Using Nudges to Implement Comparative Effectiveness

NCT01575171 | Completed DMC

• 1 other identifier: 10-01287
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Behavioral economics represents a powerful, albeit underutilized tool to influence provider and systems behavior in a large-scale, meaningful, and sustainable way. The investigators propose to use a sophisticated electronic health record (EHR) system to change the default choice for physicians to the choice most supported by clinical practice guidelines (CPG). Multiple guidelines exist describing best practices for effective interventions, yet a large gap persists between actual and optimal guideline compliance. The proposed study will examine the comparative effectiveness of an opt-out medication management protocol relative to usual care for patients not at goal, using national guidelines for cholesterol management implemented in large multispecialty private practices that use an Electronic Health Record system. Specific Aim: To determine the effectiveness of altering the default option in an EHR in prescribing statins to selected patients using clinical decision support. Hypotheses: Compared to usual care, a CPG-concordant intervention designed using behavioral economics principles will significantly improve the proportion of patients who are prescribed statins.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Nudge Acceptance or Rejection

  A "Nudge" or opt-out default option is implemented in the electronic health record system based on national clinical guidelines. We plan to measure if the Nudge is accepted or rejected by doctors.

  Doctor visit to 6 months

Study Arms (1)

Intervention/"Nudge"

Individuals will be analyzed according to their assigned intervention group, to compare the effectiveness of an opt-out EHR decision support system to enhance the prescription of statins to those patients with an elevated LDL-C and to subsequently titrate the medication dose until LDL-C control is obtained. Physicians randomized to the automated clinical decision support "nudge" will see the new "optout" prescribing procedure as part of their EHR interface. This will include initially prescribing the guideline-based medication, simvastatin 20mg. Nearly six months after this visit, physicians will receive a reminder via EHR to schedule a follow-up fasting lipid profile as recommended by ATP III guidelines.

Behavioral: Nudge

Interventions

Nudge BEHAVIORAL

Behavioral economics recognizes that individuals often are not fully "rational" in the purely economic sense, but are subject to the influence of various social, environmental and cognitive factors in their decision making. And, one can take advantage of these findings to "nudge" individuals, in our case physicians, towards more optimal choices. Physicians randomized to the automated clinical decision support "nudge" will see the new "optout" prescribing procedure as part of their EHR interface. This will include initially prescribing the guideline-based medication, simvastatin 20mg. Nearly six months after this visit, physicians will receive a reminder via EHR to schedule a follow-up fasting lipid profile as recommended by ATP III guidelines.

Intervention/"Nudge"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Doctors in a large multi-specialty private practice

You may not qualify if:

• Male patients 18+
• Female patients age 50+ (to avoid the possibility of women of childbearing age being started on statin)
• Fasting lipid profile from the past year who meet ATP III guidelines for requiring a statin
• Women less than 50 years of age
• Patients with allergy/myopathy to statins in the past
• Patients with active liver disease

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Murray Hill Medical Group

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joseph Ravenell, MD, MS

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

• Brian Elbel, PhD, MPH

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 11, 2012
• Study Start: September 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 3, 2015

Record last verified: 2015-07

Locations

US (1)