Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05735314

Conditions

Anemia

Decreased Glomerular Filtration Rate

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced diagnostic team implementing three evidence-based interventions

Usual care

Study Details

Brief 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 degree of implementation of these EBIs.

Conditions

Anemia

Decreased Glomerular Filtration Rate

Study ID

NCT05735314

Start date

Jan 8, 2024

Status verified date

Dec, 2025

Completion date

Jul 16, 2026

Anticipated

Primary completion date

Jul 16, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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

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

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

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

Interventions

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.

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) .

Primary outcome measure

  • 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 glomerular filtration [ Time Frame: within 6 months from baseline ]

Central Contacts and Locations

Central contacts

Eric Thomas, MD,MPH

713-500-7958Eric.Thomas@uth.tmc.edu

Eric Thomas, MD, MPH

713-500-7958eric.thomas@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Eric Thomas, MD, MPH

713-500-7958Eric.Thomas@uth.tmc.edu

Eric Thomas

713-500-7958eric.thomas@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-12-30.