- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00217945
Does Shared Decision-Making Improve Adherence in Asthma
연구 개요
상세 설명
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.
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
공동 작업자 및 조사자
수사관
- Sandra Wilson, Palo Alto Medical Foundation
간행물 및 유용한 링크
일반 간행물
- Wilson SR, Strub P, Buist AS, Knowles SB, Lavori PW, Lapidus J, Vollmer WM; Better Outcomes of Asthma Treatment (BOAT) Study Group. Shared treatment decision making improves adherence and outcomes in poorly controlled asthma. Am J Respir Crit Care Med. 2010 Mar 15;181(6):566-77. doi: 10.1164/rccm.200906-0907OC. Epub 2009 Dec 17.
- Wilson SR, Buist AS, Holup J, Brown NL, Lapidus J, Luna V, Verghese S. Shared Decision Making vs. Management by Guidelines: Impact on Medication Regimen. Poster presented at the 2005 Annual Meeting of the American Thoracic Society, San Diago, CA, May 24, 2005. Proceedings of the American Thoracic Society; Vol.2 Abstracts Issue; 2005.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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