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

Study Overview
=================
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.

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

Conditions
-----------------
Patient Activation

Intervention / Treatment
-----------------
* Other: Adult Medical Care Coordination
* Other: Remote Patient Monitoring


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adult Medical Care Coordination<br>This group will receive adult medical care coordination following discharge from a recent hospitalization. | Other: Adult Medical Care Coordination<br>* Nurse-based support that includes a home visit and follow-up coaching telephone calls to monitor patient status and ability to self-manage symptoms.<br>|
| Active Comparator: Remote Patient Monitoring<br>This group will receive remote patient monitoring following discharge from a recent hospitalization. | Other: Remote Patient Monitoring<br>* Nurse-based support and coaching that incorporates the use of technology to monitor patient status and ability to self-manage symptoms.<br>|
| No Intervention: Usual Care<br>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 |