Combined evidence-based steps to make primary care diagnosis safer and faster

A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency: a Stepped Wedge Cluster Randomized Control Trial (RCT)

This project will test whether combining three evidence-based steps for primary care teams makes diagnosing anemia and reduced kidney function safer and faster for patients at participating clinics.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of Texas Health Science Center, Houston (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05735314 on ClinicalTrials.gov

What this trial studies

This interventional trial compares an enhanced diagnostic team that implements three evidence-based interventions (EBIs) to usual care across 13 University of Texas primary care clinics. It enrolls primary care clinicians and adult patients who recently show low hemoglobin or an eGFR drop below 60 with prior normal labs in the past two years. The study measures clinical diagnostic safety and efficiency outcomes alongside implementation outcomes including acceptability, appropriateness, cost, fidelity, penetration, and sustainability. Investigators will also identify facilitators and barriers that influence how well the EBIs are adopted in routine care.

Who should consider this trial

Good fit: Ideal candidates are adult patients at the participating clinics who are not pregnant, speak English or Spanish, and have new lab values showing hemoglobin below 10.8 g/dL for females or 12.5 g/dL for males or an eGFR under 60 with prior normal results in the preceding two years.

Not a fit: Patients with chronic, already-diagnosed anemia or chronic kidney disease without a recent normal result in the two-year lookback, pregnant patients, people who do not speak English or Spanish, or those who do not receive care at the participating clinics are unlikely to benefit from this specific program.

Why it matters

Potential benefit: If successful, the approach could reduce diagnostic delays and errors and make follow-up for anemia and reduced kidney function more consistent and timely.

How similar studies have performed: Single evidence-based interventions have improved diagnostic follow-up in primary care, but combining multiple EBIs into a coordinated diagnostic team is relatively novel and less well studied.

Eligibility criteria

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.

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Eric Thomas, MD,MPH — The University of Texas Health Science Center, Houston
• Study coordinator: Eric Thomas, MD,MPH

Conditions Anemia; Decreased Glomerular Filtration Rate