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

NCT ID: NCT03490188

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2018-12-31

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.

Conditions

Kidney Transplant; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Discharge Mentoring

Intervention Type: BEHAVIORAL

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Discharge Mentoring

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Aravind Chandrasekaran

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Comprehensive Transplant Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karla Zadnik, OD PhD

Role: CONTACT

irbinfo@osu.edu

614 688 8457

Facility Contacts

Kristen Hill, RN

Role: primary

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.

Reference Type: BACKGROUND

PMID: 27329569 (View on PubMed)

Other Identifiers

2017H0190

Identifier Type: -

Identifier Source: org_study_id