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

NCT ID: NCT04224220

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1947 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Adult Medical Care Coordination

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

Group Type: ACTIVE_COMPARATOR

Adult Medical Care Coordination

Intervention Type: 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.

Remote Patient Monitoring

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

Group Type: ACTIVE_COMPARATOR

Remote Patient Monitoring

Intervention Type: OTHER

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

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adult 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.

Intervention Type: OTHER

Remote Patient Monitoring

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Michelle A. Lampman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Lampman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

19-009784

Identifier Type: -

Identifier Source: org_study_id