Clinical trial NCT03679494: Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases.
Official title: Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases: A Cluster Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Degenerative Disease
Shared Decision Making
Patient Decision Aids
Evidence-based Medicine
Quality of Care
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 130
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* First-time diagnosis of Spine Degeneration Diseases ICD-10 codes M48.05-08, M43.05-08, M43.15-18, M54.5; ICD-9 codes 724.01-02、724.09、724.2、738.4
* Ability to follow instructions and complete the interviews
* Age\>20 years
* Interested to participate and able to sign consent

Exclusion Criteria:

* Cognitive impairment (Mini-Mental State Examination scores\<24)
* Having major mental diseases (i.e., depression, dementia, delirium, etc.)
* Inability to read/answer questionnaires

Primary outcomes:
measure: The Change of Patients' Control Preference
timeFrame: Before intervention, up to 12 weeks after intervention
measure: The Change of Patients' Decision Self-efficacy
timeFrame: Before intervention, after intervention immediately, up to 12 weeks after intervention
Secondary outcomes:
measure: Assess Decision Process Quality in Making the Decision
timeFrame: After intervention immediately
measure: Assess Patients' Satisfaction With Decision
timeFrame: After intervention immediately, up to 12 weeks after the intervention
measure: Assess Patients' Decisional Conflict
timeFrame: After intervention immediately and up to 12 weeks after intervention
measure: Assess the Degree of Disability of Lower Back Pain
timeFrame: Before intervention, up to 12 weeks after intervention
measure: Assess the Quality of Healthy Living About Patients
timeFrame: Before intervention, up to 12 weeks after intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
References: