CClinicalTrials.gg
CompletedNCT04224220Updated Feb 15, 2023

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

An interventional study of Adult Medical Care Coordination and Remote Patient Monitoring in Patient Activation, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-15.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,947
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patient Activation
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
1,947 participants (actual)

Study arms

  • 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

  • Active comparator
    Remote Patient Monitoring

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

    Other: Remote Patient Monitoring

  • 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.

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.

  • OtherRemote Patient Monitoring

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

06

What researchers measure

Primary outcomes

  1. Rate of Readmission

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

    Time frame: 30 days

07

Study locations

1 site
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04224220
Lead sponsor
Mayo Clinic
Responsible party
Michelle A. Lampman (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 13, 2020
Start date
Jan 1, 2020
Primary completion
Jul 1, 2022
Completion
Jan 1, 2023
Last update
Feb 15, 2023

Study contacts

Michelle Lampman, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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