N/A
N=90
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
Trapeziometacarpal Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03181724 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Decision Conflict Scale (DCS) — 9.3; 17 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision Aid (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decision Conflict Scale (DCS) |
9.3; 17 | — |
| SECONDARY QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire |
5.3; 5.6 | — |
| SECONDARY Patient Health Questionnaire-2 (PHQ-2) |
0.44; 0.98 | — |
| SECONDARY Consultation and Relational Empathy (CARE) Measure |
47; 45 | — |
| SECONDARY 11-point Ordinal Satisfaction Scale |
9.5; 9.4 | — |
| SECONDARY Change in Decision Regret Scale After 6 Weeks and 6 Months |
20; 26; 23; 27 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03181724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.