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| Name | Class |
|---|---|
| Newton-Wellesley Hospital | OTHER |
| The New England Baptist Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive Decision Aid and Usual Care | Experimental | 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. |
|
| Video decision aid and usual care | Experimental | 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. |
|
| Interactive Decision Aid and Provider Report | Experimental | 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. |
|
| Video decision aid and Provider report | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive decision aid | Behavioral | The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Knowledge | 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. | before orthopedic visit |
| Percentage of Patients Who Received Preferred Treatment | 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. | 1 week after visit with orthopedic 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. | before orthopedic visit |
| Change in Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| New England Baptist 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. | |
| 30804032 | Background |
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| ID | Type | URL | Comment |
|---|---|---|---|
| outcome measure | View IPD |
A complete, cleaned, de-identified copy of the final data set that includes survey data for the primary and secondary outcomes from patient participants has been created. The PI will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital (MGH) policies for data sharing. Investigators from other sites are able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team, etc.
The data will be available September 2019 and will be available for at least 7 years from that time.
Interested investigators may consult the DECIDE-OA study page on the Massachusetts General Hospital's Health Decision Sciences Center website for information about data sharing.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (Post Decision Aid, Pre-visit) |
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| 1 Week Post-visit |
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| 6 Month Follow-up |
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Participants who attended a visit with an orthopedic surgeon, completed a Baseline survey, and subsequently remained clinically eligible post-visit. Study staff reviewed patient medical record post-visit to finalize enrollment in study, as limited data pre-visit meant there were some post-randomization exclusions.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| 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 | Patients Knowledge | 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. | 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. | Posted | Mean | Standard Deviation | percentage of correct answers | before orthopedic visit |
|
The 1 week post visit and 6 month follow-up surveys were checked as they came in for evidence of adverse events.
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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 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen R. Sepucha | Massachusetts General Hospital | 617-724-3350 | KSEPUCHA@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2017 | Oct 30, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2017 | Oct 30, 2019 | SAP_001.pdf |
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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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| Video decision aid | Behavioral | Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis |
|
| Provider Report | Behavioral | A short report that includes the patients' goals and treatment preferences |
|
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. |
| before orthopedic visit; 12 months from date of orthopedic visit |
| Surgical Rates | Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit. | 6 months after the initial visit |
| Boston |
| Massachusetts |
| 02120 |
| United States |
| Newton Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| 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. |
Hip Osteoarthritis Decision Quality Instrument |
| outcome measure | View IPD | Knee Osteoarthritis Decision Quality Instrument |
| COMPLETED |
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| NOT COMPLETED |
|
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| COMPLETED |
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| NOT COMPLETED |
|
|
| BG001 |
| 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Joint | Diagnosis of hip or knee osteoarthritis. Dx status collected from visit note and/or confirmed via x-ray report. | Count of Participants | Participants |
|
| Decision aid delivery | Mode of delivery for the patient decision aid (DA). Participants who were registered users for the online Patient Gateway platform were sent the DA online to their account; all other patients were mailed a paper version. | Count of Participants | Participants |
|
| Health literacy | Single item literacy screener. One question assessing how often patients need help reading and understanding medical paperwork. Patient self-reported at T2 (pre-visit) survey. | Count of Participants | Participants |
|
| Education | One question assessing highest level of education achieved. Patient self-reported at T2 (post-visit) survey. | Count of Participants | Participants |
|
| Insurance | Primary insurance type. Information collected from patient medical record. | Count of Participants | Participants |
|
| Body Mass Index | Body Mass Index (BMI) calculated as a function of weight (kg)/height squared (m2). Information collected from patient medical record. | Mean | Standard Deviation | kg/m^2 |
|
| Charlson co-morbidity index (CCI) | A summary score representing the burden of disease for a patient. A total of 18 comorbidities, with subcategories for diabetes, liver disease, and cancer were collected from the medical record. Each comorbidity is assigned a score from 1 to 6 based on mortality risk and disease severity, then summed to form the total CCI score (0 minimum score - 39 maximum score). Higher scores indicate higher mortality and burden of disease. | Count of Participants | Participants |
|
| Quality of life (EQ-5D) | 5 item summary measure of overall health status. It generates a single index value, that ranges from best health 1 to worst health -0.11. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 |
| OG002 | 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 |
| OG003 | 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 |
|
|
|
| Primary | Percentage of Patients Who Received Preferred Treatment | 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. | 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. | Posted | Count of Participants | Participants | 1 week after visit with orthopedic surgeon |
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|
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| 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. | Participants must answer the program usage question on the Baseline survey. Only 1091/1124 participants provided sufficient information to calculate decision aid usage. | Posted | Count of Participants | Participants | before orthopedic visit |
|
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|
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| Secondary | Change in Quality of Life | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | before orthopedic visit; 12 months from date of orthopedic visit |
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| Secondary | Surgical Rates | Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit. | Excluding patients who did not provide information to calculate the Informed, Patient-Centered (IPC) variable. | Posted | Count of Participants | Participants | 6 months after the initial visit |
|
|
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|
| 0 |
| 282 |
| 0 |
| 282 |
| 0 |
| 282 |
| EG001 | 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 | 0 | 292 | 0 | 292 | 0 | 292 |
| EG002 | 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 | 0 | 275 | 0 | 275 | 0 | 275 |
| EG003 | 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 | 0 | 275 | 0 | 275 | 0 | 275 |
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We tested for interaction effects. Comparison groups are: Interactive decision versus Video decision aid |
| Regression, Logistic |
General Estimating Equations accounted for clustering of patients within surgeons and controlling for baseline EQ-5D, BMI, joint and education. |
| 0.75 |
| Odds Ratio (OR) |
| 1.06 |
| 2-Sided |
| 95 |
| 0.76 |
| 1.47 |
| Superiority |
| Some |
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| Most |
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| All |
|