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

NCT ID: NCT05735314

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2026-07-16

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia Decreased Glomerular Filtration Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Experimental: Step 1 (3 clinics) - 24 months of intervention

Group Type EXPERIMENTAL

Enhanced diagnostic team implementing three evidence-based interventions

Intervention Type 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

Intervention Type OTHER

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

Experimental: Step 2 (3 clinics) - 1 month of control followed by 18 months of intervention

Group Type EXPERIMENTAL

Enhanced diagnostic team implementing three evidence-based interventions

Intervention Type 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

Intervention Type OTHER

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

Experimental: Step 3 (3 clinics) - 2 months control followed by 12 months of intervention

Group Type EXPERIMENTAL

Enhanced diagnostic team implementing three evidence-based interventions

Intervention Type 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

Intervention Type OTHER

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

Experimental: Step 4 (4 clinics) - 2 months control followed by 12 months of intervention

Group Type EXPERIMENTAL

Enhanced diagnostic team implementing three evidence-based interventions

Intervention Type 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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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) .

Intervention Type OTHER

Other Intervention Names

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Control

Eligibility Criteria

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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.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Eric Thomas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Thomas, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eric Thomas, MD,MPH

Role: CONTACT

Phone: 713-500-7958

Email: [email protected]

Eric Thomas, MD, MPH

Role: CONTACT

Phone: 713-500-7958

Email: [email protected]

Facility Contacts

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Eric Thomas, MD, MPH

Role: primary

Eric Thomas

Role: backup

Other Identifiers

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HSC-MS-22-0815

Identifier Type: -

Identifier Source: org_study_id