An interventional study of Prioritized Clinical Decision Support in Chronic Disease, Mental Disorder and Health Behavior, sponsored by HealthPartners Institute. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-11-05.
Sponsored by HealthPartners Institute · Not applicable, Interventional, and Treatment
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.
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.
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's enrollment of 10,347 is above the median of 120 across 722 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
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Exclusion Criteria:
Patients receiving care in clinics randomized to the intervention arm of the study and their primary care 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 visit.
Behavioral: Prioritized Clinical Decision Support
Patients receiving care in clinics randomized to the usual care arm of the study and their providers were not presented with the prioritized 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.
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
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.
| Milestone | Prioritized Clinical Support | Usual Care |
|---|---|---|
| Started | 5264 | 5083 |
| Completed | 4550 | 4387 |
| Not completed | 714 | 696 |
| Withdrew: Did not have qualifying follow-up visit. | 714 | 696 |
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.
| percentage of annual rate of change | Prioritized Clinical Decision Support | Usual Care |
|---|---|---|
| Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke | 14.2 | 20.8 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prioritized Clinical Decision Support | 526/4,550 (11.6%) | 722/4,550 (15.9%) | 1,593/4,550 (35%) |
| Usual Care | 581/4,837 (12%) | 763/4,387 (17.4%) | 1,882/4,387 (42.9%) |
| Event | Prioritized Clinical Decision Support | Usual Care |
|---|---|---|
| In Patient HospitalizationGeneral disorders | 702/4550 | 734/4387 |
| Suicide AttemptGeneral disorders | 80/4550 | 118/4387 |
| Event | Prioritized Clinical Decision Support | Usual Care |
|---|---|---|
| Emergency Room VisitGeneral disorders | 1593/4550 | 1882/4387 |
Patients whose data was included in the baseline analysis population met eligibility criteria, had an index visit at a randomized clinic at which they were eligible for the CV Wizard intervention, and had at least one follow-up visit in a randomized primary care clinic.
| Age, Continuous(years) | Prioritized Clinical Decision Support | Usual Care | Total |
|---|---|---|---|
| Mean | 48.6 ± 13.3 | 48.1 ± 13.4 | 48.4 ± 13.4 |
| Sex: Female, Male(Participants) | Prioritized Clinical Decision Support | Usual Care | Total |
|---|---|---|---|
| Female | 2530 | 2393 | 4923 |
| Male | 2020 | 1994 | 4014 |
| Ethnicity (NIH/OMB)(Participants) | Prioritized Clinical Decision Support | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 42 | 66 | 108 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 4508 | 4321 | 8829 |
| Race (NIH/OMB)(Participants) | Prioritized Clinical Decision Support | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 113 | 68 | 181 |
| Asian | 76 | 54 | 130 |
| Native Hawaiian or Other Pacific Islander | 5 | 5 | 10 |
| Black or African American | 517 | 390 | 907 |
| White | 3749 | 3741 | 7490 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 90 | 129 | 219 |
| Region of Enrollment(participants) | Prioritized Clinical Decision Support | Usual Care | Total |
|---|---|---|---|
| United States | 4550 | 4387 | 8937 |
| Systolic Blood Pressure(mm Hg) | Prioritized Clinical Decision Support | Usual Care | Total |
|---|---|---|---|
| Mean | 124.4 ± 16.6 | 124.2 ± 16.5 | 124.3 ± 16.6 |
| Diastolic Blood Pressure(mmHg) | Prioritized Clinical Decision Support | Usual Care | Total |
|---|---|---|---|
| Mean | 78.3 ± 11.4 | 78.3 ± 11.4 | 78.3 ± 11.4 |
| Active Smoker(Participants) | Prioritized Clinical Decision Support | Usual Care | Total |
|---|---|---|---|
| Count of participants | 2131 | 2027 | 4158 |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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