A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
Primary Purpose
Trapeziometacarpal Arthrosis, Carpal Tunnel Syndrome, Cubital Tunnel Syndrome
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
About this trial
This is an interventional treatment trial for Trapeziometacarpal Arthrosis
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).
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No decision aid
Decision Aid
Arm Description
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
One cohort will receive a decision aid.
Outcomes
Primary Outcome Measures
Decision conflict scale (DCS)
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
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
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
The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment
11-point ordinal satisfaction scale
11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.
Knowledge questionnaire
The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.
Stage of decision making
The Stage of decision making is meant to gauge patients' progress in making a treatment decision.
Decision Self-efficacy Scale
The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.
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.
Pain Self efficacy Questionnaire (PSEQ)
The PSEQ measures the efficacy of patients regarding pain.
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.
EuroQol-5D-5L Questionnaire (EQ-5D-5L)
EQ-5D-5L measures the health outcome of the patient.
Decision Regret scale
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.
Full Information
NCT ID
NCT01693094
First Posted
September 13, 2012
Last Updated
June 11, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01693094
Brief Title
A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
Not adequate number of staff to continue study at the moment.
Study Start Date
June 10, 2014 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trapeziometacarpal Arthrosis, Carpal Tunnel Syndrome, Cubital Tunnel Syndrome, Distal Radius Fractures, Trigger Finger
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No decision aid
Arm Type
No Intervention
Arm Description
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
Arm Title
Decision Aid
Arm Type
Active Comparator
Arm Description
One cohort will receive a decision aid.
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decision conflict scale (DCS)
Description
Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.
Time Frame
At enrollment
Title
Change from baseline in Decision conflict scale (DCS) at 6 weeks
Description
Change from baseline in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
Time Frame
At 6-week follow-up
Title
Change from baseline Decision conflict scale (DCS) at 6 months
Description
6-month Change in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action.
Time Frame
At 6 month follow-up
Secondary Outcome Measure Information:
Title
11-point ordinal satisfaction scale
Description
The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment
Time Frame
At enrollment
Title
11-point ordinal satisfaction scale
Description
11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.
Time Frame
At enrollment
Title
Knowledge questionnaire
Description
The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.
Time Frame
At Enrollment
Title
Stage of decision making
Description
The Stage of decision making is meant to gauge patients' progress in making a treatment decision.
Time Frame
At Enrollment
Title
Decision Self-efficacy Scale
Description
The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.
Time Frame
At enrollment
Title
Acceptability
Description
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.
Time Frame
At Enrollment
Title
Pain Self efficacy Questionnaire (PSEQ)
Description
The PSEQ measures the efficacy of patients regarding pain.
Time Frame
At enrollment
Title
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
Description
The Quick-DASH measures the patient's ability to do following activities in the week before a visit.
Time Frame
At enrollment
Title
EuroQol-5D-5L Questionnaire (EQ-5D-5L)
Description
EQ-5D-5L measures the health outcome of the patient.
Time Frame
At Enrollment
Title
Decision Regret scale
Description
The Decision Regret Scale measures distress or remorse after a health care decision.
Time Frame
At the 6-month follow-up
Title
Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
Description
6-week change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
Time Frame
At the 6 week follow-up
Title
Change from baseline in 11-point ordinal satisfaction scale at 6 months
Description
6-month change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment
Time Frame
At the 6 month follow-up
Title
Change from baseline in 11-point ordinal satisfaction scale at 6 weeks
Description
6-week change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
Time Frame
At the 6 week follow-up
Title
Change from baseline in 11-point ordinal satisfaction scale at 6 months
Description
6-month change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making.
Time Frame
At the 6 month follow-up
Title
Change from baseline in Stage of decision making at 6 weeks
Description
6-week change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
Time Frame
At the 6 week follow-up
Title
Change from baseline in Stage of decision making at 6 months
Description
6-month change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision.
Time Frame
At the 6 week follow-up
Title
Change from baseline in the Knowledge questionnaire at 6 weeks
Description
6-week change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
Time Frame
At the 6 week follow-up
Title
Change from baseline in the Knowledge questionnaire at 6 months
Description
6-month change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options.
Time Frame
At the 6 month follow-up
Title
Change from baseline in the Decision Self-efficacy Scale at 6 weeks
Description
6-week change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
Time Frame
At the 6 week follow-up
Title
Change from the baseline in the Decision Self-Efficacy Scale at 6 months
Description
6-month change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
Time Frame
At the 6 month follow-up
Title
Change from the baseline in the Acceptability questionnaire at 6 weeks
Description
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.
Time Frame
At the 6-week follow-up
Title
Change from the baseline in the Acceptability questionnaire at 6 months
Description
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.
Time Frame
At the 6 month follow-up
Title
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks
Description
6-week change in the PSEQ, which measures the efficacy of patients regarding pain.
Time Frame
At the 6 week follow-up
Title
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months
Description
6-month change in the PSEQ, which measures the efficacy of patients regarding pain.
Time Frame
At the 6 month follow-up
Title
Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 weeks
Description
6-week change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
Time Frame
At the 6 week follow-up
Title
Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months
Description
6-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
Time Frame
At the 6 month follow-up
Title
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks
Description
6-week change in the EQ-5D-5L, which measures the health outcome of the patient.
Time Frame
At the 6 week follow-up
Title
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months
Description
6-month change in the EQ-5D-5L, which measures the health outcome of the patient.
Time Frame
At the 6 month follow-up
Title
Change in the Decision Regret scale at 6 months
Description
Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.
Time Frame
At the 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Chen, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
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