Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention

Transplant Clinical Trial

— ISTEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03860818
• Other study ID #: IIR 15-359
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: June 14, 2021

Study information

• Verified date: July 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2022
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Veteran organ transplant recipients will be identified using 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 - oICD-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.

Related Conditions & MeSH terms

• Transplant

Intervention

Other:
• Health services delivery
Technology-enabled pharmacist intervention

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Taber DJ, Ward R, Axon RN, Walker RJ, Egede LE, Gebregziabher M. The Impact of Dual Health Care System Use for Obtaining Prescription Medications on Nonadherence in Veterans With Type 2 Diabetes. Ann Pharmacother. 2019 Jul;53(7):675-682. doi: 10.1177/1060 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hospitalization and emergency room visits	24-month rate of hospitalization and emergency room visits compared between the intervention and usual care groups	24-months
Secondary	Total estimated health care costs	24-month total estimated health care costs, compared between the intervention and usual care groups	24-months
Secondary	Graft survival	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 24-month study	24-months
Secondary	Patient survival	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 24-month study	24-months
Secondary	Medication safety issues	Potential medication safety issues, defined as the proportion of patients with the following, based on automated reports for the transplant medication dashboard	12-months
Secondary	Clinical relevant alerts	Proportion of alerts that were deemed clinical relevant and actionable by the intervention pharmacists	12-months
Secondary	Accepted interventions	Proportion of interventions that were deemed to be accepted when made to other providers based on dashboard reporting information	12-months
Secondary	Time requirements	Average time each intervention pharmacist spent on assessing the dashboard alerts	12-months