Patient Advocacy + Home Visits for Asthma
(HAP3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults over 18 with uncontrolled asthma living in low-income areas of Philadelphia. Participants must have a doctor's diagnosis of asthma, be prescribed an inhaled corticosteroid, and have had recent severe asthma issues like needing prednisone or hospital visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Clinical Intervention
Participants receive a clinical intervention facilitated by a community health worker, including preparation for, attendance at, and confirmation of understanding of office visits.
Home Visits
Participants receive home visits for care coordination, taking into account the home environment and its social and physical characteristics.
Follow-up
Participants are monitored for sustainability of interventions and outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- Clinical intervention
- Feedback
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator