Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

• ClinicalTrials.gov Identifier: NCT02729831
• Recruitment Status: Completed
• First Posted: April 6, 2016
• Results First Posted: December 13, 2019
• Last Update Posted: December 13, 2019
• Sponsor: Massachusetts General Hospital
• Collaborators: Newton-Wellesley Hospital; The New England Baptist Hospital
• Information provided by (Responsible Party): Karen Sepucha, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hip Osteoarthritis; Knee Osteoarthritis	Behavioral: Interactive decision aid; Behavioral: Video decision aid; Behavioral: Provider Report	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1220 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery: A Factorial Randomized Trial
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: December 2018
• Actual Study Completion Date: January 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Patients Knowledge [ Time Frame: before orthopedic visit ]
   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.
2. Percentage of Patients Who Received Preferred Treatment [ Time Frame: 1 week after visit with orthopedic surgeon ]
   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.

Secondary Outcome Measures :

1. Percentage of Participants Who Used the Decision Aid [ Time Frame: before orthopedic visit ]
   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.
2. Change in Quality of Life [ Time Frame: before orthopedic visit; 12 months from date of orthopedic visit ]
   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.
3. Surgical Rates [ Time Frame: 6 months after the initial visit ]
   Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

New England Baptist Hospital

Boston, Massachusetts, United States, 02120

Newton Wellesley Hospital

Newton, Massachusetts, United States, 02462

Sponsors and Collaborators

Massachusetts General Hospital

Newton-Wellesley Hospital

The New England Baptist Hospital

Investigators

• Principal Investigator: Karen Sepucha, PhD; Massachusetts General Hospital

  Study Documents (Full-Text)

Documents provided by Karen Sepucha, Massachusetts General Hospital:

Study Protocol  [PDF] December 21, 2017

Statistical Analysis Plan  [PDF] December 21, 2017

More Information

Study Data/Documents: outcome measure 

Hip Osteoarthritis Decision Quality Instrument

outcome measure 

Knee Osteoarthritis Decision Quality Instrument

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.

• Responsible Party: Karen Sepucha, Director, Health Decision Sciences Center, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02729831
• Other Study ID Numbers: 2016P000229
• First Posted: April 6, 2016
• Results First Posted: December 13, 2019
• Last Update Posted: December 13, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code
• Time Frame: The data will be available September 2019 and will be available for at least 7 years from that time.
• 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.
• URL: https://www.mghdecisionsciences.org

Keywords provided by Karen Sepucha, Massachusetts General Hospital:

decision making; decision aids; decision quality instruments; osteoarthritis; shared decision making

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases