Trapeziometacarpal ArthrosisNCT01693094
A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
A study testing Decision Aid in people with Trapeziometacarpal Arthrosis and Carpal Tunnel Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trapeziometacarpal Arthrosis, Carpal Tunnel Syndrome, Cubital Tunnel Syndrome
- What is being tested?
- Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2014to Jun 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above
- Diagnosis of moderate or severe:
- 2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Trapeziometacarpal Arthrosis, Carpal Tunnel Syndrome, Cubital Tunnel Syndrome, Distal Radius Fractures, Trigger Finger
- Being tested
- Decision Aid
- Medical subject headings
- Carpal Tunnel Syndrome, Cubital Tunnel Syndrome, Wrist Fractures, Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No decision aid | No intervention | One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment. |
| Decision Aid | Active comparator | One cohort will receive a decision aid. Receives: Behavioral: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision conflict scale (DCS)
Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action.
Measured: At enrollment
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.
Measured: At 6-week follow-up
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.
Measured: At 6 month follow-up
Secondary outcomes (29)
11-point ordinal satisfaction scale
The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment
Measured: At enrollment
11-point ordinal satisfaction scale
11-point ordinal satisfaction scale quantifies the satisfaction with decision-making.
Measured: At enrollment
Knowledge questionnaire
The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options.
Measured: At Enrollment
Stage of decision making
The Stage of decision making is meant to gauge patients' progress in making a treatment decision.
Measured: At Enrollment
Decision Self-efficacy Scale
The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions.
Measured: At enrollment
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.
Measured: At Enrollment
Pain Self efficacy Questionnaire (PSEQ)
The PSEQ measures the efficacy of patients regarding pain.
Measured: At enrollment
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.
Measured: At enrollment
EuroQol-5D-5L Questionnaire (EQ-5D-5L)
EQ-5D-5L measures the health outcome of the patient.
Measured: At Enrollment
Decision Regret scale
The Decision Regret Scale measures distress or remorse after a health care decision.
Measured: At the 6-month follow-up
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
Measured: At the 6 week follow-up
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
Measured: At the 6 month follow-up
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.
Measured: At the 6 week follow-up
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.
Measured: At the 6 month follow-up
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.
Measured: At the 6 week follow-up
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.
Measured: At the 6 week follow-up
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.
Measured: At the 6 week follow-up
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.
Measured: At the 6 month follow-up
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.
Measured: At the 6 week follow-up
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.
Measured: At the 6 month follow-up
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.
Measured: At the 6-week follow-up
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.
Measured: At the 6 month follow-up
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.
Measured: At the 6 week follow-up
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.
Measured: 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
6-week change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
Measured: 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
6-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
Measured: At the 6 month follow-up
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.
Measured: At the 6 week follow-up
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.
Measured: At the 6 month follow-up
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.
Measured: At the 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study start10 Jun 2014
- Primary completion31 Aug 2017
- Study completionJun 2027 (estimated)
Why it stopped: Not adequate number of staff to continue study at the moment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trapeziometacarpal ArthrosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Chung-Jen Chen, Massachusetts General Hospital
- Investigators
- Neal Chen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693094
- Sponsor's protocol ID
- 2012P002281
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2012
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
- ClinicalTrials.gov ID
- NCT01693094
- Acronym / sponsor ID
- 2012P002281
- Conditions
- Trapeziometacarpal Arthrosis, Carpal Tunnel Syndrome, Cubital Tunnel Syndrome, Distal Radius Fractures, Trigger Finger
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Not adequate number of staff to continue study at the moment.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Jun 2014 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No decision aid | No intervention | –One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment. |
| Decision Aid | Active comparator | Behavioral: Decision AidOne cohort will receive a decision aid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and above
- Diagnosis of moderate or severe:
- 2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidCohort 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. | Behavioural | Decision Aid |
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.
29 secondary outcomes
11-point ordinal satisfaction scale
Time frame: At enrollment
11-point ordinal satisfaction scale
Time frame: At enrollment
Knowledge questionnaire
Time frame: At Enrollment
Stage of decision making
Time frame: At Enrollment
Decision Self-efficacy Scale
Time frame: At enrollment
Acceptability
Time frame: At Enrollment
Pain Self efficacy Questionnaire (PSEQ)
Time frame: At enrollment
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
Time frame: At enrollment
EuroQol-5D-5L Questionnaire (EQ-5D-5L)
Time frame: At Enrollment
Decision Regret scale
Time frame: 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
Change from baseline in 11-point ordinal satisfaction scale at 6 months
Time frame: 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
Change from baseline in 11-point ordinal satisfaction scale at 6 months
Time frame: 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
Change from baseline in Stage of decision making at 6 months
Time frame: At the 6 week follow-up
Change from baseline in the Knowledge questionnaire at 6 weeks
Time frame: At the 6 week follow-up
Change from baseline in the Knowledge questionnaire at 6 months
Time frame: 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
Change from the baseline in the Decision Self-Efficacy Scale at 6 months
Time frame: 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
Change from the baseline in the Acceptability questionnaire at 6 months
Time frame: 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
Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months
Time frame: 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
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
Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks
Time frame: 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
Change in the Decision Regret scale at 6 months
Time frame: At the 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal Chen, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Trapeziometacarpal Arthrosis and Carpal Tunnel Syndrome, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision conflict scale (DCS) (time frame: At enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.