Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery
Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02729831
Collaborator
Newton-Wellesley Hospital (Other), The New England Baptist Hospital (Other)
1,220
3
4
33
406.7
12.3
Study Details
Study Description
Brief Summary
This study is a 2X2 factorial randomized trial that will the examine the comparative effectiveness of two patient decision aids for hip and knee osteoarthritis (OA) as well as the impact of a surgeon-focused intervention.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study is a 2X2 factorial randomized trial that will examine the comparative effectiveness of different decision support strategies for patients making treatment decisions about hip or knee osteoarthritis (OA). Eligible patient subjects will be randomly assigned to receive one of two decision aids before their upcoming clinic visit with a participating orthopedic specialist. Participating providers are randomly assigned to either usual care or an intervention (a report that includes patients' goals and treatment preferences). Patient participants will complete three surveys at different time points: before their orthopedic visit, one week after the clinic visit, and 12 months later. Providers will complete a short survey for a subset of patient participants. The study is titled the DECIDE-OA study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
1220 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery: A Factorial Randomized Trial
Actual Study Start Date
:
Apr 1, 2016
Actual Primary Completion Date
:
Dec 1, 2018
Actual Study Completion Date
:
Jan 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Interactive decision aid
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
|
| Experimental: 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. |
Behavioral: Video decision aid
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
|
| Experimental: 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. |
Behavioral: Interactive decision aid
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Behavioral: Provider Report
A short report that includes the patients' goals and treatment preferences
|
| Experimental: 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. |
Behavioral: Interactive decision aid
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Behavioral: Provider Report
A short report that includes the patients' goals and treatment preferences
|
Outcome Measures
Primary Outcome Measures
- Patients Knowledge [before orthopedic visit]
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.
- Percentage of Patients Who Received Preferred Treatment [1 week after visit with orthopedic surgeon]
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.
Secondary Outcome Measures
- Percentage of Participants Who Used the Decision Aid [before orthopedic visit]
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.
- Change in Quality of Life [before orthopedic visit; 12 months from date of orthopedic visit]
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.
- Surgical Rates [6 months after the initial visit]
Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
All
Accepts 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 joint replacement within last 5 years
-
hip fracture or asceptic necrosis (AVN) in last 12 months
-
Rheumatoid arthritis
-
Psoriatic arthritis
-
Unable to read English or Spanish
-
Unable to consent for self due to cognitive or medical issue
-
Hip or knee decision aid provided by Partners Healthcare clinician within 12 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | New England Baptist Hospital | Boston | Massachusetts | United States | 02120 |
| 3 | Newton Wellesley Hospital | Newton | Massachusetts | United States | 02462 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Newton-Wellesley Hospital
- The New England Baptist Hospital
Investigators
- Principal Investigator: Karen Sepucha, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
More Information
Publications
- Mangla M, Bedair H, Chang Y, Daggett S, Dwyer MK, Freiberg AA, Mwangi S, Talmo C, Vo H, Sepucha K. Protocol for a randomised trial evaluating the comparative effectiveness of strategies to promote shared decision making for hip and knee osteoarthritis (DECIDE-OA study). BMJ Open. 2019 Feb 24;9(2):e024906. doi: 10.1136/bmjopen-2018-024906.
- 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.
Responsible Party:
Karen Sepucha,
Director, Health Decision Sciences Center,
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02729831
Other Study ID Numbers:
- 2016P000229
First Posted:
Apr 6, 2016
Last Update Posted:
Dec 13, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Karen Sepucha,
Director, Health Decision Sciences Center,
Massachusetts General Hospital
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 |
| Period Title: Baseline (Post Decision Aid, Pre-visit) | ||||
| STARTED | 320 | 315 | 293 | 292 |
| COMPLETED | 282 | 292 | 275 | 275 |
| NOT COMPLETED | 38 | 23 | 18 | 17 |
| Period Title: Baseline (Post Decision Aid, Pre-visit) | ||||
| STARTED | 282 | 292 | 275 | 275 |
| COMPLETED | 239 | 252 | 237 | 239 |
| NOT COMPLETED | 43 | 40 | 38 | 36 |
| Period Title: Baseline (Post Decision Aid, Pre-visit) | ||||
| STARTED | 282 | 292 | 275 | 275 |
| COMPLETED | 227 | 238 | 227 | 232 |
| NOT COMPLETED | 55 | 54 | 48 | 43 |
Baseline Characteristics
| Arm/Group Title | Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 of all reporting groups |
| Overall Participants | 282 | 292 | 275 | 275 | 1124 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
64.8
(9.6)
|
64.6
(9.9)
|
64.3
(10.3)
|
64.9
(9.5)
|
64.7
(9.9)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
152
53.9%
|
179
61.3%
|
173
62.9%
|
141
51.3%
|
645
57.4%
|
| Male |
130
46.1%
|
113
38.7%
|
102
37.1%
|
134
48.7%
|
479
42.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
3
1.1%
|
13
4.5%
|
5
1.8%
|
3
1.1%
|
24
2.1%
|
| Not Hispanic or Latino |
230
81.6%
|
235
80.5%
|
227
82.5%
|
229
83.3%
|
921
81.9%
|
| Unknown or Not Reported |
49
17.4%
|
44
15.1%
|
43
15.6%
|
43
15.6%
|
179
15.9%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
1
0.4%
|
0
0%
|
0
0%
|
0
0%
|
1
0.1%
|
| Asian |
3
1.1%
|
4
1.4%
|
2
0.7%
|
8
2.9%
|
17
1.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
2
0.7%
|
0
0%
|
0
0%
|
2
0.2%
|
| Black or African American |
6
2.1%
|
8
2.7%
|
1
0.4%
|
4
1.5%
|
19
1.7%
|
| White |
258
91.5%
|
261
89.4%
|
255
92.7%
|
243
88.4%
|
1017
90.5%
|
| More than one race |
3
1.1%
|
5
1.7%
|
4
1.5%
|
4
1.5%
|
16
1.4%
|
| Unknown or Not Reported |
11
3.9%
|
12
4.1%
|
13
4.7%
|
16
5.8%
|
52
4.6%
|
| Joint (Count of Participants) | |||||
| Hip |
85
30.1%
|
79
27.1%
|
95
34.5%
|
108
39.3%
|
367
32.7%
|
| Knee |
197
69.9%
|
213
72.9%
|
180
65.5%
|
167
60.7%
|
757
67.3%
|
| Decision aid delivery (Count of Participants) | |||||
| Paper |
225
79.8%
|
232
79.5%
|
218
79.3%
|
217
78.9%
|
892
79.4%
|
| Online |
57
20.2%
|
60
20.5%
|
57
20.7%
|
58
21.1%
|
232
20.6%
|
| Health literacy (Count of Participants) | |||||
| Never |
191
67.7%
|
197
67.5%
|
197
71.6%
|
197
71.6%
|
782
69.6%
|
| Rarely |
43
15.2%
|
52
17.8%
|
42
15.3%
|
44
16%
|
181
16.1%
|
| Sometimes |
30
10.6%
|
24
8.2%
|
24
8.7%
|
18
6.5%
|
96
8.5%
|
| Often |
6
2.1%
|
10
3.4%
|
3
1.1%
|
7
2.5%
|
26
2.3%
|
| Always |
8
2.8%
|
5
1.7%
|
5
1.8%
|
7
2.5%
|
25
2.2%
|
| Missing |
4
1.4%
|
4
1.4%
|
4
1.5%
|
2
0.7%
|
14
1.2%
|
| Education (Count of Participants) | |||||
| 8th grade or less |
4
1.4%
|
3
1%
|
1
0.4%
|
2
0.7%
|
10
0.9%
|
| Some high school but did not graduate |
1
0.4%
|
3
1%
|
2
0.7%
|
3
1.1%
|
9
0.8%
|
| High school graduate or GED |
31
11%
|
38
13%
|
26
9.5%
|
22
8%
|
117
10.4%
|
| Some college or 2-year degree |
54
19.1%
|
60
20.5%
|
47
17.1%
|
47
17.1%
|
208
18.5%
|
| 4-year college graduate |
45
16%
|
55
18.8%
|
59
21.5%
|
53
19.3%
|
212
18.9%
|
| More than a 4-year college degree |
101
35.8%
|
89
30.5%
|
98
35.6%
|
105
38.2%
|
393
35%
|
| Missing |
46
16.3%
|
44
15.1%
|
42
15.3%
|
43
15.6%
|
175
15.6%
|
| Insurance (Count of Participants) | |||||
| Medicare |
81
28.7%
|
93
31.8%
|
68
24.7%
|
79
28.7%
|
321
28.6%
|
| Medicaid/Dual eligible |
41
14.5%
|
30
10.3%
|
19
6.9%
|
25
9.1%
|
115
10.2%
|
| Commercial |
109
38.7%
|
119
40.8%
|
93
33.8%
|
80
29.1%
|
401
35.7%
|
| Missing |
51
18.1%
|
50
17.1%
|
95
34.5%
|
91
33.1%
|
287
25.5%
|
| Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [kg/m^2] |
31.4
(6.8)
|
30.9
(6.3)
|
28.9
(6.4)
|
29.7
(6.3)
|
30.1
(6.5)
|
| Charlson co-morbidity index (CCI) (Count of Participants) | |||||
