Clinic Navigation and Home Visits to Improve Guideline-based Care and Outcomes in Low Income Minority Adults With Asthma

NCT04023422 | Active Not Recruiting DMC

• 1 other identifier: R01HL143364
• Study Type: interventional
• Target: 367
• Locations: 1 country
• Sites: 2

Brief 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

Asthma

Outcome Measures

Primary Outcomes (7)

• Asthma Control at baseline

  Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  At randomization

• Asthma Control at 3 months

  Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  3 months

• Asthma Control at 6 months

  Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  6 months

• Asthma Control at 9 months

  Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  9 months

• Asthma Control at 12 months

  Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  12 months

• Asthma Control at 15 months

  Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  15 months

• Asthma Control at 18 months

  Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  18 months

Secondary Outcomes (20)

• hospitalizations for asthma

  hospitalizations at 3 months

• hospitalizations for asthma

  hospitalizations at 6 months

• hospitalizations for asthma

  hospitalizations at 9 months

• hospitalizations for asthma

  hospitalizations at 12 months

• hospitalizations for asthma

  hospitalizations at 15 months

Study Arms (4)

Clinical intervention

ACTIVE COMPARATOR

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

Behavioral: Clinical intervention; Behavioral: Feedback

Clinical intervention AND Home Visit

EXPERIMENTAL

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

Behavioral: Clinical intervention; Behavioral: Feedback

Clinical intervention AND Feedback

EXPERIMENTAL

Behavioral: Clinical intervention; Behavioral: Feedback

Clinical intervention AND Home Visit AND Feedback

EXPERIMENTAL

Behavioral: Clinical intervention; Behavioral: Feedback

Interventions

Clinical intervention BEHAVIORAL

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.

Also known as: Home Visit

Clinical intervention; Clinical intervention AND Feedback; Clinical intervention AND Home Visit; Clinical intervention AND Home Visit AND Feedback

Feedback BEHAVIORAL

The community health navigator will give the clinician real-time feedback on guideline-related health.

Clinical intervention; Clinical intervention AND Feedback; Clinical intervention AND Home Visit; Clinical intervention AND Home Visit AND Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male \> 18 years and living in a Philadelphia neighborhood in which at least 20% of households have incomes below the federal poverty level (19104, 19120, 19121, 19122, 19124, 19125, 19131, 19132, 19133, 19134, 19139, 19140, 19141, 19142, 19143, 19144, 19145, 19146, 19153, 19151)
• A patient in a participating clinic
• Doctor's diagnosis of asthma
• Prescribed an inhaled corticosteroid for asthma
• Required prednisone or an Emergency Department (ED) visit or hospitalization for asthma within 12 months before enrollment.
• Some patients with a diagnosis of asthma and prescribed inhaled corticosteroid may also have mention of Chronic Obstructive Pulmonary Disease (COPD) in their record, particularly if they smoke. Asthma and COPD are both heterogeneous diseases, and may be impossible to distinguish by clinical characteristics.Both COPD and asthma can have evidence of reversible obstruction and also of irreversible obstruction. It is important not to exclude these patients, sometimes called overlap patients as they may benefit from these interventions.

You may not qualify if:

• Severe psychiatric or cognitive problems making it impossible to understand or carry out the protocol;
• Excluded are those with other chronic lung diseases: lung cancer, cystic fibrosis, heart failure, chronic bronchitis, pulmonary hypertension, a candidate or recipient for lung transplant, a history of bronchial thermoplasty.
• Excluded are those with more than 20 pack year tobacco use.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Pennsylvania Health Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

House Calls

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator, Professor of Medicine

Model Details: All patients will receive the clinical intervention (CI). In a 2-factor, 2-level factorial design, patients will be randomized to one of four groups by home visitor (HV) and/or physician feedback(CF) intervention: CI + HV, CI + CF, CI + HV + CF, CI. Well-suited for the investigation of the separate components of an intervention, a factorial design permits simple and powerful comparisons between the two factors (home visitor (HV) and clinician feedback CF), cell specific contrasts (the addition of home visitors among patients who have no physician feedback), and the interaction of both interventions. Each patient will be followed over time, so that the additional power of the factorial design will complement the confounder control inherent in randomization plus longitudinal analysis.

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 17, 2019
• Study Start: August 21, 2019
• Primary Completion: January 20, 2025
• Study Completion: April 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

US (2)