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

Not Applicable

Suspended

• Conditions: Cubital Tunnel Syndrome; Distal Radius Fractures; Trapeziometacarpal Arthrosis; Carpal Tunnel Syndrome; Trigger Finger
• Interventions: Behavioral: Decision Aid

• Registration Number: NCT01693094
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-26
• Study Start: 2014-06-10
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 126

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision Aid	Decision Aid	One cohort will receive a decision aid.

Primary Outcome Measures

Name	Time	Method
Decision conflict scale (DCS)	At enrollment	Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.
Change from baseline Decision conflict scale (DCS) at 6 months	At 6 month follow-up	6-month Change in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
Change from baseline in Decision conflict scale (DCS) at 6 weeks	At 6-week follow-up	Change from baseline in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.

Secondary Outcome Measures

Name	Time	Method
Knowledge questionnaire	At Enrollment	The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)	At enrollment	The Quick-DASH measures the patient's ability to do following activities in the week before a visit.
EuroQol-5D-5L Questionnaire (EQ-5D-5L)	At Enrollment	EQ-5D-5L measures the health outcome of the patient.
Change from baseline in 11-point ordinal satisfaction scale at 6 months	At the 6 month follow-up	6-month change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
Change from the baseline in the Acceptability questionnaire at 6 months	At the 6 month follow-up	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.
Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months	At the 6 month follow-up	6-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks	At the 6 week follow-up	6-week change in the EQ-5D-5L, which measures the health outcome of the patient.
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months	At the 6 month follow-up	6-month change in the EQ-5D-5L, which measures the health outcome of the patient.
11-point ordinal satisfaction scale	At enrollment	11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.
Decision Regret scale	At the 6-month follow-up	The Decision Regret Scale measures distress or remorse after a health care decision.
Change from baseline in 11-point ordinal satisfaction scale at 6 weeks	At the 6 week follow-up	6-week change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
Change from baseline in the Knowledge questionnaire at 6 weeks	At the 6 week follow-up	6-week change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
Change from baseline in the Decision Self-efficacy Scale at 6 weeks	At the 6 week follow-up	6-week change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
Change from the baseline in the Decision Self-Efficacy Scale at 6 months	At the 6 month follow-up	6-month change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
Change from the baseline in the Acceptability questionnaire at 6 weeks	At the 6-week follow-up	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.
Stage of decision making	At Enrollment	The Stage of decision making is meant to gauge patients' progress in making a treatment decision.
Decision Self-efficacy Scale	At enrollment	The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.
Acceptability	At Enrollment	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.
Pain Self efficacy Questionnaire (PSEQ)	At enrollment	The PSEQ measures the efficacy of patients regarding pain.
Change from baseline in Stage of decision making at 6 weeks	At the 6 week follow-up	6-week change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
Change from baseline in the Knowledge questionnaire at 6 months	At the 6 month follow-up	6-month change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months	At the 6 month follow-up	6-month change in the PSEQ, which measures the efficacy of patients regarding pain.
Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 weeks	At the 6 week follow-up	6-week change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
Change from baseline in Stage of decision making at 6 months	At the 6 week follow-up	6-month change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks	At the 6 week follow-up	6-week change in the PSEQ, which measures the efficacy of patients regarding pain.
Change in the Decision Regret scale at 6 months	At the 6 month follow-up	Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States