Does Shared Decision-Making Improve Adherence in Asthma

To evaluate a model of shared decision-making for asthma treatment, appropriate to the needs of African American, Latino, Chinese, and other Asian and low income Caucasian patients to adherence to asthma controller medications in a two-year randomized clinical trial in 302 minority and low-income adults, 18-70 years of age, with suboptimally controlled, persistent asthma, paralleling a simultaneous evaluation being conducted in 311 Caucasian and Asian/Pacific Island adults, (total n=613), and to examine psychological mechanisms mediating the effects of the intervention on adherence and of adherence on asthma outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

Asthma is a chronic inflammatory disorder of the airways. Despite major advances in understanding of its pathophysiology and management, asthma outcomes have not shown parallel improvement. Many patients with asthma are poorly controlled and have sub-optimal health status. Asthma care management by a trained non-physician health professional has developed as a means of addressing the problems of patients evidencing poor control and/or poor adherence to controller medications. Shared decision making (SDM) between clinician and patient has also been proposed as a means of getting greater patient involvement in their care, with the idea that this may improve medication adherence and outcomes. However, significant patient involvement also might result in less adequate regimens than would management based on guidelines (MBG). Even so, increased adherence to a less adequate regimen might result in better outcomes than poor adherence to an optimal regimen.

DESIGN NARRATIVE:

Better Outcomes of Asthma Treatment (BOAT) is a randomized controlled trial (a collaborative study designed to compare the effectiveness of three strategies for managing patients, 18-70 years of age, with suboptimally controlled, persistent asthma. The three treatment strategies are: usual care (UC); management by guidelines (MG); and a third, shared decision making (SDM) arm, that seeks to formally involve the patient in the therapeutic decision-making process. Under the present grant, 302 study participants were recruited from the membership of the Kaiser Permanente - Northern California Region (KPNC), San Francisco, Oakland, and Richmond medical centers. In the collaborating grant (No.HL67092-03) 311 patients were recruited from Kaiser Permanente clinical facilities in Portland, OR, and Honolulu, HI. Patients were randomized equally to the three treatment arms following baseline assessment of asthma control, medication use, lung function, and other behavioral and psychological characteristics. Their health care utilization for asthma and acquisition of asthma medications is being followed for a total of 24 months post-randomization through health system records, and they are being reassessed at 12 mos. Those assigned to the care management conditions received asthma education and objective feedback on their level of asthma control. Those assigned to the MBG condition were prescribed a regimen appropriate to the severity of their asthma in accordance with standard guidelines for asthma management. Those assigned to the SDM condition participated in a process to elicit their goals for their asthma treatment and their priorities regarding their asthma medications, and then engaged in a process of shared decision making with the care manager designed to arrive at a prescribed regimen that satisfied their goals and preferences. Analysis of the data will compare the two care management approaches with usual care and with each other in terms of the primary outcomes.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Kaiser Health Care Program member for more than 1 yr.
  • Site: Portland, OR, Honolulu, HI, San Francisco, Oakland, or Richmond, CA.
  • Confirmed diagnosis of persistent asthma with currently prescribed medications; no daily or alternate daily oral corticosteroid
  • Evidence of poorly controlled asthma: score of >=1 on ATAQ asthma control questionnaire1 and either overuse of rescue medication vs. controller medications and/or recent emergency visit or hospitalization for asthma
  • COPD not the primary lung disease diagnosis
  • Regular use of Inhaled Corticosteroid (ICS) and current/ex-smokers: >= 8% increase in FEV1 post-bronchodilator; if no routine ICS use +/- smoking HX: >= 12% increase required; non-smokers using ICS regularly not required to reverse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Sandra Wilson, Palo Alto Medical Foundation

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

January 1, 2008

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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