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

• Sponsor: Taipei Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03679494
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.1
• Patients Per Site Per Month: 8.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Degenerative Disease; Shared Decision Making; Patient Decision Aids; Evidence-based Medicine; Quality of Care	Other: Shared decision making support tool	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Other
• Official Title: Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases: A Cluster Randomized Controlled Trail
• Actual Study Start Date: Sep 26, 2018
• Actual Primary Completion Date: Dec 29, 2019
• Actual Study Completion Date: Dec 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SDM intervention group Using shared decision making support tool for intervention	Other: Shared decision making support tool; Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions
No Intervention: Usual care group No intervention, just continue using usual care

Outcome Measures

Primary Outcome Measures

1. The Change of Patients' Control Preference [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.

2. The Change of Patients' Decision Self-efficacy [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.

Secondary Outcome Measures

1. Assess Decision Process Quality in Making the Decision [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 the decision-sharing on behalf of the patient.

2. Assess Patients' Satisfaction With Decision [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.

3. Assess Patients' Decisional Conflict [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.

4. Assess the Degree of Disability of Lower Back Pain [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.

5. Assess the Quality of Healthy Living About Patients [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 least healthy and 1 is the most healthy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Medical University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Taipei Medical University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 25, 2018

More Information

Publications

None provided.

• Responsible Party: Taipei Medical University
• ClinicalTrials.gov Identifier: NCT03679494
• Other Study ID Numbers: N201712035
• First Posted: Sep 20, 2018
• Last Update Posted: Feb 19, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	SDM Intervention Group	Usual Care Group
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	No intervention, just continue using usual care
Period Title: Overall Study
STARTED	67	63
COMPLETED	67	63
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	SDM Intervention Group	Usual Care Group	Total
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	No intervention, just continue using usual care	Total of all reporting groups
Overall Participants	67	63	130
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	56.46 (14.853)	55.78 (15.315)	56.13 (15.024)
Sex: Female, Male (Count of Participants)
Female	45 67.2%	38 60.3%	83 63.8%
Male	22 32.8%	25 39.7%	47 36.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	67 100%	63 100%	130 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	The Change of Patients' Control Preference
Description	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.
Time Frame	Before intervention, up to 12 weeks after intervention

Outcome Measure Data

Analysis Population Description

Patients lost after 12 weeks of intervention.

Arm/Group Title	SDM Intervention Group	Usual Care Group
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	No intervention, just continue using usual care
Measure Participants	67	62
Make final selection I will receive	1 1.5%	1 1.6%
Make selection with doctor's opinion	16 23.9%	14 22.2%
Make selection with doctor	38 56.7%	35 55.6%
Make selection by doctor	12 17.9%	12 19%
Make final selection I will receive	0 0%	3 4.8%
Make selection with doctor's opinion	1 1.5%	0 0%
Make selection with doctor	52 77.6%	51 81%
Make selection by doctor	3 4.5%	3 4.8%

2. Primary Outcome

Title	The Change of Patients' Decision Self-efficacy
Description	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.
Time Frame	Before intervention, after intervention immediately, up to 12 weeks after intervention

Outcome Measure Data

Analysis Population Description

Patients lost after the intervention immediately and up to 12 weeks after intervention.

Arm/Group Title	SDM Intervention Group	Usual Care Group
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	No intervention, just continue using usual care
Measure Participants	67	62
Before intervention	77.78 (16.78)	79.51 (19.31)
After intervention immediately	88.57 (10.03)	81.27 (18.96)
Up to 12 weeks after intervention	84.01 (18.61)	85.39 (16.91)

3. Secondary Outcome

Title	Assess Decision Process Quality in Making the Decision
Description	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 the decision-sharing on behalf of the patient.
Time Frame	After intervention immediately

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SDM Intervention Group	Usual Care Group
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	No intervention, just continue using usual care
Measure Participants	66	62
Mean (Standard Deviation) [score on a scale]	87.47 (12.30)	81.76 (19.55)

4. Secondary Outcome

Title	Assess Patients' Satisfaction With Decision
Description	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.
Time Frame	After intervention immediately, up to 12 weeks after the intervention

Outcome Measure Data

Analysis Population Description

The patients lost up to 12 weeks after the intervention.

Arm/Group Title	SDM Intervention Group	Usual Care Group
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	No intervention, just continue using usual care
Measure Participants	66	62
After intervention immediately	26.29 (3.40)	25.06 (4.60)
Up to 12 weeks after the intervention	26.02 (3.89)	25.44 (4.71)

5. Secondary Outcome

Title	Assess Patients' Decisional Conflict
Description	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.
Time Frame	After intervention immediately and up to 12 weeks after intervention

Outcome Measure Data

Analysis Population Description

Patients lost after up to 12 weeks after intervention.

Arm/Group Title	SDM Intervention Group	Usual Care Group
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	No intervention, just continue using usual care
Measure Participants	66	62
After intervention immediately	10.30 (10.46)	18.25 (18.44)
Up to 12 weeks after intervention	15.77 (17.56)	15.27 (14.75)

6. Secondary Outcome

Title	Assess the Degree of Disability of Lower Back Pain
Description	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.
Time Frame	Before intervention, up to 12 weeks after intervention

Outcome Measure Data

Analysis Population Description

Patients lost up to 12 weeks after intervention.

Arm/Group Title	SDM Intervention Group	Usual Care Group
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	No intervention, just continue using usual care
Measure Participants	67	62
Before intervention	24.38 (15.67)	24.62 (12.90)
Up to 12 weeks after intervention	24.22 (31.06)	21.12 (25.20)

7. Secondary Outcome

Title	Assess the Quality of Healthy Living About Patients
Description	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 least healthy and 1 is the most healthy.
Time Frame	Before intervention, up to 12 weeks after intervention

Outcome Measure Data

Analysis Population Description

Patients lost up to 12 weeks after intervention.

Arm/Group Title	SDM Intervention Group	Usual Care Group
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions	No intervention, just continue using usual care
Measure Participants	67	62
Before intervention	0.70 (0.17)	0.72 (0.13)
Up to 12 weeks after intervention	0.86 (0.17)	0.85 (0.18)

Adverse Events

Time Frame	Up to 12 weeks
Adverse Event Reporting Description	This is a questionnaire interview study, if patients are tired or feel unwell due to the long questionnaire, they can stop the visit at any time and immediately contact the relevant medical unit.
Arm/Group Title	SDM Intervention Group		Usual Care Group
Arm/Group Description	Using shared decision making support tool for intervention Shared deicision making support tool: Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions		No intervention, just continue using usual care
All Cause Mortality
	SDM Intervention Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/63 (0%)
Serious Adverse Events
	SDM Intervention Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	SDM Intervention Group		Usual Care Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/63 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.