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The Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis

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Mass General Brigham

Status

Completed

Conditions

Trapeziometacarpal Arthritis

Treatments

Behavioral: Decision Aid

Study type

Interventional

Funder types

Other

Identifiers

NCT03181724
2015P002550

Details and patient eligibility

About

The investigators plan a prospective randomized controlled study that compares whether the use of a decision aid results in different scores on variables reflective of the decision-making process, behavior, health outcomes, communication, and healthcare system.

Full description

Decision aids (shared decision making tools-websites, videos, or pamphlets) are interventions to prepare patients to make more informed decisions and satisfying decisions that match their preferences and values. With greater understanding of the risks and benefits of the treatment options patients may make a more informed choice.

Decision aids - delivered online, on paper, or on video - increase patient participation in the decision-making process,1 and can result in a decrease in discretionary surgery for knee osteoarthritis, herniated disk, and benign prostatic hypertrophy.2-4 They also reduce decisional conflict. Relatively few studies have investigated the influence of decision aids in orthopedic or hand surgery. Decision aids might affect decisional conflict, satisfaction, and outcomes in hand surgery where many treatments are discretionary and address quality of life.

Utilizing the Ottawa Decision Support Framework- an evidence-based, practical theory used to guide the development of decision aids - and the International Patient Decision Aid Standards criteria the investigators developed a decision aid for trapeziometacarpal arthritis.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • at least 18 years of age
  • English-speaking
  • Diagnosis of trapeziometacarpal (TMC) arthritis

Exclusion criteria

  • Prior surgical intervention for trapeziometacarpal (TMC) arthritis
  • Previously accessed or used the online TMC arthritis Decision Aid (DA)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Decision Aid
Active Comparator group
Description:
Cohort that will receive a decision aid.
Treatment:
Behavioral: Decision Aid
No Decision Aid (control)
No Intervention group
Description:
One cohort will not receive the decision aid, and instead will receive only a brochure as standard treatment.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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