| 0 |
205
72.7%
|
217
74.3%
|
201
73.1%
|
203
73.8%
|
826
73.5%
|
| 1 |
33
11.7%
|
38
13%
|
36
13.1%
|
35
12.7%
|
142
12.6%
|
| 2 |
33
11.7%
|
21
7.2%
|
24
8.7%
|
28
10.2%
|
106
9.4%
|
| 3+ |
10
3.5%
|
14
4.8%
|
12
4.4%
|
8
2.9%
|
44
3.9%
|
| Missing |
1
0.4%
|
2
0.7%
|
2
0.7%
|
1
0.4%
|
6
0.5%
|
| Quality of life (EQ-5D) (units on a scale) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [units on a scale] |
0.63
(0.19)
|
0.62
(0.21)
|
0.65
(0.20)
|
0.65
(0.18)
|
0.64
(0.20)
|
Outcome Measures
| Title | Patients Knowledge |
|---|---|
| Description | 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. |
| Time Frame | before orthopedic visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 |
| Measure Participants | 274 | 276 | 268 | 264 |
| Mean (Standard Deviation) [percentage of correct answers] |
79
(25)
|
71
(24)
|
84
(21)
|
75
(23)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Interactive Decision Aid and Usual Care, Video Decision Aid and Usual Care, Interactive Decision Aid and Provider Report, Video Decision Aid and Provider Report |
|---|---|---|
| Comments | The comparison groups were: Interactive decision versus Video decision aid. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 9 | |
| Confidence Interval |
(2-Sided) 95% 6 to 12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Patients Who Received Preferred Treatment |
|---|---|
| Description | 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. |
| Time Frame | 1 week after visit with orthopedic surgeon |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 |
| Measure Participants | 237 | 249 | 232 | 238 |
| Count of Participants [Participants] |
175
62.1%
|
182
62.3%
|
166
60.4%
|
177
64.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Interactive Decision Aid and Usual Care, Video Decision Aid and Usual Care, Interactive Decision Aid and Provider Report, Video Decision Aid and Provider Report |
|---|---|---|
| Comments | We tested for interaction effects. Comparison groups were: MD Usual Care vs. MD Provider report. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.86 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.03 | |
| Confidence Interval |
(2-Sided) 95% 0.74 to 1.44 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Interactive Decision Aid and Usual Care, Video Decision Aid and Usual Care, Interactive Decision Aid and Provider Report, Video Decision Aid and Provider Report |
|---|---|---|
| Comments | We tested for interaction effects. Comparison groups are: Interactive decision versus Video decision aid | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.75 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.06 | |
| Confidence Interval |
(2-Sided) 95% 0.76 to 1.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Who Used the Decision Aid |
|---|---|
| Description | 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 | before orthopedic visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants must answer the program usage question on the Baseline survey. Only 1091/1124 participants provided sufficient information to calculate decision aid usage. |
| Arm/Group Title | Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 |
| Measure Participants | 277 | 283 | 262 | 269 |
| None |
42
14.9%
|
38
13%
|
27
9.8%
|
34
12.4%
|
| Some |
38
13.5%
|
45
15.4%
|
32
11.6%
|
42
15.3%
|
| Most |
24
8.5%
|
68
23.3%
|
24
8.7%
|
66
24%
|
| All |
173
61.3%
|
132
45.2%
|
179
65.1%
|
127
46.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Interactive Decision Aid and Usual Care, Video Decision Aid and Usual Care, Interactive Decision Aid and Provider Report, Video Decision Aid and Provider Report |
|---|---|---|
| Comments | Comparison groups were: patients who reported using all of the DA versus everyone else. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | Compared patients who reported using all of the DA compared to everyone else. | |
| Method of Estimation | Estimation Parameter | Risk Difference (RD) |
| Estimated Value | 18.5 | |
| Confidence Interval |
(2-Sided) 95% 12.8 to 24.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in Quality of Life |
