Clinical trial NCT05735314: A New Combination of Evidence-Based Interventions to Improve Primary Care Diagnostic Safety and Efficiency
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anemia
Decreased Glomerular Filtration Rate
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 1368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a stepped wedge cluster-randomized trial. There will be 4 clusters, with 3-4 clinics per cluster. In a stepped wedge fashion, the 4 clusters will receive the control followed by the study intervention--that is, in the first step the first cluster will receive the intervention after 6 months of control, in the second step the second cluster will receive intervention after 12 months of control, in the third step the third cluster will receive the intervention after 18 months of control, and in the fourth step the fourth cluster will receive the intervention after 24 months of control.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* new, significant abnormal anemia (Hgb \>1g/dl below normal, with normal white cells and platelets) or decreased estimated glomerular filtration rate (eGFR) (\<60 ml/min/1.73m2 ) seen in one of the University of Texas Physicians (UTP) adult primary care clinics.

Exclusion Criteria:

Primary outcomes:
measure: Percentage of subjects who have correct diagnosis of cause of low hemoglobin
timeFrame: within 6 months from baseline
measure: Percentage of subjects who have correct diagnosis of cause of low glomerular filtration
timeFrame: within 6 months from baseline
Secondary outcomes:
measure: Time until diagnosis
timeFrame: initial abnormal test result to the day the diagnosis was communicated to the patient (about 1-6 months)
measure: Percentage of tests appropriately utilized
timeFrame: within 6 months from baseline
measure: Cost of treatment
timeFrame: from baseline to 6 months
measure: Number of primary care physicians (PCPs) who find the intervention acceptable as assessed by survey of PCPs
timeFrame: 8 weeks after baseline
measure: Number of PCPs who find the intervention appropriate as assessed by survey of PCPs
timeFrame: 8 weeks after baseline
measure: Number of PCPs who find the intervention feasible as assessed by survey of PCPs
timeFrame: 8 weeks after baseline
measure: Fidelity as assessed by the percentage of participants who moved through each step of the diagnostic process needed for their diagnosis
timeFrame: 8 weeks after baseline
measure: Penetration as assessed by the percentage of participants with abnormal tests who receive the intervention
timeFrame: within 6 months
measure: Sustainability as assessed by number of clinics that continued the intervention
timeFrame: 2.5 years
measure: Patient activation as assessed by the short form of the Patient Activation Measure (PAM)
timeFrame: between 1 to 6 months
measure: Number of clinics with more facilitators than barriers
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Eric Thomas, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: