Trial Outcomes & Findings for mHealth Medication Safety Intervention (NCT NCT03247322)
NCT ID: NCT03247322
Last Updated: 2021-02-25
Results Overview
Medication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
1 year
Results posted on
2021-02-25
Participant Flow
Participant milestones
| Measure |
mHealth Group
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Usual Care Group
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
66
|
68
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
mHealth Medication Safety Intervention
Baseline characteristics by cohort
| Measure |
Intervention Group
n=68 Participants
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Control Group
n=68 Participants
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 12 • n=99 Participants
|
51 years
STANDARD_DEVIATION 14 • n=107 Participants
|
51 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
40 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Participants with History of Diabetes
|
19 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Number of Participants with History of Hypertension
|
63 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Number of Participants on Dialysis at Transplant
|
58 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearMedication errors will be defined as documentation that a patient is taking a medication in a manner that was not intended
Outcome measures
| Measure |
Intervention Group
n=68 Participants
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Control Group
n=68 Participants
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
|---|---|---|
|
Number of Medication Errors
|
9 number of medication errors
Standard Deviation 5.4
|
20 number of medication errors
Standard Deviation 14
|
PRIMARY outcome
Timeframe: 1 yearAdverse Events will be defined according to the AHRQ Patient Safety Network as an injury resulting from medical care. Rates of Events Per Patient Year by AE Grade
Outcome measures
| Measure |
Intervention Group
n=68 Participants
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Control Group
n=68 Participants
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
|---|---|---|
|
Incidence and Severity of Adverse Drug Events
Overall
|
20.68 adverse events per patient year
Standard Deviation 18.35
|
21.26 adverse events per patient year
Standard Deviation 25.24
|
|
Incidence and Severity of Adverse Drug Events
Grade 1
|
13.96 adverse events per patient year
Standard Deviation 1.47
|
14 adverse events per patient year
Standard Deviation 15.10
|
|
Incidence and Severity of Adverse Drug Events
Grade 2
|
5.53 adverse events per patient year
Standard Deviation 0.72
|
5.28 adverse events per patient year
Standard Deviation 0.94
|
|
Incidence and Severity of Adverse Drug Events
Grade 3
|
1.10 adverse events per patient year
Standard Deviation .22
|
1.57 adverse events per patient year
Standard Deviation .34
|
|
Incidence and Severity of Adverse Drug Events
Grade 4
|
.07 adverse events per patient year
Standard Deviation .05
|
0.38 adverse events per patient year
Standard Deviation .15
|
|
Incidence and Severity of Adverse Drug Events
Grade 5
|
0 adverse events per patient year
Standard Deviation 0
|
.01 adverse events per patient year
Standard Deviation .01
|
|
Incidence and Severity of Adverse Drug Events
Grade 3 or higher
|
1.18 adverse events per patient year
Standard Deviation .25
|
1.97 adverse events per patient year
Standard Deviation .46
|
PRIMARY outcome
Timeframe: 1 yearSeverity of Medication Errors were measured using the Overhage criteria
Outcome measures
| Measure |
Intervention Group
n=68 Participants
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Control Group
n=68 Participants
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
|---|---|---|
|
Severity of Medication Errors
Potentially Lethal
|
0 number of medication errors
|
0 number of medication errors
|
|
Severity of Medication Errors
Serious
|
0 number of medication errors
|
1 number of medication errors
|
|
Severity of Medication Errors
Significant
|
586 number of medication errors
|
1320 number of medication errors
|
|
Severity of Medication Errors
Minor
|
28 number of medication errors
|
64 number of medication errors
|
SECONDARY outcome
Timeframe: 1 yearNumber of hospitalizations per patient-year
Outcome measures
| Measure |
Intervention Group
n=68 Participants
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Control Group
n=68 Participants
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
|---|---|---|
|
Hospitalization Rate
|
0.65 Hospitalizations per patient-year
Interval 0.4 to 0.94
|
1.08 Hospitalizations per patient-year
Interval 0.6 to 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearNumber of infections per patient-year
Outcome measures
| Measure |
Intervention Group
n=68 Participants
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Control Group
n=68 Participants
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
|---|---|---|
|
Infection Rate
|
1.32 Infections per patient-year
Interval 0.92 to 1.72
|
1.26 Infections per patient-year
Interval 0.76 to 1.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOpportunistic infections per patient-year
