Trial Outcomes & Findings for Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention (NCT NCT03860818)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2196 participants

Primary outcome timeframe

24-months

Results posted on

2024-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Control Arm The control arm received usual care. Usual care for veteran organ transplant recipients across the 10 study sites is not standardized but generally includes the following: at most sites, nurse coordinators and/or midlevel practitioners are responsible for general transplant patient oversight, including ensuring laboratory assessments are scheduled/reviewed and medication regimens are accurate and up to date. However, large patient numbers and workload constraints preclude these health care professionals from prospective detailed daily monitoring of patients. Within usual follow-up care, pharmacists do not conduct routine daily surveillance of all transplant patients.	Intervention Arm Technology-enabled pharmacist intervention Health services delivery: Technology-enabled pharmacist intervention. The intervention consists of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Overall Study STARTED	896	1300
Overall Study COMPLETED	720	1060
Overall Study NOT COMPLETED	176	240

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Arm The control arm received usual care. Usual care for veteran organ transplant recipients across the 10 study sites is not standardized but generally includes the following: at most sites, nurse coordinators and/or midlevel practitioners are responsible for general transplant patient oversight, including ensuring laboratory assessments are scheduled/reviewed and medication regimens are accurate and up to date. However, large patient numbers and workload constraints preclude these health care professionals from prospective detailed daily monitoring of patients. Within usual follow-up care, pharmacists do not conduct routine daily surveillance of all transplant patients.	Intervention Arm Technology-enabled pharmacist intervention Health services delivery: Technology-enabled pharmacist intervention. The intervention consists of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Overall Study Death	144	195
Overall Study Graft Loss	32	45

Baseline Characteristics

Improving Transplant Medication Safety Through A Technology and Pharmacist Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Arm n=896 Participants Usual Care. The control arm received usual care. Usual care for veteran organ transplant recipients across the 10 study sites is not standardized but generally includes the following: at most sites, nurse coordinators and/or midlevel practitioners are responsible for general transplant patient oversight, including ensuring laboratory assessments are scheduled/reviewed and medication regimens are accurate and up to date. However, large patient numbers and workload constraints preclude these health care professionals from prospective detailed daily monitoring of patients. Within usual follow-up care, pharmacists do not conduct routine daily surveillance of all transplant patients.	Intervention Arm n=1300 Participants Technology-enabled pharmacist intervention Health services delivery: Technology-enabled pharmacist intervention The intervention consists of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.	Total n=2196 Participants Total of all reporting groups
Age, Continuous	67 years n=99 Participants	66 years n=107 Participants	66 years n=206 Participants
Sex: Female, Male Female	41 Participants n=99 Participants	57 Participants n=107 Participants	98 Participants n=206 Participants
Sex: Female, Male Male	855 Participants n=99 Participants	1243 Participants n=107 Participants	2098 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non-Hispanic White	608 Participants n=99 Participants	834 Participants n=107 Participants	1442 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	39 Participants n=99 Participants	47 Participants n=107 Participants	86 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non-Hispanic Black	206 Participants n=99 Participants	386 Participants n=107 Participants	592 Participants n=206 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other or Missing	43 Participants n=99 Participants	33 Participants n=107 Participants	76 Participants n=206 Participants
Region of Enrollment United States · Midwest	148 Participants n=99 Participants	961 Participants n=107 Participants	1109 Participants n=206 Participants
Region of Enrollment United States · Northeast	269 Participants n=99 Participants	0 Participants n=107 Participants	269 Participants n=206 Participants
Region of Enrollment United States · Northwest	274 Participants n=99 Participants	0 Participants n=107 Participants	274 Participants n=206 Participants
Region of Enrollment United States · Southeast	205 Participants n=99 Participants	339 Participants n=107 Participants	544 Participants n=206 Participants
Emergency department visits year prior to study	1.1 visits STANDARD_DEVIATION 1.9 • n=99 Participants	0.9 visits STANDARD_DEVIATION 1.7 • n=107 Participants	1.0 visits STANDARD_DEVIATION 1.8 • n=206 Participants
Inpatient stays year prior to study	0.8 stays STANDARD_DEVIATION 1.6 • n=99 Participants	0.4 stays STANDARD_DEVIATION 1.1 • n=107 Participants	0.6 stays STANDARD_DEVIATION 1.3 • n=206 Participants

