Trial Outcomes & Findings for Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery (NCT NCT02729831)
NCT ID: NCT02729831
Last Updated: 2019-12-13
Results Overview
Knowledge sub-score generated from responses to the Hip or Knee Decision Quality Instrument (DQI). Scores range from 0-100%, with higher score meaning higher knowledge.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1220 participants
Primary outcome timeframe
before orthopedic visit
Results posted on
2019-12-13
Participant Flow
April 2016-December 2017. Adults diagnosed with hip or knee osteoarthritis who had a visit scheduled with a participating orthopedic surgeon at 3 sites were invited to participate before their visit.
Participants were randomized to a study arm after screening the surgeons' schedules. To be eligible for the study, patients needed to attend the visit with the surgeon. The majority of post randomization exclusions are due to patients not showing up to the visit. Some are due to limited clinical information available at screening.
Participant milestones
| Measure |
Interactive Decision Aid and Usual Care
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
|
Video Decision Aid and Usual Care
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
|
Interactive Decision Aid and Provider Report
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
Video Decision Aid and Provider Report
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
|---|---|---|---|---|
|
Baseline (Post Decision Aid, Pre-visit)
STARTED
|
320
|
315
|
293
|
292
|
|
Baseline (Post Decision Aid, Pre-visit)
COMPLETED
|
282
|
292
|
275
|
275
|
|
Baseline (Post Decision Aid, Pre-visit)
NOT COMPLETED
|
38
|
23
|
18
|
17
|
|
1 Week Post-visit
STARTED
|
282
|
292
|
275
|
275
|
|
1 Week Post-visit
COMPLETED
|
239
|
252
|
237
|
239
|
|
1 Week Post-visit
NOT COMPLETED
|
43
|
40
|
38
|
36
|
|
6 Month Follow-up
STARTED
|
282
|
292
|
275
|
275
|
|
6 Month Follow-up
COMPLETED
|
227
|
238
|
227
|
232
|
|
6 Month Follow-up
NOT COMPLETED
|
55
|
54
|
48
|
43
|
Reasons for withdrawal
| Measure |
Interactive Decision Aid and Usual Care
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
|
Video Decision Aid and Usual Care
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
|
Interactive Decision Aid and Provider Report
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
Video Decision Aid and Provider Report
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
|---|---|---|---|---|
|
Baseline (Post Decision Aid, Pre-visit)
Ineligible post completion
|
38
|
23
|
18
|
17
|
|
1 Week Post-visit
Lost to Follow-up
|
43
|
40
|
38
|
36
|
|
6 Month Follow-up
Lost to Follow-up
|
54
|
51
|
48
|
42
|
|
6 Month Follow-up
Death
|
1
|
3
|
0
|
1
|
Baseline Characteristics
Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery
Baseline characteristics by cohort
| Measure |
Interactive Decision Aid and Usual Care
n=282 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
|
Video Decision Aid and Usual Care
n=292 Participants
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
|
Interactive Decision Aid and Provider Report
n=275 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
Video Decision Aid and Provider Report
n=275 Participants
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
Total
n=1124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
64.7 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
645 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
479 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
230 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
229 Participants
n=4 Participants
|
921 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
179 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
258 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
243 Participants
n=4 Participants
|
1017 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Joint
Hip
|
85 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
367 Participants
n=21 Participants
|
|
Joint
Knee
|
197 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
757 Participants
n=21 Participants
|
|
Decision aid delivery
Paper
|
225 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
217 Participants
n=4 Participants
|
892 Participants
n=21 Participants
|
|
Decision aid delivery
Online
|
57 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
232 Participants
n=21 Participants
|
|
Health literacy
Never
|
191 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
197 Participants
n=4 Participants
|
782 Participants
n=21 Participants
|
|
Health literacy
Rarely
|
43 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
|
Health literacy
Sometimes
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Health literacy
Often
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Health literacy
Always
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Health literacy
Missing
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Education
8th grade or less
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Education
Some high school but did not graduate
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Education
High school graduate or GED
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
|
Education
Some college or 2-year degree
|
54 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
208 Participants
n=21 Participants
|
|
Education
4-year college graduate
|
45 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Education
More than a 4-year college degree
|
101 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
393 Participants
n=21 Participants
|
|
Education
Missing
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
175 Participants
n=21 Participants
|
|
Insurance
Medicare
|
81 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
321 Participants
n=21 Participants
|
|
Insurance
Medicaid/Dual eligible
|
41 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
115 Participants
n=21 Participants
|
|
Insurance
Commercial
|
109 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
401 Participants
n=21 Participants
|
|
Insurance
Missing
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
287 Participants
n=21 Participants
|
|
Body Mass Index
|
31.4 kg/m^2
STANDARD_DEVIATION 6.8 • n=5 Participants
|
30.9 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 6.4 • n=5 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 6.3 • n=4 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 6.5 • n=21 Participants
|
|
Charlson co-morbidity index (CCI)
0
|
205 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
826 Participants
n=21 Participants
|
|
Charlson co-morbidity index (CCI)
1
|
33 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
142 Participants
n=21 Participants
|
|
Charlson co-morbidity index (CCI)
2
|
33 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Charlson co-morbidity index (CCI)
3+
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Charlson co-morbidity index (CCI)
Missing
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Quality of life (EQ-5D)
|
0.63 units on a scale
STANDARD_DEVIATION 0.19 • n=5 Participants
|
0.62 units on a scale
STANDARD_DEVIATION 0.21 • n=7 Participants
|
0.65 units on a scale
STANDARD_DEVIATION 0.20 • n=5 Participants
|
0.65 units on a scale
STANDARD_DEVIATION 0.18 • n=4 Participants
|
0.64 units on a scale
STANDARD_DEVIATION 0.20 • n=21 Participants
|
PRIMARY outcome
Timeframe: before orthopedic visitPopulation: There were a total of 5 hip and knee specific knowledge questions in the DQI. Participants must answer at least 3 out of 5 questions to get a total knowledge score out of 100%. Only 1082/1124 participants provided sufficient information to calculate a knowledge score.
