Clinical trial NCT02729831: Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery
Official title: Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery: A Factorial Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Keywords: decision making
decision aids
decision quality instruments
osteoarthritis
shared decision making
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Newton-Wellesley Hospital
name: The New England Baptist Hospital
First posted: 2016-04-06
Enrollment: 1220
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a 2X2 factorial randomized trial that will the examine the comparative effectiveness of two patient decision aids for hip and knee osteoarthritis (OA) as well as the impact of a surgeon-focused intervention.

Detailed description: This study is a 2X2 factorial randomized trial that will examine the comparative effectiveness of different decision support strategies for patients making treatment decisions about hip or knee osteoarthritis (OA). Eligible patient subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating orthopedic specialist. Participating providers are randomly assigned to either usual care or an intervention (a report that includes patients' goals and treatment preferences). Patient participants will complete three surveys at different time points: before their orthopedic visit, one week after the clinic visit, and 12 months later. Providers will complete a short survey for a subset of patient participants. The study is titled the DECIDE-OA study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of either hip or knee osteoarthritis
* Scheduled visit with participating orthopedic surgeon

Exclusion Criteria:

* prior partial or total knee or hip joint replacement within last 5 years
* hip fracture or asceptic necrosis (AVN) in last 12 months
* Rheumatoid arthritis
* Psoriatic arthritis
* Unable to read English or Spanish
* Unable to consent for self due to cognitive or medical issue
* Hip or knee decision aid provided by Partners Healthcare clinician within 12 months

Primary outcomes:
measure: Patients Knowledge
timeFrame: before orthopedic visit
measure: Percentage of Patients Who Received Preferred Treatment
timeFrame: 1 week after visit with orthopedic surgeon
Secondary outcomes:
measure: Percentage of Participants Who Used the Decision Aid
timeFrame: before orthopedic visit
measure: Change in Quality of Life
timeFrame: before orthopedic visit; 12 months from date of orthopedic visit
measure: Surgical Rates
timeFrame: 6 months after the initial visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Newton
country: United States
facility: Newton Wellesley Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sepucha K, Feibelmann S, Chang Y, Clay CF, Kearing SA, Tomek I, Yang T, Katz JN. Factors associated with the quality of patients' surgical decisions for treatment of hip and knee osteoarthritis. J Am Coll Surg. 2013 Oct;217(4):694-701. doi: 10.1016/j.jamcollsurg.2013.06.002. Epub 2013 Jul 25.
citation: Mangla M, Bedair H, Chang Y, Daggett S, Dwyer MK, Freiberg AA, Mwangi S, Talmo C, Vo H, Sepucha K. Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study). BMJ Open. 2019 Feb 24;9(2):e024906. doi: 10.1136/bmjopen-2018-024906.