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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anemia, Decreased Glomerular Filtration Rate

Intervention / Treatment
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* Other: consultation with a specialist
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step 1 (3 clinics) - 6 months control followed by 24 months of intervention<br> | Other: consultation with a specialist<br>* 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.<br>Other: Usual care<br>* Usual care involves primary care physicians ordering additional tests and referrals to evaluate patients with new anemia and decreased glomerular filtration rate (GFR) .<br>* Other names: Control;|
| Experimental: Step 2 (3 clinics) - 12 months control followed by 18 months of intervention<br> | Other: consultation with a specialist<br>* 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.<br>Other: Usual care<br>* Usual care involves primary care physicians ordering additional tests and referrals to evaluate patients with new anemia and decreased glomerular filtration rate (GFR) .<br>* Other names: Control;|
| Experimental: Step 3 (3 clinics) - 18 months control followed by 12 months of intervention<br> | Other: consultation with a specialist<br>* 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.<br>Other: Usual care<br>* Usual care involves primary care physicians ordering additional tests and referrals to evaluate patients with new anemia and decreased glomerular filtration rate (GFR) .<br>* Other names: Control;|
| Experimental: Step 4 (4 clinics) - 24 months control followed by 6 months of intervention<br> | Other: consultation with a specialist<br>* 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.<br>Other: Usual care<br>* Usual care involves primary care physicians ordering additional tests and referrals to evaluate patients with new anemia and decreased glomerular filtration rate (GFR) .<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | 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 | 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 acceptable as assessed by survey of PCPs |  | 8 weeks after baseline | 
| Number of PCPs who find the intervention appropriate as assessed by survey of PCPs |  | 8 weeks after baseline | 
| Number of PCPs who find the intervention feasible 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 | 
| Penetration as assessed by the percentage of participants with abnormal tests who receive the intervention |  | within 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 |  | 6 months |