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Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

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ClinicalTrials.gov Identifier: NCT02729831
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
Newton-Wellesley Hospital
The New England Baptist Hospital
Information provided by (Responsible Party):
Karen Sepucha, Massachusetts General Hospital

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 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. 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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. Patients knowledge [ Time Frame: before orthopedic surgeon visit ]
    Knowledge sub-score generated from responses to the Hip or Knee Decision Quality Instrument

  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

  3. Surgical rates [ Time Frame: 12 months after the initial visit ]
    Medical chart review and patient report of whether or not surgery was used in the 12 months after the visit will be captured.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729831


Locations
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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
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Principal Investigator: Karen Sepucha, PhD Massachusetts General Hospital

Study Data/Documents: outcome measure  This link exits the ClinicalTrials.gov site
Hip Osteoarthritis Decision Quality Instrument
outcome measure  This link exits the ClinicalTrials.gov site
Knee Osteoarthritis Decision Quality Instrument

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karen Sepucha, Director, Health Decision Sciences Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02729831     History of Changes
Other Study ID Numbers: 2016P000229
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: As per requirements of the funder, the study team will create a complete, cleaned, de-identified copy of the final data set that will include survey data from participants. The PI will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital policies for data sharing. Investigators from other sites will be 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.
Keywords provided by Karen Sepucha, Massachusetts General Hospital:
decision making
decision aids
decision quality instruments
osteoarthritis
shared decision making
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases