Evidence-based Medicine, Lumbar Degenerative Disease, Patient Decision Aids, Quality of Care, Shared Decision Making
Conditions
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.
Interventions
Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SDM Intervention Group 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 | 67 |
| Usual Care Group No intervention, just continue using usual care | 63 |
| Total | 130 |
Baseline characteristics
| Characteristic | Usual Care Group | Total | SDM Intervention Group |
|---|---|---|---|
| Age, Continuous | 55.78 years STANDARD_DEVIATION 15.315 | 56.13 years STANDARD_DEVIATION 15.024 | 56.46 years STANDARD_DEVIATION 14.853 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 63 Participants | 130 Participants | 67 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 38 Participants | 83 Participants | 45 Participants |
| Sex: Female, Male Male | 25 Participants | 47 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 63 |
| other Total, other adverse events | 0 / 67 | 0 / 63 |
| serious Total, serious adverse events | 0 / 67 | 0 / 63 |
Outcome results
Primary
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.
Time frame: Before intervention, up to 12 weeks after intervention
Population: Patients lost after 12 weeks of intervention.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SDM Intervention Group | The Change of Patients' Control Preference | Before intervention | Make final selection I will receive | 1 Participants |
| SDM Intervention Group | The Change of Patients' Control Preference | Before intervention | Make selection with doctor's opinion | 16 Participants |
| SDM Intervention Group | The Change of Patients' Control Preference | Before intervention | Make selection with doctor | 38 Participants |
| SDM Intervention Group | The Change of Patients' Control Preference | Before intervention | Make selection by doctor | 12 Participants |
| SDM Intervention Group | The Change of Patients' Control Preference | Up to 12 weeks after intervention | Make final selection I will receive | 0 Participants |
| SDM Intervention Group | The Change of Patients' Control Preference | Up to 12 weeks after intervention | Make selection with doctor's opinion | 1 Participants |
| SDM Intervention Group | The Change of Patients' Control Preference | Up to 12 weeks after intervention | Make selection with doctor | 52 Participants |
| SDM Intervention Group | The Change of Patients' Control Preference | Up to 12 weeks after intervention | Make selection by doctor | 3 Participants |
| Usual Care Group | The Change of Patients' Control Preference | Up to 12 weeks after intervention | Make selection by doctor | 3 Participants |
| Usual Care Group | The Change of Patients' Control Preference | Before intervention | Make final selection I will receive | 1 Participants |
| Usual Care Group | The Change of Patients' Control Preference | Up to 12 weeks after intervention | Make final selection I will receive | 3 Participants |
| Usual Care Group | The Change of Patients' Control Preference | Before intervention | Make selection with doctor's opinion | 14 Participants |
| Usual Care Group | The Change of Patients' Control Preference | Up to 12 weeks after intervention | Make selection with doctor | 51 Participants |
| Usual Care Group | The Change of Patients' Control Preference | Before intervention | Make selection with doctor | 35 Participants |
| Usual Care Group | The Change of Patients' Control Preference | Up to 12 weeks after intervention | Make selection with doctor's opinion | 0 Participants |
| Usual Care Group | The Change of Patients' Control Preference | Before intervention | Make selection by doctor | 12 Participants |
Primary
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.
Time frame: Before intervention, after intervention immediately, up to 12 weeks after intervention
Population: Patients lost after the intervention immediately and up to 12 weeks after intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SDM Intervention Group | The Change of Patients' Decision Self-efficacy | Up to 12 weeks after intervention | 84.01 score on a scale | Standard Deviation 18.61 |
| SDM Intervention Group | The Change of Patients' Decision Self-efficacy | Before intervention | 77.78 score on a scale | Standard Deviation 16.78 |
| SDM Intervention Group | The Change of Patients' Decision Self-efficacy | After intervention immediately | 88.57 score on a scale | Standard Deviation 10.03 |
| Usual Care Group | The Change of Patients' Decision Self-efficacy | After intervention immediately | 81.27 score on a scale | Standard Deviation 18.96 |
| Usual Care Group | The Change of Patients' Decision Self-efficacy | Before intervention | 79.51 score on a scale | Standard Deviation 19.31 |
| Usual Care Group | The Change of Patients' Decision Self-efficacy | Up to 12 weeks after intervention | 85.39 score on a scale | Standard Deviation 16.91 |
Secondary
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.
