An interventional study of Health services delivery in Transplant, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
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.
VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
The following codes will be utilized - ICD-9 codes:
OR
oICD-10 codes:
AND
These medications include:
Exclusion Criteria:
Usual Care
Technology-enabled pharmacist intervention
Other: Health services delivery
Technology-enabled pharmacist intervention
Any Hospitalization or Any Emergency Room Visits
24-month count hospitalization and emergency room visits compared between the intervention and usual care groups
Time frame: 24-months
Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups
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.
Time frame: 27-months
Number of Participants With 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 27-month study
Time frame: 27-months
Patient Survival- Percentage of Patients That Died During Study
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.
Time frame: 27-months
Medication Safety Issues
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
Time frame: 23-months
Clinically Relevant Alerts
Proportion of alerts that were deemed clinical relevant and actionable by the intervention pharmacists 22 months (August 2019-June 2021)
Time frame: 22-months
Dashboard-Accepted Interventions
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
Time frame: 23-months
Average Time Responding to Dashboard Alerts
Average time each intervention pharmacist spent on assessing the dashboard alerts per week over the course of 23 months.
Time frame: 23-months
| Milestone | Control Arm | Intervention Arm |
|---|---|---|
| Started | 896 | 1300 |
| Completed | 720 | 1060 |
| Not completed | 176 | 240 |
| Withdrew: Death | 144 | 195 |
| Withdrew: Graft loss | 32 | 45 |
24-month count hospitalization and emergency room visits compared between the intervention and usual care groups
| Participants | Control Arm | Intervention Arm |
|---|---|---|
| Any ED Visit During Study | 497 | 574 |
| Any Inpatient stay During Study | 380 | 391 |
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.
| dollars | Control Arm | Intervention Arm |
|---|---|---|
| Inpatient costs | 37,505 (16,797 to 81,891) | 56,600 (22,417 to 108,634) |
| Outpatient costs | 17,077 (6,473 to 38,164) | 25,560 (10,388 to 51,971) |
| Pharmacy costs | 10,306 (4,534 to 19,869) | 10,555 (5,374 to 20,485) |
| Total costs | 36,255 (15,672 to 80,508) | 51,811 (21,967 to 133,045) |
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
| Participants | Control Arm | Intervention Arm |
|---|---|---|
| Number of Participants With Graft Survival | 864 | 1255 |
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.
| Participants | Control Arm | Intervention Arm |
|---|---|---|
| Patient Survival- Percentage of Patients That Died During Study | 144 | 195 |
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
| Participants | Intervention Arm |
|---|---|
| Percent of patient with missing labs | 733 |
| Percent of patients alarming lab values without follow up scheduled | 760 |
| Immunosuppression adherence, estimated using the proportion of days covered (PDC) <80% | 756 |
| Percent of patients with hospital discharge or ED visit without follow up scheduled | 196 |
Proportion of alerts that were deemed clinical relevant and actionable by the intervention pharmacists 22 months (August 2019-June 2021)
| Dashboard alerts | Intervention Arm |
|---|---|
| Clinically Relevant Alerts | 15013 |
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
| Participants | Intervention Arm |
|---|---|
| Patients with an alert that led to a pharmacist conducting a medication change | 102 |
| Patients with an alert addressed by a non-pharmacist | 570 |
Average time each intervention pharmacist spent on assessing the dashboard alerts per week over the course of 23 months.
| Minutes | Participating Pharmacists in Intervention Arm |
|---|---|
| Average Time Responding to Dashboard Alerts | 70 ± 188 |
Collected over 27-month study period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Arm | 144/896 (16.1%) | 412/896 (46%) | — |
| Intervention Arm | 195/1,300 (15%) | 436/1,300 (33.5%) | — |
| Event | Control Arm | Intervention Arm |
|---|---|---|
| Inpatient hospitalizationGeneral disorders | 380/896 | 391/1300 |
| Graft FailureGeneral disorders | 32/896 | 45/1300 |
| Age, Continuous(years) | Control Arm | Intervention Arm | Total |
|---|---|---|---|
| Median | 67 (60 to 71) | 66 (60 to 71) | 66 (60 to 71) |
| Sex: Female, Male(Participants) | Control Arm | Intervention Arm | Total |
|---|---|---|---|
| Female | 41 | 57 | 98 |
| Male | 855 | 1243 | 2098 |
| Race/Ethnicity, Customized(Participants) | Control Arm | Intervention Arm | Total |
|---|---|---|---|
| Race/Ethnicity — Non-Hispanic White | 608 | 834 | 1442 |
| Race/Ethnicity — Hispanic | 39 | 47 | 86 |
| Race/Ethnicity — Non-Hispanic Black | 206 | 386 | 592 |
| Race/Ethnicity — Other or Missing | 43 | 33 | 76 |
| Region of Enrollment(Participants) | Control Arm | Intervention Arm | Total |
|---|---|---|---|
| United States — Midwest | 148 | 961 | 1109 |
| United States — Northeast | 269 | 0 | 269 |
| United States — Northwest | 274 | 0 | 274 |
| United States — Southeast | 205 | 339 | 544 |
| Emergency department visits year prior to study(visits) | Control Arm | Intervention Arm | Total |
|---|---|---|---|
| Mean | 1.1 ± 1.9 | 0.9 ± 1.7 | 1.0 ± 1.8 |
| Inpatient stays year prior to study(stays) | Control Arm | Intervention Arm | Total |
|---|---|---|---|
| Mean | 0.8 ± 1.6 | 0.4 ± 1.1 | 0.6 ± 1.3 |
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