Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Step 1 (3 clinics) - 24 months of intervention | Experimental |
| |
| Experimental: Step 2 (3 clinics) - 1 month of control followed by 18 months of intervention | Experimental |
| |
| Experimental: Step 3 (3 clinics) - 2 months control followed by 12 months of intervention | Experimental |
| |
| Experimental: Step 4 (4 clinics) - 2 months control followed by 12 months of intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced diagnostic team implementing three evidence-based interventions | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who have correct diagnosis of cause of low hemoglobin | 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 | Percentage of subjects who have correct diagnosis of cause of low glomerular filtration | within 6 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Percentage of tests appropriately utilized |
Not provided
Primary care providers' inclusion criteria:
Patients' inclusion criteria are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Thomas, MD,MPH | Contact | 713-500-7958 | Eric.Thomas@uth.tmc.edu | |
| Eric Thomas, MD, MPH | Contact | 713-500-7958 | eric.thomas@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eric Thomas, MD,MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41644166 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Usual care | Other | Usual care involves primary care physicians ordering additional tests and referrals to evaluate patients with new anemia and decreased glomerular filtration rate (GFR) . |
|
|
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 |
| 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 |
| Number of primary care physicians (PCPs) who find the intervention as acceptable assessed by survey of PCPs | Number of primary care physicians (PCPs) who find the intervention as acceptable | 12 weeks after PCP's patient enrolled |
| Number of PCPs who find the intervention appropriate as assessed by survey of PCPs | 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 | 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 | 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 | Penetration as assessed by the percentage of participants with abnormal tests who receive | 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) | 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 |
| Number of clinics with more facilitators than barriers | Number of clinics with more facilitators than barriers | 6 months |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided