Lumbar Degenerative DiseaseNCT03679494
Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases.
A study testing Shared decision making support tool in people with Lumbar Degenerative Disease and Shared Decision Making, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Degenerative Disease, Shared Decision Making, Patient Decision Aids
- What is being tested?
- Shared decision making support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Sep 2018to 29 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment (Mini-Mental State Examination scores<24)
- Having major mental diseases (i.e., depression, dementia, delirium, etc.)
- Inability to read/answer questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases: A Cluster Randomized Controlled Trail
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.
Read more
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
- Being tested
- Shared decision making support tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision making support toolOther
Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions
| Study group | Role | What they receive |
|---|---|---|
| SDM intervention group | Experimental | Using shared decision making support tool for intervention Receives: Other: Shared decision making support tool |
| Usual care group | No intervention | No intervention, just continue using usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before intervention, after intervention immediately, up to 12 weeks after intervention
Secondary outcomes (5)
Assess Decision Process Quality in Making the Decision
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.
Measured: After intervention immediately
Assess Patients' Satisfaction With Decision
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.
Measured: After intervention immediately, up to 12 weeks after the intervention
Assess Patients' Decisional Conflict
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.
Measured: After intervention immediately and up to 12 weeks after intervention
Assess the Degree of Disability of Lower Back Pain
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.
Measured: Before intervention, up to 12 weeks after intervention
Assess the Quality of Healthy Living About Patients
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.
Measured: Before intervention, up to 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start26 Sep 2018
- Primary completion29 Dec 2019
- Study completion29 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lumbar Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679494
- Sponsor's protocol ID
- N201712035
- Status last verified
- Dec 2019
- First submitted
- 6 Sep 2018
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases: A Cluster Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT03679494
- Acronym / sponsor ID
- N201712035
- Conditions
- Lumbar Degenerative Disease, Shared Decision Making, Patient Decision Aids, Evidence-based Medicine, Quality of Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 29 Dec 2019 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Posted 19 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDM intervention group | Experimental | Other: Shared decision making support toolUsing shared decision making support tool for intervention |
| Usual care group | No intervention | –No intervention, just continue using usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive impairment (Mini-Mental State Examination scores<24)
- Having major mental diseases (i.e., depression, dementia, delirium, etc.)
- Inability to read/answer questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision making support toolHealth education materials containing treatments and questions about patient values to help patients make the most appropriate decisions | Other | SDM intervention group |
Primary outcome
The Change of Patients' Control Preference
Time frame: 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.
The Change of Patients' Decision Self-efficacy
Time frame: 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.
5 secondary outcomes
Assess Decision Process Quality in Making the Decision
Time frame: After intervention immediately
Assess Patients' Satisfaction With Decision
Time frame: After intervention immediately, up to 12 weeks after the intervention
Assess Patients' Decisional Conflict
Time frame: After intervention immediately and up to 12 weeks after intervention
Assess the Degree of Disability of Lower Back Pain
Time frame: Before intervention, up to 12 weeks after intervention
Assess the Quality of Healthy Living About Patients
Time frame: Before intervention, up to 12 weeks after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making support tool in people with Lumbar Degenerative Disease and Shared Decision Making, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change of Patients' Control Preference (time frame: Before intervention, up to 12 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.