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| Name | Class |
|---|---|
| Newton-Wellesley Hospital | OTHER |
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This pilot RCT study is to examine the comparative effectiveness of two decision aids for hip and knee osteoarthritis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive decision aid | Experimental | Group receiving brief interactive decision aid. The decision aids are the Shared Decision Points for hip and knee osteoarthritis from Healthwise |
|
| Video decision aid | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief interactive decision aid | Behavioral | The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of Participants With a Clear Treatment Preference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen R Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Newton Wellesley Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23891070 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Outcome measure | View IPD |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study participants between both groups were quite balanced. Mean age and gender did not have any significant differences based on group assignment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The total knowledge score of 5 multiple questions with a total score of 0-100% was generated for all study patients. | Posted | Mean | Standard Deviation | units on a scale | In clinic, immediately before the first visit with surgeon |
|
Serious and other (not including serious) adverse events were not collected/assessed.
Adverse events were not collected as part of this survey study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Sepucha | Massachusetts General Hospital | 6177243350 | ksepucha@partners.org |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Long video decision aid | Behavioral | Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis |
|
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 |
| Newton |
| Massachusetts |
| 02462 |
| United States |
Hip Osteoarthritis Decision Quality Instrument |
| Outcome measure | View IPD | Knee Osteoarthritis Decision Quality Instrument |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Gender data was collected through chart review of enrolled patients. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| 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 |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | In clinic, immediately before the first visit with surgeon |
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|
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| 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. | Posted | Count of Participants | Participants | In clinic, immediately before the first visit with surgeon |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 |
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