Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis

NCT ID: NCT02625402

Last Updated: 2018-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis. The vendors employ different design features (e.g. use of video for patient narratives, interactive values clarification exercise) and the study will examine the relative impact of the different features on decision quality. Eligible subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating provider. Immediately before the visit, participants will complete a short questionnaire about the decision aid. This pilot study will assist with determining the potential difference between these two decision aids on improving knowledge and use of decision aids.

Conditions

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Hip Osteoarthritis Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Interactive decision aid

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

Group Type EXPERIMENTAL

Brief interactive decision aid

Intervention Type BEHAVIORAL

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

Video decision aid

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

Group Type EXPERIMENTAL

Long video decision aid

Intervention Type BEHAVIORAL

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

Interventions

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Brief interactive decision aid

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

Intervention Type BEHAVIORAL

Long video decision aid

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Newton-Wellesley Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Sepucha

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen R Sepucha, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Newton Wellesley Hospital

Newton, Massachusetts, United States

Site Status

Countries

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United States

References

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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)

Study Documents

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Document Type: Outcome measure

Hip Osteoarthritis Decision Quality Instrument

View Document

Document Type: Outcome measure

Knee Osteoarthritis Decision Quality Instrument

View Document

Other Identifiers

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2013P001794

Identifier Type: -

Identifier Source: org_study_id

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