Does Shared Decision-Making Improve Asthma Outcomes?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Shared Decision-Making Improve Adherence in Asthma

NCT00217945

Lung Diseases Asthma

COMPLETED NA

Assessment of Shared Decision Making Aids in Asthma

NCT02516449

Asthma

COMPLETED NA

Evaluation of Decisional Conflict and Needs Assessment in Asthma Management

NCT01520883

Asthma

COMPLETED

Primary Care Implementation and Evaluation of Coach McLungs

NCT05059210

Asthma

ACTIVE_NOT_RECRUITING NA

An Electronic Shared Decision-Making Application to Improve Asthma Outcomes

NCT04951102

Asthma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Shared Decision-Making

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Exclusion: Mild intermittent asthma, defined as either seasonal asthma or (daytime asthma symptoms \<2x/week and nocturnal symptoms \<2x/month and no use of controller medications); under the ongoing care of an allergist or pulmonologist; regular use of oral corticosteroids; currently receiving case-management for their asthma; unable to speak, read or understand English; planning to leave the catchment area within the next two years

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No