Prioritized Clinical Decision Support to Reduce Cardiovascular Risk
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|ClinicalTrials.gov Identifier: NCT01420016|
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : November 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Hyperlipidemia Diabetes Smoking||Behavioral: Prioritized Clinical Decision Support||Not Applicable|
The objective of this project is to develop and implement sophisticated point-of-care EHR-based clinical decision support that (a) identifies and (b) prioritizes all available evidence-based treatment options to reduce a given patient's cardiovascular risk (CVR). The prioritized list of treatment options is provided in different formats to both the primary care physician (PCP) and patient at the time of each office visit made by a patient with moderate to high CVR and sub-optimally controlled and potentially reversible CVR factors. Available evidence-based treatment options are prioritized based on the magnitude of potential CVR reduction of each treatment option. This intervention strategy, referred to as Prioritized Clinical Decision Support (PCS), is specifically designed for widespread use in primary care settings and has the potential to substantially augment current efforts to control CVR in the 35% of American adults with 10-year Framingham CVR of 10% or higher.
To assess the ability of the PCS intervention to reduce CVR in adults, we will randomize 18 primary care clinics with 60 primary care physicians (PCPs) and approximately 18,000 eligible adults with baseline Framingham 10-year risk of a major CV event (either heart attack or stroke) of 10% or more into one of two experimental conditions: Group 1 includes 9 clinics (with 30 PCPs and 9,000 patients) that will receive prioritized clinical decision support (PCS) to reduce CVR at the time of each clinical encounter made by an eligible adult. Group 2 includes 9 clinics (with 30 PCPs and 9,000 patients) that receive no study intervention and constitute a usual care control group. The study will formally test the hypothesis that after control for baseline CVR, post-intervention 10-year Framingham CVR will be better in Group 1 than Group 2 at 12 and 24 months after start of the intervention. In addition, impact of the intervention on specific components of CVR (BP, lipids, glucose, aspirin use, and smoking) will be assessed, and the cost-effectiveness of the intervention will be quantified.
This innovative project builds upon 10 years of prior work by our research team, and extends prior successful EHR clinical decision support interventions by introducing prioritization, by providing decision support to both patients and PCPs at the time of the office visit, and by extending the decision support across the broad and critically important clinical terrain of CVR reduction. The results of this project, whether positive or negative, will extend our understanding of how to maximize the clinical return on massive public and private sector investments now being made in sophisticated outpatient EHR systems. If successful, this decision support tool could be broadly used to both standardize and personalize care delivered by case managers, pharmacists, and other providers in a wide range of care delivery configurations.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29950 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Prioritized Clinical Decision Support to Reduce Cardiovascular Risk|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||July 2015|
|Active Comparator: Prioritized Clinical Decision Support||
Behavioral: Prioritized Clinical Decision Support
Eighteen primary care clinics will be blocked on size and on patient characteristics, and each clinic randomly assigned to one of 2 study arms. All consenting PCPs will be allocated to the study arm that their clinic is assigned to and the estimated 400 eligible adults with 10-year CVR >= 10% under the care of each consenting physician will be allocated to the same treatment arm as their PCP.
|No Intervention: Usual Care|
- 12 month Cardiovascular risk reduction [ Time Frame: baseline and 12 months ]measured according to Framingham risk score
- 24 month Cardiovascular Risk reduction [ Time Frame: baseline, 12 and 24 months ]measured by Framingham risk score
- Quality adjusted life years (QALY) [ Time Frame: 12 and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420016
|United States, Minnesota|
|HealthPartners Medical Group|
|Minneapolis, Minnesota, United States, 55440|
|Principal Investigator:||Patrick J O'Connor, MD, MPH||HealthPartners Institute|