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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625402
• Other study ID #: 2013P001794
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Behavioral:
• Brief interactive decision aid
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
• Long video decision aid
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Newton Wellesley Hospital	Newton	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Newton-Wellesley Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Who Used the Decision Aid	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.	In clinic, immediately before the first visit with surgeon
Secondary	Percentage of Participants With a Clear Treatment Preference	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.	In clinic, immediately before the first visit with surgeon