Anemia, Decreased Glomerular Filtration Rate
Conditions
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.
Interventions
OTHEREnhanced diagnostic team implementing three evidence-based interventions
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.
OTHERUsual care
Usual care involves primary care physicians ordering additional tests and referrals to evaluate patients with new anemia and decreased glomerular filtration rate (GFR) .
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary care providers' inclusion criteria: * physicians, physicians assistants and advanced practice registered nurses in the 13 clinic locations of UTP are eligible if they care for patients at the time patient enrollment at their clinic begins * agree to participate. Patients' inclusion criteria are: * hemoglobin result \< 10.8 for females and \< 12.5 for males with normal white cell count and platelet count (the prior hemoglobin results must have been in normal range, with a look-back period of two years) * an eGFR value \< 60 (the prior eGFR results must have been in normal range, with a look-back range of two years) * the matching creatinine results must also be in normal range * not pregnant * speak English or Spanish.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 hemoglobin |
| Percentage of subjects who have correct diagnosis of cause of low glomerular filtration | within 6 months from baseline | Percentage of subjects who have correct diagnosis of cause of low glomerular filtration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 primary care physicians (PCPs) who find the intervention as acceptable assessed by survey of PCPs | 12 weeks after PCP's patient enrolled | Number of primary care physicians (PCPs) who find the intervention as acceptable |
| 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 appropriate 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 | Number of PCPs who find the intervention feasible as assessed by survey of PCPs |
| 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 | 6 months | Penetration as assessed by the percentage of participants with abnormal tests who receive |
| 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 | 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. |
| Number of clinics with more facilitators than barriers | 6 months | Number of clinics with more facilitators than barriers |
| Fidelity as assessed by the percentage of participants who moved through each step of the diagnostic process needed for their diagnosis | 6 months | Fidelity as assessed by the percentage of participants who moved through each step of the diagnostic process needed for their diagnosis |
| 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. |
Countries
United States
Contacts
Primary ContactEric Thomas, MD,MPH
Backup ContactEric Thomas, MD, MPH
Outcome results
None listed