Knowledge sub-score generated from responses to the Hip or Knee Decision Quality Instrument (DQI). Scores range from 0-100%, with higher score meaning higher knowledge.
Outcome measures
| Measure |
Interactive Decision Aid and Usual Care
n=274 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
|
Video Decision Aid and Usual Care
n=276 Participants
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
|
Interactive Decision Aid and Provider Report
n=268 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
Video Decision Aid and Provider Report
n=264 Participants
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
|---|---|---|---|---|
|
Patients Knowledge
|
79 percentage of correct answers
Standard Deviation 25
|
71 percentage of correct answers
Standard Deviation 24
|
84 percentage of correct answers
Standard Deviation 21
|
75 percentage of correct answers
Standard Deviation 23
|
PRIMARY outcome
Timeframe: 1 week after visit with orthopedic surgeonPopulation: Participants must complete the 1 week survey and answer the treatment preference question. Only 956/967 participants provided sufficient information to calculate a treatment match.
Patient preferred treatment item from the Hip or Knee Decision Quality Instrument will be compared with the treatment received to determine percentage of patients who received treatment that matched their preferences.
Outcome measures
| Measure |
Interactive Decision Aid and Usual Care
n=237 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
|
Video Decision Aid and Usual Care
n=249 Participants
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
|
Interactive Decision Aid and Provider Report
n=232 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
Video Decision Aid and Provider Report
n=238 Participants
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
|---|---|---|---|---|
|
Percentage of Patients Who Received Preferred Treatment
|
175 Participants
|
182 Participants
|
166 Participants
|
177 Participants
|
SECONDARY outcome
Timeframe: before orthopedic visitPopulation: Participants must answer the program usage question on the Baseline survey. Only 1091/1124 participants provided sufficient information to calculate decision aid usage.
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
| Measure |
Interactive Decision Aid and Usual Care
n=277 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
|
Video Decision Aid and Usual Care
n=283 Participants
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
|
Interactive Decision Aid and Provider Report
n=262 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
Video Decision Aid and Provider Report
n=269 Participants
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
|---|---|---|---|---|
|
Percentage of Participants Who Used the Decision Aid
None
|
42 Participants
|
38 Participants
|
27 Participants
|
34 Participants
|
|
Percentage of Participants Who Used the Decision Aid
Most
|
24 Participants
|
68 Participants
|
24 Participants
|
66 Participants
|
|
Percentage of Participants Who Used the Decision Aid
All
|
173 Participants
|
132 Participants
|
179 Participants
|
127 Participants
|
|
Percentage of Participants Who Used the Decision Aid
Some
|
38 Participants
|
45 Participants
|
32 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: before orthopedic visit; 12 months from date of orthopedic visitPopulation: Participants must answer all 5 items of the EQ-5D measure from the Baseline and 6 months follow-up survey. Only 868/1124 participants provided sufficient information at both time points to calculate a change in quality of life score.
Overall quality of life (EQ-5D) scores will be calculated and the impact of decision support strategies on change in quality of life will be examined. Scale ranges from -0.11 to 1.00, with higher (positive) values meaning better overall health. The minimum important change is 0.10 points.
Outcome measures
| Measure |
Interactive Decision Aid and Usual Care
n=212 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
|
Video Decision Aid and Usual Care
n=224 Participants
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
|
Interactive Decision Aid and Provider Report
n=215 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
Video Decision Aid and Provider Report
n=217 Participants
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
|---|---|---|---|---|
|
Change in Quality of Life
|
0.17 units on a scale
Standard Deviation 0.21
|
0.15 units on a scale
Standard Deviation 0.22
|
0.15 units on a scale
Standard Deviation 0.23
|
0.16 units on a scale
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: 6 months after the initial visitPopulation: Excluding patients who did not provide information to calculate the Informed, Patient-Centered (IPC) variable.
Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit.
Outcome measures
| Measure |
Interactive Decision Aid and Usual Care
n=239 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to usual care. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
|
Video Decision Aid and Usual Care
n=252 Participants
Group receiving long video decision aids and being seen by a provider assigned to usual care. The decision aids are the DVD and Booklets for hip and knee osteoarthritis from Health Dialog.
Video decision aid: Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
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Interactive Decision Aid and Provider Report
n=237 Participants
Group receiving brief interactive decision aid and being seen by a provider assigned to intervention arm. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise. The provider intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
Video Decision Aid and Provider Report
n=239 Participants
Group receiving long video decision aids and being seen by a provider assigned to intervention arm. The decision aids are the hip or knee DVD and Booklets for hip and knee osteoarthritis from Health Dialog. The intervention is a report that includes the patients' goals and treatment preferences.
Interactive decision aid: The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Provider Report: A short report that includes the patients' goals and treatment preferences
|
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Surgical Rates
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140 Participants
|
153 Participants
|
134 Participants
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154 Participants
|
Adverse Events
Interactive Decision Aid and Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video Decision Aid and Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interactive Decision Aid and Provider Report
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video Decision Aid and Provider Report
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place