Hip OsteoarthritisNCT02729831
Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery
A study testing Interactive decision aid, Video decision aid and Provider Report in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Massachusetts General Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Interactive decision aid, Video decision aid and Provider Report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of either hip or knee osteoarthritis
- Scheduled visit with participating orthopedic surgeon
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
New England Baptist Hospital
Boston, Massachusetts, 02120
Newton Wellesley Hospital
Newton, Massachusetts, 02462
About this study
Official title: Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery: A Factorial Randomized Trial
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.
Read the 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.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Being tested
- Interactive decision aid, Video decision aid, Provider Report
- Keywords
- decision making, decision aids, decision quality instruments, osteoarthritis, shared decision making
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive decision aidBehavioural
The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
Video decision aidBehavioural
Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
Provider ReportBehavioural
A short report that includes the patients' goals and treatment preferences
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Interactive decision aid |
| 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. Receives: Behavioral: Video decision aid |
| 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. Receives: Behavioral: Interactive decision aid; Behavioral: Provider Report |
| 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. Receives: Behavioral: Interactive decision aid; Behavioral: Provider Report |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week after visit with orthopedic surgeon
Secondary outcomes (3)
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.
Measured: before orthopedic visit
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.
Measured: 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.
Measured: 6 months after the initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Newton-Wellesley Hospital, The New England Baptist Hospital
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
- Investigators
- Karen Sepucha, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729831
- Sponsor's protocol ID
- 2016P000229
- Status last verified
- Dec 2019
- First submitted
- 28 Mar 2016
- Last updated
- 13 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 23891070Mangla 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.
PubMed 30804032
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Decision Support Strategies for Joint Replacement Surgery: A Factorial Randomized Trial
- ClinicalTrials.gov ID
- NCT02729831
- Acronym / sponsor ID
- 2016P000229
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Keywords
- decision making, decision aids, decision quality instruments, osteoarthritis, shared decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Newton-Wellesley Hospital, The New England Baptist Hospital
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Posted 13 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Interactive Decision Aid and Usual Care | Experimental | Behavioral: Interactive decision aidGroup 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 | Behavioral: Video decision aidGroup 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 | Behavioral: Interactive decision aid, Behavioral: Provider ReportGroup 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 | Behavioral: Interactive decision aid, Behavioral: Provider ReportGroup 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of either hip or knee osteoarthritis
- Scheduled visit with participating orthopedic surgeon
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive decision aidThe Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis | Behavioural | Interactive Decision Aid and Provider Report, Interactive Decision Aid and Usual Care, Video decision aid and Provider report |
| Video decision aidHealth Dialog DVD and booklet decision aids for hip and knee osteoarthritis | Behavioural | Video decision aid and usual care |
| Provider ReportA short report that includes the patients' goals and treatment preferences | Behavioural | Interactive Decision Aid and Provider Report, Video decision aid and Provider report |
Primary outcome
Patients Knowledge
Time frame: 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
Time frame: 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.
3 secondary outcomes
Percentage of Participants Who Used the Decision Aid
Time frame: before orthopedic visit
Change in Quality of Life
Time frame: before orthopedic visit; 12 months from date of orthopedic visit
Surgical Rates
Time frame: 6 months after the initial visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23891070Sepucha 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.
- Background: PubMed 30804032Mangla 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Sepucha, PhD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive decision aid, Video decision aid and Provider Report in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Knowledge (time frame: before orthopedic visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02729831, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.