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

NCT04224220 | Completed

• 1 other identifier: 19-009784
• Study Type: interventional
• Target: 1,947
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Activation

Outcome Measures

Primary Outcomes (1)

• Rate of Readmission

  The rate of patients revisiting the emergency department or being admitted to the hospital

  30 days

Study Arms (3)

Adult Medical Care Coordination

ACTIVE COMPARATOR

This group will receive adult medical care coordination following discharge from a recent hospitalization.

Other: Adult Medical Care Coordination

Remote Patient Monitoring

ACTIVE COMPARATOR

This group will receive remote patient monitoring following discharge from a recent hospitalization.

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.

Interventions

Adult Medical Care Coordination OTHER

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

Adult Medical Care Coordination

Remote Patient Monitoring OTHER

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

Remote Patient Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Patient Participation

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Michelle Lampman, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: January 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)