Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 7:11 AM
Study NCT ID:
NCT01492257
Status:
COMPLETED
Last Update Posted:
2012-12-13
First Post:
2011-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shared Decision Making in Patients With Osteoarthritis of the Hip and Knee
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Shared Decision Making in Patients With Osteoarthritis of the Hip and Knee
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SDM
Brief Summary:
Total joint arthroplasty (TJA) is an effective procedure for reducing pain and improving function in patients with disabling osteoarthritis (OA) of the hip or knee. However, as with all invasive procedures, TJA is associated with certain risks and substantial costs. Since the indications for TJA are heavily dependent on patients' quality of life and expectations. TJA utilization rates vary widely throughout the United States, as seen with other 'preference-sensitive' procedures. Early evidence suggests shared decision making (SDM) strategies are effective in enhancing patient decision quality, or the degree to which treatment decisions reflect the preferences of fully informed patients, especially for preference-sensitive procedures like TJA. Despite these advantages, however, SDM has not been embraced or widely adopted in orthopaedics. To investigate this limited uptake, the investigators propose a series of evaluations of individual-level strategies. The investigators innovative and unique contribution is to approach patients, surgeons and healthcare purchasers as having symmetric and equally valid concerns about the benefits and cost associated with SDM. The investigators overall objective is to facilitate wider dissemination of SDM strategies in orthopaedic practices. The specific aims of the project are to assess, for SDM strategies, the impact on key patient, surgeon, and healthcare purchaser priorities; By achieving this aim our project will produce new interventions and incentives for disseminating SDM that are endorsed as feasible and acceptable by a coalition of patients, surgeons, and purchasers. The investigators plans for evaluation include a randomized controlled trial to evaluate the impact of SDM on outcomes of interest to patients, surgeons, and purchasers.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: