Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/24/2019 |
| Start Date: | March 18, 2019 |
| End Date: | June 30, 2022 |
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.
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.
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.
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.
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.
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