Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Intervention / Treatment: Behavioral: Interactive decision aid; Behavioral: Video decision aid; Behavioral: Provider Report

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.

• Study Type: Interventional
• Enrollment (Actual): 1220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02120
      • New England Baptist Hospital
    • Newton, Massachusetts, United States, 02462
      • Newton Wellesley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interactive Decision Aid and Usual Care; Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.	Behavioral: Interactive decision aid; The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
EXPERIMENTAL: Video decision aid and usual care; Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.	Behavioral: Video decision aid; Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
EXPERIMENTAL: Interactive Decision Aid and Provider Report; Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.	Behavioral: Interactive decision aid; The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis; Behavioral: Provider Report; A short report that includes the patients' goals and treatment preferences
EXPERIMENTAL: Video decision aid and Provider report; Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.	Behavioral: Interactive decision aid; The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis; Behavioral: Provider Report; A short report that includes the patients' goals and treatment preferences

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Newton-Wellesley Hospital; The New England Baptist Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (ESTIMATE): April 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: osteoarthritis; shared decision making; decision making; decision aids; decision quality instruments
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: 2016P000229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A complete, cleaned, de-identified copy of the final data set that includes survey data for the primary and secondary outcomes from patient participants has been created. The PI will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital (MGH) policies for data sharing. Investigators from other sites are able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team, etc.
• IPD Sharing Time Frame: The data will be available September 2019 and will be available for at least 7 years from that time.
• IPD Sharing Access Criteria: Interested investigators may consult the DECIDE-OA study page on the Massachusetts General Hospital's Health Decision Sciences Center website for information about data sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Study Data/Documents

1. outcome measure
   Information comments: Hip Osteoarthritis Decision Quality Instrument
2. outcome measure
   Information comments: Knee Osteoarthritis Decision Quality Instrument