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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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) .

Первичные конечные точки

• Percentage of subjects who have correct diagnosis of cause of low hemoglobin [Срок оценки: within 6 months from baseline]
• Percentage of subjects who have correct diagnosis of cause of low glomerular filtration [Срок оценки: within 6 months from baseline]

Вторичные конечные точки (11)

• Time until diagnosis [Срок оценки: initial abnormal test result to the day the diagnosis was communicated to the patient (about 1-6 months)]
• Percentage of tests appropriately utilized [Срок оценки: within 6 months from baseline]
• Cost of treatment [Срок оценки: from baseline to 6 months]
• Number of primary care physicians (PCPs) who find the intervention as acceptable assessed by survey of PCPs [Срок оценки: 12 weeks after PCP's patient enrolled]
• Number of PCPs who find the intervention appropriate as assessed by survey of PCPs [Срок оценки: 12 weeks after PCP's patient enrolled]
• Number of PCPs who find the intervention feasible as assessed by survey of PCPs [Срок оценки: 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 [Срок оценки: 6 months]
• Penetration as assessed by the percentage of participants with abnormal tests who receive the intervention [Срок оценки: 6 months]
• Sustainability as assessed by number of clinics that continued the intervention [Срок оценки: 2.5 years]
• Patient activation as assessed by the short form of the Patient Activation Measure (PAM) [Срок оценки: between 1 to 6 months]
• Number of clinics with more facilitators than barriers [Срок оценки: 6 months]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Публикации

• 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

Идентификаторы

NCT: NCT05735314 · HSC-MS-22-0815

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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