Quality of Care Clinical Trial
Official title:
Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases: A Cluster Randomized Controlled Trail
Verified date | December 2019 |
Source | Taipei Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | December 29, 2019 |
Est. primary completion date | December 29, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Before intervention, up to 12 weeks after intervention | |
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. | Before intervention, after intervention immediately, up to 12 weeks after intervention | |
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. | After intervention immediately | |
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. | After intervention immediately, up to 12 weeks after the intervention | |
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. | After intervention immediately and up to 12 weeks after intervention | |
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. | Before intervention, up to 12 weeks after intervention | |
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. | Before intervention, up to 12 weeks after intervention |
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