Trial Outcomes & Findings for Reducing Cardiovascular Risk in Adults With Serious Mental Illness (NCT NCT02451670)

Last Updated: 2019-11-05

Results Overview

A modifiable risk component for each cardiovascular risk factor not at optimal goal at the time of each encounter was calculated as the difference between total 10-year atherosclerotic cardiovascular disease risk with the patient's actual values and the goal value. Total modifiable cardiovascular risk was calculated by summing the modifiable cardiovascula risk components across cardiovascular risk factors not at optimal goal at the time of the encounter, and was calculated for each enrolled patient at the index visit and each subsequent encounter during the intervention period. Annual rate of change in modifiable cardiovascular risk was estimated from all patient encounters. A comparison of the difference in model-estimated rate of change in modifiable cardiovascular risk at 12 months post-index tested the primary efficacy hypothesis.

Recruitment status

COMPLETED

Study phase

Target enrollment

10347 participants

Primary outcome timeframe

Index to 12 months post index visit

Results posted on

2019-11-05

Participant Flow

All patients with an adult primary care visit with a primary care provider in a randomized clinic were assessed for study eligibility. After entry of blood pressure data, relevant health record data were automatically extracted, encrypted and processed through Web-based clinical algorithms that determined eligibility.

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	Prioritized Clinical Support Patients and their primary care providers in the intervention arm were presented with patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record-based alert during their primary care visit.	Usual Care Patients and their primary care providers in the usual care arm were not presented with prioritized clinical decision support.
Overall Study STARTED	5264 47	5083 38
Overall Study COMPLETED	4550 47	4387 38
Overall Study NOT COMPLETED	714 0	696 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Prioritized Clinical Support Patients and their primary care providers in the intervention arm were presented with patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record-based alert during their primary care visit.	Usual Care Patients and their primary care providers in the usual care arm were not presented with prioritized clinical decision support.
Overall Study Did not have qualifying follow-up visit.	714	696

Baseline Characteristics

Only patients that met criteria for aspirin therapy were included in this measure.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prioritized Clinical Decision Support n=4550 Participants Patients and their primary care providers were presented with patient-specific written instructions as to prioritized treatment and lifestyle changes that could reduce cardiovascular risk, prompted by an electronic health record-based alert during their primary care visits.	Usual Care n=4387 Participants Patients and their providers were not presented with the prioritized clinical decision support.	Total n=8937 Participants Total of all reporting groups
Age, Continuous	48.6 years STANDARD_DEVIATION 13.3 • n=4550 Participants	48.1 years STANDARD_DEVIATION 13.4 • n=4387 Participants	48.4 years STANDARD_DEVIATION 13.4 • n=8937 Participants
Sex: Female, Male Female	2530 Participants n=4550 Participants	2393 Participants n=4387 Participants	4923 Participants n=8937 Participants
Sex: Female, Male Male	2020 Participants n=4550 Participants	1994 Participants n=4387 Participants	4014 Participants n=8937 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=4550 Participants	66 Participants n=4387 Participants	108 Participants n=8937 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=4550 Participants	0 Participants n=4387 Participants	0 Participants n=8937 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4508 Participants n=4550 Participants	4321 Participants n=4387 Participants	8829 Participants n=8937 Participants
Race (NIH/OMB) American Indian or Alaska Native	113 Participants n=4550 Participants	68 Participants n=4387 Participants	181 Participants n=8937 Participants
Race (NIH/OMB) Asian	76 Participants n=4550 Participants	54 Participants n=4387 Participants	130 Participants n=8937 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=4550 Participants	5 Participants n=4387 Participants	10 Participants n=8937 Participants
Race (NIH/OMB) Black or African American	517 Participants n=4550 Participants	390 Participants n=4387 Participants	907 Participants n=8937 Participants
Race (NIH/OMB) White	3749 Participants n=4550 Participants	3741 Participants n=4387 Participants	7490 Participants n=8937 Participants
Race (NIH/OMB) More than one race	0 Participants n=4550 Participants	0 Participants n=4387 Participants	0 Participants n=8937 Participants
Race (NIH/OMB) Unknown or Not Reported	90 Participants n=4550 Participants	129 Participants n=4387 Participants	219 Participants n=8937 Participants
Region of Enrollment United States	4550 participants n=4550 Participants	4387 participants n=4387 Participants	8937 participants n=8937 Participants
Systolic Blood Pressure	124.4 mm Hg STANDARD_DEVIATION 16.6 • n=4550 Participants	124.2 mm Hg STANDARD_DEVIATION 16.5 • n=4387 Participants	124.3 mm Hg STANDARD_DEVIATION 16.6 • n=8937 Participants
Diastolic Blood Pressure	78.3 mmHg STANDARD_DEVIATION 11.4 • n=4550 Participants	78.3 mmHg STANDARD_DEVIATION 11.4 • n=4387 Participants	78.3 mmHg STANDARD_DEVIATION 11.4 • n=8937 Participants
Active Smoker	2131 Participants n=4550 Participants	2027 Participants n=4387 Participants	4158 Participants n=8937 Participants
Aspirin Use	519 Participants n=907 Participants • Only patients that met criteria for aspirin therapy were included in this measure.	461 Participants n=822 Participants • Only patients that met criteria for aspirin therapy were included in this measure.	980 Participants n=1729 Participants • Only patients that met criteria for aspirin therapy were included in this measure.
Low-Density Lipoprotein Cholesterol	104.9 mg/dl STANDARD_DEVIATION 35.4 • n=3680 Participants • Only patients that had a recent Low-Density Lipoprotein result in their electronic medical record were included in this measure.	104.6 mg/dl STANDARD_DEVIATION 35.6 • n=3536 Participants • Only patients that had a recent Low-Density Lipoprotein result in their electronic medical record were included in this measure.	104.8 mg/dl STANDARD_DEVIATION 7978 • n=7216 Participants • Only patients that had a recent Low-Density Lipoprotein result in their electronic medical record were included in this measure.
Body Mass Index	32.5 kg/m^2 STANDARD_DEVIATION 7.8 • n=4135 Participants • Only patients with a recent weight in their electronic medical record were included in this measure.	32.7 kg/m^2 STANDARD_DEVIATION 7.9 • n=3943 Participants • Only patients with a recent weight in their electronic medical record were included in this measure.	32.6 kg/m^2 STANDARD_DEVIATION 7.9 • n=8078 Participants • Only patients with a recent weight in their electronic medical record were included in this measure.

