Does Shared Decision-Making Improve Asthma Outcomes?
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      To improve asthma outcomes by developing and evaluating strategies for enhancing the
      clinic-patient partnership. To develop a model of shared decision-making for asthma
      treatment, and to evaluate it in a two-year randomized clinical trial in 342 adults aged
      18-70 years with sub-optimally controlled persistent asthma.
    

Detailed description: 
      BACKGROUND:

      Although much is now known about asthma, and there is effective asthma treatment, only about
      half of the patients with persistent asthma adhere to their prescribed long-term controller
      medication. One way to change this might be to involve patients more in decisions about their
      treatment.

      DESIGN NARRATIVE:

      Overview and study design This study is designed to evaluate the effectiveness of a model of
      shared decision-making in improving outcomes in adults aged 18-70 years with suboptimally
      controlled, mild-moderate persistent asthma. The shared decision-making model (SD) is being
      compared in a randomized controlled trial with a model based on national asthma guidelines
      (MG), and with usual care (UC).

      Initially, we adapted the model of shared decision-making that has been used successfully in
      cancer to make it appropriate for a chronic disease (asthma). We will also adapted the KP
      Asthma Guidelines so that the two models (Management by Guidelines and Shared
      Decision-Making) take a similar amount of clinician-patient interaction time. We are
      comparing the two models and usual care in the primary care setting at Kaiser Permanente
      Northwest and Kaiser Permanente Hawaii in a randomized controlled trial with 24-month follow
      up. The individual asthma patient will be the unit of randomization.

      Interventions were done by a care manager (nurse practitioner or clinical pharmacist) with
      experience in asthma, and the authority to change medication regimens. Different staff were
      used for the two intervention groups to minimize contamination between the groups
      attributable to the intervention. Eligible participants were randomized into the three groups
      (UC, MG, and SD) on an equal 1:1:1 basis, stratifying on prior health care utilization and
      within center (KPNW or KPH). All study participants are being followed for 24 months with
      clinic visits for data collection at 12 months. The MG and SD arms are receiving interim
      phone calls from the care managers at three, six, and nine months to assess problems with
      their treatment regimens, discuss changes that may be desired in treatment regimens, and
      encourage adherence. Different staff are responsible for data collection and intervention.

      We will compare the MG and SD models versus usual care (UC vs MG; UC vs SD), and the MG and
      SD models (MG vs SD).

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): Shared Decision-Making
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment