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NCT Number: NCT05735314

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

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.

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Key information

Conditions

Anemia Decreased Glomerular Filtration Rate Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced diagnostic team implementing three evidence-based interventions

Other

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 Care

Other

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

Other names: Control

Primary outcomes

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

    Time frame: within 6 months from baseline

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

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

    Time frame: within 6 months from baseline

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

Secondary outcomes

  1. Time until diagnosis

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

    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.

  2. Percentage of tests appropriately utilized

    Time frame: within 6 months from baseline

    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.

  3. Cost of treatment

    Time frame: from baseline to 6 months

    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.

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

    Time frame: 12 weeks after PCP's patient enrolled

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

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

    Time frame: 12 weeks after PCP's patient enrolled

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

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

    Time frame: 12 weeks after PCP's patient enrolled

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 2.5 years

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

    Time frame: between 1 to 6 months

    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.

  11. Number of clinics with more facilitators than barriers

    Time frame: 6 months

    Number of clinics with more facilitators than barriers

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Thomas, MD, MPH

CONTACT

[email protected]

713-500-7958

Eric Thomas, MD,MPH

CONTACT

[email protected]

713-500-7958

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2023
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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