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

NCT03490188 | Unknown

• 1 other identifier: 2017H0190
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• 30-day readmissions

  30-days

Secondary Outcomes (2)

• Post Transplant Anxiety

  1 Day of Discharge and 30-days after discharge

• Preventable Re-admissions

  30-days after day of discharge

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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

Interventions

Discharge Mentoring BEHAVIORAL

Phone Conversations on the importance of complying to discharge instructions delivered before discharge

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Comprehensive Transplant Center

Columbus, Ohio, 43210, United States

RECRUITING

Related 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.

  PMID: 27329569 BACKGROUND

Central Study Contacts

Karla Zadnik, OD PhD

CONTACT

614 688 8457; irbinfo@osu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A single institution randomized control trial assigning patients getting discharged after a kidney transplant to treatment and control group

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: April 6, 2018
• Study Start: August 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 21, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)