A Study of the Effect of a Nurse Navigator Program on High Risk Patients

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05592847

Collaborator

(none)

300

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.

Condition or Disease	Intervention/Treatment	Phase
Patient Readmission Arthroplasty, Replacement, Knee Arthroplasty, Replacement, Hip Heart Failure Pulmonary Disease, Chronic Obstructive Renal Insufficiency Body Mass Index Alcoholism	Other: Nurse Navigator Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Effect of a Nurse Navigator Program on Readmission Rates for Patients With Elevated BMI, COPD, CHF, Dialysis Use, and H/o Alcohol Abuse

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Practice Patients with chronic conditions slated for surgery contacted once by pre-operative nurse to discuss surgery
Experimental: Nurse Navigator Patients with chronic conditions slated for surgery contacted once by pre-operative nurse to discuss surgery, then contacted at intervals by nurse navigator study team members	Other: Nurse Navigator Program Identification of specific chronic conditions and suggestion of management care of primary care physicians and referrals to specialists via nurse navigator team members.

Arm

Intervention/Treatment

No Intervention: Usual Practice

Patients with chronic conditions slated for surgery contacted once by pre-operative nurse to discuss surgery

Experimental: Nurse Navigator

Patients with chronic conditions slated for surgery contacted once by pre-operative nurse to discuss surgery, then contacted at intervals by nurse navigator study team members

Other: Nurse Navigator Program

Identification of specific chronic conditions and suggestion of management care of primary care physicians and referrals to specialists via nurse navigator team members.

Outcome Measures

Primary Outcome Measures

Readmission rates [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Require total or partial hip or knee replacement and have one or more of the following diagnosis: Heart Failure (HF); Chronic obstructive pulmonary disease (COPD); Dialysis; Alcohol Abuse; Low BMI.

Exclusion Criteria:

Decrease cognitive capacity to consent to the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: George Pujalte, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

George Pujalte, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05592847

Other Study ID Numbers:

21-013158

First Posted:

Oct 25, 2022

Last Update Posted:

Oct 25, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive

Renal Insufficiency

Alcoholism

Study Results

No Results Posted as of Oct 25, 2022