PRIMARY outcome

Timeframe: 24-months

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

Outcome measures

Outcome measures
Measure	Control Arm n=896 Participants No intervention. Patients received standard usual care, which generally included the following: nurse coordinators or midlevel practitioners were responsible for general solid organ transplantation (SOT) patient oversight, including ensuring laboratory assessments were scheduled/reviewed and medication regimens were accurate and up to date. For usual care, pharmacists typically were consultants and were only involved in direct patient care if an issue arose, and the nurse or provider engaged the pharmacist for assistance. Within usual follow-up care, pharmacists did not conduct routine daily surveillance of SOT patients.	Intervention Arm n=1300 Participants Patients received the technology-enabled pharmacist intervention in addition to the usual standard of care. The intervention consisted of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Any Hospitalization or Any Emergency Room Visits Any ED Visit During Study	497 Participants	574 Participants
Any Hospitalization or Any Emergency Room Visits Any Inpatient stay During Study	380 Participants	391 Participants

SECONDARY outcome

Timeframe: 27-months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Control Arm n=742 Participants No intervention. Patients received standard usual care, which generally included the following: nurse coordinators or midlevel practitioners were responsible for general solid organ transplantation (SOT) patient oversight, including ensuring laboratory assessments were scheduled/reviewed and medication regimens were accurate and up to date. For usual care, pharmacists typically were consultants and were only involved in direct patient care if an issue arose, and the nurse or provider engaged the pharmacist for assistance. Within usual follow-up care, pharmacists did not conduct routine daily surveillance of SOT patients.	Intervention Arm n=1073 Participants Patients received the technology-enabled pharmacist intervention in addition to the usual standard of care. The intervention consisted of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups Inpatient costs	37,505 dollars	56,600 dollars
Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups Outpatient costs	17,077 dollars	25,560 dollars
Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups Pharmacy costs	10,306 dollars	10,555 dollars
Total Estimated Health Care Costs, Compared Between the Intervention and Control Groups Total costs	36,255 dollars	51,811 dollars

SECONDARY outcome

Timeframe: 27-months

Population: All participants who were assigned to the arm

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

Outcome measures

Outcome measures
Measure	Control Arm n=896 Participants No intervention. Patients received standard usual care, which generally included the following: nurse coordinators or midlevel practitioners were responsible for general solid organ transplantation (SOT) patient oversight, including ensuring laboratory assessments were scheduled/reviewed and medication regimens were accurate and up to date. For usual care, pharmacists typically were consultants and were only involved in direct patient care if an issue arose, and the nurse or provider engaged the pharmacist for assistance. Within usual follow-up care, pharmacists did not conduct routine daily surveillance of SOT patients.	Intervention Arm n=1300 Participants Patients received the technology-enabled pharmacist intervention in addition to the usual standard of care. The intervention consisted of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Number of Participants With Graft Survival	864 Participants	1255 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Arm n=896 Participants No intervention. Patients received standard usual care, which generally included the following: nurse coordinators or midlevel practitioners were responsible for general solid organ transplantation (SOT) patient oversight, including ensuring laboratory assessments were scheduled/reviewed and medication regimens were accurate and up to date. For usual care, pharmacists typically were consultants and were only involved in direct patient care if an issue arose, and the nurse or provider engaged the pharmacist for assistance. Within usual follow-up care, pharmacists did not conduct routine daily surveillance of SOT patients.	Intervention Arm n=1300 Participants Patients received the technology-enabled pharmacist intervention in addition to the usual standard of care. The intervention consisted of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Patient Survival- Percentage of Patients That Died During Study	144 Participants	195 Participants

SECONDARY outcome

Timeframe: 23-months

Population: 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.

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

Outcome measures

Outcome measures
Measure	Control Arm n=1 Participants No intervention. Patients received standard usual care, which generally included the following: nurse coordinators or midlevel practitioners were responsible for general solid organ transplantation (SOT) patient oversight, including ensuring laboratory assessments were scheduled/reviewed and medication regimens were accurate and up to date. For usual care, pharmacists typically were consultants and were only involved in direct patient care if an issue arose, and the nurse or provider engaged the pharmacist for assistance. Within usual follow-up care, pharmacists did not conduct routine daily surveillance of SOT patients.	Intervention Arm Patients received the technology-enabled pharmacist intervention in addition to the usual standard of care. The intervention consisted of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Medication Safety Issues Percent of patient with missing labs	733 Participants	—
Medication Safety Issues Percent of patients alarming lab values without follow up scheduled	760 Participants	—
Medication Safety Issues Immunosuppression adherence, estimated using the proportion of days covered (PDC) <80%	756 Participants	—
Medication Safety Issues Percent of patients with hospital discharge or ED visit without follow up scheduled	196 Participants	—

SECONDARY outcome

Timeframe: 22-months

Population: 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.

