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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title:

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 Summary:

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.

Sponsor: Massachusetts General Hospital

Current Primary Outcome:

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 11-point ordinal satisfaction scale [ Time Frame: At enrollment ]
  The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment
• 11-point ordinal satisfaction scale [ Time Frame: At enrollment ]
  11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.
• Knowledge questionnaire [ Time Frame: At Enrollment ]
  The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.
• Stage of decision making [ Time Frame: At Enrollment ]
  The Stage of decision making is meant to gauge patients' progress in making a treatment decision.
• Decision Self-efficacy Scale [ Time Frame: At enrollment ]
  The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.
• Acceptability [ Time Frame: 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) [ Time Frame: At enrollment ]
  The PSEQ measures the efficacy of patients regarding pain.
• Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) [ Time Frame: 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) [ Time Frame: At Enrollment ]
  EQ-5D-5L measures the health outcome of the patient.
• Decision Regret scale [ Time Frame: 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 [ Time Frame: At the 6 week follow-up ]
  6-week change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
• Change from baseline in 11-point ordinal satisfaction scale at 6 months [ Time Frame: At the 6 month follow-up ]
  6-month change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
• Change from baseline in 11-point ordinal satisfaction scale at 6 weeks [ Time Frame: 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 11-point ordinal satisfaction scale at 6 months [ Time Frame: 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 baseline in Stage of decision making at 6 weeks [ Time Frame: 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 Stage of decision making at 6 months [ Time Frame: 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 from baseline in the Knowledge questionnaire at 6 weeks [ Time Frame: 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 Knowledge questionnaire at 6 months [ Time Frame: At the 6 month follow-up ]
  6-month 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 [ Time Frame: At the 6 week follow-up ]
  6-week change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
• Same as current
  
  Information By: Massachusetts General Hospital
  

  Dates:
  Date Received: September 13, 2012
  Date Started: September 2012
  Date Completion:
  Last Updated: December 20, 2016
  Last Verified: December 2016