- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01492257
Shared Decision Making in Patients With Osteoarthritis of the Hip and Knee (SDM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
We propose an RCT based on a non-randomized pilot study conducted at UCSF that included 115 patients who were referred for evaluation of hip and knee OA. The results of this pilot study suggested that DESI's were associated with greater patient knowledge, higher decision quality, higher patient and surgeon satisfaction, and no substantial impact on length of office visit or treatment decision. As in the pilot study, the RCT intervention will include a package of decision and communication aids shown in prior studies to increase patient knowledge, question-asking, and information recall. The intervention includes digital video discs and booklets produced by the Foundation for Informed Medical Decision Making and Health Dialog; a question-prompting phone call with a trained health coach; audio-recordings of the patient-surgeon consultation; and a copy of the surgeon's dictated note. The control arm will consist of usual care. Our primary outcome is the proportion of patients who arrive at an informed decision during the first visit. This outcome is of interest to patients, surgeons and healthcare purchasers, all of whom value efficiency and quality in delivery of care. Our hypothesis is that a higher proportion of patients in the intervention group will arrive at an informed decision during the first visit, as a result of being more knowledgeable and prepared for their visit, thus conserving resources while advancing quality. Secondary outcomes of interest will include treatment decision (e.g., surgical vs. non-surgical); patient and provider satisfaction; length of office visits; and adherence to treatment recommendations.
We will assess whether patients are informed or not using a survey instrument testing 19 consensus "key facts" developed by FIMDM based on evidence and expert opinion. We will measure whether patients arrive at a decision using the Stage of Decision Making instrument. We will administer both instruments immediately after the patient's first consultation with their surgeon.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Redwood City, California, United States, 94063
- Stanford University
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic unilateral or bilateral osteoarthritis of the hip or knee
- At least 18 years of age
- Must be psychosocially, mentally, and physically able to fully complete the questionnaires
- No previous joint replacement surgery
- First time visit to surgeon
Exclusion Criteria:
- Prior history of joint replacement surgery, ipsilateral or contralateral hip/knee replacement
- Subjects whose primary diagnosis is not osteoarthritis
- Subjects who cannot speak or read English
- Subjects who are cognitively impaired
- Subjects who refuse to complete surveys
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: SDM Control
The control arm will consist of usual care, patients will receive existing educational materials.
|
|
EXPERIMENTAL: SDM Intervention
RCT intervention will include a package of decision and communication aids question-asking, and information recall.
The intervention includes digital video discs and booklets produced by the Foundation for Informed Medical Decision Making and Health Dialog; a question-prompting phone call with a trained health coach; audio-recordings of the patient-surgeon consultation; and a copy of the surgeon's dictated note.
|
Digital video discs and booklets produced by the Foundation for Informed Medical Decision Making and Health Dialog; a question-prompting phone call with a trained health coach; audio-recordings of the patient-surgeon consultation; and a copy of the surgeon's dictated note.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stage of decision making
Time Frame: Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
We will measure the proportion of patients who will arrive at a more informed decision during the clinic visit through surveys administered before the clinic visit and immediately after the clinic visit.
We will ask patients before the clinic visit what treatment decision they are leaning towards, how far along they are with this decision.
We will ask patients after the clinic visit, what treatment they want and how far along they are with the decision.
|
Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
Knowledge Score
Time Frame: Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
We will assess whether patients are informed or not using a survey instrument testing 19 consensus "key facts" developed by the Foundation for Informed Decision Making (FIMDM) based on evidence and expert opinion.
|
Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Decision
Time Frame: Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
Patients will be asked in a questionnaire what treatment decision (surgical vs. non surgical) they chose immediately after their clinic visit.
|
Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
Patient and Surgeon Satisfaction
Time Frame: Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
Patients will be asked in the questionnaire to rate on a scale of 0-10, with 0 being lowest satisfaction, and 10 being highest satisfaction, how satisfied they were with the consultation.
Surgeons will be asked, to rate on a scale of 0-10, how appropriate the content of the patient's questions were, how appropriate the number of the patient's questions were, how satisfied the surgeon was with the efficiency of the consultation, and overall satisfaction of the visit.
Both surveys will be administered immediately after the clinic visit.
|
Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
Length of office visit
Time Frame: Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
A research associate will measure and record the start and stop time of the entire visit and the start and stop time of the surgeon consultation.
|
Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours
|
Adherence to treatment recommendations
Time Frame: At least 6 Weeks
|
We will measure adherence to treatment recommendations through a 6 week follow up questionnaire administered at least6 weeks after the date of patient's clinic visit or 6 weeks after the date of the patient's surgery, if they had surgery.
The questionnaire will ask patients what treatment decision they decided on, to rate on a scale of 0-10 how often they participated in physical therapy if prescribed, rate on a scale of 0-10 how often they took medication if prescribed within the past 6 weeks.
|
At least 6 Weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kevin J Bozic, MD, MBA, University of California, San Francisco
- Study Director: Vanessa Chiu, MPH, University of California, San Francisco
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCSFSDMv1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Osteoarthritis
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Novartis PharmaceuticalsRecruitingSymptomatic Knee OsteoarthritisUnited States, Spain, Hungary, Argentina, Germany, Slovakia, Czechia, Belgium, Romania
-
University of BathUniversity of Oxford; 3D Metal Printing Ltd; Versus ArthritisRecruitingMedial Knee OsteoarthritisUnited Kingdom
-
Max Biocare Pty. Ltd.Completed
Clinical Trials on Shared Decision Making Intervention
-
University Hospitals, LeicesterCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
Xavier University of Louisiana.Tulane UniversityCompletedProstate CancerUnited States
-
The University of Texas Health Science Center,...TerminatedPregnancy Related | Elective InductionUnited States
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingDepressive Symptoms | Coronary Heart DiseaseUnited States
-
Shalvata Mental Health CenterUnknownShared Decision Making With PatientsIsrael
-
Umeå UniversityUnknownPsychosis | Participation, Patient | Psychiatric HospitalizationSweden
-
AstraZenecaBrigham Women's HealthCompletedDiabetes Mellitus Type 2United States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedLung Diseases | Asthma
-
Yokohama City UniversityCompleted
-
Christiana Care Health ServicesNational Institute of General Medical Sciences (NIGMS); Thomas Jefferson University and other collaboratorsCompleted