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Completed

NCT Number: NCT02625402

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

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

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief interactive decision aid

Behavioral

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

Long video decision aid

Behavioral

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

Primary outcomes

  1. Hip and Knee Decision Quality Instruments Knowledge Subscale Scores

    Time frame: In clinic, immediately before the first visit with surgeon

    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.

Secondary outcomes

  1. Percentage of Participants Who Used the Decision Aid

    Time frame: In clinic, immediately before the first visit with surgeon

    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. Percentage of Participants With a Clear Treatment Preference

    Time frame: In clinic, immediately before the first visit with surgeon

    1 item assessing patient's treatment preference (surgery, non-surgical options, or not sure). The percentage who have a clear preference (either for surgery or non surgical options) will be calculated.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Newton-Wellesley Hospital

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 9, 2015
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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