Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

Knee Osteoarthritis Clinical Trial

Official title:

Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery: A Factorial Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729831
• Other study ID #: 2016P000229
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: January 2019

Study information

• Verified date: December 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1220
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Behavioral:
• Interactive decision aid
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
• Video decision aid
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
• Provider Report
A short report that includes the patients' goals and treatment preferences

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	New England Baptist Hospital	Boston	Massachusetts
United States	Newton Wellesley Hospital	Newton	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Newton-Wellesley Hospital, The New England Baptist Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Knowledge	Knowledge sub-score generated from responses to the Hip or Knee Decision Quality Instrument (DQI). Scores range from 0-100%, with higher score meaning higher knowledge.	before orthopedic visit
Primary	Percentage of Patients Who Received Preferred Treatment	Patient preferred treatment item from the Hip or Knee Decision Quality Instrument will be compared with the treatment received to determine percentage of patients who received treatment that matched their preferences.	1 week after visit with orthopedic surgeon
Secondary	Percentage of Participants Who Used the Decision Aid	1 item asking patients how much they reviewed the program (none, some, most, all). The percentage who report viewing most or all will be calculated.	before orthopedic visit
Secondary	Change in Quality of Life	Overall quality of life (EQ-5D) scores will be calculated and the impact of decision support strategies on change in quality of life will be examined. Scale ranges from -0.11 to 1.00, with higher (positive) values meaning better overall health. The minimum important change is 0.10 points.	before orthopedic visit; 12 months from date of orthopedic visit
Secondary	Surgical Rates	Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit.	6 months after the initial visit