An interventional study of Decision Aid in Trapeziometacarpal Arthrosis, Carpal Tunnel Syndrome and Cubital Tunnel Syndrome, sponsored by Massachusetts General Hospital. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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.
587 studies on the registry are indexed under Carpal Tunnel Syndrome; 134 are open to participants now.
This study's enrollment of 126 is above the median of 60 across 443 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of moderate or severe:
2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)
Exclusion Criteria:
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
One cohort will receive a decision aid.
Behavioral: Decision Aid
Cohort I will be managed with a decision aid (henceforth "DA"), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them.
Decision conflict scale (DCS)
Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.
Time frame: At enrollment
Change from baseline in Decision conflict scale (DCS) at 6 weeks
Change from baseline in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
Time frame: At 6-week follow-up
Change from baseline Decision conflict scale (DCS) at 6 months
6-month Change in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
Time frame: At 6 month follow-up
11-point ordinal satisfaction scale
The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment
Time frame: At enrollment
11-point ordinal satisfaction scale
11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.
Time frame: At enrollment
Knowledge questionnaire
The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.
Time frame: At Enrollment
Stage of decision making
The Stage of decision making is meant to gauge patients' progress in making a treatment decision.
Time frame: At Enrollment
Decision Self-efficacy Scale
The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.
Time frame: At enrollment
Acceptability
The Acceptability questionnaire measures the acceptability of the decision aid, including the content of the decision aid. It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.
Time frame: At Enrollment
Pain Self efficacy Questionnaire (PSEQ)
The PSEQ measures the efficacy of patients regarding pain.
Time frame: At enrollment
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
The Quick-DASH measures the patient's ability to do following activities in the week before a visit.
Time frame: At enrollment
EuroQol-5D-5L Questionnaire (EQ-5D-5L)
EQ-5D-5L measures the health outcome of the patient.
Time frame: At Enrollment
Decision Regret scale
The Decision Regret Scale measures distress or remorse after a health care decision.
Time frame: At the 6-month follow-up
Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
6-week change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
Time frame: At the 6 week follow-up
Change from baseline in 11-point ordinal satisfaction scale at 6 months
6-month change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
Time frame: At the 6 month follow-up
Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
6-week change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
Time frame: At the 6 week follow-up
Change from baseline in 11-point ordinal satisfaction scale at 6 months
6-month change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
Time frame: At the 6 month follow-up
Change from baseline in Stage of decision making at 6 weeks
6-week change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
Time frame: At the 6 week follow-up
Change from baseline in Stage of decision making at 6 months
6-month change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
Time frame: At the 6 week follow-up
Change from baseline in the Knowledge questionnaire at 6 weeks
6-week change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
Time frame: At the 6 week follow-up
Change from baseline in the Knowledge questionnaire at 6 months
6-month change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
Time frame: At the 6 month follow-up
Change from baseline in the Decision Self-efficacy Scale at 6 weeks
6-week change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
Time frame: At the 6 week follow-up
Change from the baseline in the Decision Self-Efficacy Scale at 6 months
6-month change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
Time frame: At the 6 month follow-up
Change from the baseline in the Acceptability questionnaire at 6 weeks
6-week change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid. It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.
Time frame: At the 6-week follow-up
Change from the baseline in the Acceptability questionnaire at 6 months
6-month change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid. It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making.
Time frame: At the 6 month follow-up
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks
6-week change in the PSEQ, which measures the efficacy of patients regarding pain.
Time frame: At the 6 week follow-up
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months
6-month change in the PSEQ, which measures the efficacy of patients regarding pain.
Time frame: 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
6-week change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
Time frame: At the 6 week follow-up
Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months
6-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
Time frame: At the 6 month follow-up
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks
6-week change in the EQ-5D-5L, which measures the health outcome of the patient.
Time frame: At the 6 week follow-up
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months
6-month change in the EQ-5D-5L, which measures the health outcome of the patient.
Time frame: At the 6 month follow-up
Change in the Decision Regret scale at 6 months
Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.
Time frame: At the 6 month follow-up
Ran from Jun 2014 to primary completion in Aug 2017, 38 months.
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