N/A N=2,196 Randomized Health Services Research

Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention

Transplant

Bottom Line

View on ClinicalTrials.gov: NCT03860818 ↗

Enrolled (actual)

2,196

Serious AEs

38.6%

Results posted

Aug 2024

Primary outcome: Primary: Any Hospitalization or Any Emergency Room Visits — 497; 574; 380; 391 Participants — p=<.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Health services delivery (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Any Hospitalization or Any Emergency Room Visits	497; 574; 380; 391	<.001 sig
SECONDARY Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups	37,505; 56,600; 17,077; 25,560; 10,306; 10,555	<0.001 sig
SECONDARY Number of Participants With Graft Survival	864; 1255	0.9064
SECONDARY Patient Survival- Percentage of Patients That Died During Study	144; 195	0.51
SECONDARY Medication Safety Issues	733; 760; 756; 196	—
SECONDARY Clinically Relevant Alerts	15013	—
SECONDARY Dashboard-Accepted Interventions	102; 570	—
SECONDARY Average Time Responding to Dashboard Alerts	70	—

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.

Eligibility Criteria

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03860818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.