A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome
NCT ID: NCT01693094
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
SUSPENDED
NA
126 participants
INTERVENTIONAL
2014-06-10
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Testing of a Tool to Elicit Patient Preferences for CTS
NCT03532373
Cost Information on Carpal Tunnel Syndrome Treatment Decisions
NCT03880812
Decision Making in Hypothetical Carpal Tunnel Syndrome
NCT03730376
Question Prompt List for Common Hand Conditions
NCT03868449
Trigger Finger Preference Elicitation Tool
NCT03909490
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No decision aid
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.
No interventions assigned to this group
Decision Aid
One cohort will receive a decision aid.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of moderate or severe:
2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)
Exclusion Criteria
* Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Neal Chung-Jen Chen
Principal Investigator, Hand Service
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neal Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012P002281
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.