Back to resultsEHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia
Primary Purpose
Iron-deficiency Anemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical supports
Sponsored by
About this trial
This is an interventional health services research trial for Iron-deficiency Anemia
Eligibility Criteria
Inclusion Criteria:
Northwestern Medical Group primary care physician (internal medicine, family medicine or geriatrics)
Exclusion Criteria:
No primary care office practice within Northwestern Medical Group
Sites / Locations
- Northwestern University, Division of General Internal Medicine
- Stephen D Persell
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention: Quality Improvement tools
Control: usual care
Arm Description
Quality improvement tools including: computer-assisted identification of iron deficiency anemia patients with an EHR registry, facilitated GI referral, an EHR tool for documentation, and physician education.
Physicians will be notified at the start of the study that 120 days after the study start they will receive access to the quality improvement tools available to the intervention group.
Outcomes
Primary Outcome Measures
Bidirectional endoscopy completed
Completion of upper and lower endoscopy, assessed using automated queries of the Northwestern Medicine Enterprise Data Warehouse occurring within the three years prior to the study start date and the 120 days following the study start date.
Specificially, presence of one or more terms for a completed procedure from the code set for Espohagoduodenoscopy/Upper Endoscopy and one or more terms from the code set for Colonoscopy within the indicated time frame constitutes completion of the measure.
Note:the investigators use a three-year look back because eligible patients may have completed either upper or lower endoscopy previously and only require one form of endoscopy during the study period.
Secondary Outcome Measures
Endoscopy completed or scheduled
Discrete evidence in the EHR that endoscopy has been completed or scheduled on or after the study start date.
Specificially, presence in the Northwestern Medicine EHR of a completed or future scheduled procedure for one or more terms from the code set for Espohagoduodenoscopy/Upper Endoscopy or one or more terms from the code set for Colonoscopy within the indicated time frame constitutes completion of the measure.
Note:the investigators use a three-year look back because eligible patients may have completed either upper or lower endoscopy previously and only require one form of endoscopy during the study period.
Gastroenterology consultation completed
Completion of a consultation with gastroenterology (in person or telehealth) on or after the study start date
Specificially, this outcome is indicated by the presence in the Northwestern Medicine EHR of a completed office visit or telehealth visit with a physician, physician assistant or advance practice nurse in the within the specialty department of gastroenterology.
GI referral provided or completed
Receipt of a referral to gastroenterology or completion of a consultation with gastroenterology
Specificially, this outcome is indicated by the presence in the Northwestern Medicine EHR of a completed office visit or telehealth visit with a physician, physician assistant or advance practice nurse in the within the specialty department of gastroenterology or the presence of a signed order for a gastroenterology referral or an endoscopy referral.
Full Information
NCT ID
NCT05365308
First Posted
April 14, 2022
Last Updated
February 6, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05365308
Brief Title
EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia
Official Title
EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia, a Pragmatic Primary Care Physician Randomized Trial of a Quality Improvement Method
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
January 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective is to determine if a set of clinical supports that includes computer-assisted identification, an EHR registry, facilitated GI referral, and an EHR tool for documentation improves the timely referral and completion of bidirectional endoscopy in men aged 18 years and older and women aged 40 years and older with iron deficiency anemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency Anemia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stratified physician-randomized controlled quality improvement intervention study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Quality Improvement tools
Arm Type
Experimental
Arm Description
Quality improvement tools including: computer-assisted identification of iron deficiency anemia patients with an EHR registry, facilitated GI referral, an EHR tool for documentation, and physician education.
Arm Title
Control: usual care
Arm Type
No Intervention
Arm Description
Physicians will be notified at the start of the study that 120 days after the study start they will receive access to the quality improvement tools available to the intervention group.
Intervention Type
Behavioral
Intervention Name(s)
Clinical supports
Intervention Description
Quality improvement tools for iron deficiency anemia that include computer-assisted identification, an EHR registry, facilitated GI referral, an EHR tool for documentation, and physician education
Primary Outcome Measure Information:
Title
Bidirectional endoscopy completed
Description
Completion of upper and lower endoscopy, assessed using automated queries of the Northwestern Medicine Enterprise Data Warehouse occurring within the three years prior to the study start date and the 120 days following the study start date.
Specificially, presence of one or more terms for a completed procedure from the code set for Espohagoduodenoscopy/Upper Endoscopy and one or more terms from the code set for Colonoscopy within the indicated time frame constitutes completion of the measure.
Note:the investigators use a three-year look back because eligible patients may have completed either upper or lower endoscopy previously and only require one form of endoscopy during the study period.
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Endoscopy completed or scheduled
Description
Discrete evidence in the EHR that endoscopy has been completed or scheduled on or after the study start date.
Specificially, presence in the Northwestern Medicine EHR of a completed or future scheduled procedure for one or more terms from the code set for Espohagoduodenoscopy/Upper Endoscopy or one or more terms from the code set for Colonoscopy within the indicated time frame constitutes completion of the measure.
Note:the investigators use a three-year look back because eligible patients may have completed either upper or lower endoscopy previously and only require one form of endoscopy during the study period.
Time Frame
120 days
Title
Gastroenterology consultation completed
Description
Completion of a consultation with gastroenterology (in person or telehealth) on or after the study start date
Specificially, this outcome is indicated by the presence in the Northwestern Medicine EHR of a completed office visit or telehealth visit with a physician, physician assistant or advance practice nurse in the within the specialty department of gastroenterology.
Time Frame
120 days
Title
GI referral provided or completed
Description
Receipt of a referral to gastroenterology or completion of a consultation with gastroenterology
Specificially, this outcome is indicated by the presence in the Northwestern Medicine EHR of a completed office visit or telehealth visit with a physician, physician assistant or advance practice nurse in the within the specialty department of gastroenterology or the presence of a signed order for a gastroenterology referral or an endoscopy referral.
Time Frame
120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Northwestern Medical Group primary care physician (internal medicine, family medicine or geriatrics)
Exclusion Criteria:
No primary care office practice within Northwestern Medical Group
Facility Information:
Facility Name
Northwestern University, Division of General Internal Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Stephen D Persell
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data sharing plan.
Learn more about this trial
EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia
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