standard RPM program inclusion and exclusion criteria for the any of the chronic disease RPM programs (congestive heart failure, coronary artery disease, hypertension, type 2 diabetes, COPD, and general complex care).
Who cannot join
- < 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Analysis of the Impact and Utilization of Workflow-Integrated Artificial Intelligence for RPM Enrollment
The objective of this study is to evaluate effectiveness, usability and clinical utility of the remote patient monitoring (RPM) "fit" score when choosing patients to enter the RPM Program.
- Conditions
- Nursing
- Being tested
- Interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionalOther
Also called FitScore
The FitScore is a machine learning algorithm embedded within the electronic health record that identifies patients most likely to benefit from remote patient monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Arm Not Applicable | Other | Not described Receives: Other: Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effectiveness, usability, and clinical utility of the RPM "fit" score as displayed in the Acute Multipatient Viewer (AMP) and underlying AI models in the real-world setting
FitScore effectiveness will determined by the patient care utilization outcomes of those who did or did not participate in RPM (for those enrolled with or without the FitScore). Usability and clinical utility will be self-reported by nursing staff collected through surveys or as directly observed by study staff (as to experience with or without the FitScore).
Measured: 1 year
Secondary outcomes (1)
Assessment of "fit" score overall effect on nursing efficiency and clinical workflows
Efficiency will be measured by timing studies of nurse patient screening for RPM eligibility as directly observed by study staff. The effect on clinical workflows will be self-reported by nursing staff collected through surveys (as to experience with or without the FitScore).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start19 Jun 2023
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NursingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tufia C. Haddad, Mayo Clinic
- Investigators
- Tufia Haddad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744180
- Sponsor's protocol ID
- 22-008014
- Status last verified
- Oct 2024
- First submitted
- 2 Feb 2023
- Last updated
- 9 Oct 2024
- 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 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Analysis of the Impact and Utilization of Workflow-Integrated Artificial Intelligence for RPM Enrollment
- ClinicalTrials.gov ID
- NCT05744180
- Acronym / sponsor ID
- 22-008014
- Conditions
- Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 24 Feb 2023 (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 objective of this study is to evaluate effectiveness, usability and clinical utility of the remote patient monitoring (RPM) "fit" score when choosing patients to enter the RPM Program.
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 |
|---|---|---|
| Arm Not Applicable | Other | Other: Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The study participants will be nurses who are part of the RPM care team that cares for adult patients ≥18 years.
- A patient's data will be included in the analysis if the patient is ≥18 years old and receives care from a participating nurse.
- Patient data will only be collected if permitted (based on the use of the Minnesota Research Authorization Retrieval Tool).
- Patients who will be considered for this study will be assessed based on standard RPM program inclusion and exclusion criteria for the any of the chronic disease RPM programs (congestive heart failure, coronary artery disease, hypertension, type 2 diabetes, COPD, and general complex care).
Key exclusion criteria (1 listed)
- < 18 years old.
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 |
|---|---|---|
| InterventionalAlso: FitScoreThe FitScore is a machine learning algorithm embedded within the electronic health record that identifies patients most likely to benefit from remote patient monitoring. | Other | Arm Not Applicable |
Primary outcome
Evaluation of the effectiveness, usability, and clinical utility of the RPM "fit" score as displayed in the Acute Multipatient Viewer (AMP) and underlying AI models in the real-world setting
Time frame: 1 year
FitScore effectiveness will determined by the patient care utilization outcomes of those who did or did not participate in RPM (for those enrolled with or without the FitScore). Usability and clinical utility will be self-reported by nursing staff collected through surveys or as directly observed by study staff (as to experience with or without the FitScore).
1 secondary outcome
Assessment of "fit" score overall effect on nursing efficiency and clinical workflows
Time frame: 1 year
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 9 Oct 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Tufia Haddad, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional in people with Nursing, run by Mayo Clinic 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 4 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 9 Oct 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 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?
Evaluation of the effectiveness, usability, and clinical utility of the RPM "fit" score as displayed in the Acute Multipatient Viewer (AMP) and underlying AI models in the real-world setting (time frame: 1 year). 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 9 Oct 2024.