Proportion of alerts that were deemed clinical relevant and actionable by the intervention pharmacists 22 months (August 2019-June 2021)

Outcome measures

Outcome measures
Measure	Control Arm n=18132 Dashboard alerts No intervention. Patients received standard usual care, which generally included the following: nurse coordinators or midlevel practitioners were responsible for general solid organ transplantation (SOT) patient oversight, including ensuring laboratory assessments were scheduled/reviewed and medication regimens were accurate and up to date. For usual care, pharmacists typically were consultants and were only involved in direct patient care if an issue arose, and the nurse or provider engaged the pharmacist for assistance. Within usual follow-up care, pharmacists did not conduct routine daily surveillance of SOT patients.	Intervention Arm Patients received the technology-enabled pharmacist intervention in addition to the usual standard of care. The intervention consisted of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Clinically Relevant Alerts	15013 Dashboard alerts	—

SECONDARY outcome

Timeframe: 23-months

Population: 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.

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

Outcome measures

Outcome measures
Measure	Control Arm n=1197 Participants No intervention. Patients received standard usual care, which generally included the following: nurse coordinators or midlevel practitioners were responsible for general solid organ transplantation (SOT) patient oversight, including ensuring laboratory assessments were scheduled/reviewed and medication regimens were accurate and up to date. For usual care, pharmacists typically were consultants and were only involved in direct patient care if an issue arose, and the nurse or provider engaged the pharmacist for assistance. Within usual follow-up care, pharmacists did not conduct routine daily surveillance of SOT patients.	Intervention Arm Patients received the technology-enabled pharmacist intervention in addition to the usual standard of care. The intervention consisted of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Dashboard-Accepted Interventions Patients with an alert that led to a pharmacist conducting a medication change	102 Participants	—
Dashboard-Accepted Interventions Patients with an alert addressed by a non-pharmacist	570 Participants	—

SECONDARY outcome

Timeframe: 23-months

Population: The dashboard intervention was not utilized in the control group and therefore could not be analyzed for this measure.

Average time each intervention pharmacist spent on assessing the dashboard alerts per week over the course of 23 months.

Outcome measures

Outcome measures
Measure	Control Arm n=8 Participants No intervention. Patients received standard usual care, which generally included the following: nurse coordinators or midlevel practitioners were responsible for general solid organ transplantation (SOT) patient oversight, including ensuring laboratory assessments were scheduled/reviewed and medication regimens were accurate and up to date. For usual care, pharmacists typically were consultants and were only involved in direct patient care if an issue arose, and the nurse or provider engaged the pharmacist for assistance. Within usual follow-up care, pharmacists did not conduct routine daily surveillance of SOT patients.	Intervention Arm Patients received the technology-enabled pharmacist intervention in addition to the usual standard of care. The intervention consisted of increased review of patients by a pharmacist and increased scrutiny of patients' medication regimens and laboratory values using a dashboard surveillance system.
Average Time Responding to Dashboard Alerts	70 Minutes Standard Deviation 188	—

Adverse Events

Control Arm

Serious events: 412 serious events

Other events: 0 other events

Deaths: 144 deaths

Intervention Arm

Serious events: 436 serious events

Other events: 0 other events

Deaths: 195 deaths

Serious adverse events

Serious adverse events
Measure	Control Arm n=896 participants at risk Usual Care, no intervention. The control arm received usual care. Usual care for veteran organ transplant recipients across the 10 study sites is not standardized but generally includes the following: at most sites, nurse coordinators and/ or midlevel practitioners are responsible for general transplant patient oversight, including ensuring laboratory assessments are scheduled/reviewed and medication regimens are accurate and up to date. However, large patient numbers and workload constraints preclude these health care professionals from prospective detailed daily monitoring of patients. Within usual follow-up care, pharmacists do not conduct routine daily surveillance of all transplant patients	Intervention Arm n=1300 participants at risk Technology-enabled pharmacist intervention Health services delivery: Technology-enabled pharmacist intervention
General disorders Graft Failure	3.6% 32/896 • 27-month study period Only death and serious adverse events (SAEs) were assessed. SAEs are defined as patients who had an inpatient stay or graft lost during the study.	3.5% 45/1300 • 27-month study period Only death and serious adverse events (SAEs) were assessed. SAEs are defined as patients who had an inpatient stay or graft lost during the study.
General disorders Inpatient hospitalization	42.4% 380/896 • 27-month study period Only death and serious adverse events (SAEs) were assessed. SAEs are defined as patients who had an inpatient stay or graft lost during the study.	30.1% 391/1300 • 27-month study period Only death and serious adverse events (SAEs) were assessed. SAEs are defined as patients who had an inpatient stay or graft lost during the study.

Other adverse events

Adverse event data not reported

Additional Information

Dr. David J. Taber

Ralph H. Johnson VA Healthcare System

Phone: 843.789.6624

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place