Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases.

NCT03679494 | Completed Results

• 1 other identifier: N201712035
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Degenerative Disease; Shared Decision Making; Patient Decision Aids; Evidence-based Medicine; Quality of Care

Outcome Measures

Primary Outcomes (2)

• The Change of Patients' Control Preference

  Use Control Preference Scale to measure the patients' preferred role whether change in making decisions with the medical provider before intervention and after intervention. It consists of five cards, each of which presents a different character in medical decision-making in a cartoon pattern, and performs a series of comparisons to rank the preference.

  Before intervention, up to 12 weeks after intervention

• The Change of Patients' Decision Self-efficacy

  Use Decision Self Efficacy Scale to measure patients' self-confidence and belief in measuring the ability of patients to participate in decision-making. It has 11 items with 5 level Likert scale. The scale range is 0-100, higher scores indicate better decision self-efficacy.

  Before intervention, after intervention immediately, up to 12 weeks after intervention

Secondary Outcomes (5)

• Assess Decision Process Quality in Making the Decision

  After intervention immediately

• Assess Patients' Satisfaction With Decision

  After intervention immediately, up to 12 weeks after the intervention

• Assess Patients' Decisional Conflict

  After intervention immediately and up to 12 weeks after intervention

• Assess the Degree of Disability of Lower Back Pain

  Before intervention, up to 12 weeks after intervention

• Assess the Quality of Healthy Living About Patients

  Before intervention, up to 12 weeks after intervention

Study Arms (2)

SDM intervention group

EXPERIMENTAL

Using shared decision making support tool for intervention

Other: Shared decision making support tool

Usual care group

NO INTERVENTION

No intervention, just continue using usual care

Interventions

Shared decision making support tool OTHER

Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions

SDM intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan

Location

Results Point of Contact

• Title: MS. Po-Yao Chiu
• Organization: Taipei MU

m437106006@tmu.edu.tw

+886-2-27361661

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 20, 2018
• Study Start: September 26, 2018
• Primary Completion: December 29, 2019
• Study Completion: December 29, 2019
• Last Updated: February 19, 2020
• Results First Posted: February 19, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)