Hip Osteoarthritis, Knee Osteoarthritis
Conditions
Keywords
decision making, decision aids, decision quality instruments, osteoarthritis, shared decision making
Brief summary
This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis.
Detailed 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.
Interventions
BEHAVIORALBrief interactive decision aid
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
BEHAVIORALLong video decision aid
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Sponsors
Newton-Wellesley Hospital
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hip and Knee Decision Quality Instruments Knowledge Subscale Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Used the Decision Aid | 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. |
| Percentage of Participants With a Clear Treatment Preference | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| 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 | 25 |
| Total | 58 |
Baseline characteristics
| Characteristic | Interactive Decision Aid | Video Decision Aid | Total |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 8.7 | 62.8 years STANDARD_DEVIATION 8.5 | 63.7 years STANDARD_DEVIATION 8.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 17 Participants | 11 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interactive Decision Aid | Hip and Knee Decision Quality Instruments Knowledge Subscale Scores | 55.2 units on a scale | Standard Deviation 25.5 |
| Video Decision Aid | Hip and Knee Decision Quality Instruments Knowledge Subscale Scores | 48.8 units on a scale | Standard Deviation 32.2 |
p-value: <0.0595% CI: [-8.8, 21.5]t-test, 2 sided
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interactive Decision Aid | Percentage of Participants Who Used the Decision Aid | Reviewed most or all of the DA | 23 Participants |
| Interactive Decision Aid | Percentage of Participants Who Used the Decision Aid | Reviewed none or some of the DA | 8 Participants |
| Interactive Decision Aid | Percentage of Participants Who Used the Decision Aid | Missing | 2 Participants |
| Video Decision Aid | Percentage of Participants Who Used the Decision Aid | Reviewed most or all of the DA | 14 Participants |
| Video Decision Aid | Percentage of Participants Who Used the Decision Aid | Reviewed none or some of the DA | 11 Participants |
| Video Decision Aid | Percentage of Participants Who Used the Decision Aid | Missing | 0 Participants |
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.
Time frame: In clinic, immediately before the first visit with surgeon
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Interactive Decision Aid | Percentage of Participants With a Clear Treatment Preference | Clear preference | 22 Participants |
| Interactive Decision Aid | Percentage of Participants With a Clear Treatment Preference | Not sure | 11 Participants |
| Video Decision Aid | Percentage of Participants With a Clear Treatment Preference | Clear preference | 15 Participants |
| Video Decision Aid | Percentage of Participants With a Clear Treatment Preference | Not sure | 10 Participants |