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

NCT01492257 | Completed

• 1 other identifier: UCSFSDMv1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Osteoarthritis; Knee Osteoarthritis

Keywords

shared decision making; decision aids; total joint arthroplasty; osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Treatment Decision

  Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours

• Patient and Surgeon Satisfaction

  Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours

• Length of office visit

  Participants will be followed for the duration of the clinic visit, expected to last up to 4 hours

• Adherence to treatment recommendations

  At least 6 Weeks

Study Arms (2)

SDM Control

NO INTERVENTION

The control arm will consist of usual care, patients will receive existing educational materials.

SDM Intervention

EXPERIMENTAL

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.

Other: Shared Decision Making Intervention

Interventions

Shared Decision Making Intervention OTHER

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.

SDM Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Stanford University: collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (2)

Stanford University

Redwood City, California, 94063, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kevin J Bozic, MD, MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Vanessa Chiu, MPH

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 14, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

US (2)