Improving Asthma Outcomes Through Cultural Competence Training for Physicians

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Noreen M. Clark, University of Michigan
ClinicalTrials.gov Identifier:
NCT01251523
First received: December 1, 2010
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Asthma
Behavioral: PACE
Behavioral: PACE Plus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Improving Asthma Outcomes Through Cultural Competence Training for Physicians

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Emergency Department Visits - 1st time point [ Time Frame: 12 months prior to baseline interview ] [ Designated as safety issue: No ]
    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.

  • Emergency Department Visits - 2nd time point [ Time Frame: Interval between baseline and 12 months ] [ Designated as safety issue: No ]
    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 12 month follow up telephone interview about the frequency of asthma related ED visits (for the child) during the interval since the baseline interview (baseline - 12 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.

  • Emergency Department Visits - 3rd time point [ Time Frame: interval between 12 month and 24 month telephone interview ] [ Designated as safety issue: No ]
    The investigators will collect health care utilization data related to asthma. Parents of the child subjects in the study will be asked during their 24 month telephone interview to recall the frequency of asthma related ED visits for the child in the last year since their 12 month telephone interview. In addition, a subset of children will have their records accessed at their drs office for a reporting of ED visits.


Secondary Outcome Measures:
  • Hospitalizations - first time point [ Time Frame: Year prior to baseline interview ] [ Designated as safety issue: No ]
    The investigators will ask parents of the child subjects during their baseline telephone interview to provide information on hospitalizations related to asthma in the year prior to their baseline interview. In addition, the investigators will review patient records at the clinic for a subset of the children for hospitalizations during this period.

  • Hospitalizations - 2nd time point [ Time Frame: Interval between baseline and 12 month telephone interview ] [ Designated as safety issue: No ]
    The investigators will ask parents of the child subjects during their 12 month telephone interview to provide information on hospitalizations related to asthma in the year between their baseline and 12 month interview. In addition, the investigators will review patient records at the clinic for a subset of the children for hospitalizations during this period.

  • Hospitalizations - 3rd time point [ Time Frame: interval between 12 month and 24 month telephone interview ] [ Designated as safety issue: No ]
    The investigators will ask parents of the child subjects during their 24 month telephone interview to provide information on hospitalizations related to asthma in the year between their 12 month and 24 month interview. In addition, the investigators will review patient records at the clinic for a subset of the children for hospitalizations during this period.


Estimated Enrollment: 1282
Study Start Date: November 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PACE Plus
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
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.
Active Comparator: PACE
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
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.
Other Name: PACE (Physician Asthma Care Education)
No Intervention: Control
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251523

Contacts
Contact: Lara J Thomas, MPH 734-615-3253 ljthomas@umich.edu

Locations
United States, Michigan
University of Michigan School of Public Health Recruiting
Ann Arbor, Michigan, United States, 48109-2029
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Noreen M Clark, PhD University of Michigan School of Public Health
  More Information

No publications provided by University of Michigan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Noreen M. Clark, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01251523     History of Changes
Other Study ID Numbers: 1R01HL09338601A2
Study First Received: December 1, 2010
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014