Design of a Standardized Patient: Mentoring Program for Kidney Transplant Patients

An Innovative Patient-mentoring Program for Kidney Transplant Patients to Reduce Anxiety and Readmission Rates: a Randomized Controlled Trial Leveraging Patients

There is an increasing number in patient's undergoing kidney transplantation in the United States. Furthermore, kidney recipients have high occurrence of 30-day readmissions that leads to high hospital costs and decreased quality of life for transplant recipients. A previous research finds that high levels of post-transplant anxiety is correlated with increased likelihood of 30-day readmissions. The goal of this study is to design and implementat a randomized control trial (RCT) using a standardized post-transplant mentoring program in order to reduce 30-day readmission and post-transplant anxiety among recipients.

Study Overview

• Status: Unknown
• Conditions: Kidney Transplant; Complications
• Intervention / Treatment: Behavioral: Discharge Mentoring

Detailed Description

In this research, the investigators will seek to examine the efficacy of using former patients as mentors to newly transplanted patients and its relationship with patient anxiety following discharge as well as the prevention of 30-day readmissions for kidney transplant recipients. The primary hypothesis is that the treatment group of patients who undergo a targeted mentorship program will be better compliant with the discharge instructions and will perform better when compared to the control group who undergoes current routine post-transplantation care. Evidence from this experiment can help advance our understanding of patient-engagement in the continuity of care delivery, decrease patient readmission rates, and improve overall cost utilization.

Methods:

The investigators will conduct a single institution randomized control trial assigning patients getting discharged after a kidney transplant to a treatment group that involves a 30-day mentoring initiative by former transplant patients, and comparing the efficacy with a similar control group. The overall study period will be divided into the following sections, summarized in Figure 1.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karla Zadnik, OD PhD; Phone Number: 614 688 8457; Email: irbinfo@osu.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Comprehensive Transplant Center
      • Contact: Kristen Hill, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• any patient who received a kidney transplantation, deceased or living donor, during the study period.

Exclusion Criteria:

• anyone younger than 18 years old or older than 70 years old.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Patients assigned to treatment arm will receive standard post-transplantation discharge care that includes weekly follow-up visits and 24-hour access to transplant triage call center. In addition, they will be matched with a mentor who will conduct 5 meetings with the patients (which includes one video chat meeting, 4 30-minute phone calls) and discuss the following topics related to post-discharge: Medications, Lab Work, Fluid Intake and Adherence to doctor's appointment	Behavioral: Discharge Mentoring; Phone Conversations on the importance of complying to discharge instructions delivered before discharge
No Intervention: Control Arm; Control arm recipient will receive standard post-transplantation discharge care that includes weekly follow-up visits and 24-hour access to transplant triage call center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day readmissions	30-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Transplant Anxiety	State-Trait Anxiety Inventory (STAI) for Adults	1 Day of Discharge and 30-days after discharge
Preventable Re-admissions	Re admissions due to missed labs or medications as measured by time of readmission for any readmission that was deemed preventable by physiologic laboratory data, reason for readmission, and primary complaint determined by trained kidney transplantation nurses	30-days after day of discharge

Collaborators and Investigators

• Sponsor: Ohio State University

Publications and helpful links

General Publications

• Chandrasekaran A, Anand G, Sharma L, Pesavanto T, Hauenstein ML, Nguyen M, Gadkari M, Moffatt-Bruce S. Role of in-hospital care quality in reducing anxiety and readmissions of kidney transplant recipients. J Surg Res. 2016 Sep;205(1):252-259.e1. doi: 10.1016/j.jss.2016.05.032. Epub 2016 May 27.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: April 5, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2017H0190

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