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

Anemia Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05735314
• Other study ID #: HSC-MS-22-0815
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Eric Thomas, MD,MPH
• Phone: 713-500-7958
• Email: Eric.Thomas[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1368
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Anemia

Intervention

Other:
• consultation with a specialist
The intervention consists of consultation with a specialist, use of a nurse navigator to help patients with appointments and help them understand their condition, and use of a data query of the electronic health record (EHR) to identify abnormal test results to make sure they are appropriately addressed.
• 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) .

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects who have correct diagnosis of cause of low hemoglobin		within 6 months from baseline
Primary	Percentage of subjects who have correct diagnosis of cause of low glomerular filtration		within 6 months from baseline
Secondary	Time until diagnosis	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.	initial abnormal test result to the day the diagnosis was communicated to the patient (about 1-6 months)
Secondary	Percentage of tests appropriately utilized	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.	within 6 months from baseline
Secondary	Cost of treatment	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.	from baseline to 6 months
Secondary	Number of primary care physicians (PCPs) who find the intervention acceptable as assessed by survey of PCPs		8 weeks after baseline
Secondary	Number of PCPs who find the intervention appropriate as assessed by survey of PCPs		8 weeks after baseline
Secondary	Number of PCPs who find the intervention feasible as assessed by survey of PCPs		8 weeks after baseline
Secondary	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
Secondary	Penetration as assessed by the percentage of participants with abnormal tests who receive the intervention		within 6 months
Secondary	Sustainability as assessed by number of clinics that continued the intervention		2.5 years
Secondary	Patient activation as assessed by the short form of the Patient Activation Measure (PAM)	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.	between 1 to 6 months
Secondary	Number of clinics with more facilitators than barriers		6 months