Using Nudges to Implement Comparative Effectiveness

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01575171
First received: April 2, 2012
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Hypercholesterolemia
Behavioral: Nudge

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Using Nudges to Implement Comparative Effectiveness: Behavioral Economics and Statins

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Nudge Acceptance or Rejection [ Time Frame: Doctor visit to 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention
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.
Behavioral: Nudge
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Doctors in a large multi-specialty private practice

Criteria

Doctors who have patients that meet the inclusion/exclusion criteria below.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Women less than 50 years of age
  • Patients with allergy/myopathy to statins in the past
  • Patients with active liver disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575171

Locations
United States, New York
Murray Hill Medical Group
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Joseph Ravenell, MD, MS NYU School of Medicine
Principal Investigator: Brian Elbel, PhD, MPH NYU School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01575171     History of Changes
Other Study ID Numbers: 10-01287
Study First Received: April 2, 2012
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014