NCT05365308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

April 14, 2022

Last Update Submit

February 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Endoscopy completed or scheduled

    120 days

  • Gastroenterology consultation completed

    120 days

  • GI referral provided or completed

    120 days

Study Arms (2)

Intervention: Quality Improvement tools

EXPERIMENTAL

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

Control: usual care

NO INTERVENTION

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.

Interventions

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

Intervention: Quality Improvement tools

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Northwestern Medical Group primary care physician (internal medicine, family medicine or geriatrics)

You may not qualify if:

  • No primary care office practice within Northwestern Medical Group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University, Division of General Internal Medicine

Chicago, Illinois, 60611, United States

Location

Stephen D Persell

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Priyanath Gupta A, Patel D, Lee JY, Volpentesta M, Schachter M, Persell SD. Health information technology tools to accelerate gastrointestinal evaluation in patients with iron deficiency anaemia: a cluster randomised controlled trial. BMJ Open Qual. 2024 Apr 15;13(2):e002565. doi: 10.1136/bmjoq-2023-002565.

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Stratified physician-randomized controlled quality improvement intervention study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 14, 2022

First Posted

May 9, 2022

Study Start

February 28, 2022

Primary Completion

June 28, 2022

Study Completion

January 11, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

No data sharing plan.

Locations