Shared Decision Making Clinical Trial
Official title:
Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases: A Cluster Randomized Controlled Trail
Background:
Shared decision making (SDM) is a patient-centered and evidence-based model of clinical
decision making. The feature of SDM is that clinicians work together with patients to plan
the most appropriate and practical treatment for patients based on the patients' preferences
and values. Recently, SDM has been implemented throughout the world to improve patients'
health literacy and to have a better understanding of the treatment options, thereby
improving patient-doctor communication and promoting the quality of care.
Lumbar degenerative disease is a critical public health issue in the aging society. SDM now
becomes an important process because there is no consensus of evidence-based practice
guidelines among the multiple complex treatment options for patients with lumbar degenerative
disease. In addition, there is a lack of evidence to support the effect of patient decision
aids (PDAs) to promote the quality of healthcare for patients with lumbar degenerative
disease in Taiwan.
Purposes:
This project has two purposes. The first purpose is to develop a multimedia interactive
patient doctor communication system called the Taiwan Shared Decision Making for Lumbar Spine
Treatment (Taiwan SDM LumST). The second and ultimate purpose is to conduct a cluster
randomized controlled trial (cRCT) for the validation of the integrated SDM model and the
effectiveness of SDM related outcome indicators.
Methods:
In the first year of the 3-year project, investigators will develop the SDM communication
teaching materials, PDAs, as well as the computerized platform of Taiwan SDM LumST through
focus groups and consensus meetings. In the second to third year, investigators will recruit
130 patients with lumbar degenerative disease to participate in double blind cRCT in the
affiliated hospitals of Taipei Medical University. Investigators will use structural equation
modeling to validate the factors of the SDM model and adopt generalized linear regression
models with generalized estimating equations to examine the immediate, short-term, and
long-term benefits of the Taiwan SDM LumST in implementing the SDM model among patients with
lumbar degenerative disease.
Expected results:
Investigators expect that the implementation of the Taiwan SDM LumST system will
significantly improve the patients' decision preference, health literacy in the care of
lumbar degenerative disease, and self-efficacy in SDM. It will also promote the health care
quality and health outcomes (e.g., participation in SDM, quality of decisions, regret in
decisions, health outcomes, and quality-of-life) in patients with lumbar degenerative
disease.
Expected impacts on the society, economy, and academic developments:
The Taiwan SDM LumST will be an efficient and effective way to facilitate patient doctor
communication and thereby, promote health outcomes and improve the quality of decisions made
by patients with lumbar degenerative disease. No computerized interactive PDA of SDM system
for patients with lumbar degenerative disease exists in Taiwan yet. Thus, our system would be
the first in Taiwan for the lumbar degenerative population. Investigators hope that the
Taiwan SDM LumST will not only contribute to academic research, but also facilitate SDM
between patients and healthcare professionals in order to improve patient safety and enhance
the quality of care in Taiwan.
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