Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases: A Cluster Randomized Controlled Trail
Phase: NA
Conditions: Lumbar Degenerative Disease, Shared Decision Making, Patient Decision Aids, Evidence-based Medicine, Quality of Care
Sponsor: Taipei Medical University

Official title: Effectiveness of Implementing Shared Decision-Making on Quality of Care 
Among Patients With Lumbar Degenerative Diseases. 
NCT number: NCT03679494 
Document date: September 25, 2018 
 
 

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 Analysis of covariance (ANCOVA) and Pearson's chi-
squared test were used to analyze the difference in outcomes between two groups. 
Using 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.