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

Overview

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.

Full Title of Study: “An Innovative Patient-mentoring Program for Kidney Transplant Patients to Reduce Anxiety and Readmission Rates: a Randomized Controlled Trial Leveraging Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2018

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.

Interventions

  • Behavioral: Discharge Mentoring
    • Phone Conversations on the importance of complying to discharge instructions delivered before discharge

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 30-day readmissions
    • Time Frame: 30-days

Secondary Measures

  • Post Transplant Anxiety
    • Time Frame: 1 Day of Discharge and 30-days after discharge
    • State-Trait Anxiety Inventory (STAI) for Adults
  • Preventable Re-admissions
    • Time Frame: 30-days after day of discharge
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ohio State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Aravind Chandrasekaran, Associate Professor – Ohio State University
  • Overall Contact(s)
    • Karla Zadnik, OD PhD, 614 688 8457, irbinfo@osu.edu

References

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.

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