Improving Asthma Outcomes Through Cultural Competence Training for Physicians

NCT01251523 | Completed DMC

• 1 other identifier: 1R01HL09338601A2
• Study Type: interventional
• Target: 1,176
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed randomized clinical trial will compare two educational interventions: Physicians Asthma Care Education (PACE) and PACE Plus with 90 physicians in Atlanta and the Bronx and their 1192 patients.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (3)

• Emergency Department Visits - 1st time point

  The investigators will collect health care utilization data related to the child's asthma. Parents of the pediatric subjects will complete a telephone interview at baseline. During that interview they will be asked to provide information regarding the frequency of asthma related Emergency Department visits (for the child) during the year prior to the baseline interview. A subset of the patients will have their records reviewed at their doctor's office for asthma related ED visits during this time period.

  12 months prior to baseline interview

• Emergency Department Visits - 2nd time point

  The investigators will collect health care utilization data on the child subject of this study. Parents of the pediatric patients will be asked during their 9 month follow up telephone interview about the frequency of asthma related ED visits (for the child) during the interval since the baseline interview (baseline - 9 months). In addition, a subset of the patients in the study will have their records reviewed in the clinic for a reporting of asthma related ED visits.

  Interval between baseline and 9 months

• Emergency Department Visits - 3rd time point

  The investigators will collect health care utilization data related to asthma. Parents of the child subjects in the study will be asked during their 18 month telephone interview to recall the frequency of asthma related ED visits for the child in the last year since their 9 month telephone interview. In addition, a subset of children will have their records accessed at their drs office for a reporting of ED visits.

  interval between 9 month and 18 month telephone interview

Secondary Outcomes (3)

• Hospitalizations - first time point

  Year prior to baseline interview

• Hospitalizations - 2nd time point

  Interval between baseline and 9 month telephone interview

• Hospitalizations - 3rd time point

  interval between 9 month and 18 month telephone interview

Study Arms (3)

PACE Plus

ACTIVE COMPARATOR

Physicians enrolled in the study will be randomized to one of three arms: Control, PACE intervention or PACE Plus intervention. Their pediatric asthma patients enrolled in the study will follow them into their randomization assignment.

Behavioral: PACE Plus

PACE

ACTIVE COMPARATOR

Physicians enrolled in the study will be randomized to one of three arms: Control, PACE intervention or PACE Plus intervention. Their pediatric asthma patients enrolled in the study will follow them into their randomization assignment.

Behavioral: PACE

Control

NO INTERVENTION

Physicians enrolled in the study will be randomized to one of three arms: Control, PACE intervention or PACE Plus intervention. Their pediatric asthma patients enrolled in the study will follow them into their randomization assignment.

Interventions

PACE BEHAVIORAL

The first intervention to be tested, Physician Asthma Care Education (PACE), is a rigorously evaluated intervention for physicians that has reached hundreds of clinicians across the U.S. and also has been implemented in the United Kingdom and Australia. The efficacy trial of PACE was supported by the National Heart, Lung and Blood Institute and the effectiveness trial by the Robert Wood Johnson Foundation. PACE is now widely available to clinicians, through, among other channels, the National Asthma Education and Prevention Program (NAEPP). It is designed to enhance physician communication, counseling and therapeutics for assisting the general population of children with asthma.

Also known as: PACE (Physician Asthma Care Education)

PACE

PACE Plus BEHAVIORAL

In the PACE PLUS intervention a cultural competence component will be added to the PACE curriculum. The cultural competence component uses mini-lecture, video demonstration (video to be developed as part of this proposal), case studies and self observation tools to present the principles of cultural competence derived from the study of the literature. The component integrates into the skills taught, specific content related to working with African American and Puerto Rican families where a child has asthma.

PACE Plus

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician enrollment criteria are: 1) licensed physician in practice and board certified in pediatrics or family medicine; 2) treating children with asthma; 3) full-time in a practice in Atlanta, GA or New York City, NY; 4) not Latino/Hispanic or African American in ethnicity/race; 5) consenting to participate and 6) will generate a roster of pediatric asthma patients.
• The following patient selection criteria will be used.
• The child must: 1) be treated by the participating physician during the study intake period; 2) be between one and 16 years of age; 3) have a diagnosis of asthma made by a physician using the NAEPP Guidelines for the diagnosis of asthma (NHLBI, 2007) (The investigators will not accept alternative descriptions such as reactive airway disease, bronchitis, or wheezy bronchitis. The determination must be asthma); 4) have at least one emergency medical care visit in the previous year (hospitalization, or ED or physician office visit on an emergency basis defined as administration of epinephrine sub-cutaneously or bronchodilators by aerosol); 5) not have other chronic disorders that have pulmonary complications, e.g. sickle cell disease; 6) be of self-identified African American or Latino/Hispanic race/ethnicity.
• In addition, the parent/caretaker must meet the following criteria: 1) be the one usually responsible for the child's car; 2) be of self identified African American or Latino/Hispanic race/ethnicity; 3) have access to a telephone; and 4) consent to participate.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Public Health

Ann Arbor, Michigan, 48109-2029, United States

Location

Related Publications (2)

• Patel MR, Song PXK, Bruzzese JM, Hao W, Evans D, Thomas LJ, Pinkett-Heller M, Meyerson K, Brown RW. Does cross-cultural communication training for physicians improve pediatric asthma outcomes? A randomized trial. J Asthma. 2019 Mar;56(3):273-284. doi: 10.1080/02770903.2018.1455856. Epub 2018 Apr 11.

  PMID: 29641357 DERIVED

• Patel MR, Thomas LJ, Hafeez K, Shankin M, Wilkin M, Brown RW. Study protocol for improving asthma outcomes through cross-cultural communication training for physicians: a randomized trial of physician training. BMC Med Educ. 2014 Jun 16;14:118. doi: 10.1186/1472-6920-14-118.

  PMID: 24935221 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Randall Brown, MD, MPH

  University of Michigan School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

US (1)