Clinical trial NCT03181724: 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
Official title: A Randomized Trial Measuring 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trapeziometacarpal Arthritis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Decision Conflict Scale (DCS)
timeFrame: Day 1
Secondary outcomes:
measure: QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
timeFrame: Day 1
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Day 1
measure: Consultation and Relational Empathy (CARE) Measure
timeFrame: Day 1
measure: 11-point Ordinal Satisfaction Scale
timeFrame: Day 1
measure: Change in Decision Regret Scale After 6 Weeks and 6 Months
timeFrame: 6 week and 6 month follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4.
citation: Deyo RA, Cherkin DC, Weinstein J, Howe J, Ciol M, Mulley AG Jr. Involving patients in clinical decisions: impact of an interactive video program on use of back surgery. Med Care. 2000 Sep;38(9):959-69. doi: 10.1097/00005650-200009000-00009.
citation: Jayadev C, Khan T, Coulter A, Beard DJ, Price AJ. Patient decision aids in knee replacement surgery. Knee. 2012 Dec;19(6):746-50. doi: 10.1016/j.knee.2012.02.001. Epub 2012 Mar 2.
citation: Murray E, Davis H, Tai SS, Coulter A, Gray A, Haines A. Randomised controlled trial of an interactive multimedia decision aid on benign prostatic hypertrophy in primary care. BMJ. 2001 Sep 1;323(7311):493-6. doi: 10.1136/bmj.323.7311.493.