Recruiting NCT05735314
A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enhanced diagnostic team implementing three evidence-based interventions, Usual care.
- Who it may be relevant to
- Registry conditions: Anemia, Decreased Glomerular Filtration Rate. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency: a Stepped Wedge Cluster Randomized Control Trial (RCT)
Overview
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.
Interventions
- 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. - 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) .
Primary outcome measures
- 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]
Secondary outcome measures (11)
- Time until diagnosis [Time frame: initial abnormal test result to the day the diagnosis was communicated to the patient (about 1-6 months)]
- Percentage of tests appropriately utilized [Time frame: within 6 months from baseline]
- Cost of treatment [Time frame: from baseline to 6 months]
- Number of primary care physicians (PCPs) who find the intervention as acceptable assessed by survey of PCPs [Time frame: 12 weeks after PCP's patient enrolled]
- Number of PCPs who find the intervention appropriate as assessed by survey of PCPs [Time frame: 12 weeks after PCP's patient enrolled]
- Number of PCPs who find the intervention feasible as assessed by survey of PCPs [Time frame: 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 [Time frame: 6 months]
- Penetration as assessed by the percentage of participants with abnormal tests who receive the intervention [Time frame: 6 months]
- Sustainability as assessed by number of clinics that continued the intervention [Time frame: 2.5 years]
- Patient activation as assessed by the short form of the Patient Activation Measure (PAM) [Time frame: between 1 to 6 months]
- Number of clinics with more facilitators than barriers [Time frame: 6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston — Houston
Publications
- 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
Identifiers
NCT: NCT05735314 · HSC-MS-22-0815