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AnemiaNCT05735314

A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency

A study testing Enhanced diagnostic team implementing three evidence-based interventions in people with Anemia and Decreased Glomerular Filtration Rate, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to measure the evidence-based intervention's (EBIs) impact on patient safety and efficiency, to assess the EBIs implementation by measuring acceptability, appropriateness, cost, fidelity, penetration, and sustainability and to identify the facilitators and barriers that influence the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia, Decreased Glomerular Filtration Rate
What is being tested?
Enhanced diagnostic team implementing three evidence-based interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteUnited States
Study dates
8 Jan 2024to 16 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Primary care providers' inclusion criteria:

  • physicians, physicians assistants and advanced practice registered nurses in the 13 clinic locations of UTP are eligible if they care for patients at the time patient enrollment at their clinic begins
  • agree to participate.

Patients' inclusion criteria are:

  • hemoglobin result < 10.8 for females and < 12.5 for males with normal white cell count and platelet count (the prior hemoglobin results must have been in normal range, with a look-back period of two years)
  • an eGFR value < 60 (the prior eGFR results must have been in normal range, with a look-back range of two years)
  • the matching creatinine results must also be in normal range
  • not pregnant
  • speak English or Spanish.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eric Thomas, MD,MPH contact

713-500-7958

Eric.Thomas@uth.tmc.edu

Eric Thomas, MD, MPH contact

713-500-7958

eric.thomas@uth.tmc.edu

United States1 site, 1 recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Eric Thomas, MD, MPH, 713-500-7958, Eric.Thomas@uth.tmc.edu

    Eric Thomas, 713-500-7958, eric.thomas@uth.tmc.edu

    Recruiting

Other trials in United States

About this study

Official title: A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency: a Stepped Wedge Cluster Randomized Control Trial (RCT)

The purpose of this study is to measure the evidence-based intervention's (EBIs) impact on patient safety and efficiency, to assess the EBIs implementation by measuring acceptability, appropriateness, cost, fidelity, penetration, and sustainability and to identify the facilitators and barriers that influence the degree of implementation of these EBIs.

Being tested
Enhanced diagnostic team implementing three evidence-based interventions, Usual care
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced diagnostic team implementing three evidence-based interventionsOther

    we designed an enhanced team process entailing: 1) using automated abnormal test result detection and tracking; 2) expanding the primary care team to include CPs to guide the evaluation of anemia to identify underlying causes; and 3) using NNs to engage patients in the healthcare team and diagnostic process and increase patient activation.

  • Usual careOther

    Also called Control

    Usual care involves primary care physicians ordering additional tests and referrals to evaluate patients with new anemia and decreased glomerular filtration rate (GFR) .

Study groups in NCT05735314
Study groupRoleWhat they receive
Experimental: Step 1 (3 clinics) - 24 months of interventionExperimentalNot described
Receives: Other: Enhanced diagnostic team implementing three evidence-based interventions; Other: Usual care
Experimental: Step 2 (3 clinics) - 1 month of control followed by 18 months of interventionExperimentalNot described
Receives: Other: Enhanced diagnostic team implementing three evidence-based interventions; Other: Usual care
Experimental: Step 3 (3 clinics) - 2 months control followed by 12 months of interventionExperimentalNot described
Receives: Other: Enhanced diagnostic team implementing three evidence-based interventions; Other: Usual care
Experimental: Step 4 (4 clinics) - 2 months control followed by 12 months of interventionExperimentalNot described
Receives: Other: Enhanced diagnostic team implementing three evidence-based interventions; Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects who have correct diagnosis of cause of low hemoglobin

    Percentage of subjects who have correct diagnosis of cause of low hemoglobin

    Measured: within 6 months from baseline

  2. Percentage of subjects who have correct diagnosis of cause of low glomerular filtration

    Percentage of subjects who have correct diagnosis of cause of low glomerular filtration

    Measured: within 6 months from baseline

Secondary outcomes (11)

  1. Time until diagnosis

    Time until diagnosis is defined as number of days from the initial abnormal test result to the day the diagnosis was communicated to the patient.

    Measured: initial abnormal test result to the day the diagnosis was communicated to the patient (about 1-6 months)

  2. Percentage of tests appropriately utilized

    Percentage of tests appropriately utilized will be calculated as the number of appropriate tests ordered to evaluate the abnormal test divided by the total number of tests ordered to evaluate the abnormal test, multiplied by 100.

