Trial · NCT03860818
Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention
NCT03860818, Not applicable, Completed, VA Office of Research and Development; results first posted 2024-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention. Trials, record NCT03860818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03860818
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention
- NCT number
- NCT03860818
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 2,196 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Transplant
- Interventions
- Health services delivery
- First posted
- 2019-03-04
- Last updated
- 2024-08-01
- Results first posted
- 2024-08-01
- 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.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Any Hospitalization or Any Emergency Room Visits | 24-months | 24-month count hospitalization and emergency room visits compared between the intervention and usual care groups |
| Secondary | Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups | 27-months | 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. |
| Secondary | Number of Participants With Graft Survival | 27-months | 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 |
| Secondary | Patient Survival- Percentage of Patients That Died During Study | 27-months | 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. |
| Secondary | Medication Safety Issues | 23-months | 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 |
| Secondary | Clinically Relevant Alerts | 22-months | Proportion of alerts that were deemed clinical relevant and actionable by the intervention pharmacists 22 months (August 2019-June 2021) |
| Secondary | Dashboard-Accepted Interventions | 23-months | 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 |
| Secondary | Average Time Responding to Dashboard Alerts | 23-months | Average time each intervention pharmacist spent on assessing the dashboard alerts per week over the course of 23 months. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Any Hospitalization or Any Emergency Room Visits | 24-months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups | 27-months | The number analyzed in some of the rows of the outcome measure data table differ from the overall number of participants analyzed because not every patient had every type of cost - some didn't have any emergency department (ED) visits, some didn't have any hospitalizations, and a few didn't have any outpatient visits - no visit, no cost. | dollars | MEDIAN |
| SECONDARY | Number of Participants With Graft Survival | 27-months | All participants who were assigned to the arm | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Survival- Percentage of Patients That Died During Study | 27-months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Medication Safety Issues | 23-months | The dashboard intervention was not utilized in the control group and therefore could not be analyzed for this measure. The number of participants reported in here is inconsistent with total number of participants reported in this arm because there are two levels of analysis, the patient level and at the transplant level. Some patients had multiple transplants. Also, not every patient triggered an alert in the dashboard, so the alert numbers may differ from the number of clinical participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinically Relevant Alerts | 22-months | The dashboard intervention was not utilized in the control group and therefore could not be analyzed for this measure. The number of participants reported in here is inconsistent with total number of participants reported in this arm because there are two levels of analysis, the patient level and at the transplant level. Some patients had multiple transplants. Also, not every patient triggered an alert in the dashboard, so the alert numbers may differ from the number of clinical participants. | Dashboard alerts | COUNT_OF_UNITS |
| SECONDARY | Dashboard-Accepted Interventions | 23-months | The dashboard intervention was not utilized in the control group and therefore could not be analyzed for this measure. The number of participants reported in here is inconsistent with total number of participants reported in this arm because there are two levels of analysis, the patient level and at the transplant level. Some patients had multiple transplants. Also, not every patient triggered an alert in the dashboard, so the alert numbers may differ from the number of clinical participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Average Time Responding to Dashboard Alerts | 23-months | The dashboard intervention was not utilized in the control group and therefore could not be analyzed for this measure. | Minutes | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Any Hospitalization or Any Emergency Room Visits | Control Arm | Any ED Visit During Study | 497 | Participants | |
| Any Hospitalization or Any Emergency Room Visits | Intervention Arm | Any ED Visit During Study | 574 | Participants | |
| Any Hospitalization or Any Emergency Room Visits | Control Arm | Any Inpatient stay During Study | 380 | Participants | |
| Any Hospitalization or Any Emergency Room Visits | Intervention Arm | Any Inpatient stay During Study | 391 | Participants | |
| Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups | Control Arm | Inpatient costs | 37,505 | Inter-Quartile Range 16,797 to 81,891 | dollars |
| Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups | Intervention Arm | Inpatient costs | 56,600 | Inter-Quartile Range 22,417 to 108,634 | dollars |
| Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups | Control Arm | Outpatient costs | 17,077 | Inter-Quartile Range 6,473 to 38,164 | dollars |
| Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups | Intervention Arm | Outpatient costs | 25,560 | Inter-Quartile Range 10,388 to 51,971 | dollars |
| Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups | Control Arm | Pharmacy costs | 10,306 | Inter-Quartile Range 4,534 to 19,869 | dollars |
| Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups | Intervention Arm | Pharmacy costs | 10,555 | Inter-Quartile Range 5,374 to 20,485 | dollars |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Arm | 896 | |
| Overall Study | STARTED | Intervention Arm | 1,300 | |
| Overall Study | COMPLETED | Control Arm | 720 | |
| Overall Study | COMPLETED | Intervention Arm | 1,060 | |
| Overall Study | NOT COMPLETED | Control Arm | 176 | |
| Overall Study | NOT COMPLETED | Intervention Arm | 240 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Graft Failure | General disorders | Control Arm | 32 | 896 | |
| serious | Graft Failure | General disorders | Intervention Arm | 45 | 1,300 | |
| serious | Inpatient hospitalization | General disorders | Control Arm | 380 | 896 | |
| serious | Inpatient hospitalization | General disorders | Intervention Arm | 391 | 1,300 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Arm | 144 | 896 |
| Total, all-cause mortality | Intervention Arm | 195 | 1,300 |
| Total, other adverse events | Control Arm | 0 | 0 |
| Total, other adverse events | Intervention Arm | 0 | 0 |
| Total, serious adverse events | Control Arm | 412 | 896 |
| Total, serious adverse events | Intervention Arm | 436 | 1,300 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intervention Arm vs Control Arm: Patient Survival- Percentage of Patients That Died During Study | Trial comparisons |
| Intervention Arm vs Control Arm: Number of Participants With Graft Survival | Trial comparisons |
| Intervention Arm vs Control Arm: deaths from any cause | Trial comparisons |
| Intervention Arm vs Control Arm: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03860818
GET https://conductscience.org/api/trials/v1/NCT03860818/results?page=2