A Randomized Trial Measuring 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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trapeziometacarpal Arthritis
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Decision Conflict Scale (DCS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Neal Chung-Jen Chen
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •at least 18 years of age
- •English-speaking
- •Diagnosis of trapeziometacarpal (TMC) arthritis
Exclusion Criteria
- •Prior surgical intervention for trapeziometacarpal (TMC) arthritis
- •Previously accessed or used the online TMC arthritis Decision Aid (DA)
Outcomes
Primary Outcomes
Decision Conflict Scale (DCS)
Time Frame: 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 Outcomes
- Change in Decision Regret Scale After 6 Weeks and 6 Months(6 week and 6 month follow up)
- Patient Health Questionnaire-2 (PHQ-2)(Day 1)
- Consultation and Relational Empathy (CARE) Measure(Day 1)
- 11-point Ordinal Satisfaction Scale(Day 1)
- QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire(Day 1)