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| ID | Type | Description | Link |
|---|---|---|---|
| U19MH092201 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Essentia Health | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
| Park Nicollet Clinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prioritized Clinical Decision Support | Experimental | 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. |
|
| Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prioritized Clinical Decision Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Index to 12 months post index visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca C Rossom, MD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essentia Health | Duluth | Minnesota | 55805 | United States | ||
| Park Nicollet Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21318195 | Background | Weiner M, Warren L, Fiedorowicz JG. Cardiovascular morbidity and mortality in bipolar disorder. Ann Clin Psychiatry. 2011 Feb;23(1):40-7. | |
| 17283292 | Background | Osborn DP, Levy G, Nazareth I, Petersen I, Islam A, King MB. Relative risk of cardiovascular and cancer mortality in people with severe mental illness from the United Kingdom's General Practice Rsearch Database. Arch Gen Psychiatry. 2007 Feb;64(2):242-9. doi: 10.1001/archpsyc.64.2.242. |
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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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Patients and their primary care providers in the usual care arm were not presented with prioritized clinical decision support. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | percentage of annual rate of change | Index to 12 months post index visit |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prioritized Clinical Decision Support | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| In Patient Hospitalization | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room Visit | General disorders | Systematic Assessment |
Because the study was conducted in three large medical groups in the same area of the country, generalizability of results to other care systems or populations is uncertain.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Rossom | HealthPartnersInstitute | 952-883-5466 | Rebecca.C.Rossom@HealthPartners.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 23, 2014 | Sep 9, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D001714 | Bipolar Disorder |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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Clinics have been randomized into a treatment and a control arm.
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|
| Minneapolis |
| Minnesota |
| 55416 |
| United States |
| HealthPartners | Minneapolis | Minnesota | 55425 | United States |
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| 37428030 | Derived | Rossom RC, Crain AL, Waring S, Sperl-Hillen JM, Hooker SA, Miley K, O'Connor PJ. Differential Effects of an Intervention to Reduce Cardiovascular Risk for Patients With Bipolar Disorder, Schizoaffective Disorder, or Schizophrenia: A Randomized Clinical Trial. J Clin Psychiatry. 2023 Jul 5;84(4):22m14710. doi: 10.4088/JCP.22m14710. |
| 36201392 | Derived | Sperl-Hillen JM, Anderson JP, Margolis KL, Rossom RC, Kopski KM, Averbeck BM, Rosner JA, Ekstrom HL, Dehmer SP, O'Connor PJ. Bolstering the Business Case for Adoption of Shared Decision-Making Systems in Primary Care: Randomized Controlled Trial. JMIR Form Res. 2022 Oct 6;6(10):e32666. doi: 10.2196/32666. |
| 35261265 | Derived | Rossom RC, Hooker SA, O'Connor PJ, Crain AL, Sperl-Hillen JM. Cardiovascular Risk for Patients With and Without Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder. J Am Heart Assoc. 2022 Mar 15;11(6):e021444. doi: 10.1161/JAHA.121.021444. Epub 2022 Mar 9. |
| 35254433 | Derived | Rossom RC, Crain AL, O'Connor PJ, Waring SC, Hooker SA, Ohnsorg K, Taran A, Kopski KM, Sperl-Hillen JM. Effect of Clinical Decision Support on Cardiovascular Risk Among Adults With Bipolar Disorder, Schizoaffective Disorder, or Schizophrenia: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e220202. doi: 10.1001/jamanetworkopen.2022.0202. |
| 32087336 | Derived | Rossom RC, O'Connor PJ, Crain AL, Waring S, Ohnsorg K, Taran A, Kopski K, Sperl-Hillen JM. Pragmatic trial design of an intervention to reduce cardiovascular risk in people with serious mental illness. Contemp Clin Trials. 2020 Apr;91:105964. doi: 10.1016/j.cct.2020.105964. Epub 2020 Feb 20. |
| Usual Care |
Patients and their providers were not presented with the prioritized clinical decision support. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Active Smoker | Count of Participants | Participants |
|
| Aspirin Use | Only patients that met criteria for aspirin therapy were included in this measure. | Count of Participants | Participants |
|
| Low-Density Lipoprotein Cholesterol | Only patients that had a recent Low-Density Lipoprotein result in their electronic medical record were included in this measure. | Mean | Standard Deviation | mg/dl |
|
| Body Mass Index | Only patients with a recent weight in their electronic medical record were included in this measure. | Mean | Standard Deviation | kg/m^2 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Prioritized Clinical Decision Support | 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. |
| OG001 | Usual Care | Patients and providers were not presented with the prioritized clinical decision support. |
|
|
| 526 |
| 4,550 |
| 722 |
| 4,550 |
| 1,593 |
| 4,550 |
| EG001 | Usual Care | Patients and providers were not presented with the prioritized clinical decision support. | 581 | 4,837 | 763 | 4,387 | 1,882 | 4,387 |
| Suicide Attempt | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|