PRIMARY outcome

Timeframe: Index to 12 months post index visit

Population: The patients whose data were included in the primary outcome analysis met eligibility criteria, had an index visit at a randomized clinic at which they were eligible for the Cardiovascular Wizard intervention, and had at least one follow-up visit in a randomized primary care clinic.

Outcome measures

Outcome measures
Measure	Prioritized Clinical Decision Support n=4550 Participants Patients and their primary care providers were presented with their patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record based alert during their primary care visits.	Usual Care n=4387 Participants Patients and providers were not presented with the prioritized clinical decision support.
Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke	14.2 percentage of annual rate of change	20.8 percentage of annual rate of change

Adverse Events

Prioritized Clinical Decision Support

Serious events: 722 serious events

Other events: 1593 other events

Deaths: 526 deaths

Usual Care

Serious events: 763 serious events

Other events: 1882 other events

Deaths: 581 deaths

Serious adverse events

Serious adverse events
Measure	Prioritized Clinical Decision Support n=4550 participants at risk Patients and providers were presented with patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record based alert during their primary care visits.	Usual Care n=4387 participants at risk Patients and providers were not presented with the prioritized clinical decision support.
General disorders In Patient Hospitalization	15.4% 702/4550 • Number of events 1331 • The adverse event data was collected on the date of the after-index visit and every subsequent visit through the end of the intervention period on September 19, 2018.	16.7% 734/4387 • Number of events 1415 • The adverse event data was collected on the date of the after-index visit and every subsequent visit through the end of the intervention period on September 19, 2018.
General disorders Suicide Attempt	1.8% 80/4550 • Number of events 126 • The adverse event data was collected on the date of the after-index visit and every subsequent visit through the end of the intervention period on September 19, 2018.	2.7% 118/4387 • Number of events 170 • The adverse event data was collected on the date of the after-index visit and every subsequent visit through the end of the intervention period on September 19, 2018.

Other adverse events

Other adverse events
Measure	Prioritized Clinical Decision Support n=4550 participants at risk Patients and providers were presented with patient-specific written advice as to prioritized treatment and lifestyle changes that could reduce their cardiovascular risk, prompted by an electronic health record based alert during their primary care visits.	Usual Care n=4387 participants at risk Patients and providers were not presented with the prioritized clinical decision support.
General disorders Emergency Room Visit	35.0% 1593/4550 • Number of events 5373 • The adverse event data was collected on the date of the after-index visit and every subsequent visit through the end of the intervention period on September 19, 2018.	42.9% 1882/4387 • Number of events 6863 • The adverse event data was collected on the date of the after-index visit and every subsequent visit through the end of the intervention period on September 19, 2018.

Additional Information

Rebecca Rossom

HealthPartnersInstitute

Phone: 952-883-5466

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place