MedDataX Logo

Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery

NCT ID: NCT02729831

Last Updated: 2019-12-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Osteoarthritis Knee Osteoarthritis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

decision making decision aids decision quality instruments osteoarthritis shared decision making

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Interactive decision aid

Intervention Type BEHAVIORAL

The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis

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.

Group Type EXPERIMENTAL

Video decision aid

Intervention Type BEHAVIORAL

Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis

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.

Group Type EXPERIMENTAL

Interactive decision aid

Intervention Type BEHAVIORAL

The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis

Provider Report

Intervention Type BEHAVIORAL

A short report that includes the patients' goals and treatment preferences

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.

Group Type EXPERIMENTAL

Interactive decision aid

Intervention Type BEHAVIORAL

The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis

Provider Report

Intervention Type BEHAVIORAL

A short report that includes the patients' goals and treatment preferences

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interactive decision aid

The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis

Intervention Type BEHAVIORAL

Video decision aid

Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis

Intervention Type BEHAVIORAL

Provider Report

A short report that includes the patients' goals and treatment preferences

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Newton-Wellesley Hospital

OTHER

Sponsor Role collaborator

The New England Baptist Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karen Sepucha

Director, Health Decision Sciences Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karen Sepucha, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

New England Baptist Hospital

Boston, Massachusetts, United States

Site Status

Newton Wellesley Hospital

Newton, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23891070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30804032 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: outcome measure

View Document

Document Type: outcome measure

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016P000229

Identifier Type: -

Identifier Source: org_study_id