Patient ActivationNCT04224220
Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial
A study testing Adult Medical Care Coordination and Remote Patient Monitoring in people with Patient Activation, run by Mayo Clinic at 1 site in United States.
Trial summary
This trial will evaluate the effectiveness of nurse-based care coordination and nurse-based remote patient monitoring on hospital readmissions among primary care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Activation
- What is being tested?
- Adult Medical Care Coordination and Remote Patient Monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,947 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Jan 2023
- 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
- Discharged from the hospital in the past 7 days
- LACE+ score of 59 or greater and at least two chronic conditions
- Index hospitalization with discharge directly to community dwelling home (home, assisted living)
- English speaking
- Normal cognitive function - mild dementia or mild cognitive impairment is allowed if a caregiver is able to work with the care coordinator and patient during program enrollment
- Mayo Clinic or Mayo Clinic Health System provider managing the patient's care (e.g. primary care); patient is assigned to the panel of a Mayo Clinic Medical Doctor/Nurse Practitioner/Physician Assistant
- Access to and ability to communicate via telephone (either patient or caregiver)
Who cannot join
- Psychiatric hospital admission
- Patients with a serious and persistent mental health disorder or severe treatment interfering behavior that require a higher level of service than is available at the patient's clinic
- Untreated active substance or alcohol abuse
- Dementia or moderate to severe cognitive impairment
- Discharged to one of the following: rehabilitation unit, skilled nursing facility, assisted living memory unit, group home
- Pregnancy
Show all 14Show fewer
- Active treatment for cancer
- Receiving dialysis or transplant services
- Life expectancy < 6 months or enrolled in hospice or palliative care programs
- Patient is unwilling to sign a Release of Information (ROI); ROI allows those providing care, internal and external, to be actively involved in the patient's care coordination
- Patients with active tuberculosis (TB)
- Violent patient flag noted in Epic (for adult medical care coordination)
- Patient declines home visit (for adult medical care coordination)
- Patient is already enrolled in remote patient monitoring or the care transitions program
Trial locations and contacts
1 site in 1 country.
About this study
This trial will evaluate the effectiveness of nurse-based care coordination and nurse-based remote patient monitoring on hospital readmissions among primary care patients.
- Conditions
- Patient Activation
- Being tested
- Adult Medical Care Coordination, Remote Patient Monitoring
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult Medical Care CoordinationOther
Nurse-based support that includes a home visit and follow-up coaching telephone calls to monitor patient status and ability to self-manage symptoms.
Remote Patient MonitoringOther
Nurse-based support and coaching that incorporates the use of technology to monitor patient status and ability to self-manage symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Adult Medical Care Coordination | Active comparator | This group will receive adult medical care coordination following discharge from a recent hospitalization. Receives: Other: Adult Medical Care Coordination |
| Remote Patient Monitoring | Active comparator | This group will receive remote patient monitoring following discharge from a recent hospitalization. Receives: Other: Remote Patient Monitoring |
| Usual Care | No intervention | The usual care group will not receive additional supportive care following discharge from a recent hospitalization beyond what is typically offered through their primary care team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Readmission
The rate of patients revisiting the emergency department or being admitted to the hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jan 2020
- Primary completion1 Jul 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ActivationStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,947 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle A. Lampman, Mayo Clinic
- Investigators
- Michelle Lampman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224220
- Sponsor's protocol ID
- 19-009784
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2020
- Last updated
- 15 Feb 2023
- 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 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT04224220
- Acronym / sponsor ID
- 19-009784
- Conditions
- Patient Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,947 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 13 Jan 2020 (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 trial will evaluate the effectiveness of nurse-based care coordination and nurse-based remote patient monitoring on hospital readmissions among primary care patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult Medical Care Coordination | Active comparator | Other: Adult Medical Care CoordinationThis group will receive adult medical care coordination following discharge from a recent hospitalization. |
| Remote Patient Monitoring | Active comparator | Other: Remote Patient MonitoringThis group will receive remote patient monitoring following discharge from a recent hospitalization. |
| Usual Care | No intervention | –The usual care group will not receive additional supportive care following discharge from a recent hospitalization beyond what is typically offered through their primary care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Discharged from the hospital in the past 7 days
- LACE+ score of 59 or greater and at least two chronic conditions
- Index hospitalization with discharge directly to community dwelling home (home, assisted living)
- English speaking
- Normal cognitive function - mild dementia or mild cognitive impairment is allowed if a caregiver is able to work with the care coordinator and patient during program enrollment
Key exclusion criteria (14 listed)
- Psychiatric hospital admission
- Patients with a serious and persistent mental health disorder or severe treatment interfering behavior that require a higher level of service than is available at the patient's clinic
- Untreated active substance or alcohol abuse
- Dementia or moderate to severe cognitive impairment
- Discharged to one of the following: rehabilitation unit, skilled nursing facility, assisted living memory unit, group home
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 |
|---|---|---|
| Adult Medical Care CoordinationNurse-based support that includes a home visit and follow-up coaching telephone calls to monitor patient status and ability to self-manage symptoms. | Other | Adult Medical Care Coordination |
| Remote Patient MonitoringNurse-based support and coaching that incorporates the use of technology to monitor patient status and ability to self-manage symptoms. | Other | Remote Patient Monitoring |
Primary outcome
Rate of Readmission
Time frame: 30 days
The rate of patients revisiting the emergency department or being admitted to the hospital
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 15 Feb 2023.
- 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.
Michelle Lampman, 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 Adult Medical Care Coordination and Remote Patient Monitoring in people with Patient Activation, 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 7 inclusion and 14 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 15 Feb 2023. 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?
Rate of Readmission (time frame: 30 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 15 Feb 2023.