Clinic Navigation and Home Visits to Improve Guideline-based Care and Outcomes in Low Income Minority Adults With Asthma
NCT04023422 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 367
Last updated 2025-05-18
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
Clinical intervention
The community health navigator will ask patient to produce medications, to indicate if there are current smokers in the home, to look for structural problems within the home, presence of pests, allergens, pollutants. Pt will be asked to produce their current medications. At the end a report will be written for the clinician.
- BEHAVIORAL
-
Feedback
The community health navigator will give the clinician real-time feedback on guideline-related health.
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH - lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-08-21
- Primary Completion
- 2025-01-20
- Completion
- 2026-04-30
Countries
- United States
Study Locations
More Related Trials
-
Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
NCT03066596 ·Status: COMPLETED ·Phase: NA
-
Evaluation of the Asthma Management Program to Promote Activity for Students in Schools (Asthma-PASS)
NCT04576442 ·Status: COMPLETED ·Phase: NA
-
Integrative Medicine Approach to the Management of Asthma in Adults
NCT00843544 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Family Approach to Managing Asthma in Early Teens
NCT00241852 ·Status: COMPLETED ·Phase: PHASE3
-
Asthma Navigator Intervention to Improve Health Equity in Children
NCT06513832 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Asthma Self-Management in Older Adults
NCT00941694 ·Status: COMPLETED ·Phase: NA
-
Community Intervention for Minority Children With Asthma
NCT00005715 ·Status: COMPLETED
-
Supporting Asthma Management Behaviors in Aging Adults
NCT02316223 ·Status: COMPLETED ·Phase: NA
-
An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care
NCT03847142 ·Status: COMPLETED ·Phase: NA
-
Improving Parent Understanding of Instructions About Asthma Care
NCT01405625 ·Status: COMPLETED ·Phase: NA
-
Improving Asthma Communication in Minority Families
NCT00133666 ·Status: COMPLETED ·Phase: PHASE2
-
Asthma Academy: Use of Simulation and Telehealth to Empower Family Caregivers
NCT04132297 ·Status: COMPLETED ·Phase: NA
-
AQI and Childhood Asthma: an Intervention
NCT04454125 ·Status: COMPLETED ·Phase: NA
-
School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence
NCT01175434 ·Status: COMPLETED ·Phase: NA
-
Assessing Decision Maker Tools for Asthma: the Asthma APGAR
NCT01446315 ·Status: UNKNOWN ·Phase: PHASE4
-
Asthma in a Decentralized Patient Population: Is Traditional Disease Management Enough?
NCT00124085 ·Status: COMPLETED ·Phase: NA
-
Coaching in Childhood Asthma
NCT00910585 ·Status: COMPLETED ·Phase: PHASE3
-
Reducing Asthma Attacks in Disadvantaged School Children With Asthma
NCT06003569 ·Status: RECRUITING ·Phase: NA
-
A Multifaceted Prompting Intervention for Urban Children With Asthma
NCT01105754 ·Status: COMPLETED ·Phase: NA
-
Breathing Counts: Evaluating Adherence in the Presence of Asthma Navigation Support
NCT03065205 ·Status: COMPLETED ·Phase: NA
-
Project ASTHMA - Aligning With Schools To Help Manage Asthma and Improve Outcomes
NCT06539312 ·Status: RECRUITING ·Phase: NA
-
A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents
NCT01106326 ·Status: COMPLETED ·Phase: NA
-
Self Management Education Asthma
NCT00005712 ·Status: TERMINATED
-
Symptom Perception
NCT03646669 ·Status: COMPLETED ·Phase: NA
-
Reducing Asthma Disparities by Improving Provider-Patient Communication
NCT00181194 ·Status: COMPLETED