- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693094
A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decision conflict scale (DCS)
Time Frame: At enrollment
|
Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.
|
At enrollment
|
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.
|
At 6-week follow-up
|
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.
|
At 6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
11-point ordinal satisfaction scale
Time Frame: At enrollment
|
The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment
|
At enrollment
|
11-point ordinal satisfaction scale
Time Frame: At enrollment
|
11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.
|
At enrollment
|
Knowledge questionnaire
Time Frame: At Enrollment
|
The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.
|
At Enrollment
|
Stage of decision making
Time Frame: At Enrollment
|
The Stage of decision making is meant to gauge patients' progress in making a treatment decision.
|
At Enrollment
|
Decision Self-efficacy Scale
Time Frame: At enrollment
|
The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.
|
At enrollment
|
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. |
At Enrollment
|
Pain Self efficacy Questionnaire (PSEQ)
Time Frame: At enrollment
|
The PSEQ measures the efficacy of patients regarding pain.
|
At enrollment
|
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.
|
At enrollment
|
EuroQol-5D-5L Questionnaire (EQ-5D-5L)
Time Frame: At Enrollment
|
EQ-5D-5L measures the health outcome of the patient.
|
At Enrollment
|
Decision Regret scale
Time Frame: At the 6-month follow-up
|
The Decision Regret Scale measures distress or remorse after a health care decision.
|
At the 6-month follow-up
|
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
|
At the 6 week follow-up
|
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
|
At the 6 month follow-up
|
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.
|
At the 6 week follow-up
|
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.
|
At the 6 month follow-up
|
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.
|
At the 6 week follow-up
|
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.
|
At the 6 week follow-up
|
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.
|
At the 6 week follow-up
|
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.
|
At the 6 month follow-up
|
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.
|
At the 6 week follow-up
|
Change from the baseline in the Decision Self-Efficacy Scale at 6 months
Time Frame: At the 6 month follow-up
|
6-month change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions.
|
At the 6 month follow-up
|
Change from the baseline in the Acceptability questionnaire at 6 weeks
Time Frame: 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. |
At the 6-week follow-up
|
Change from the baseline in the Acceptability questionnaire at 6 months
Time Frame: 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. |
At the 6 month follow-up
|
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks
Time Frame: At the 6 week follow-up
|
6-week change in the PSEQ, which measures the efficacy of patients regarding pain.
|
At the 6 week follow-up
|
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months
Time Frame: At the 6 month follow-up
|
6-month change in the PSEQ, which measures the efficacy of patients regarding pain.
|
At the 6 month follow-up
|
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
|
6-week change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
|
At the 6 week follow-up
|
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
|
6-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
|
At the 6 month follow-up
|
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks
Time Frame: At the 6 week follow-up
|
6-week change in the EQ-5D-5L, which measures the health outcome of the patient.
|
At the 6 week follow-up
|
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months
Time Frame: At the 6 month follow-up
|
6-month change in the EQ-5D-5L, which measures the health outcome of the patient.
|
At the 6 month follow-up
|
Change in the Decision Regret scale at 6 months
Time Frame: At the 6 month follow-up
|
Change in the Decision Regret Scale, which measures distress or remorse after a health care decision.
|
At the 6 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neal Chen, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Fractures, Bone
- Wounds and Injuries
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Muscular Diseases
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Median Neuropathy
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Tendinopathy
- Arm Injuries
- Forearm Injuries
- Tendon Entrapment
- Ulnar Nerve Compression Syndromes
- Ulnar Neuropathies
- Wrist Injuries
- Syndrome
- Osteoarthritis
- Carpal Tunnel Syndrome
- Radius Fractures
- Trigger Finger Disorder
- Cubital Tunnel Syndrome
- Wrist Fractures
Other Study ID Numbers
- 2012P002281
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel Syndrome
-
Stanford UniversityMayo Clinic; Brown University; Duke University; Harvard University; University of...CompletedCarpal Tunnel Syndrome | Carpal Tunnel | Carpal Tunnel Syndrome Bilateral | Carpal Tunnel Syndrome Left | Carpal Tunnel Syndrome RightUnited States
-
Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
-
University of Split, School of MedicineCompletedCarpal Tunnel Syndrome BilateralCroatia
-
Ohio State UniversityCompletedBilateral Carpal Tunnel Syndrome (Diagnosis)United States
-
CMC Ambroise ParéCompletedCarpal Tunnel ReleaseFrance
-
Vanderbilt UniversityOrthopedic Research and Education FoundationCompleted
-
University of PittsburghWithdrawnPain After Carpal Tunnel ReleaseUnited States
-
Centre Hospitalier Saint Joseph Saint Luc de LyonRecruitingCarpal Tunnel Syndrome BilateralFrance
-
Istituto Ortopedico RizzoliCompletedEntrapment Neuropathy, Carpal Tunnel | Compression Neuropathy, Carpal Tunnel | Median Neuropathy, Carpal TunnelItaly
-
David TangRecruitingCarpal Tunnel Syndrome | Splints | Carpal Tunnel | Nerve Compression | Carpal Tunnel Release | Hand Injuries and DisordersCanada
Clinical Trials on Decision Aid
-
University of LeedsBaxter Healthcare Corporation; National Health Service, United Kingdom; Foundation... and other collaboratorsCompletedChronic Kidney FailureUnited Kingdom
-
Massachusetts General HospitalCompletedCoronary Artery Disease | Stable AnginaUnited States
-
University Hospital HeidelbergInnovationsfonds des Gemeinsamen Bundesausschusses, GermanyCompletedPatient Decision Aid | Treatment As UsualGermany
-
Massachusetts General HospitalUnknownDecision Making | Video Decision AidsUnited States
-
Kaiser PermanenteFoundation for Informed Medical Decision MakingCompletedObesity | Obesity, Morbid | Bariatric Surgery | Decision AidsUnited States
-
Case Comprehensive Cancer CenterCompletedProstate CancerUnited States
-
Duke UniversityFoundation for Informed Medical Decision MakingCompletedOsteoarthritisUnited States
-
University of UtahPatient-Centered Outcomes Research Institute; Mayo Clinic; Northwestern University and other collaboratorsActive, not recruitingAtrial FibrillationUnited States
-
University of MichiganNational Cancer Institute (NCI)Completed
-
Massachusetts General HospitalCompleted