Clinical trial NCT01251523: Improving Asthma Outcomes Through Cultural Competence Training for Physicians
Official title: Improving Asthma Outcomes Through Cultural Competence Training for Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 1176
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Massive resources are expended every year on cultural competence training for physicians. However no rigorous study that has assessed whether cultural competence training for physicians results in better health outcomes for their patients.

The investigators propose to conduct a randomized clinical trial to compare two interventions. The study will involve three groups. The first, Physician Asthma Care Education (PACE), is a proven program for enhancing communication, therapeutic practice and the ability of physicians to foster effective management of asthma by their patients in general. The second is the PACE program plus skills and concepts considered in the literature essential to culturally competent practice (PACE PLUS). It is designed to give clinicians a higher degree of certainty and confidence in working across cultures. PACE PLUS was specifically developed to enable physicians to understand and overcome potential biases in their interactions with patients whose racial/ethnic identity is different from their own. The third is a control group that will not receive an intervention. Two racial/ethnic groups of patients will be the focus of the research: African American and Latino/Hispanic, specifically, Puerto Rican children with asthma and their parents or caretakers. The proposed study will evaluate the effects of the training for physicians on health outcomes for the children and performance ratings given to the physician by the parent of the child.

The proposed study will address two questions:

1. Does cultural competence training (PACE PLUS) produce better outcomes for minority patients, specifically African American and Puerto Rican children, and their respective parents, than a general communication training program (PACE)?
2. Compared to the control group, is the Physician Asthma Care Education program (PACE), already shown to be effective with the general population of patients, effective when used with minority patients, specifically African American and Puerto Rican children, and their parents?

The study hypothesis is that there will be positive outcomes for patients of physicians in both interventions but better outcomes for those patients whose doctors participate in the cultural competence training (PACE PLUS). That is:

1. PACE PLUS compared to PACE will produce:

   * reductions in children's health care use for asthma
   * improved symptom experience for the children
   * greater parent/caretaker satisfaction with the physician's performance
   * enhanced asthma related quality of life for parents/caretakers of the patients
   * higher levels of confidence and value placed by physicians on skills needed when working cross culturally
   * increased use of National Asthma Education and Prevention Program (NAEPP) recommended therapies by physicians
2. PACE compared to a control group will produce better outcomes on these six dimensions.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Physicians and patients who cannot meet the above inclusion criteria

Primary outcomes:
measure: Emergency Department Visits - 1st time point
timeFrame: 12 months prior to baseline interview
measure: Emergency Department Visits - 2nd time point
timeFrame: Interval between baseline and 9 months
measure: Emergency Department Visits - 3rd time point
timeFrame: interval between 9 month and 18 month telephone interview
Secondary outcomes:
measure: Hospitalizations - first time point
timeFrame: Year prior to baseline interview
measure: Hospitalizations - 2nd time point
timeFrame: Interval between baseline and 9 month telephone interview
measure: Hospitalizations - 3rd time point
timeFrame: interval between 9 month and 18 month telephone interview
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Public Health
state: Michigan
Study officials:
affiliation: University of Michigan School of Public Health
name: Randall Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.