Bipolar Disorder, Chronic Disease, Health Behavior, Mental Disorder, Schizophrenia
Conditions
Brief summary
This purpose of this study is to adapt, implement and test the ability of a sophisticated point-of-care electronic health record-based clinical decision support that identifies and prioritizes all available evidence-based treatment options to reduce cardiovascular risk in patients with serious mental illness.
Detailed description
This study adapted a point-of-care electronic health record-based clinical decision support system (The Cardiovascular Wizard) to help primary care providers identify, provide appropriate care for, and control cardiovascular risk factors for patients with serious mental illness (bipolar disorder, schizophrenia, schizo-affective disorder). The Cardiovascular Wizard is designed to educate primary care providers about the increased risk of cardiovascular disease and mortality in people with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, identify elevated cardiovascular risk factors in patients with serious mental illness, prioritize these cardiovascular risk based on how much improvement in cardiovascular risk a patient would experience if the cardiovascular risk factor was adequately addressed, recommend specific medications and other interventions to decrease each elevated cardiovascular risk factor, and provide this information in an easy-to-understand format for both patients with serious mental illness and their primary care providers. The Cardiovascular Wizard was printed in intervention clinics and (i) compiled lab data (most recent glycated hemoglobin, systolic blood pressure and low-density lipoprotein levels), body mass index, smoking status, and aspirin use, (ii) calculated a modifiable 10 year cardiovascular risk for stroke or heart attack using the American College of Cardiology/American Heart Association 10-year atherosclerotic cardiovascular disease risk equation, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to liver and renal function, creatinine kinase level, and previous diagnoses (Congestive Heart Failure, Cardiovascular Disease, Diabetes Mellitus, and (v) provided recommendations for intensification of therapy for glycated hemoglobin, systolic blood pressure, and/or low-density lipoproteins if not at goal. Recommendations were based on evidence-based protocols including Joint National Committee, American Diabetes Association, and the Institute for Clinical Systems Improvement.
Interventions
BEHAVIORALPrioritized Clinical Decision Support
After entry of blood pressure data at all primary care visits, relevant electronic health record data were automatically extracted, encrypted and processed through Web-based clinical algorithms that determined if the patient met intervention eligibility criteria. In intervention clinics, the rooming staff received a best practice alert and printed patient and primary care provider versions of the clinical decision support that identified evidence-based treatment options for any uncontrolled cardiovascular risk factors and prioritized treatment recommendations based on potential cardiovascular risk reduction. Cardiovascular risk factors addressed in study participants were control of lipids, blood pressure, weight, tobacco, glucose and appropriate aspirin use. In control clinics, rooming staff did not receive a best practice alert and patients and primary care providers did not receive and were not able to access the clinical decision support.
Sponsors
Essentia Health
National Institute of Mental Health (NIMH)
Park Nicollet Clinic
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Clinics have been randomized into a treatment and a control arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Serious Mental Illness diagnosis * Age 18-75 * Index visit during the enrollment period * First primary care visit where patient was not at goal for at least one of the six cardiovascular risk factor areas, and patient was not pregnant * One or more post-index visits during the intervention period
Exclusion criteria
* No Serious Mental Illness diagnosis * Under age 18 or over age 75 * In hospice or nursing home * At goal for all cardiovascular risk 6 areas * On research exclusion list
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke | Index to 12 months post index visit | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Prioritized Clinical Decision Support 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. | 4,550 |
| Usual Care Patients and their providers were not presented with the prioritized clinical decision support. | 4,387 |
| Total | 8,937 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not have qualifying follow-up visit. | 714 | 696 |
Baseline characteristics
| Characteristic | Total | Usual Care | Prioritized Clinical Decision Support |
|---|---|---|---|
| Active Smoker | 4158 Participants | 2027 Participants | 2131 Participants |
| Age, Continuous | 48.4 years STANDARD_DEVIATION 13.4 | 48.1 years STANDARD_DEVIATION 13.4 | 48.6 years STANDARD_DEVIATION 13.3 |
| Aspirin Use | 980 Participants | 461 Participants | 519 Participants |
| Body Mass Index | 32.6 kg/m^2 STANDARD_DEVIATION 7.9 | 32.7 kg/m^2 STANDARD_DEVIATION 7.9 | 32.5 kg/m^2 STANDARD_DEVIATION 7.8 |
| Diastolic Blood Pressure | 78.3 mmHg STANDARD_DEVIATION 11.4 | 78.3 mmHg STANDARD_DEVIATION 11.4 | 78.3 mmHg STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 108 Participants | 66 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8829 Participants | 4321 Participants | 4508 Participants |
| Low-Density Lipoprotein Cholesterol | 104.8 mg/dl STANDARD_DEVIATION 7978 | 104.6 mg/dl STANDARD_DEVIATION 35.6 | 104.9 mg/dl STANDARD_DEVIATION 35.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 181 Participants | 68 Participants | 113 Participants |
| Race (NIH/OMB) Asian | 130 Participants | 54 Participants | 76 Participants |
| Race (NIH/OMB) Black or African American | 907 Participants | 390 Participants | 517 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 10 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 219 Participants | 129 Participants | 90 Participants |
| Race (NIH/OMB) White | 7490 Participants | 3741 Participants | 3749 Participants |
| Region of Enrollment United States | 8937 participants | 4387 participants | 4550 participants |
| Sex: Female, Male Female | 4923 Participants | 2393 Participants | 2530 Participants |
| Sex: Female, Male Male | 4014 Participants | 1994 Participants | 2020 Participants |
| Systolic Blood Pressure | 124.3 mm Hg STANDARD_DEVIATION 16.6 | 124.2 mm Hg STANDARD_DEVIATION 16.5 | 124.4 mm Hg STANDARD_DEVIATION 16.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 526 / 4,550 | 581 / 4,837 |
| other Total, other adverse events | 1,593 / 4,550 | 1,882 / 4,387 |
| serious Total, serious adverse events | 722 / 4,550 | 763 / 4,387 |
Outcome results
Primary
Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 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 |
| Usual Care | Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke | 20.8 percentage of annual rate of change |