Trial Outcomes & Findings for Piloting Healthcare Coordination in Hypertension (NCT NCT02988193)
NCT ID: NCT02988193
Last Updated: 2019-09-18
Results Overview
Total number of participants that undergone a treatment change. This measure allows to evaluate the adoption of the optima4BP treatment recommendation based on the total number of patients that benefited from a treatment recommendation that was implemented by the treating physician.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
6 months
Results posted on
2019-09-18
Participant Flow
Participant milestones
| Measure |
optima4BP Medication Optimization
optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:
1. curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;
2. medication treatment recommendation;
3. active link to access additional analysis tools.
optima4BP medication optimization: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.
|
Usual Care Management
Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
16
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Piloting Healthcare Coordination in Hypertension
Baseline characteristics by cohort
| Measure |
optima4BP Medication Management
n=12 Participants
optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:
1. curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;
2. medication treatment recommendation;
3. active link to access additional analysis tools.
optima4BP Medication Management: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.
|
Usual Care Medication Management
n=16 Participants
Usual Care Medication Management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Continuous
|
71 years
STANDARD_DEVIATION 3 • n=5 Participants
|
69 years
STANDARD_DEVIATION 5 • n=7 Participants
|
70 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Clinical adoption based on physician acceptance of the treatment recommendation
Total number of participants that undergone a treatment change. This measure allows to evaluate the adoption of the optima4BP treatment recommendation based on the total number of patients that benefited from a treatment recommendation that was implemented by the treating physician.
Outcome measures
| Measure |
optima4BP Treatment Management
n=12 Participants
optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:
1. curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;
2. medication treatment recommendation;
3. active link to access additional analysis tools.
optima4BP medication optimization: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.
|
Usual Care Treatment Management
n=16 Participants
Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.
|
|---|---|---|
|
Clinical Adoption of a Decision Support Artificial Intelligence
|
10 Participants
|
3 Participants
|
Adverse Events
optima4BP Treatment Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Treatment Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place