Shared Decision Making in Patients With Osteoarthritis of the Hip and Knee

Knee Osteoarthritis Clinical Trial

— SDM  

Official title:

Shared Decision Making in Patients With Osteoarthritis of the Hip and Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492257
• Other study ID #: UCSFSDMv1
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: December 12, 2012
• Start date: July 2011
• Est. completion date: August 2012

Study information

• Verified date: December 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Redwood City	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Robert Wood Johnson Foundation, Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage of decision making	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	No
Primary	Knowledge Score	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	No
Secondary	Treatment Decision	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	No
Secondary	Patient and Surgeon Satisfaction	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	No
Secondary	Length of office visit	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	No
Secondary	Adherence to treatment recommendations	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	No