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

Not Applicable

Not yet recruiting

• Conditions: Anemia; Decreased Glomerular Filtration Rate
• Interventions: Other: consultation with a specialist; Other: Usual care

• Registration Number: NCT05735314
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06
• Study Start: 2023-05-15
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1368

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Step 2 (3 clinics) - 12 months control followed by 18 months of intervention	consultation with a specialist	-
Step 2 (3 clinics) - 12 months control followed by 18 months of intervention	Usual care	-
Step 1 (3 clinics) - 6 months control followed by 24 months of intervention	Usual care	-
Step 4 (4 clinics) - 24 months control followed by 6 months of intervention	Usual care	-
Step 1 (3 clinics) - 6 months control followed by 24 months of intervention	consultation with a specialist	-
Step 3 (3 clinics) - 18 months control followed by 12 months of intervention	consultation with a specialist	-
Step 3 (3 clinics) - 18 months control followed by 12 months of intervention	Usual care	-
Step 4 (4 clinics) - 24 months control followed by 6 months of intervention	consultation with a specialist	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects who have correct diagnosis of cause of low hemoglobin	within 6 months from baseline
Percentage of subjects who have correct diagnosis of cause of low glomerular filtration	within 6 months from baseline

Secondary Outcome Measures

Name	Time	Method
Percentage of tests appropriately utilized	within 6 months from baseline	Percentage of tests appropriately utilized will be calculated as the number of appropriate tests ordered to evaluate the abnormal test divided by the total number of tests ordered to evaluate the abnormal test, multiplied by 100.
Number of PCPs who find the intervention appropriate as assessed by survey of PCPs	8 weeks after baseline
Fidelity as assessed by the percentage of participants who moved through each step of the diagnostic process needed for their diagnosis	8 weeks after baseline
Time until diagnosis	initial abnormal test result to the day the diagnosis was communicated to the patient (about 1-6 months)	Time until diagnosis is defined as number of days from the initial abnormal test result to the day the diagnosis was communicated to the patient.
Penetration as assessed by the percentage of participants with abnormal tests who receive the intervention	within 6 months
Number of clinics with more facilitators than barriers	6 months
Number of primary care physicians (PCPs) who find the intervention acceptable as assessed by survey of PCPs	8 weeks after baseline
Sustainability as assessed by number of clinics that continued the intervention	2.5 years
Cost of treatment	from baseline to 6 months	Costs will be assessed from the health care system perspective and will include the costs of all diagnostic tests and referral consultations to evaluate the abnormal tests, emergency department (ED) visits or admissions for care for the underlying diseases causing test abnormalities, and the personnel time to provide the EBIs during the 6-month work up period.
Number of PCPs who find the intervention feasible as assessed by survey of PCPs	8 weeks after baseline
Patient activation as assessed by the short form of the Patient Activation Measure (PAM)	between 1 to 6 months	This 13-item survey uses a 5-point Likert scale to measure 4 domains related to patient activation. Total score ranges from 1 to 65, with a higher score indicating greater activation.

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States