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

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03490188
• Other study ID #: 2017H0190
• Status: Recruiting
• Phase: N/A
• Start date: August 2018
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Ohio State University
• Contact: Karla Zadnik, OD PhD
• Phone: 614 688 8457
• Email: irbinfo[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant; Complications

Intervention

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

Locations

Country	Name	City	State
United States	Comprehensive Transplant Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day readmissions		30-days
Secondary	Post Transplant Anxiety	State-Trait Anxiety Inventory (STAI) for Adults	1 Day of Discharge and 30-days after discharge
Secondary	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