The Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis
- Conditions
- Trapeziometacarpal Arthritis
- Interventions
- Behavioral: Decision Aid
- Registration Number
- NCT03181724
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The investigators plan a prospective randomized controlled study that compares whether the use of a decision aid results in different scores on variables reflective of the decision-making process, behavior, health outcomes, communication, and healthcare system.
- Detailed Description
Decision aids (shared decision making tools-websites, videos, or pamphlets) are interventions to prepare patients to make more informed decisions and satisfying decisions that match their preferences and values. With greater understanding of the risks and benefits of the treatment options patients may make a more informed choice.
Decision aids - delivered online, on paper, or on video - increase patient participation in the decision-making process,1 and can result in a decrease in discretionary surgery for knee osteoarthritis, herniated disk, and benign prostatic hypertrophy.2-4 They also reduce decisional conflict. Relatively few studies have investigated the influence of decision aids in orthopedic or hand surgery. Decision aids might affect decisional conflict, satisfaction, and outcomes in hand surgery where many treatments are discretionary and address quality of life.
Utilizing the Ottawa Decision Support Framework- an evidence-based, practical theory used to guide the development of decision aids - and the International Patient Decision Aid Standards criteria the investigators developed a decision aid for trapeziometacarpal arthritis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- at least 18 years of age
- English-speaking
- Diagnosis of trapeziometacarpal (TMC) arthritis
- Prior surgical intervention for trapeziometacarpal (TMC) arthritis
- Previously accessed or used the online TMC arthritis Decision Aid (DA)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Decision Aid Decision Aid Cohort that will receive a decision aid.
- Primary Outcome Measures
Name Time Method Decision Conflict Scale (DCS) Day 1 This scale measures patients' perception of uncertainty in making health-related decisions and consists of 3 subscales: (1) uncertainty choosing between different options, (2) modifiable factors contributing to this uncertainty-feeling uninformed, unclear about personal values, and feeling unsupported, and (3) perceived effectiveness of the decision-making an informed and values-based choice and expressing satisfaction with the decision. We used the validated statement format Decisional Conflict Scale, consisting of 16 items with 5 response options. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
- Secondary Outcome Measures
Name Time Method Change in Decision Regret Scale After 6 Weeks and 6 Months 6 week and 6 month follow up Change in the Decision Regret Scale, which measures distress or remorse after a health care decision. The scale consists of 5 questions, which range from strongly agree to strongly disagree, scoring 0-100 with higher scores indicating more regret.
Patient Health Questionnaire-2 (PHQ-2) Day 1 The PHQ-2 screens for depressive mood over the past 2 weeks. The score ranges from 0-6, where 0 is not at all depressed and 6 is major depression.
Consultation and Relational Empathy (CARE) Measure Day 1 The CARE measure is a 10-item questionnaire capturing patient perception of the physician's empathetic understanding under the office visit. Each item is rated on a 5-point Likert scale, yielding a total score from 0-50. A higher score indicates greater empathy.
11-point Ordinal Satisfaction Scale Day 1 The patient satisfaction scale measures how satisfied a patient is with their treatment for their thumb arthritis. Patients score satisfaction on a scale of 0 to 10, where 0 is not satisfied and 10 is extremely satisfied.
QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire Day 1 The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States