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NCT01420016

Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk

Completed NA Results posted Last updated 21 September 2018
What this trial tests

NA trial testing Prioritized Clinical Decision Support in Hypertension in 7,914 participants. Completed in 19 August 2014.

Timeline
20 August 2012
Primary endpoint
19 August 2014
19 August 2014

Quick facts

Lead sponsorHealthPartners Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment7,914
Start date20 August 2012
Primary completion19 August 2014
Estimated completion19 August 2014

Drugs / interventions tested

Conditions studied

Sponsor

HealthPartners Institute

Who can join

18 and older, any sex, with Hypertension or Hyperlipidemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Predicted Annual Rate of Change in 10-year Risk of Fatal or Nonfatal Heart Attack or Stroke Primary · Index to 14 months post index

Ten year cardiovascular risk was calculated at each post index visit from the most recent clinical and laboratory values in the EMR. The Framingham lipid equation was used when a lipid value was available in the previous 5 years; otherwise the Framingham BMI equation was used. The primary outcome was the annualized rate of change (slope) in 10-year CVR, estimated for each treatment group from the time and time-by-treatment parameters of a mixed regression model which predicted post-index CVR values from time elapsed since index, treatment group and the time by treatment interaction.

GroupValue95% CI
Prioritized Clinical Decision Support-0.59-1.43 – 0.26
Usual Care1.660.81 – 2.52

Adverse events — posted to ClinicalTrials.gov

Time frame: We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prioritized Clinical Decision Support
Serious: 253/6392 (4%)
Deaths:
Usual Care
Serious: 151/5159 (3%)
Deaths:

Serious adverse events (8 terms)

ReactionSystemPrioritized Clinical Decis…Usual Care
Hypotensive emergency, urgencyVascular disorders
Acute renal failureRenal and urinary disorders
HypoglycemiaEndocrine disorders
HyperglycemiaEndocrine disorders
Hypertensive emergency, urgencyVascular disorders
MyositisGeneral disorders
GI bleedGastrointestinal disorders
ASA allergy-acute anaphylaxisGeneral disorders
Other adverse events (11 terms — click to expand)

ReactionSystemPrioritized Clinical Decis…Usual Care
Any blood pressure related eventVascular disorders
Metabolic disturbanceMetabolism and nutrition disorders
Any lipid related eventCardiac disorders
Lipid drug interactionGeneral disorders
HypokalemiaMetabolism and nutrition disorders
Any glycemic related eventEndocrine disorders
Glycemic drug interactionGeneral disorders
HyponatremiaMetabolism and nutrition disorders
BP drug interactionGeneral disorders
HyperkalemiaMetabolism and nutrition disorders
Any aspirin related eventGeneral disorders

Most-reported serious reactions: Hypotensive emergency, urgency, Acute renal failure, Hypoglycemia, Hyperglycemia, Hypertensive emergency, urgency, Myositis, GI bleed, ASA allergy-acute anaphylaxis.

Data from ClinicalTrials.gov NCT01420016 adverse events section.

Sponsor's own description

The objective of this project is to develop and implement sophisticated point-of-care Electronic Health Record (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). After developing the EHR-based decision support intervention, the investigators will test its impact on CVR, the components of CVR, in a group randomized trial that includes 18 primary care clinics, 60 primary care physicians, and 18,000 adults with moderate or high CVR. This approach, if successful, will (a) improve chronic disease outcomes and reduce CVR for about 35% of the U.S. adult population, (b) maximize the clinical return on the massive investments that are increasingly being made in sophisticated outpatient EHR systems, and (c) provide a model for how to use EHR technology support to deliver "personalized medicine" in primary care settings

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical decision support directed to primary care patients and providers reduces cardiovascular risk: a randomized trial.
    Sperl-Hillen JM, Crain AL, Margolis KL, Ekstrom HL, et al · · 2018 · cited 48× · PMID 29982627 · DOI 10.1093/jamia/ocy085
  2. Abstracts of 52nd EASD Annual Meeting.
    · 2016 · cited 6× · PMID 27539147 · DOI 10.1007/s00125-016-4046-9

Verify or expand the search:

Other trials of Prioritized Clinical Decision Support

Trials testing the same drug.

Other recruiting trials for Hypertension

Currently open trials in the same condition.

Other HealthPartners Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing