Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention (ISTEP)

May 10, 2024 updated by: VA Office of Research and Development

Improving Transplant Medication Safety Through a Technology and Pharmacist (ISTEP) Intervention in Veterans

Medication safety issues in Veteran organ transplant recipients, including side effects and errors, are a major issue leading to graft failure and death. The causes of these events are complicated and involve fragmented care, communication breakdowns between the Veterans, providers and the different health care systems. This grant proposal seeks to improve medication safety within these high-risk Veterans, using two innovative components; the application of technology to leverage the massive amount of data contained within the electronic medical record in identifying Veterans with potential medication safety issues, coupled with a pharmacist-led intervention to improve the management and coordination of immunosuppression therapy. The completion of this prospective, multicenter, cluster randomized controlled clinical trial will provide evidence that these interventions can improve medication safety, clinical outcomes and costs and will be used to justify the dissemination of these interventions to all VAs caring for Veteran transplant recipients across the U.S.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anticipated Impacts on Veterans Health Care: The first three essential strategies listed within the VA's Blueprint for Excellence encompass plans to improve care to vulnerable Veterans, deliver high quality care through achieving the "Triple Aim" and leverage the use of technology to improve the efficiency of care delivery. The intervention this grant proposes focuses on improving medication safety and care coordination within a high risk vulnerable Veteran population, leverages the use of informatics and analytics to support this intervention, and aims to demonstrate improved care at reduced costs through the pharmacist intervention; thus, perfectly aligning with these three essential components of the Blueprint. The overarching goal of this study is to develop a feasibly deployable, technology-enabled intervention that will demonstrate substantial improvements in immunosuppressant medication safety, clinical outcomes and health care costs in Veteran organ transplant recipients; demonstrating this through a randomized controlled trial will provide sufficient evidence to further develop a VA-specific pharmacist learning collaborative aimed at improving care and reducing costs for Veteran organ transplant recipients across the entire VA system.

Background: Organ transplant is the gold-standard treatment for patients with end organ diseases of the kidney, liver, heart and lungs, as it substantially improves survival and quality of life. Over the past 20 years, the use of contemporary immunosuppression has reduced the risk of acute rejection rates by upwards of 80%; yet long-term allograft survival remains suboptimal. Studies have demonstrated that causes of late graft loss is predominantly driven by immunosuppression adverse events and late allograft rejection episodes from medication errors and non-adherence, which encompass issues directly related to medication safety. The investigators' research demonstrates that medication errors occur in nearly two-thirds of transplant recipients, leading to hospitalization in 1 in 8 recipients. Recipients that develop significant medication errors are at considerably higher risk of graft loss, leading to higher costs and mortality. Thus, in order to improve medication safety and long-term outcomes in transplant recipients, enhancements in immunosuppressant therapy management is needed.

Objectives: The central hypothesis for the ISTEP study (Improving Transplant Medication Safety through a TEchnology and Pharmacist Intervention) is that pharmacist-led immunosuppressant therapy management, facilitated through the use of innovative technology, will significantly improve immunosuppressant safety and clinical outcomes in Veteran transplant recipients.

Methods: This is a 24-month, prospective, cluster-randomized controlled clinical trial at 10 sites, randomizing 5 sites to standard clinical care and 5 to standard care and the technology-enabled pharmacist intervention. The technology component of this intervention consists of the use of an expanded dashboard system that has already demonstrated effectiveness in improving immunosuppression monitoring. The dashboard performs population-level surveillance of transplant recipients and identifies those with potential drug-related problems, including non-adherence, drug interactions, missing and worrisome trends in labs; then providing a real-time alert to the pharmacist, who will determine its relevance and intervene in an appropriate protocol-guided manner. Effectiveness will be determined by comparing the rates of hospitalizations and ER visits between groups, while adjusting for baseline patient, provider and facility characteristics. Secondary measures include comparing healthcare costs and determining dashboard functionality, dashboard actionability and pharmacist intervention types and acceptance rates. The investigators will also assess the overall incidence and severity of drug-related problems and graft and patient survival rates and compare these between the intervention and control sites.

Study Type

Interventional

Enrollment (Actual)

2196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Veteran organ transplant recipients will be identified using International Classification of Diseases (ICD) 9/10 codes from the VA electronic health record (CPRS).
  • Patients must have an active code stating they are a recipient of an organ transplant.

