- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02330289
Effect of Norms on Laboratory and Imaging Testing (ENLITen) (ENLITen)
April 3, 2023 updated by: Kira Ryskina, University of Pennsylvania
The Effect of Norms on Laboratory and Imaging Testing (ENLITen): a Pragmatic Randomized Controlled Trial
Studies suggest that some laboratory tests ordered for hospitalized patients are duplicative or have limited value.
This study will evaluate a normative feedback intervention to reduce overuse of laboratory tests for hospitalized patients by internal medicine physicians-in-training.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Past research has shown that 25% of diagnostic testing is duplicative or has limited value.
Academic medical centers that employ physicians-in-training may find it particularly challenging to reduce low value testing due to a historical emphasis on extensive workups by trainees.
Despite the increased emphasis on cost-consciousness in medical education, there is little existing research evaluating ways to optimize ordering behaviors of physicians-in-training.
This study will evaluate a normative feedback intervention for internal medicine physicians-in-training to reduce overuse of routine laboratory tests for hospitalized patients.
Physicians-in-training will be cluster-randomized into two arms: (1) those who receive report cards (intervention group), (2) those who will not receive report cards (control group).
We will study the use of routine laboratory tests over a pre-intervention period of 1 week and a post-randomization period of 1 week.
We will study physician attitudes about the real-time feedback dashboard with qualitative assessments in focus groups after the completion of the intervention.
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Any internal medicine physician-in-training scheduled to rotate through general medicine services at HUP during the study period will be included in the study.
Exclusion Criteria:
- Physicians-in-training pulled for weekend coverage or sick coverage will be excluded. Medical students will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Report card arm
The intervention arm will receive an email report card describing their lab use compared to their peers as well as a link to a website visually tracking the team's daily ordering of common lab tests compared to the peer teams.
|
Personalized visual report card describing physician's laboratory ordering pattern for prior week relative to peers as well as a link to a website tracking lab ordering for the team in real time compared to peer teams.
|
|
No Intervention: Control arm
Physicians in the control arm will not receive the email or website link.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Routine laboratory tests/patient-day
Time Frame: 6 months
|
the number of routine laboratory tests per patient-day ordered by the physicians-in-training
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Laboratory costs
Time Frame: 6 months
|
6 months
|
|
|
Routine imaging tests/patient-day
Time Frame: 6 months
|
6 months
|
|
|
Physicians' attitudes toward laboratory test use and receiving feedback
Time Frame: 6 months
|
Focus groups
|
6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Non-routine laboratory tests/patient-day
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kira L Ryskina, MD, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ryskina K, Jessica Dine C, Gitelman Y, Leri D, Patel M, Kurtzman G, Lin LY, Epstein AJ. Effect of Social Comparison Feedback on Laboratory Test Ordering for Hospitalized Patients: A Randomized Controlled Trial. J Gen Intern Med. 2018 Oct;33(10):1639-1645. doi: 10.1007/s11606-018-4482-y. Epub 2018 May 22.
- Kurtzman G, Dine J, Epstein A, Gitelman Y, Leri D, Patel MS, Ryskina K. Internal Medicine Resident Engagement with a Laboratory Utilization Dashboard: Mixed Methods Study. J Hosp Med. 2017 Sep;12(9):743-746. doi: 10.12788/jhm.2811.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
December 29, 2014
First Submitted That Met QC Criteria
December 30, 2014
First Posted (Estimate)
January 1, 2015
Study Record Updates
Last Update Posted (Actual)
April 6, 2023
Last Update Submitted That Met QC Criteria
April 3, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 820924
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Utilization
-
University Hospital, Clermont-FerrandFrench Federation of Physical Education and Gymnastic (EPGV)Completed
-
Children's Hospital Medical Center, CincinnatiCompletedEffect of Varied Outreach Methods on Appointment Scheduling and Appointment Completion Using MyChartHealth Care UtilizationUnited States
-
Seattle Children's HospitalCompleted
-
Children's Mercy Hospital Kansas CityCompleted
-
Geisinger ClinicCompleted
-
University of California, RiversideCultura y Arte Nativa de las Americas (CANA); Native American Health CenterRecruitingStress | Service UtilizationUnited States
-
Harvard Medical School (HMS and HSDM)Brigham and Women's Hospital; Cambridge Health AllianceCompleted
-
Ludwig Boltzmann Institute for Digital Health and...Salzburger LandesklinikenCompleted
Clinical Trials on Normative report card
-
University of PittsburghALS AssociationCompleted
-
Denver Health and Hospital AuthorityAgency for Healthcare Research and Quality (AHRQ)Completed
-
University of California, Los AngelesUCLA Health Department of MedicineCompleted
-
State University of New York at BuffaloFlorida International UniversityCompletedAttention Deficit Hyperactivity DisorderUnited States
-
University of North Carolina, Chapel HillEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedContraceptive Usage | Unintended PregnancyKenya
-
Mayo ClinicTerminatedGastroesophageal Reflux | Hernia, Hiatal | Surveys and Questionnaires | FundoplicationUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoNational Institute of Mental Health (NIMH)Enrolling by invitationAttention Deficit and Disruptive Behavior DisordersUnited States
-
Longevity Metrics, Inc.RecruitingCardiovascular Diseases | Neoplasms | Mortality | Musculoskeletal Diseases | Cognitive Dysfunction | Metabolic Syndrome | Dementia | Frailty | Aging | Activities of Daily Living | Disability Physical | Neuro-Degenerative Disease | Aging Well | All-Cause Mortality | Health-Related Quality of LifeUnited States
-
Florida International UniversityUniversity of South Florida; Florida State University; Nova Southeastern UniversityRecruitingAttention Deficit Hyperactivity DisorderUnited States