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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490188
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Aravind Chandrasekaran, Ohio State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Transplant; Complications Behavioral: Discharge Mentoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: A single institution randomized control trial assigning patients getting discharged after a kidney transplant to treatment and control group
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Innovative Patient-mentoring Program for Kidney Transplant Patients to Reduce Anxiety and Readmission Rates: a Randomized Controlled Trial Leveraging Patients
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 30-day readmissions [ Time Frame: 30-days ]

Secondary Outcome Measures :
  1. Post Transplant Anxiety [ Time Frame: 1 Day of Discharge and 30-days after discharge ]
    State-Trait Anxiety Inventory (STAI) for Adults

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490188


Contacts
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Contact: Karla Zadnik, OD PhD 614 688 8457 irbinfo@osu.edu

Locations
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United States, Ohio
Comprehensive Transplant Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Kristen Hill, RN         
Sponsors and Collaborators
Ohio State University

Publications:
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Responsible Party: Aravind Chandrasekaran, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03490188    
Other Study ID Numbers: 2017H0190
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No