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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01693094
First received: September 13, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Trapeziometacarpal Arthrosis
Carpal Tunnel Syndrome
Cubital Tunnel Syndrome
Distal Radius Fractures
Trigger Finger
Behavioral: Decision Aid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Decision conflict scale (DCS) [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    6-month Change in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.


Secondary Outcome Measures:
  • 11-point ordinal satisfaction scale [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment

  • 11-point ordinal satisfaction scale [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.

  • Knowledge questionnaire [ Time Frame: At Enrollment ] [ Designated as safety issue: No ]
    The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.

  • Stage of decision making [ Time Frame: At Enrollment ] [ Designated as safety issue: No ]
    The Stage of decision making is meant to gauge patients' progress in making a treatment decision.

  • Decision Self-efficacy Scale [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.

  • Acceptability [ Time Frame: At Enrollment ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    The PSEQ measures the efficacy of patients regarding pain.

  • Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    EQ-5D-5L measures the health outcome of the patient.

  • Decision Regret scale [ Time Frame: At the 6-month follow-up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the 6 month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the 6-week follow-up ] [ Designated as safety issue: No ]

    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.


  • Change from the baseline in the Acceptability questionnaire at 6 months [ Time Frame: At the 6 month follow-up ] [ Designated as safety issue: No ]

    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 in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks [ Time Frame: At the 6 week follow-up ] [ Designated as safety issue: No ]
    6-week change in the PSEQ, which measures the efficacy of patients regarding pain.

  • Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months [ Time Frame: At the 6 month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the 6 week follow-up ] [ Designated as safety issue: No ]
    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 the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months [ Time Frame: At the 6 month follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the 6 week follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: At the 6 month follow-up ] [ Designated as safety issue: No ]
    6-month change in the EQ-5D-5L, which measures the health outcome of the patient.

  • Change in the Decision Regret scale at 6 months [ Time Frame: At the 6 month follow-up ] [ Designated as safety issue: No ]
    Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.


Estimated Enrollment: 126
Study Start Date: September 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No decision aid
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
Active Comparator: Decision Aid
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

    1. Trapeziometacarpal Arthrosis (TMC)
    2. Carpal Tunnel Syndrome (CTS)
    3. Cubital Tunnel Syndrome (CTD)
    4. Distal Radius Fractures (DRF)
    5. Trigger Finger (TF)

Exclusion Criteria:

  • Patients with previous interventions for TMC, CTS, CTD, DRF, or TF
  • Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693094

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David Ring Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: David C. Ring, MD, Director of Research, Hand Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01693094     History of Changes
Other Study ID Numbers: 2012P002281
Study First Received: September 13, 2012
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cubital Tunnel Syndrome
Carpal Tunnel Syndrome
Radius Fractures
Syndrome
Trigger Finger Disorder
Arm Injuries
Cumulative Trauma Disorders
Disease
Forearm Injuries
Fractures, Bone
Median Neuropathy
Mononeuropathies
Muscular Diseases
Musculoskeletal Diseases
Nerve Compression Syndromes
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Peripheral Nervous System Diseases
Sprains and Strains
Tendinopathy
Tendon Entrapment
Tenosynovitis
Ulnar Nerve Compression Syndromes
Ulnar Neuropathies
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014