Clinical trial NCT01693094: A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Trapeziometacarpal Arthrosis
Carpal Tunnel Syndrome
Cubital Tunnel Syndrome
Distal Radius Fractures
Trigger Finger
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Decision conflict scale (DCS)
timeFrame: At enrollment
measure: Change from baseline in Decision conflict scale (DCS) at 6 weeks
timeFrame: At 6-week follow-up
measure: Change from baseline Decision conflict scale (DCS) at 6 months
timeFrame: At 6 month follow-up
Secondary outcomes:
measure: 11-point ordinal satisfaction scale
timeFrame: At enrollment
measure: 11-point ordinal satisfaction scale
timeFrame: At enrollment
measure: Knowledge questionnaire
timeFrame: At Enrollment
measure: Stage of decision making
timeFrame: At Enrollment
measure: Decision Self-efficacy Scale
timeFrame: At enrollment
measure: Acceptability
timeFrame: At Enrollment
measure: Pain Self efficacy Questionnaire (PSEQ)
timeFrame: At enrollment
measure: Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
timeFrame: At enrollment
measure: EuroQol-5D-5L Questionnaire (EQ-5D-5L)
timeFrame: At Enrollment
measure: Decision Regret scale
timeFrame: At the 6-month follow-up
measure: Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
timeFrame: At the 6 week follow-up
measure: Change from baseline in 11-point ordinal satisfaction scale at 6 months
timeFrame: At the 6 month follow-up
measure: Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
timeFrame: At the 6 week follow-up
measure: Change from baseline in 11-point ordinal satisfaction scale at 6 months
timeFrame: At the 6 month follow-up
measure: Change from baseline in Stage of decision making at 6 weeks
timeFrame: At the 6 week follow-up
measure: Change from baseline in Stage of decision making at 6 months
timeFrame: At the 6 week follow-up
measure: Change from baseline in the Knowledge questionnaire at 6 weeks
timeFrame: At the 6 week follow-up
measure: Change from baseline in the Knowledge questionnaire at 6 months
timeFrame: At the 6 month follow-up
measure: Change from baseline in the Decision Self-efficacy Scale at 6 weeks
timeFrame: At the 6 week follow-up
measure: Change from the baseline in the Decision Self-Efficacy Scale at 6 months
timeFrame: At the 6 month follow-up
measure: Change from the baseline in the Acceptability questionnaire at 6 weeks
timeFrame: At the 6-week follow-up
measure: Change from the baseline in the Acceptability questionnaire at 6 months
timeFrame: At the 6 month follow-up
measure: Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks
timeFrame: At the 6 week follow-up
measure: Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months
timeFrame: At the 6 month follow-up
measure: Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 weeks
timeFrame: At the 6 week follow-up
measure: Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months
timeFrame: At the 6 month follow-up
measure: Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks
timeFrame: At the 6 week follow-up
measure: Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months
timeFrame: At the 6 month follow-up
measure: Change in the Decision Regret scale at 6 months
timeFrame: At the 6 month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: