Patient Advocacy + Home Visits for Asthma

(HAP3 Trial)

Recruiting at 1 trial location

Overseen By Juliet Kohli, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Inhaled corticosteroids

Disqualifiers: Severe psychiatric, Chronic lung diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

367 Participants Needed

Trial Summary

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.

Eligibility Criteria

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

I have been diagnosed with asthma by a doctor.

A patient in a participating clinic

I have asthma and may also have COPD, especially if I smoke.

Exclusion Criteria

I do not have chronic lung diseases like cystic fibrosis or pulmonary hypertension.

Severe psychiatric or cognitive problems making it impossible to understand or carry out the protocol

I have smoked 20 or fewer pack-years of cigarettes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

12 months

Quarterly visits

Home Visits

Participants receive home visits for care coordination, taking into account the home environment and its social and physical characteristics.

12 months

Follow-up

Participants are monitored for sustainability of interventions and outcomes.

6 months

Treatment Details

Interventions

• Clinical intervention
• Feedback

Trial Overview The study tests if patient advocates and home visits improve asthma care for low-income minority adults. It compares four approaches: just an advocate; an advocate plus home visits; an advocate with real-time clinician feedback; and all combined.

Participant Groups

Group I: Clinical intervention AND Home Visit AND Feedback Experimental Treatment 2 Interventions

Group II: Clinical intervention AND Home Visit Experimental Treatment 2 Interventions

Patient receives Clinical intervention and Home visits. Care coordination activities occur taking into account the home environment, its social and physical characteristics.

Group III: Clinical intervention AND Feedback Experimental Treatment 2 Interventions

Group IV: Clinical intervention Active Control 2 Interventions

Clinical health navigator, a community health worker, facilitates preparation for, attends, and confirms patients's understanding of an office visit.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+