Iron-deficiency AnemiaNCT05365308
EHR-based Patient Identification and Panel Management of Patients With Iron Deficiency Anemia
A study testing Clinical supports in people with Iron-deficiency Anemia, run by Northwestern University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Iron-deficiency Anemia
- What is being tested?
- Clinical supports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Feb 2022to 11 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Northwestern Medical Group primary care physician (internal medicine, family medicine or geriatrics)
Who cannot join
- No primary care office practice within Northwestern Medical Group
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University, Division of General Internal Medicine
Chicago, Illinois, 60611
Stephen D Persell
Chicago, Illinois, 60611
About this study
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
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.
- Conditions
- Iron-deficiency Anemia
- Being tested
- Clinical supports
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical supportsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start28 Feb 2022
- Primary completion28 Jun 2022
- Study completion11 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stratified physician-randomized controlled quality improvement intervention study.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Persell, MD, MPH, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365308
- Sponsor's protocol ID
- STU00213747
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data sharing plan.
Publications
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.
PubMed 38626940
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05365308
- Acronym / sponsor ID
- STU00213747
- Conditions
- Iron-deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 11 Jan 2023 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stratified physician-randomized controlled quality improvement intervention study.
| Arm | Type | Receives |
|---|---|---|
| Intervention: Quality Improvement tools | Experimental | Behavioral: Clinical supportsQuality 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. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Northwestern Medical Group primary care physician (internal medicine, family medicine or geriatrics)
Key exclusion criteria (1 listed)
- No primary care office practice within Northwestern Medical Group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical supportsQuality 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 | Behavioural | Intervention: Quality Improvement tools |
Primary outcome
Bidirectional endoscopy completed
Time frame: 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.
3 secondary outcomes
Endoscopy completed or scheduled
Time frame: 120 days
Gastroenterology consultation completed
Time frame: 120 days
GI referral provided or completed
Time frame: 120 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 38626940Priyanath 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.
- Individual participant dataSharing planned: No. No data sharing plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical supports in people with Iron-deficiency Anemia, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bidirectional endoscopy completed (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05365308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.