|---|---|
| Description | 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. |
| Time Frame | before orthopedic visit; 12 months from date of orthopedic visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 |
| Measure Participants | 212 | 224 | 215 | 217 |
| Mean (Standard Deviation) [units on a scale] |
0.17
(0.21)
|
0.15
(0.22)
|
0.15
(0.23)
|
0.16
(0.20)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Interactive Decision Aid and Usual Care, Video Decision Aid and Usual Care, Interactive Decision Aid and Provider Report, Video Decision Aid and Provider Report |
|---|---|---|
| Comments | We included all 4 study groups, but the comparison group was: informed, patient centered decision yes vs. no. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | Generalized Estimating Equation accounting for clustering within surgeons. Model included treatment, sex, age, education, site and joint. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.04 | |
| Confidence Interval |
(2-Sided) 95% 0.016 to 0.065 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Surgical Rates |
|---|---|
| Description | Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit. |
| Time Frame | 6 months after the initial visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Excluding patients who did not provide information to calculate the Informed, Patient-Centered (IPC) variable. |
| Arm/Group Title | Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | 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 |
| Measure Participants | 239 | 252 | 237 | 239 |
| Count of Participants [Participants] |
140
49.6%
|
153
52.4%
|
134
48.7%
|
154
56%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Interactive Decision Aid and Usual Care, Video Decision Aid and Usual Care, Interactive Decision Aid and Provider Report, Video Decision Aid and Provider Report |
|---|---|---|
| Comments | We included all 4 study groups, but the comparison group was: informed, patient centered (IPC) decision yes vs. no. We excluded those who did not provide information to calculate the IPC variable. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Regression, Logistic | |
| Comments | General estimating equations were used to account for clustering of patients within surgeons. | |
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 25.7 | |
| Confidence Interval |
(2-Sided) 95% 16.5 to 40.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | The 1 week post visit and 6 month follow-up surveys were checked as they came in for evidence of adverse events. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report | ||||
| Arm/Group Description | 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 | 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 | 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 | 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 | ||||
All Cause Mortality |
||||||||
| Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/282 (0%) | 0/292 (0%) | 0/275 (0%) | 0/275 (0%) | ||||
Serious Adverse Events |
||||||||
| Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/282 (0%) | 0/292 (0%) | 0/275 (0%) | 0/275 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Interactive Decision Aid and Usual Care | Video Decision Aid and Usual Care | Interactive Decision Aid and Provider Report | Video Decision Aid and Provider Report | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/282 (0%) | 0/292 (0%) | 0/275 (0%) | 0/275 (0%) | ||||
Limitations/Caveats
Study staff and participating surgeons not blinded to intervention; 6 months may be too short to capture full benefit of surgery on quality of life.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Karen R. Sepucha |
|---|---|
| Organization | Massachusetts General Hospital |
| Phone | 617-724-3350 |
| KSEPUCHA@mgh.harvard.edu |
Responsible Party:
Karen Sepucha,
Director, Health Decision Sciences Center,
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02729831
Other Study ID Numbers:
- 2016P000229
First Posted:
Apr 6, 2016
Last Update Posted:
Dec 13, 2019
Last Verified:
Dec 1, 2019