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Clinical Trials/NCT05735314
NCT05735314
Recruiting
N/A

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

The University of Texas Health Science Center, Houston1 site in 1 country450 target enrollmentJanuary 8, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anemia
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
450
Locations
1
Primary Endpoint
Percentage of subjects who have correct diagnosis of cause of low hemoglobin
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2024
End Date
July 16, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eric Thomas

Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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 hemoglobin

Percentage of subjects who have correct diagnosis of cause of low glomerular filtration

Time Frame: within 6 months from baseline

Percentage of subjects who have correct diagnosis of cause of low glomerular filtration

Secondary Outcomes

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

Study Sites (1)

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