Shared Decision Making in Patients With Osteoarthritis of the Hip and Knee (SDM)
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ClinicalTrials.gov Identifier: NCT01492257 |
Recruitment Status
:
Completed
First Posted
: December 14, 2011
Last Update Posted
: December 13, 2012
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Condition or disease | Intervention/treatment | Phase |
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Hip Osteoarthritis Knee Osteoarthritis | Other: Shared Decision Making Intervention | Not Applicable |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Health Services Research |
Official Title: | Shared Decision Making in Patients With Osteoarthritis of the Hip and Knee |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
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No Intervention: SDM Control
The control arm will consist of usual care, patients will receive existing educational materials.
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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.
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Other: Shared Decision Making Intervention
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.
|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492257
United States, California | |
Stanford University | |
Redwood City, California, United States, 94063 | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Kevin J Bozic, MD, MBA | University of California, San Francisco | |
Study Director: | Vanessa Chiu, MPH | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01492257 History of Changes |
Other Study ID Numbers: |
UCSFSDMv1 |
First Posted: | December 14, 2011 Key Record Dates |
Last Update Posted: | December 13, 2012 |
Last Verified: | December 2012 |
Keywords provided by University of California, San Francisco:
shared decision making decision aids total joint arthroplasty osteoarthritis |
Additional relevant MeSH terms:
Osteoarthritis Osteoarthritis, Knee Osteoarthritis, Hip Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |