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

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: Recruiting
• Conditions: Anemia; Decreased Glomerular Filtration Rate
• Intervention / Treatment: Other: Usual care; Other: Enhanced diagnostic team implementing three evidence-based interventions

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric Thomas, MD,MPH; Phone Number: 713-500-7958; Email: Eric.Thomas@uth.tmc.edu
• Study Contact Backup: Name: Eric Thomas, MD, MPH; Phone Number: 713-500-7958; Email: Eric.Thomas@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Eric Thomas, MD, MPH; Phone Number: 713-500-7958; Email: Eric.Thomas@uth.tmc.edu
      • Contact: Eric Thomas; Phone Number: 713-500-7958; Email: eric.thomas@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until diagnosis	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	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	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		2.5 years
Patient activation as assessed by the short form of the Patient Activation Measure (PAM)	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	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	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	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	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	Penetration as assessed by the percentage of participants with abnormal tests who receive	6 months
Number of clinics with more facilitators than barriers	Number of clinics with more facilitators than barriers	6 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Eric Thomas, MD,MPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2024
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): July 16, 2026

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia
• Other Study ID 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