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

NCT01693094 | Suspended

• 1 other identifier: 2012P002281
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Trapeziometacarpal Arthrosis; Carpal Tunnel Syndrome; Cubital Tunnel Syndrome; Distal Radius Fractures; Trigger Finger

Outcome Measures

Primary Outcomes (3)

• Decision conflict scale (DCS)

  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

  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

  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 Outcomes (29)

• 11-point ordinal satisfaction scale

  At enrollment

• 11-point ordinal satisfaction scale

  At enrollment

• Knowledge questionnaire

  At Enrollment

• Stage of decision making

  At Enrollment

• Decision Self-efficacy Scale

  At enrollment

Study Arms (2)

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.

Behavioral: Decision Aid

Interventions

Decision Aid BEHAVIORAL

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.

Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above
• Diagnosis of moderate or severe:
• ) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Cubital Tunnel Syndrome; Wrist Fractures; Trigger Finger Disorder

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Ulnar Neuropathies; Ulnar Nerve Compression Syndromes; Wrist Injuries; Arm Injuries; Fractures, Bone; Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Neal Chen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Hand Service

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 26, 2012
• Study Start: June 10, 2014
• Primary Completion: August 31, 2017
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)