Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention

NCT03860818 | Completed Results DMC

• 1 other identifier: IIR 15-359
• Study Type: interventional
• Target: 2,196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transplant

Keywords

medication safety

Outcome Measures

Primary Outcomes (1)

• Any Hospitalization or Any Emergency Room Visits

  24-month count hospitalization and emergency room visits compared between the intervention and usual care groups

  24-months

Secondary Outcomes (7)

• Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups

  27-months

• Number of Participants With Graft Survival

  27-months

• Patient Survival- Percentage of Patients That Died During Study

  27-months

• Medication Safety Issues

  23-months

• Clinically Relevant Alerts

  22-months

Study Arms (2)

Control Arm

NO INTERVENTION

Usual Care

Intervention Arm

EXPERIMENTAL

Technology-enabled pharmacist intervention

Other: Health services delivery

Interventions

Health services delivery OTHER

Technology-enabled pharmacist intervention

Intervention Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• oICD-10 codes:
• C80.2
• T86.1
• T86.10
• T86.11
• T86.12

You may not qualify if:

• Patients may enter or exit the study in a rolling manner, which will be accounted for during analyses.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Related Publications (3)

• 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: 10.1177/1060028019828681. Epub 2019 Feb 6.

  PMID: 30724092 RESULT

• Taber DJ, Ward RC, Buchanan CH, Axon RN, Milfred-LaForest S, Rife K, Felkner R, Cooney D, Super N, McClelland S, McKenna D, Santa E, Gebregziabher M. Results of a multicenter cluster-randomized controlled clinical trial testing the effectiveness of a bioinformatics-enabled pharmacist intervention in transplant recipients. Am J Transplant. 2023 Dec;23(12):1939-1948. doi: 10.1016/j.ajt.2023.08.004. Epub 2023 Aug 9.

  PMID: 37562577 RESULT

• Hall CL, Fominaya CE, Gebregziabher M, Milfred-LaForest SK, Rife KM, Taber DJ. Improving Transplant Medication Safety Through a Technology and Pharmacist Intervention (ISTEP): Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2019 Oct 1;8(10):e13821. doi: 10.2196/13821.

  PMID: 31573933 DERIVED

Limitations and Caveats

This was a pragmatic study, utilization of the system was not required and not uniform across sites or pharmacists. Not all alerts produced were addressed or deemed clinically relevant by intervention site pharmacists. Only ED visits and hospitalizations that occurred within the VA system were captured and used for outcome assessment for this study, which is a limitation. SRTR data for acute rejections are not comprehensive as patients were, on average, 9-years post-transplant.

Results Point of Contact

• Title: Dr. David J. Taber
• Organization: Ralph H. Johnson VA Healthcare System

David.Taber2@va.gov

843.789.6624

Study Officials

• David J. Taber, PharmD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Prospective, cluster-randomized controlled clinical trial at 10 sites, randomizing 5 sites to standard clinical care and 5 to the intervention.

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: March 18, 2019
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)