Clinic Navigation and Home Visits to Improve Guideline-based Care and Outcomes in Low Income Minority Adults With Asthma (NCT04023422)
๐ฉบ Plain-English Summary (8th-Grade Level)
Asthma-related deaths are more numerous among low-income minority patients and older adults with chronic diseases. Guidelines for asthma management have not addressed the needs of these groups. The investigators recently demonstrated the feasibility, acceptability, and evidence of effectiveness of two interventions to improve access to care, patient-provider communication, and asthma outcomes: 1) CI: clinic intervention using a patient advocate to prepare for, attend, and confirm understanding of an office visit, and 2) HV: home visits for care coordination and informing clinicians of home barriers to managing asthma is associated with subsequent improvement in asthma outcomes. This project explores whether these interventions can be combined for greater effectiveness, delivery of guideline-based asthma care, and outcomes in low-income minority patients. In a randomized controlled factorial trial, 400 adults with uncontrolled asthma living in low-income urban neighborhoods are offered 18-months' participation: 12 months of clinical intervention and 6 months of evaluation to monitor sustainability of interventions and outcomes. Patients will be randomized to 1) a patient advocate and (2) an advocate and home visits, (3) an advocate and real-time feedback to the asthma provider (clinician) at each clinic visit of guidelines-relevant relevant information, and 4) (2), and (3). Interventions will be delivered by a community health worker. The study estimates Specific Aim 1: improvement over time of within-group (before-after in four groups) asthma outcomes (asthma control, quality of life, ED visits, hospitalizations, prednisone bursts) Specific Aim 2: across group differences in improvement over time in asthma outcomes; Specific Aim 3: the costs associated with each of the interventions. A cost-offset analysis will determine which intervention costs are offset by savings attributable to reductions in ED, hospitalization or other visits for asthma control and other outcomes. Exploratory Aim: changes in behavior from the interventions using interviews of clinicians and patients. Investigators hypothesize that improved outcomes in asthma patients will result from enhanced patient-clinician communication, clinician attention to home environmental exposures, and clinician consideration of the guidelines, at a program cost offset by lower patient health care utilization.
Who can join: Review the eligibility criteria below.
Location: University of Pennsylvania Health Center โ Philadelphia, Pennsylvania
Age range: 18 Years
๐งช Interventions in This Study
- Clinical intervention (BEHAVIORAL)
- Feedback (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- University of Pennsylvania Health Center โ Philadelphia, Pennsylvania
- University of Pennsylvania Health System โ Philadelphia, Pennsylvania
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Asthma
- Investigating Dupilumab's Effect in Asthma by Genotype โ Boston, Massachusetts
- Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma โ Bakersfield, California
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma โ Saraland, Alabama
- Reduce IDentified UNcontrolled Asthma โ San Diego, California
- A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma โ Little Rock, Arkansas
- REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study โ La Jolla, California
Explore by condition: All Asthma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.