N/A
N=1,503
A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01346189 ↗Enrolled (actual)
1,503
Serious AEs
0.1%
Results posted
Dec 2017
Primary outcome: Primary: Change in LDL From Baseline to 12 Months — 27.9; 25.1; 33.6; 25.1 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Economic Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in LDL From Baseline to 12 Months |
27.9; 25.1; 33.6; 25.1; 159.9; 160.6 | — |
| SECONDARY Change in LDL From Baseline to 15 Months |
29.1; 23.9; 32.8; 25.8 | — |
Summary
Using a 4-arm, cluster-randomized controlled trial, the investigators will test the effectiveness of different behavioral economic interventions in increasing statin use and reducing LDL cholesterol among patients with poor cholesterol control who are at very high risk for CVD. The investigators will test these approaches among primary care physicians and their patients at very high risk of CVD at Geisinger Health System and University of Pennsylvania outpatient clinics.
Eligibility Criteria
Inclusion Criteria
- Physicians: All primary care providers who have at least 5 patients who meet eligibility criteria will be eligible.
- Patients: 10-year CVD risk of between 10-20% who do not have an LDL below 140 mg/dl or 10-year CVD risk of at least 20% (including those with preexisting CHD) who do not have an LDL below 120 mg/dl will be the primary inclusion criteria. We have chosen to include all patients meeting these inclusion criteria regardless of their reported adherence to statins, as there clearly is room for improvement in the LDL through a combination of physician and patient actions.
Exclusion Criteria
- Patients will be excluded if they have a known allergy or history of side effects to statins, will not or cannot give consent, or have a markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or dementia).
Data sourced from ClinicalTrials.gov (NCT01346189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.