Clinical trial NCT03490188: Design of a Standardized Patient: Mentoring Program for Kidney Transplant Patients
Official title: An Innovative Patient-mentoring Program for Kidney Transplant Patients to Reduce Anxiety and Readmission Rates: a Randomized Controlled Trial Leveraging Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplant; Complications
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A single institution randomized control trial assigning patients getting discharged after a kidney transplant to treatment and control group
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: 30-day readmissions
timeFrame: 30-days
Secondary outcomes:
measure: Post Transplant Anxiety
timeFrame: 1 Day of Discharge and 30-days after discharge
measure: Preventable Re-admissions
timeFrame: 30-days after day of discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Comprehensive Transplant Center
state: Ohio
Study officials:
References:
citation: 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.