Clincosm LogoSign in Get a demo

EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia

Sponsor
Northwestern University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05365308
Collaborator
(none)
16
Enrollment
2
Locations
2
Arms
6
Anticipated Duration (Months)
8
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Clinical supports
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Stratified physician-randomized controlled quality improvement intervention study.Stratified physician-randomized controlled quality improvement intervention study.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
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
Actual Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Jun 28, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention: Quality Improvement tools

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.

Behavioral: Clinical supports
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
No Intervention: Control: usual care

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.

Outcome Measures

Primary Outcome Measures

  1. Bidirectional endoscopy completed [120 days]

    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

  1. Endoscopy completed or scheduled [120 days]

    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.

  2. Gastroenterology consultation completed [120 days]

    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.

  3. GI referral provided or completed [120 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University, Division of General Internal Medicine Chicago Illinois United States 60611
2 Stephen D Persell Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephen Persell, MD, MPH, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier:
NCT05365308
Other Study ID Numbers:
  • STU00213747
First Posted:
May 9, 2022
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases

Study Results

No Results Posted as of May 9, 2022