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

December 22, 2025 updated by: Eric Thomas, The University of Texas Health Science Center, Houston

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Step 1 (3 clinics) - 24 months of intervention
Other: Usual care
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
Other: Enhanced diagnostic team implementing three evidence-based interventions
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.
Experimental: Experimental: Step 2 (3 clinics) - 1 month of control followed by 18 months of intervention
Other: Usual care
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
Other: Enhanced diagnostic team implementing three evidence-based interventions
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.
Experimental: Experimental: Step 3 (3 clinics) - 2 months control followed by 12 months of intervention
Other: Usual care
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
Other: Enhanced diagnostic team implementing three evidence-based interventions
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.
Experimental: Experimental: Step 4 (4 clinics) - 2 months control followed by 12 months of intervention
Other: Usual care
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
Other: Enhanced diagnostic team implementing three evidence-based interventions
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
within 6 months from baseline
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
within 6 months from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
initial abnormal test result to the day the diagnosis was communicated to the patient (about 1-6 months)
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.
within 6 months from baseline
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.
from baseline to 6 months
Sustainability as assessed by number of clinics that continued the intervention
Time Frame: 2.5 years
2.5 years
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.
between 1 to 6 months
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
12 weeks after PCP's patient enrolled
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
12 weeks after PCP's patient enrolled
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
12 weeks after PCP's patient enrolled
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
6 months
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
6 months
Number of clinics with more facilitators than barriers
Time Frame: 6 months
Number of clinics with more facilitators than barriers
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Thomas, MD,MPH, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-22-0815

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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