NCT03679494

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

Completed NA Results posted Last updated 19 February 2020

What this trial tests

NA trial testing Shared decision making support tool in Lumbar Degenerative Disease in 130 participants. Completed in 29 December 2019.

Timeline

26 September 2018

Primary endpoint
29 December 2019

29 December 2019

Quick facts

Lead sponsor	Taipei Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	130
Start date	26 September 2018
Primary completion	29 December 2019
Estimated completion	29 December 2019
Sites	1 location across Taiwan

Drugs / interventions tested

• Shared decision making support tool

Conditions studied

• Lumbar Degenerative Disease — all drugs for Lumbar Degenerative Disease →
• Shared Decision Making — all drugs for Shared Decision Making →
• Patient Decision Aids — all drugs for Patient Decision Aids →
• Evidence-based Medicine — all drugs for Evidence-based Medicine →

Sponsor

Taipei Medical University

Who can join

20 and older, any sex, with Lumbar Degenerative Disease or Shared Decision Making. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Change of Patients' Control Preference Primary · Before intervention, up to 12 weeks after intervention

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

Group	Value	95% CI
SDM Intervention Group	1
Usual Care Group	1
SDM Intervention Group	16
Usual Care Group	14
SDM Intervention Group	38
Usual Care Group	35
SDM Intervention Group	12
Usual Care Group	12

Up to 12 weeks after intervention

Group	Value	95% CI
SDM Intervention Group	0
Usual Care Group	3
SDM Intervention Group	1
Usual Care Group	0
SDM Intervention Group	52
Usual Care Group	51
SDM Intervention Group	3
Usual Care Group	3

The Change of Patients' Decision Self-efficacy Primary · Before intervention, after intervention immediately, up to 12 weeks after intervention

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

Group	Value	95% CI
SDM Intervention Group	77.78	± 16.78
Usual Care Group	79.51	± 19.31

After intervention immediately

Group	Value	95% CI
SDM Intervention Group	88.57	± 10.03
Usual Care Group	81.27	± 18.96

Up to 12 weeks after intervention

Group	Value	95% CI
SDM Intervention Group	84.01	± 18.61
Usual Care Group	85.39	± 16.91

Assess Decision Process Quality in Making the Decision Secondary · After intervention immediately

Assess whether the medical personnel have sufficiently communicated with patients when making the decision by 9-item Shared Decision Making Questionnaire(SDM-Q-9). It has 9 items and is divided into 0 to 5 scores, 0 points = very disagree, 1 point = roughly disagree, 2 points = partial disagreement, 3 points = partial consent, 4 points = roughly agree, 5 points = very agree. After the total score of each question is added, the initial total score is 0 to 45 points. Divide the initial total score by 9 and multiply by 20 to get the final score from 0 to 100. The higher the score means the better

Group	Value	95% CI
SDM Intervention Group	87.47	± 12.30
Usual Care Group	81.76	± 19.55

Assess Patients' Satisfaction With Decision Secondary · After intervention immediately, up to 12 weeks after the intervention

Use Satisfaction with Decision Scale to assess patients satisfaction with health care decisions. It has 6 items with 5 level Likert scale. 1 point = very disagree, 2 points = disagree, 3 points = disagree or disagree, 4 points = agree, 5 points = very agree. After the total score of each question is added, the initial total score is 6 to 30 points. The higher the score, patients are more satisfied with the decision.

After intervention immediately

Group	Value	95% CI
SDM Intervention Group	26.29	± 3.40
Usual Care Group	25.06	± 4.60

Up to 12 weeks after the intervention

Group	Value	95% CI
SDM Intervention Group	26.02	± 3.89
Usual Care Group	25.44	± 4.71

Assess Patients' Decisional Conflict Secondary · After intervention immediately and up to 12 weeks after intervention

Use the Decisional Conflict Scale to assess patients whether have a conflict or something not sure about making the decision. It has 16 items with 5 levels Likert scale. 0 points = yes, 1 point = about yes, 2 points = uncertainty, 3 points = probably not, 4 points = no. After the total score of each question is added, the initial total score is 0 to 64 points. Divide the initial total score by 16 and multiply by 25 to get the final score from 0 to 100. The higher the score, patients have more conflict with the decision.

After intervention immediately

Group	Value	95% CI
SDM Intervention Group	10.30	± 10.46
Usual Care Group	18.25	± 18.44

Up to 12 weeks after intervention

Group	Value	95% CI
SDM Intervention Group	15.77	± 17.56
Usual Care Group	15.27	± 14.75

Assess the Degree of Disability of Lower Back Pain Secondary · Before intervention, up to 12 weeks after intervention

Use the Oswestry Disability Index to measure lower back pain patients' degree of disability. It has 10 items (Pain, self-care, bring, walking, sitting, standing, sleeping, sex, social, travelling). After adding up the total score of each item, the initial total score is 0 to 50 points. Then divide the total score by 5 and multiply by 20 to get the final score of 0 to 100. Higher scores indicate a more severe disability.

Before intervention

Group	Value	95% CI
SDM Intervention Group	24.38	± 15.67
Usual Care Group	24.62	± 12.90

Up to 12 weeks after intervention

Group	Value	95% CI
SDM Intervention Group	24.22	± 31.06
Usual Care Group	21.12	± 25.20

Assess the Quality of Healthy Living About Patients Secondary · Before intervention, up to 12 weeks after intervention

Use the EQ-5D-5L scale to measure patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the leas

Before intervention

Group	Value	95% CI
SDM Intervention Group	0.70	± 0.17
Usual Care Group	0.72	± 0.13

Up to 12 weeks after intervention

Group	Value	95% CI
SDM Intervention Group	0.86	± 0.17
Usual Care Group	0.85	± 0.18

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Decision aids for people facing health treatment or screening decisions.
   Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6