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

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 Overview

• Status: Completed
• Conditions: Patient Activation
• Intervention / Treatment: Other: Adult Medical Care Coordination; Other: Remote Patient Monitoring

• Study Type: Interventional
• Enrollment (Actual): 1947
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Adult Medical Care Coordination; This group will receive adult medical care coordination following discharge from a recent hospitalization.	Other: 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.
Active Comparator: Remote Patient Monitoring; This group will receive remote patient monitoring following discharge from a recent hospitalization.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Readmission	The rate of patients revisiting the emergency department or being admitted to the hospital	30 days

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-009784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No