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

NCT05735314 | Recruiting DMC

• 1 other identifier: HSC-MS-22-0815
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  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

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

  within 6 months from baseline

Secondary Outcomes (11)

• Time until diagnosis

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

• Percentage of tests appropriately utilized

  within 6 months from baseline

• Cost of treatment

  from baseline to 6 months

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

  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

Study Arms (4)

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

EXPERIMENTAL

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 intervention

EXPERIMENTAL

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 intervention

EXPERIMENTAL

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 intervention

EXPERIMENTAL

Other: Enhanced diagnostic team implementing three evidence-based interventions; Other: Usual care

Interventions

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) .

Also known as: Control

Experimental: Step 1 (3 clinics) - 24 months of intervention; Experimental: Step 2 (3 clinics) - 1 month of control followed by 18 months of intervention; Experimental: Step 3 (3 clinics) - 2 months control followed by 12 months of intervention; Experimental: Step 4 (4 clinics) - 2 months control followed by 12 months of intervention

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.

Experimental: Step 1 (3 clinics) - 24 months of intervention; Experimental: Step 2 (3 clinics) - 1 month of control followed by 18 months of intervention; Experimental: Step 3 (3 clinics) - 2 months control followed by 12 months of intervention; Experimental: Step 4 (4 clinics) - 2 months control followed by 12 months of intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41644166 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Eric Thomas, MD,MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 21, 2023
• Study Start: January 8, 2024
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): July 16, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)