A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults

NCT01972308 | Completed Results DMC

• 1 other identifier: 1R18HL116285-01
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

Few interventions to improve asthma management have targeted low-income minority asthmatic adults and even fewer have focused on the real-world practice where care is provided for these patients. This project tests the effectiveness of a Patient Advocate as a practical and sustainable method of facilitating and maintaining communication between patient and provider and access to chronic care for adults with moderate or severe asthma recruited from clinics serving low-income urban neighborhoods. We compare the use of a Patient Advocate to current asthma care and test the Patient Advocate's cost-effectiveness.

Conditions

Asthma; Communication

Keywords

asthma; patient advocate; health disparity; patient-provider communication

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control at One Year

  Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion. Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score \> 1.5 is considered inadequate control.

  baseline and 1 year

Secondary Outcomes (5)

• Change in Emergency Department(ED) Visits at One Year

  one year

• Change in Asthma-related Quality of Life

  baseline to one year

• Change in Hospitalizations

  one year

• Risk of Prednisone Bursts

  baseline and one year

• Change in Urgent Office Visit

  one year

Study Arms (2)

Patient advocate

EXPERIMENTAL

Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients.

Behavioral: Patient Advocate

usual care

OTHER

Patient receives asthma care as usual from their asthma provider

Behavioral: Usual Care

Interventions

Patient Advocate BEHAVIORAL

Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to accomplishing medical advice, and transfer of information between provider and patient.

Patient advocate

Usual Care BEHAVIORAL

Subjects receive asthma care from their proivders in the participating practices which generally follow asthma guidelines

usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age,
• physician's diagnosis of asthma,
• prescribed an inhaled-steroid-containing medication for asthma (ensuring the patient is believed to have moderate or severe reversible airways obstruction by their physician),
• moderate or severe persistent asthma according to the NHLBI Guidelines,
• evidence of reversible airflow obstruction: (a) forced expiratory volume in 1 second (FEV1) \< 80% predicted at the time of screening or within the 3 years prior to this screening, and (b) improvement with bronchodilator: either (i) an increase of \>15% and 200ml in FEV1 with asthma treatment over the previous 3 years or (ii) after 4 puffs of albuterol by MDI (or 2.5 mg by nebulizer), an increase in FEV1 or FVC \>12% and 200 ml in FEV1 within 30 minutes,
• at least one appointment scheduled with the asthma physician during the 1st 6 months of participation

You may not qualify if:

• Severe psychiatric or cognitive problems (e.g., obvious mania, schizophrenia, significant mental retardation) that make it impossible to understand and carryout PA activities.
• Unable to understand and provide informed consent,
• Unable to communicate in English or Spanish.
• Participants of the pilot study for this project are excluded

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

• Apter AJ, Wan F, Reisine S, Bogen DK, Rand C, Bender B, Bennett IM, Gonzalez R, Priolo C, Sonnad SS, Bryant-Stephens T, Ferguson M, Boyd RC, Ten Have T, Roy J. Feasibility, acceptability and preliminary effectiveness of patient advocates for improving asthma outcomes in adults. J Asthma. 2013 Oct;50(8):850-60. doi: 10.3109/02770903.2013.812655. Epub 2013 Jul 17.

  PMID: 23800333 BACKGROUND

• Apter AJ, Wan F, Reisine S, Bender B, Rand C, Bogen DK, Bennett IM, Bryant-Stephens T, Roy J, Gonzalez R, Priolo C, Have TT, Morales KH. The association of health literacy with adherence and outcomes in moderate-severe asthma. J Allergy Clin Immunol. 2013 Aug;132(2):321-7. doi: 10.1016/j.jaci.2013.02.014. Epub 2013 Apr 13.

  PMID: 23591273 BACKGROUND

• Apter AJ, Bryant-Stephens T, Morales KH, Wan F, Hardy S, Reed-Wells S, Dominguez M, Gonzalez R, Mak N, Nardi A, Park H, Howell JT, Localio R. Using IT to improve access, communication, and asthma in African American and Hispanic/Latino Adults: Rationale, design, and methods of a randomized controlled trial. Contemp Clin Trials. 2015 Sep;44:119-128. doi: 10.1016/j.cct.2015.08.001. Epub 2015 Aug 8.

  PMID: 26264737 BACKGROUND

• Bryant-Stephens T, Reed-Wells S, Canales M, Perez L, Rogers M, Localio AR, Apter AJ. Home visits are needed to address asthma health disparities in adults. J Allergy Clin Immunol. 2016 Dec;138(6):1526-1530. doi: 10.1016/j.jaci.2016.10.006. Epub 2016 Oct 21.

  PMID: 27777181 BACKGROUND

• Kramer CB, LeRoy L, Donahue S, Apter AJ, Bryant-Stephens T, Elder JP, Hamilton WJ, Krishnan JA, Shelef DQ, Stout JW, Sumino K, Teach SJ, Federman AD. Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies. J Allergy Clin Immunol. 2016 Dec;138(6):1600-1607. doi: 10.1016/j.jaci.2016.10.011. Epub 2016 Oct 24.

  PMID: 27789250 BACKGROUND

• Apter AJ, Perez L, Han X, Ndicu G, Localio A, Park H, Mullen AN, Klusaritz H, Rogers M, Cidav Z, Bryant-Stephens T, Bender BG, Reisine ST, Morales KH. Patient Advocates for Low-Income Adults with Moderate to Severe Asthma: A Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2020 Nov-Dec;8(10):3466-3473.e11. doi: 10.1016/j.jaip.2020.06.058. Epub 2020 Jul 14.

  PMID: 32673877 BACKGROUND

• Korwin A, Black H, Perez L, Morales KH, Klusaritz H, Han X, Huang J, Rogers M, Ndicu G, Apter AJ. Exploring Patient Engagement: A Qualitative Analysis of Low-Income Urban Participants in Asthma Research. J Allergy Clin Immunol Pract. 2017 Nov-Dec;5(6):1625-1631.e2. doi: 10.1016/j.jaip.2017.03.022. Epub 2017 May 10.

  PMID: 28499772 BACKGROUND

• Buckey TM, Morales KH, Apter AJ. Understanding Autonomy in Patients with Moderate to Severe Asthma. J Allergy Clin Immunol Pract. 2022 Feb;10(2):525-533. doi: 10.1016/j.jaip.2021.10.068. Epub 2021 Nov 14.

  PMID: 34785390 DERIVED

MeSH Terms

Conditions

Asthma; Communication

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Andrea J Apter, MD
• Organization: University of Pennsylvania

andrea.apter@uphs.upenn.edu

215 349-5120

Study Officials

• Andrea J Apter, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 30, 2013
• Study Start: December 12, 2013
• Primary Completion: March 16, 2017
• Study Completion: April 30, 2022
• Last Updated: September 13, 2022
• Results First Posted: August 6, 2018

Record last verified: 2022-08

Locations

US (1)