Trial Outcomes & Findings for Pilot RCT Comparing Effectiveness of Two Decision Aids for Hip and Knee Osteoarthritis (NCT NCT02625402)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

In clinic, immediately before the first visit with surgeon

Results posted on

2018-10-16

Participant Flow

Patient recruitment was conducted from December 2015 to March 2016. Patients were recruited at two hospitals. Consent for the study (or enrollment) was implied by completion of the survey, so the enrollment number is lower than the number that started the study and were assigned to a study arm.

Participant milestones

Participant milestones
Measure	Interactive Decision Aid Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: 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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Overall Study STARTED	42	37
Overall Study COMPLETED	33	25
Overall Study NOT COMPLETED	9	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interactive Decision Aid n=33 Participants Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	Video Decision Aid n=25 Participants 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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis	Total n=58 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 8.7 • n=33 Participants	62.8 years STANDARD_DEVIATION 8.5 • n=25 Participants	63.7 years STANDARD_DEVIATION 8.6 • n=58 Participants
Sex: Female, Male Female	16 Participants n=33 Participants	14 Participants n=25 Participants	30 Participants n=58 Participants
Sex: Female, Male Male	17 Participants n=33 Participants	11 Participants n=25 Participants	28 Participants n=58 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: In clinic, immediately before the first visit with surgeon

Population: The total knowledge score of 5 multiple questions with a total score of 0-100% was generated for all study patients.

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.

Outcome measures

Outcome measures
Measure	Interactive Decision Aid n=33 Participants Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	Video Decision Aid n=25 Participants 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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Hip and Knee Decision Quality Instruments Knowledge Subscale Scores	55.2 units on a scale Standard Deviation 25.5	48.8 units on a scale Standard Deviation 32.2

SECONDARY outcome

Timeframe: In clinic, immediately before the first visit with surgeon

Population: We wanted to assess how much patients reviewed whichever decision aid they were randomized to before their visit. As such, we assessed how much they reviewed of the program (none, some, most, all) and will share the categorical results.

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.

Outcome measures

Outcome measures
Measure	Interactive Decision Aid n=33 Participants Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	Video Decision Aid n=25 Participants 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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Percentage of Participants Who Used the Decision Aid Reviewed most or all of the DA	23 Participants	14 Participants
Percentage of Participants Who Used the Decision Aid Reviewed none or some of the DA	8 Participants	11 Participants
Percentage of Participants Who Used the Decision Aid Missing	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Interactive Decision Aid n=33 Participants Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise Brief interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis	Video Decision Aid n=25 Participants 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 Long video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Percentage of Participants With a Clear Treatment Preference Clear preference	22 Participants	15 Participants
Percentage of Participants With a Clear Treatment Preference Not sure	11 Participants	10 Participants

Adverse Events

Interactive Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Video Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Sepucha

Massachusetts General Hospital

Phone: 6177243350

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place