Back to resultsA Study of the Effect of a Nurse Navigator Program on High Risk Patients
Primary Purpose
Patient Readmission, Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Hip
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse Navigator Program
Sponsored by
About this trial
This is an interventional supportive care trial for Patient Readmission
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Practice
Nurse Navigator
Arm Description
Patients with chronic conditions slated for surgery contacted once by pre-operative nurse to discuss surgery
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
Outcomes
Primary Outcome Measures
Readmission rates
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05592847
Brief Title
A Study of the Effect of a Nurse Navigator Program on High Risk Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Readmission, Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Hip, Heart Failure, Pulmonary Disease, Chronic Obstructive, Renal Insufficiency, Body Mass Index, Alcoholism
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Practice
Arm Type
No Intervention
Arm Description
Patients with chronic conditions slated for surgery contacted once by pre-operative nurse to discuss surgery
Arm Title
Nurse Navigator
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Nurse Navigator Program
Intervention Description
Identification of specific chronic conditions and suggestion of management care of primary care physicians and referrals to specialists via nurse navigator team members.
Primary Outcome Measure Information:
Title
Readmission rates
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Pujalte, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of the Effect of a Nurse Navigator Program on High Risk Patients
We'll reach out to this number within 24 hrs