A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome

Carpal Tunnel Syndrome Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01693094
• Other study ID #: 2012P002281
• Status: Suspended
• Phase: N/A
• Start date: June 10, 2014
• Est. completion date: June 2026

Study information

• Verified date: June 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 126
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and above
• Diagnosis of moderate or severe:

2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Cubital Tunnel Syndrome
• Distal Radius Fractures
• Osteoarthritis
• Radius Fractures
• Syndrome
• Trapeziometacarpal Arthrosis
• Trigger Finger
• Trigger Finger Disorder
• Wrist Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision conflict scale (DCS)	Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.	At enrollment
Primary	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.	At 6-week follow-up
Primary	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.	At 6 month follow-up
Secondary	11-point ordinal satisfaction scale	The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment	At enrollment
Secondary	11-point ordinal satisfaction scale	11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.	At enrollment
Secondary	Knowledge questionnaire	The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.	At Enrollment
Secondary	Stage of decision making	The Stage of decision making is meant to gauge patients' progress in making a treatment decision.	At Enrollment
Secondary	Decision Self-efficacy Scale	The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.	At enrollment
Secondary	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.	At Enrollment
Secondary	Pain Self efficacy Questionnaire (PSEQ)	The PSEQ measures the efficacy of patients regarding pain.	At enrollment
Secondary	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.	At enrollment
Secondary	EuroQol-5D-5L Questionnaire (EQ-5D-5L)	EQ-5D-5L measures the health outcome of the patient.	At Enrollment
Secondary	Decision Regret scale	The Decision Regret Scale measures distress or remorse after a health care decision.	At the 6-month follow-up
Secondary	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	At the 6 week follow-up
Secondary	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	At the 6 month follow-up
Secondary	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.	At the 6 week follow-up
Secondary	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.	At the 6 month follow-up
Secondary	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.	At the 6 week follow-up
Secondary	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.	At the 6 week follow-up
Secondary	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.	At the 6 week follow-up
Secondary	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.	At the 6 month follow-up
Secondary	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.	At the 6 week follow-up
Secondary	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.	At the 6 month follow-up
Secondary	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.	At the 6-week follow-up
Secondary	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.	At the 6 month follow-up
Secondary	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.	At the 6 week follow-up
Secondary	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.	At the 6 month follow-up
Secondary	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.	At the 6 week follow-up
Secondary	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.	At the 6 month follow-up
Secondary	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.	At the 6 week follow-up
Secondary	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.	At the 6 month follow-up
Secondary	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.	At the 6 month follow-up