Knee OsteoarthritisNCT04011488
Shared Decision Making and How It Impacts the Patient Understanding
A study testing Shared Decision Making Tool in people with Knee Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Shared Decision Making (SDM) supports patient centered care and improves patient outcomes and satisfaction. Movement is Life (MIL) created an innovative SDM tool to provide a personalized framework for discussion of the projected impact to patients of their decisions regarding treatment options for knee… Read more about this study
- Who is it for?
- Ages 45 to 64 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Shared Decision Making Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- - Aged 45 to 64 years
- Mild to moderate knee pain consistent with a diagnosis of osteoarthritis by the clinician
- Self-identified as African American and/or Hispanic
- At least one of the following comorbidities:
- Obesity (BMI ≥ 30),
- Hypertension (ICD10 codes below)
- Diabetes (ICD10 codes below)
Who cannot join
- - Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis)
- Prior total knee replacement
- Recommended total knee replacement
- Acute knee trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Shared Decision Making and How it Impacts Patient Understanding: Using an Interactive Knee Osteoarthritis App Based on a Cost Model to Generate a Patient Shared Decision Making Tool: Multi-center Randomized Clinical Trial Study Protocol
Shared Decision Making (SDM) supports patient centered care and improves patient outcomes and satisfaction. Movement is Life (MIL) created an innovative SDM tool to provide a personalized framework for discussion of the projected impact to patients of their decisions regarding treatment options for knee osteoarthritis.
- Did use of the MIL SDM tool for knee osteoarthritis result in an increased level of self-reported physical activity at one month in African American and Hispanic women?
- Did use of the MIL SMD tool increase subject likeliness to recommend the physician?
- What is the qualitative feedback from subjects on ease of use of the MIL SDM tool?
- Conditions
- Knee Osteoarthritis
- Being tested
- Shared Decision Making Tool
- Keywords
- shared decision making
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision Making ToolOther
We've used the framework from this model and adapted it to the patient perspective to create a Patient Shared Decision Making Tool. The model is interactive so it can be customized to a specific patient. It has adjustments built in for gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes).
The strongest, underlying message is that any treatment choice is better than not seeking treatment. To illustrate this, a "Do Nothing" pathway is included for comparison purposes.
| Study group | Role | What they receive |
|---|---|---|
| Standard patient information data sheet | No intervention | Not described |
| SDM Tool | Experimental | A simple, one-page tool that provides a framework for the patient discussion, which improves the consistency of the patient-provider communication. This SDM can also be customized to a specific patient based on gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes). Receives: Other: Shared Decision Making Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Survey
The primary outcome instrument is the Patient Information Survey administered shortly after the evaluation. There is both a qualitative and quantitative portion of the survey.
Measured: One month afterwards
Secondary outcomes (5)
Personal Health Questionnaire (PHQ-8),
Depression Survey
Measured: One month post intervention
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)
joint specific functional outcome survey
Measured: One month post intervention
Patient Experience Survey
Measured: One month post intervention
Patient Information Survey- Qualitative portion
Measured: One month post intervention
Shared Decision Making (SDM) Survey
Measured: One month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study startJun 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: Low patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Johns Hopkins University, 3rd Coast Research Associates, Yale University, University Hospitals Cleveland Medical Center, PIH Family Practice Residency, Baylor College of Medicine, Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Michael L Parks, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011488
- Sponsor's protocol ID
- 2016-462
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making and How it Impacts Patient Understanding: Using an Interactive Knee Osteoarthritis App Based on a Cost Model to Generate a Patient Shared Decision Making Tool: Multi-center Randomized Clinical Trial Study Protocol
- ClinicalTrials.gov ID
- NCT04011488
- Acronym / sponsor ID
- 2016-462
- Conditions
- Knee Osteoarthritis
- Keywords
- shared decision making
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low patient recruitment
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Johns Hopkins University, 3rd Coast Research Associates, Yale University, University Hospitals Cleveland Medical Center, PIH Family Practice Residency, Baylor College of Medicine, Zimmer Biomet
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shared Decision Making (SDM) supports patient centered care and improves patient outcomes and satisfaction. Movement is Life (MIL) created an innovative SDM tool to provide a personalized framework for discussion of the projected impact to patients of their decisions regarding treatment options for knee osteoarthritis.
- Did use of the MIL SDM tool for knee osteoarthritis result in an increased level of self-reported physical activity at one month in African American and Hispanic women?
- Did use of the MIL SMD tool increase subject likeliness to recommend the physician?
- What is the qualitative feedback from subjects on ease of use of the MIL SDM tool?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard patient information data sheet | No intervention | – |
| SDM Tool | Experimental | Other: Shared Decision Making ToolA simple, one-page tool that provides a framework for the patient discussion, which improves the consistency of the patient-provider communication. This SDM can also be customized to a specific patient based on gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes). |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- - Aged 45 to 64 years
- Mild to moderate knee pain consistent with a diagnosis of osteoarthritis by the clinician
- Self-identified as African American and/or Hispanic
- At least one of the following comorbidities:
Key exclusion criteria (4 listed)
- - Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis)
- Prior total knee replacement
- Recommended total knee replacement
- Acute knee trauma
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 |
|---|---|---|
| Shared Decision Making ToolWe've used the framework from this model and adapted it to the patient perspective to create a Patient Shared Decision Making Tool. The model is interactive so it can be customized to a specific patient. It has adjustments built in for gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes). The strongest, underlying message is that any treatment choice is better than not seeking treatment. To illustrate this, a "Do Nothing" pathway is included for comparison purposes. | Other | SDM Tool |
Primary outcome
Patient Information Survey
Time frame: One month afterwards
The primary outcome instrument is the Patient Information Survey administered shortly after the evaluation. There is both a qualitative and quantitative portion of the survey.
5 secondary outcomes
Personal Health Questionnaire (PHQ-8),
Time frame: One month post intervention
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)
Time frame: One month post intervention
Patient Experience Survey
Time frame: One month post intervention
Patient Information Survey- Qualitative portion
Time frame: One month post intervention
Shared Decision Making (SDM) Survey
Time frame: One month post intervention
Results and safety
The study was stopped early (reason given: Low patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Michael L Parks, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making Tool in people with Knee Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Low patient recruitment). Results are not available in the source record.
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?
Patient Information Survey (time frame: One month afterwards). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2019.