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

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

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.

Study Overview

• Status: Completed
• Conditions: Iron-deficiency Anemia
• Intervention / Treatment: Behavioral: Clinical supports

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Division of General Internal Medicine
    • Chicago, Illinois, United States, 60611
      • Stephen D Persell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	120 days
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.	120 days
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.	120 days

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2022
• Primary Completion (ACTUAL): June 28, 2022
• Study Completion (ACTUAL): January 11, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (ACTUAL): May 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases
• Other Study ID Numbers: STU00213747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No