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Clinic Navigation and Home Visits to Improve Guideline-based Care and Outcomes in Low Income Minority Adults With Asthma (HAP3)

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ClinicalTrials.gov Identifier: NCT04023422
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Andrea Apter, University of Pennsylvania

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.


Condition or disease Intervention/treatment Phase
Asthma Behavioral: Clinical intervention Behavioral: Feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 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.
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Clinic Navigation and Home Visits to Improve Guideline-based Care and Outcomes in Low Income Minority Adults With Asthma
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : February 28, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Clinical intervention
Clinical health navigator, a community health worker, facilitates preparation for, attends, and confirms patients's understanding of an office visit.
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.
Other Name: Home Visit

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

Experimental: Clinical intervention AND Home Visit
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
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.
Other Name: Home Visit

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

Experimental: Clinical intervention AND Feedback 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.
Other Name: Home Visit

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

Experimental: Clinical intervention AND Home Visit AND Feedback 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.
Other Name: Home Visit

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




Primary Outcome Measures :
  1. Asthma Control at baseline [ Time Frame: At randomization ]
    Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  2. Asthma Control at 3 months [ Time Frame: 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. Asthma Control at 6 months [ Time Frame: 6 months ]
    Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  4. Asthma Control at 9 months [ Time Frame: 9 months ]
    Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  5. Asthma Control at 12 months [ Time Frame: 12 months ]
    Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  6. Asthma Control at 15 months [ Time Frame: 15 months ]
    Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control

  7. Asthma Control at 18 months [ Time Frame: 18 months ]
    Asthma Control Questionnaire. The questionnaire has a numerical result 0 - 6 based on response to questionnaire, with lower number indicating better control


Secondary Outcome Measures :
  1. hospitalizations for asthma [ Time Frame: hospitalizations at 3 months ]
    number of hospitalizations as indicated in the electronic medical record. If no record is available, the patient's report and verified if possible with patients' record from the outside institution will be used

  2. hospitalizations for asthma [ Time Frame: hospitalizations at 6 months ]
    Number of hospitalizations as indicated in the electronic medical record. If no record is available, patient's report and verified if possible with patients' record from the outside institution will be used.

  3. hospitalizations for asthma [ Time Frame: hospitalizations at 9 months ]
    Number of hospitalizations as indicated in the electronic medical record. If no record is available, patient's report and verified if possible with patients' record from the outside institution will be used.

  4. hospitalizations for asthma [ Time Frame: hospitalizations at 12 months ]
    Number of hospitalizations as indicated in the electronic medical record. If no record is available, patient's report and verified if possible with patients' record from the outside institution will be used.

  5. hospitalizations for asthma [ Time Frame: hospitalizations at 15 months ]
    Number of hospitalizations as indicated in the electronic medical record. If no record is available, patient's report and verified if possible with patients' record from the outside institution will be used.

  6. hospitalizations for asthma [ Time Frame: hospitalizations at 18 months ]
    Number of hospitalizations as indicated in the electronic medical record. If no record is available, patient's report and verified if possible with patients' record from the outside institution will be used.patient's report and verified if possible with patients' record from the outside institution

  7. Emergency Department (ED) visits for asthma [ Time Frame: 3 months ]
    Number of ED visits as indicated in the electronic medical record. If no record is available patient's report and verified if possible with patients' record from the outside institution will be used.

  8. Emergency Department (ED) visits for asthma [ Time Frame: 6 months ]
    Number of ED visits as indicated in the electronic medical record. If no record is available patient's report and verified if possible with patients' record from the outside institution will be used.

  9. Emergency Department (ED) visits for asthma [ Time Frame: 9 months ]
    Number of ED visits as indicated in the electronic medical record. If no record is available patient's report and verified if possible with patients' record from the outside institution will be used.

  10. Emergency Department (ED) visits for asthma [ Time Frame: 12 months ]
    Number of ED visits as indicated in the electronic medical record. If no record is available patient's report and verified if possible with patients' record from the outside institution will be used. report and verified if possible with patients' record from the outside institution

  11. Emergency Department (ED) visits for asthma [ Time Frame: 15 months ]
    Number of ED visits as indicated in the electronic medical record. If no record is available patient's report and verified if possible with patients' record from the outside institution will be used.

  12. Emergency Department (ED) visits for asthma [ Time Frame: 18 months ]
    Number of ED visits as indicated in the electronic medical record. If no record is available patient's report and verified if possible with patients' record from the outside institution will be used.

  13. asthma-related quality of life [ Time Frame: 3 months ]
    Score is the mean of the 15-items each scored 1-7. Higher score indicates better quality of life.

  14. asthma-related quality of life [ Time Frame: 6 months ]
    Score is the mean of the 15-items each scored 1-7. Higher score indicates better quality of life.

  15. asthma-related quality of life [ Time Frame: 9 months ]
    Score is the mean of the 15-items each scored 1-7. Higher score indicates better quality of life.

  16. asthma-related quality of life [ Time Frame: 12 months ]
    Score is the mean of the 15-items each scored 1-7. Higher score indicates better quality of life.

  17. asthma-related quality of life [ Time Frame: 15 months ]
    Score is the mean of the 15-items each scored 1-7. Higher score indicates better quality of life.

  18. asthma-related quality of life [ Time Frame: 18 months ]
    Score is the mean of the 15-items each scored 1-7. Higher score indicates better quality of life.

  19. Forced expiratory volume in 1 second (FEV1) [ Time Frame: Month 12 ]
    forced vital capacity in 1 second

  20. Forced expiratory volume in 1 second (FEV1) [ Time Frame: Month 18 ]
    forced vital capacity in 1 second



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023422


Contacts
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Contact: Hami Park 215-615-4957 Hami.Park@uphs.upenn.edu
Contact: Grace Ndicu 215-615-4793 Grace.Ndicu@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Health System Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Andrea J Apter, MD, MSc, MA    215-349-5120    apter@mail.med.upenn.edu   
Principal Investigator: Andrea J Apter, MD, MSc, MA         
Sponsors and Collaborators
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
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Responsible Party: Andrea Apter, Prinicipal Investigator, Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04023422    
Other Study ID Numbers: R01HL143364 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases