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Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial

Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04224220
Enrollment
1947
Registered
2020-01-13
Start date
2020-01-01
Completion date
2023-01-01
Last updated
2023-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Activation

Brief 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.

Interventions

OTHERAdult Medical Care Coordination

Nurse-based support that includes a home visit and follow-up coaching telephone calls to monitor patient status and ability to self-manage symptoms.

Nurse-based support and coaching that incorporates the use of technology to monitor patient status and ability to self-manage symptoms.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Readmission30 daysThe rate of patients revisiting the emergency department or being admitted to the hospital

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026