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

The University of Texas System (UT)

Status: Enrolling

Conditions: Anemia; Decreased Glomerular Filtration Rate

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05735314

HSC-MS-22-0815

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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450 participants in 4 patient groups

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

Experimental group

Treatment:

Other: Usual care

Other: Enhanced diagnostic team implementing three evidence-based interventions

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

Experimental group

Treatment:

Other: Usual care

Other: Enhanced diagnostic team implementing three evidence-based interventions

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

Experimental group

Treatment:

Other: Usual care

Other: Enhanced diagnostic team implementing three evidence-based interventions

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

Experimental group

Treatment:

Other: Usual care

Other: Enhanced diagnostic team implementing three evidence-based interventions