NCT02625402

Brief Summary

This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 18, 2017

Completed
Last Updated

October 16, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

December 4, 2015

Results QC Date

March 21, 2017

Last Update Submit

September 18, 2018

Conditions

Hip OsteoarthritisKnee Osteoarthritis

Keywords

decision makingdecision aidsdecision quality instrumentsosteoarthritisshared decision making

Outcome Measures

Primary Outcomes (1)

  • Hip and Knee Decision Quality Instruments Knowledge Subscale Scores

    5 multiple choice knowledge items from the Hip and Knee Decision Quality Instruments will be averaged into a knowledge subscale score (0-100%) with higher scores indicating higher knowledge.

    In clinic, immediately before the first visit with surgeon

Secondary Outcomes (2)

  • Percentage of Participants Who Used the Decision Aid

    In clinic, immediately before the first visit with surgeon

  • Percentage of Participants With a Clear Treatment Preference

    In clinic, immediately before the first visit with surgeon

Study Arms (2)

Interactive decision aid

EXPERIMENTAL

Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise

Behavioral: Brief interactive decision aid

Video decision aid

EXPERIMENTAL

Group receiving long video decision aids. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog

Behavioral: Long video decision aid

Interventions

Brief interactive decision aidBEHAVIORAL

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

Interactive decision aid
Long video decision aidBEHAVIORAL

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

Video decision aid

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of either hip or knee osteoarthritis
  • Scheduled visit with participating orthopedic surgeon

You may not qualify if:

  • Prior partial or total knee or hip replacement surgery
  • Hip fracture or aseptic necrosis in the last 12 months
  • Rheumatoid arthritis or psoriatic arthritis
  • Unable to read or speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Related Publications (1)

  • 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.

    PMID: 23891070BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Karen Sepucha
Organization
Massachusetts General Hospital
ksepucha@partners.org
6177243350

Study Officials

  • Karen R Sepucha, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 4, 2015

First Posted

December 9, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

October 16, 2018

Results First Posted

December 18, 2017

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Outcome measure Access
Outcome measure Access

Locations

US(2)