Outcome measures
| Measure |
Intervention Group
n=68 Participants
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Control Group
n=68 Participants
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
|---|---|---|
|
Opportunistic Infection Rate
|
.19 Opportunistic infection per patient-year
Interval 0.09 to 0.3
|
.14 Opportunistic infection per patient-year
Interval 0.01 to 0.3
|
Adverse Events
Intervention Group
Serious events: 6 serious events
Other events: 68 other events
Deaths: 0 deaths
Control Group
Serious events: 16 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Group
n=68 participants at risk
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Control Group
n=68 participants at risk
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
|---|---|---|
|
Gastrointestinal disorders
GI Dysfunction
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
2.9%
2/68 • Number of events 2 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Metabolism and nutrition disorders
Laboratory abnormality
|
0.00%
0/68 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
5.9%
4/68 • Number of events 4 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
General disorders
General Disorder
|
0.00%
0/68 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/68 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
2.9%
2/68 • Number of events 2 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Nervous system disorders
Nervous System Disorder
|
0.00%
0/68 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
4.4%
3/68 • Number of events 3 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Psychiatric disorders
Psychiatric Disorder
|
0.00%
0/68 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
General disorders
Abnormal Vital Signs
|
4.4%
3/68 • Number of events 3 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
Other adverse events
| Measure |
Intervention Group
n=68 participants at risk
Patients in the intervention cohort will have enhanced medication safety monitoring utilizing a Pharmacist-led medication therapy using mHealth application. The application will provide patients a useful tool to conduct self-care monitoring and management, including timely reminders to take medications, automated messages when patients miss multiple medication doses, tracking of medication side effects and reporting trends in blood pressures and glucoses (when applicable).
Pharmacist-led medication therapy using mHealth application: This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
|
Control Group
n=68 participants at risk
Subjects in the control group will receive the usual standard of follow up care for kidney transplant patients.
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
86.8%
59/68 • Number of events 59 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
92.6%
63/68 • Number of events 63 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Ear and labyrinth disorders
Ear disorders
|
4.4%
3/68 • Number of events 3 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Eye disorders
Eye disorder
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
44.1%
30/68 • Number of events 30 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
42.6%
29/68 • Number of events 29 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Injury, poisoning and procedural complications
Procedural complications
|
4.4%
3/68 • Number of events 3 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
0.00%
0/68 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Investigations
Laboratory Abnormality
|
94.1%
64/68 • Number of events 64 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
94.1%
64/68 • Number of events 64 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.5%
1/68 • Number of events 1 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
0.00%
0/68 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal disorder
|
19.1%
13/68 • Number of events 13 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
14.7%
10/68 • Number of events 10 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Nervous system disorders
Nervous System Disorder
|
33.8%
23/68 • Number of events 23 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
27.9%
19/68 • Number of events 19 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Psychiatric disorders
Psychiatric Disorders
|
5.9%
4/68 • Number of events 4 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
7.4%
5/68 • Number of events 5 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders
|
26.5%
18/68 • Number of events 18 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
10.3%
7/68 • Number of events 7 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
|
Skin and subcutaneous tissue disorders
Skin disorders
|
2.9%
2/68 • Number of events 2 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
2.9%
2/68 • Number of events 2 • 1 year
The data was analyzed by adverse event type and severity, not specific adverse event terms.
|
Additional Information
David Taber, PharmD, MS
Medical University of South Carolina
Phone: 843-792-3368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place