HypercholesterolemiaNCT01575171
Using Nudges to Implement Comparative Effectiveness
An observational study of Hypercholesterolemia, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Nudge
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Doctors in a large multi-specialty private practice
Who may be able to join
- 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
Who cannot join
- Women less than 50 years of age
- Patients with allergy/myopathy to statins in the past
- Patients with active liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Nudges to Implement Comparative Effectiveness: Behavioral Economics and Statins
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.
Read more
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.
Read the detailed description
Historically, many interventions have been studied to improve the quality, safety, and effectiveness of medical care, particularly through the new focus on comparative effectiveness research. Unfortunately, sustained provider and system uptake of these interventions has been severely lacking, to the serious detriment of patient health. The most commonly tried tools to increase uptake, including pay-for-performance, have substantially fallen short of expectations. Moreover, often these interventions are created in highly artificial settings, and we have not come up with ways to implement them in the long-term. The challenge, therefore, is to create sustainable change that impacts care in meaningful ways.
In contrast, behavioral economics represents a powerful tool by which to influence provider and systems behavior in a large-scale, meaningful, and sustainable way. Briefly, 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. While the application of behavioral economics has been incredibly successful in altering behavior outside the health sphere, surprisingly little attention has been given to health.
We have chosen to focus on physician behavior in prescribing HMG-CoA reductase inhibitors (statins) to patients with elevated cardiac risk and elevated low density lipoprotein cholesterol (LDL-C) as recommended by cholesterol management guidelines. In a cluster randomized trial at several private, community-based, multispecialty practices, we propose to compare usual care to a system of automated, default, opt-out clinical decision support that prescribes statins as appropriate.
We propose to use a cluster randomized trial design in several multispecialty private practices to examine the comparative effectiveness of an EHR-based lipid management protocol based on ATP III guidelines vs. usual care. Cluster randomization of participating physicians is useful when blinding is impossible and "contamination" might be a problem, i.e. more aggressive management among a physician's non-intervention patients as a result of experience with intervention patients. Of an estimated 150 primary care physicians at the recruited private practices, we expect at least 100 to consent to participate. Physicians will be clustered for randomization based on the number of patients in their panel that meet ATP III guidelines for statin. Physicians in each cluster will then be individually randomized to the intervention or control arm.
Physicians randomized to usual care will not get the intervention or decision support. 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.
- Conditions
- Hypercholesterolemia
- Being tested
- Nudge
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NudgeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Doctor visit to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startSep 2010
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Ravenell, MD, MS, Principal investigator, NYU School of MedicineBrian Elbel, PhD, MPH, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575171
- Sponsor's protocol ID
- 10-01287
- Status last verified
- Jul 2015
- First submitted
- 2 Apr 2012
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Nudges to Implement Comparative Effectiveness: Behavioral Economics and Statins
- ClinicalTrials.gov ID
- NCT01575171
- Acronym / sponsor ID
- 10-01287
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Historically, many interventions have been studied to improve the quality, safety, and effectiveness of medical care, particularly through the new focus on comparative effectiveness research. Unfortunately, sustained provider and system uptake of these interventions has been severely lacking, to the serious detriment of patient health. The most commonly tried tools to increase uptake, including pay-for-performance, have substantially fallen short of expectations. Moreover, often these interventions are created in highly artificial settings, and we have not come up with ways to implement them in the long-term. The challenge, therefore, is to create sustainable change that impacts care in meaningful ways.
In contrast, behavioral economics represents a powerful tool by which to influence provider and systems behavior in a large-scale, meaningful, and sustainable way. Briefly, 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. While the application of behavioral economics has been incredibly successful in altering behavior outside the health sphere, surprisingly little attention has been given to health.
We have chosen to focus on physician behavior in prescribing HMG-CoA reductase inhibitors (statins) to patients with elevated cardiac risk and elevated low density lipoprotein cholesterol (LDL-C) as recommended by cholesterol management guidelines. In a cluster randomized trial at several private, community-based, multispecialty practices, we propose to compare usual care to a system of automated, default, opt-out clinical decision support that prescribes statins as appropriate.
We propose to use a cluster randomized trial design in several multispecialty private practices to examine the comparative effectiveness of an EHR-based lipid management protocol based on ATP III guidelines vs. usual care. Cluster randomization of participating physicians is useful when blinding is impossible and "contamination" might be a problem, i.e. more aggressive management among a physician's non-intervention patients as a result of experience with intervention patients. Of an estimated 150 primary care physicians at the recruited private practices, we expect at least 100 to consent to participate. Physicians will be clustered for randomization based on the number of patients in their panel that meet ATP III guidelines for statin. Physicians in each cluster will then be individually randomized to the intervention or control arm.
Physicians randomized to usual care will not get the intervention or decision support. 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention/"Nudge" | – | Behavioral: NudgeIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Doctors in a large multi-specialty private practice
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Women less than 50 years of age
- Patients with allergy/myopathy to statins in the past
- Patients with active liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NudgeBehavioral 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. | Behavioural | Intervention/"Nudge" |
Primary outcome
Nudge Acceptance or Rejection
Time frame: Doctor visit to 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Ravenell, MD, MS principal investigator
NYU School of Medicine
Brian Elbel, PhD, MPH principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nudge Acceptance or Rejection (time frame: Doctor visit to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2015.