Trial Outcomes & Findings for Effectiveness of Implementing Shared Decision-Making on Quality of Care Among Patients With Lumbar Degenerative Diseases. (NCT NCT03679494)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

130 participants

Primary outcome timeframe

Before intervention, up to 12 weeks after intervention

Results posted on

2020-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	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	Usual Care Group No intervention, just continue using usual care
Overall Study STARTED	67	63
Overall Study COMPLETED	67	63
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SDM Intervention Group n=67 Participants 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	Usual Care Group n=63 Participants No intervention, just continue using usual care	Total n=130 Participants Total of all reporting groups
Age, Continuous	56.46 years STANDARD_DEVIATION 14.853 • n=93 Participants	55.78 years STANDARD_DEVIATION 15.315 • n=4 Participants	56.13 years STANDARD_DEVIATION 15.024 • n=27 Participants
Sex: Female, Male Female	45 Participants n=93 Participants	38 Participants n=4 Participants	83 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	25 Participants n=4 Participants	47 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	67 Participants n=93 Participants	63 Participants n=4 Participants	130 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Before intervention, up to 12 weeks after intervention

Population: Patients lost after 12 weeks of 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.

Outcome measures

Outcome measures
Measure	SDM Intervention Group n=67 Participants 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	Usual Care Group n=62 Participants No intervention, just continue using usual care
The Change of Patients' Control Preference Before intervention · Make final selection I will receive	1 Participants	1 Participants
The Change of Patients' Control Preference Before intervention · Make selection with doctor's opinion	16 Participants	14 Participants
The Change of Patients' Control Preference Up to 12 weeks after intervention · Make final selection I will receive	0 Participants	3 Participants
The Change of Patients' Control Preference Up to 12 weeks after intervention · Make selection with doctor's opinion	1 Participants	0 Participants
The Change of Patients' Control Preference Before intervention · Make selection with doctor	38 Participants	35 Participants
The Change of Patients' Control Preference Before intervention · Make selection by doctor	12 Participants	12 Participants
The Change of Patients' Control Preference Up to 12 weeks after intervention · Make selection with doctor	52 Participants	51 Participants
The Change of Patients' Control Preference Up to 12 weeks after intervention · Make selection by doctor	3 Participants	3 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	SDM Intervention Group n=67 Participants 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	Usual Care Group n=62 Participants No intervention, just continue using usual care
The Change of Patients' Decision Self-efficacy Up to 12 weeks after intervention	84.01 score on a scale Standard Deviation 18.61	85.39 score on a scale Standard Deviation 16.91
The Change of Patients' Decision Self-efficacy Before intervention	77.78 score on a scale Standard Deviation 16.78	79.51 score on a scale Standard Deviation 19.31
The Change of Patients' Decision Self-efficacy After intervention immediately	88.57 score on a scale Standard Deviation 10.03	81.27 score on a scale Standard Deviation 18.96

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SDM Intervention Group n=66 Participants 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	Usual Care Group n=62 Participants No intervention, just continue using usual care
Assess Decision Process Quality in Making the Decision	87.47 score on a scale Standard Deviation 12.30	81.76 score on a scale Standard Deviation 19.55

SECONDARY outcome

Timeframe: After intervention immediately, up to 12 weeks after the intervention

Population: The patients lost 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.

Outcome measures

Outcome measures
Measure	SDM Intervention Group n=66 Participants 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	Usual Care Group n=62 Participants No intervention, just continue using usual care
Assess Patients' Satisfaction With Decision After intervention immediately	26.29 score on a scale Standard Deviation 3.40	25.06 score on a scale Standard Deviation 4.60
Assess Patients' Satisfaction With Decision Up to 12 weeks after the intervention	26.02 score on a scale Standard Deviation 3.89	25.44 score on a scale Standard Deviation 4.71

SECONDARY outcome

Timeframe: After intervention immediately and up to 12 weeks after intervention

Population: Patients lost after 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.

Outcome measures

Outcome measures
Measure	SDM Intervention Group n=66 Participants 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	Usual Care Group n=62 Participants No intervention, just continue using usual care
Assess Patients' Decisional Conflict After intervention immediately	10.30 score on a scale Standard Deviation 10.46	18.25 score on a scale Standard Deviation 18.44
Assess Patients' Decisional Conflict Up to 12 weeks after intervention	15.77 score on a scale Standard Deviation 17.56	15.27 score on a scale Standard Deviation 14.75

SECONDARY outcome

Timeframe: Before intervention, up to 12 weeks after intervention

Population: Patients lost 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.

Outcome measures

Outcome measures
Measure	SDM Intervention Group n=67 Participants 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	Usual Care Group n=62 Participants No intervention, just continue using usual care
Assess the Degree of Disability of Lower Back Pain Before intervention	24.38 score on a scale Standard Deviation 15.67	24.62 score on a scale Standard Deviation 12.90
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	21.12 score on a scale Standard Deviation 25.20

SECONDARY outcome

Timeframe: Before intervention, up to 12 weeks after intervention

Population: Patients lost 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.

Outcome measures

Outcome measures
Measure	SDM Intervention Group n=67 Participants 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	Usual Care Group n=62 Participants No intervention, just continue using usual care
Assess the Quality of Healthy Living About Patients Up to 12 weeks after intervention	0.86 score on a scale Standard Deviation 0.17	0.85 score on a scale Standard Deviation 0.18
Assess the Quality of Healthy Living About Patients Before intervention	0.70 score on a scale Standard Deviation 0.17	0.72 score on a scale Standard Deviation 0.13

Adverse Events

SDM Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MS. Po-Yao Chiu

Taipei MU

Phone: +886-2-27361661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place