    Measured: within 6 months from baseline

  3. Cost of treatment

    Costs will be assessed from the health care system perspective and will include the costs of all diagnostic tests and referral consultations to evaluate the abnormal tests, emergency department (ED) visits or admissions for care for the underlying diseases causing test abnormalities, and the personnel time to provide the EBIs during the 6-month work up period.

    Measured: from baseline to 6 months

  4. Number of primary care physicians (PCPs) who find the intervention as acceptable assessed by survey of PCPs

    Number of primary care physicians (PCPs) who find the intervention as acceptable

    Measured: 12 weeks after PCP's patient enrolled

  5. Number of PCPs who find the intervention appropriate as assessed by survey of PCPs

    Number of PCPs who find the intervention appropriate as assessed by survey of PCPs

    Measured: 12 weeks after PCP's patient enrolled

  6. Number of PCPs who find the intervention feasible as assessed by survey of PCPs

    Number of PCPs who find the intervention feasible as assessed by survey of PCPs

    Measured: 12 weeks after PCP's patient enrolled

  7. Fidelity as assessed by the percentage of participants who moved through each step of the diagnostic process needed for their diagnosis

    Fidelity as assessed by the percentage of participants who moved through each step of the diagnostic process needed for their diagnosis

    Measured: 6 months

  8. Penetration as assessed by the percentage of participants with abnormal tests who receive the intervention

    Penetration as assessed by the percentage of participants with abnormal tests who receive

    Measured: 6 months

  9. Sustainability as assessed by number of clinics that continued the intervention

    Measured: 2.5 years

  10. Patient activation as assessed by the short form of the Patient Activation Measure (PAM)

    This 13-item survey uses a 5-point Likert scale to measure 4 domains related to patient activation. Total score ranges from 1 to 65, with a higher score indicating greater activation.

    Measured: between 1 to 6 months

  11. Number of clinics with more facilitators than barriers

    Number of clinics with more facilitators than barriers

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start8 Jan 2024
  3. Primary completion16 Jul 2026 (estimated)
  4. Study completion16 Jul 2026 (estimated)

Resources

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
Crossover
Model description
This is a stepped wedge cluster-randomized trial. There will be 4 clusters, with 3-4 clinics per cluster. In a stepped wedge fashion, the 4 clusters will receive the control followed by the study intervention--that is, in the first step the first cluster will receive the intervention after 6 months of control, in the second step the second cluster will receive intervention after 12 months of control, in the third step the third cluster will receive the intervention after 18 months of control, and in the fourth step the fourth cluster will receive the intervention after 24 months of control.
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05735314
Sponsor's protocol ID
HSC-MS-22-0815
Status last verified
Dec 2025
First submitted
7 Feb 2023
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wells R, Li X, Novikov Z, Espinoza M, Janecka M, Olguin XK, Adebowale B, Thomas EJ. Implementation of Expanding Primary Care Teams to Improve Anemia Diagnosis. J Prim Care Community Health. 2026 Jan-Dec;17:21501319261480463. doi: 10.1177/21501319261480463. Epub 2026 Sep 4.

    PubMed 42695125

  • Novikov Z, Mehra N, Li X, Wells R, Ottosen M, Hwang K, Avritscher EBC, Green C, Lee KH, Oguin X, Janecka M, Espinoza M, Adebowale B, Araya A, Wahed A, Thomas E. Evidence-based team intervention to reduce diagnostic errors in anaemia and CKD diagnoses in primary care: protocol for a stepped-wedge cluster RCT. BMJ Open. 2026 Feb 5;16(2):e112391. doi: 10.1136/bmjopen-2025-112391.

    PubMed 41644166

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced diagnostic team implementing three evidence-based interventions in people with Anemia and Decreased Glomerular Filtration Rate, run by The University of Texas Health Science Center, Houston at 1 site 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?

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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric Thomas, MD,MPH (713-500-7958, Eric.Thomas@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects who have correct diagnosis of cause of low hemoglobin (time frame: within 6 months from baseline). The study lists 2 primary outcomes in all. 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 NCT05735314, which also lists 2 linked publications.

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 30 Dec 2025.

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