A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Decision conflict scale (DCS)
研究概览
简要总结
The investigators plan a prospective randomized controlled study that compares the treatment decisions made by patients who receive decision aids, as compared to patients treated with usual care and the American Society for Surgery of the Hand brochures. The investigators expect to enroll 126 patients.
详细描述
Decision aids are tools that help patients participate in making decisions by providing detailed, specific, and personalized information regarding the benefits and risks of various potential treatment options for a diagnosis. Decision aids can reduce the level of uncertainty and mental anguish associated with choosing a particular course of action, i.e. 'decisional conflict'. The most common manifestations of decisional conflict include verbalized uncertainty about choices or undesired consequences of alternatives, vacillation between choices, and delayed decision making.
Besides the advantages of decision aids in the process of decision-making, the literature is not conclusive about the effect of decision aids on patient satisfaction. Of the 86 randomized controlled trials identified by authors Stacey et al., eleven studies measured satisfaction. Of these, four studies reported that people exposed to decision aids had higher satisfaction with their choice compared to usual care, and the remaining seven reported no statistically significant difference.
Studies that have directly investigated the effect of decision aids in orthopaedic practice are limited and further study is necessary to determine the best way to implement decision aids in a clinical orthopedic practice. 7-12 Randomized trials evaluating the impact of decision aids on patient knowledge, decisional conflict, satisfaction, and outcomes may have substantial impact in hand surgery where most treatments are elective and address quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above
- •Diagnosis of moderate or severe:
- •2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)
排除标准
- •Patients with previous interventions for CTS or TF
- •Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
研究组 & 干预措施
No decision aid
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
Decision Aid
One cohort will receive a decision aid.
干预措施: Decision Aid (Behavioral)
结局指标
主要结局
Decision conflict scale (DCS)
时间窗: At enrollment
Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.
Change from baseline Decision conflict scale (DCS) at 6 months
时间窗: At 6 month follow-up
6-month Change in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
Change from baseline in Decision conflict scale (DCS) at 6 weeks
时间窗: At 6-week follow-up
Change from baseline in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
次要结局
- Knowledge questionnaire(At Enrollment)
- Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)(At enrollment)
- EuroQol-5D-5L Questionnaire (EQ-5D-5L)(At Enrollment)
- Change from the baseline in the Acceptability questionnaire at 6 months(At the 6 month follow-up)
- Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months(At the 6 month follow-up)
- Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks(At the 6 week follow-up)
- Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months(At the 6 month follow-up)
- Decision Regret scale(At the 6-month follow-up)
- Change from baseline in the Knowledge questionnaire at 6 weeks(At the 6 week follow-up)
- Change from baseline in the Decision Self-efficacy Scale at 6 weeks(At the 6 week follow-up)
- Change from the baseline in the Decision Self-Efficacy Scale at 6 months(At the 6 month follow-up)
- Change from the baseline in the Acceptability questionnaire at 6 weeks(At the 6-week follow-up)
- Stage of decision making(At Enrollment)
- Decision Self-efficacy Scale(At enrollment)
- Acceptability(At Enrollment)
- Pain Self efficacy Questionnaire (PSEQ)(At enrollment)
- Change from baseline in Stage of decision making at 6 weeks(At the 6 week follow-up)
- Change from baseline in the Knowledge questionnaire at 6 months(At the 6 month follow-up)
- Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months(At the 6 month follow-up)
- Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 weeks(At the 6 week follow-up)
- Change from baseline in Stage of decision making at 6 months(At the 6 week follow-up)
- Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks(At the 6 week follow-up)
- Change in the Decision Regret scale at 6 months(At the 6 month follow-up)
- 11-point ordinal satisfaction scale(At enrollment)
- Change from baseline in 11-point ordinal satisfaction scale at 6 weeks(At the 6 week follow-up)
- Change from baseline in 11-point ordinal satisfaction scale at 6 months(At the 6 month follow-up)
研究者
Neal Chung-Jen Chen
Principal Investigator, Hand Service
Massachusetts General Hospital