Time frame: After intervention immediately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SDM Intervention Group | Assess Decision Process Quality in Making the Decision | 87.47 score on a scale | Standard Deviation 12.3 |
| Usual Care Group | Assess Decision Process Quality in Making the Decision | 81.76 score on a scale | Standard Deviation 19.55 |
Secondary
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.
Time frame: After intervention immediately and up to 12 weeks after intervention
Population: Patients lost after up to 12 weeks after intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SDM Intervention Group | Assess Patients' Decisional Conflict | After intervention immediately | 10.30 score on a scale | Standard Deviation 10.46 |
| SDM Intervention Group | Assess Patients' Decisional Conflict | Up to 12 weeks after intervention | 15.77 score on a scale | Standard Deviation 17.56 |
| Usual Care Group | Assess Patients' Decisional Conflict | After intervention immediately | 18.25 score on a scale | Standard Deviation 18.44 |
| Usual Care Group | Assess Patients' Decisional Conflict | Up to 12 weeks after intervention | 15.27 score on a scale | Standard Deviation 14.75 |
Secondary
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.
Time frame: After intervention immediately, up to 12 weeks after the intervention
Population: The patients lost up to 12 weeks after the intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SDM Intervention Group | Assess Patients' Satisfaction With Decision | After intervention immediately | 26.29 score on a scale | Standard Deviation 3.4 |
| SDM Intervention Group | Assess Patients' Satisfaction With Decision | Up to 12 weeks after the intervention | 26.02 score on a scale | Standard Deviation 3.89 |
| Usual Care Group | Assess Patients' Satisfaction With Decision | After intervention immediately | 25.06 score on a scale | Standard Deviation 4.6 |
| Usual Care Group | Assess Patients' Satisfaction With Decision | Up to 12 weeks after the intervention | 25.44 score on a scale | Standard Deviation 4.71 |
Secondary
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.
Time frame: Before intervention, up to 12 weeks after intervention
Population: Patients lost up to 12 weeks after intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SDM Intervention Group | Assess the Degree of Disability of Lower Back Pain | Before intervention | 24.38 score on a scale | Standard Deviation 15.67 |
| SDM Intervention Group | Assess the Degree of Disability of Lower Back Pain | Up to 12 weeks after intervention | 24.22 score on a scale | Standard Deviation 31.06 |
| Usual Care Group | Assess the Degree of Disability of Lower Back Pain | Before intervention | 24.62 score on a scale | Standard Deviation 12.9 |
| Usual Care Group | Assess the Degree of Disability of Lower Back Pain | Up to 12 weeks after intervention | 21.12 score on a scale | Standard Deviation 25.2 |
Secondary
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.
Time frame: Before intervention, up to 12 weeks after intervention
Population: Patients lost up to 12 weeks after intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SDM Intervention Group | Assess the Quality of Healthy Living About Patients | Before intervention | 0.70 score on a scale | Standard Deviation 0.17 |
| SDM Intervention Group | Assess the Quality of Healthy Living About Patients | Up to 12 weeks after intervention | 0.86 score on a scale | Standard Deviation 0.17 |
| Usual Care Group | Assess the Quality of Healthy Living About Patients | Before intervention | 0.72 score on a scale | Standard Deviation 0.13 |
| Usual Care Group | Assess the Quality of Healthy Living About Patients | Up to 12 weeks after intervention | 0.85 score on a scale | Standard Deviation 0.18 |