  • The following codes will be utilized - ICD-9 codes:

    • V42.0
    • V42.1
    • V42.6
    • V42.7
    • V42.83
    • V42.84
    • 996.81
    • 996.82
    • 996.83
    • 996.84
    • 996.86
    • 52.80

OR

  • oICD-10 codes:

    • C80.2
    • T86.1
    • T86.10
    • T86.11
    • T86.12
    • T86.13
    • T86.19
    • T86.2
    • T86.20
    • T86.21
    • T86.22
    • T86.23
    • T86.290
    • T86.298
    • T86.3
    • T86.30
    • T86.31
    • T86.32
    • T86.33
    • T86.39
    • T86.4
    • T86.40
    • T86.41
    • T86.42
    • T86.43
    • T86.49
    • T86.810
    • T86.811
    • T86.812
    • T86.818
    • T86.819
    • T86.9
    • Z48.2
    • Z48.21
    • Z48.22
    • Z48.23
    • Z48.24
    • Z48.280
    • Z48.288
    • Z48.298
    • Z94.0
    • Z94.1
    • Z94.2
    • Z94.3
    • Z94.4
    • Z94.83

AND

  • Actively receiving at least one anti-rejection medication dispensed by the VA site.

  • These medications include:

    • tacrolimus
    • cyclosporine
    • azathioprine
    • mycophenolate
    • sirolimus
    • everolimus
    • belatacept

Exclusion Criteria:

  • There are no exclusion criteria for patients in this study as recruitment is at the level of the VA site.
  • All veterans meeting inclusion criteria will be monitored by the dashboard system and will be included in the outcomes assessment.
  • Patients may enter or exit the study in a rolling manner, which will be accounted for during analyses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Usual Care
Experimental: Intervention Arm
Technology-enabled pharmacist intervention
Other: Health services delivery
Technology-enabled pharmacist intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any Hospitalization or Any Emergency Room Visits
Time Frame: 24-months
24-month count hospitalization and emergency room visits compared between the intervention and usual care groups
24-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups
Time Frame: 27-months

27-month total estimated health care costs, compared between the intervention and control groups (non-zero cost).

Inpatient cost, outpatient cost, pharmacy cost, total cost

Time Period (start to censor date) March 01, 2019 to June 30, 2021.
27-months
Number of Participants With Graft Survival
Time Frame: 27-months
Estimated graft survival rates, compared between the intervention and usual care groups and defined as the proportion of patients that continue to have a functioning allograft at the end of the 27-month study
27-months
Patient Survival- Percentage of Patients That Died During Study
Time Frame: 27-months
Estimated patient survival rates, compared between the intervention and usual care groups and defined as the proportion of patients alive at the end of the 27-month study. Number of patients who died during the study (March 2019 - June 2021), Scientific Registry of Transplant Recipients (SRTR) or VA reported.
27-months
Medication Safety Issues
Time Frame: 23-months

23-months, (August 2019-June 2021)

Potential medication safety issues, defined as the proportion of patients with the following, based on automated reports for the transplant medication dashboard:

  1. Percent of patients with missing labs
  2. Percent of patients alarming lab values without follow up scheduled
  3. Immunosuppression adherence, estimated using the proportion of days covered (PDC)
  4. Percent of patients on significant drug interaction without a immunosuppressant level
  5. Percent of patients with hospital discharge or ED visit without follow up scheduled
23-months
Clinically Relevant Alerts
Time Frame: 22-months

Proportion of alerts that were deemed clinical relevant and actionable by the intervention pharmacists

22 months (August 2019-June 2021)
22-months
Dashboard-Accepted Interventions
Time Frame: 23-months

Proportion of interventions that were deemed to be accepted when made to other providers based on dashboard reporting information

Percentage of patients that had an alert accepted and addressed by a clinician

23 months, August 2019 - June 2021
23-months
Average Time Responding to Dashboard Alerts
Time Frame: 23-months
Average time each intervention pharmacist spent on assessing the dashboard alerts per week over the course of 23 months.
23-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: David J. Taber, PharmD, Ralph H. Johnson VA Medical Center, Charleston, SC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2019

Primary Completion (Actual)

June 14, 2021

Study Completion (Actual)

June 14, 2021

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 4, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIR 15-359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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