SurgeryRPMNCT04881708
Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay
A study testing Remote Monitoring in people with Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
The investigators believe that hospital readmissions for intermediate- to high-complexity surgeries can be reduced by remote patient monitoring follow-up post-discharge, which involves daily touchpoints with a clinical nurse, vital sign evaluation and a symptom directed communication escalation process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Remote Monitoring
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 18 Jan 2022
- 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
- Adults (over 18 years of age)
- Undergoing one of the following inpatient elective surgery procedures: abdominal wall reconstruction, bariatrics, hepatectomy, pancreatectomy, aortic surgery, lower extremity bypass, esophagectomy and colectomy at Mayo Clinic Rochester.
- Must be willing to actively work with RPM nurses with vital sign capturing.
Who cannot join
- Have uncontrolled mental illness and/or drug or alcohol abuse
- Reside in a long-term care facility
- Are being actively followed by dialysis or transplant services
- Pregnant
- Are being actively treated for cancer, receiving chemo or radiation therapy during the remote monitoring
- Are identified as end-of-life by provider
- Have dementia, cognitive impairment, or physical condition that limits ability to use home remote monitoring equipment independently or interact with remote patient monitoring staff (unless a caregiver commits to assisting daily).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The investigators believe that hospital readmissions for intermediate- to high-complexity surgeries can be reduced by remote patient monitoring follow-up post-discharge, which involves daily touchpoints with a clinical nurse, vital sign evaluation and a symptom directed communication escalation process.
- Conditions
- Surgery
- Being tested
- Remote Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote MonitoringDevice
Subjects assigned to the Remote Care group will receive education from a clinical nurse from Mayo Clinic's Department of Connected Care on use of the equipment as part of Remote Monitoring. The equipment will be shipped along with instructions and Welcome Letter describing the Mayo Clinic Remote Patient Monitoring program. The Remote Patient Monitoring kit includes a digital tablet, a blood pressure cuff, a thermometer, a pulse oximeter, and a weight scale. Subjects will be contacted by phone at the end of the study to be instructed how to return the kit by mail.
| Study group | Role | What they receive |
|---|---|---|
| Current Care Group | No intervention | The current care group will receive the standard of care currently in place within the subspecialty practices in the Department of Surgery, Mayo Clinic Rochester. This includes postoperative inpatient care directed by the surgical team, including timing of discharge and follow-up. |
| Remote Care Group | Active comparator | Patients randomized to the remote monitoring arm will engage in a Connected Care Remote Patient Monitoring (RPM) Complex Care program. RPM Complex Care programs utilize established and standardized equipment, logistics/reverse logistic, engagement methods, and nursing clinical practice. Use of RPM Complex Care programs in this manner, is considered standard practice. Patients will be monitored for 30 days by the Connected Care nursing team as is standard for surgical RPM Complex Care programs. Receives: Device: Remote Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Track the length of hospital stay in each group and compare.
Measured: Until hospital discharge, typically 3 to 7 days
Secondary outcomes (1)
30-day readmission rates
Evaluate the number of patients that are readmitted to the hospital in each group and compare.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start19 Apr 2021
- Primary completion17 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janani S. Reisenauer, Mayo Clinic
- Investigators
- Janani Reisenauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881708
- Sponsor's protocol ID
- 21-000817
- Acronym
- RPM
- Status last verified
- Jul 2022
- First submitted
- 6 May 2021
- Last updated
- 8 Jul 2022
- 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 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Surgical Based Efforts to Reduce Preventable Readmissions and Optimize Length of Stay
- ClinicalTrials.gov ID
- NCT04881708
- Acronym / sponsor ID
- RPM / 21-000817
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 11 May 2021 (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 believe that hospital readmissions for intermediate- to high-complexity surgeries can be reduced by remote patient monitoring follow-up post-discharge, which involves daily touchpoints with a clinical nurse, vital sign evaluation and a symptom directed communication escalation process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current Care Group | No intervention | –The current care group will receive the standard of care currently in place within the subspecialty practices in the Department of Surgery, Mayo Clinic Rochester. This includes postoperative inpatient care directed by the surgical team, including timing of discharge and follow-up. |
| Remote Care Group | Active comparator | Device: Remote MonitoringPatients randomized to the remote monitoring arm will engage in a Connected Care Remote Patient Monitoring (RPM) Complex Care program. RPM Complex Care programs utilize established and standardized equipment, logistics/reverse logistic, engagement methods, and nursing clinical practice. Use of RPM Complex Care programs in this manner, is considered standard practice. Patients will be monitored for 30 days by the Connected Care nursing team as is standard for surgical RPM Complex Care programs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (over 18 years of age)
- Undergoing one of the following inpatient elective surgery procedures: abdominal wall reconstruction, bariatrics, hepatectomy, pancreatectomy, aortic surgery, lower extremity bypass, esophagectomy and colectomy at Mayo Clinic Rochester.
- Must be willing to actively work with RPM nurses with vital sign capturing.
Key exclusion criteria (7 listed)
- Have uncontrolled mental illness and/or drug or alcohol abuse
- Reside in a long-term care facility
- Are being actively followed by dialysis or transplant services
- Pregnant
- Are being actively treated for cancer, receiving chemo or radiation therapy during the remote monitoring
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 |
|---|---|---|
| Remote MonitoringSubjects assigned to the Remote Care group will receive education from a clinical nurse from Mayo Clinic's Department of Connected Care on use of the equipment as part of Remote Monitoring. The equipment will be shipped along with instructions and Welcome Letter describing the Mayo Clinic Remote Patient Monitoring program. The Remote Patient Monitoring kit includes a digital tablet, a blood pressure cuff, a thermometer, a pulse oximeter, and a weight scale. Subjects will be contacted by phone at the end of the study to be instructed how to return the kit by mail. | Device | Remote Care Group |
Primary outcome
Length of Stay
Time frame: Until hospital discharge, typically 3 to 7 days
Track the length of hospital stay in each group and compare.
1 secondary outcome
30-day readmission rates
Time frame: 30 day
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 8 Jul 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Janani Reisenauer, 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 Remote Monitoring in people with Surgery, 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 3 inclusion and 7 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 8 Jul 2022. 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?
Length of Stay (time frame: Until hospital discharge, typically 3 to 7 days). 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 8 Jul 2022.