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Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee

Primary Purpose

Osteo Arthritis Knee

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Joint Insights decision aid
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteo Arthritis Knee

Eligibility Criteria

45 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • New patients
  • Presumptive diagnosis of knee OA
  • Aged 45 to 89
  • K-L Joint OA severity grade 3 to 4 (moderate to severe)
  • KOOS JR score 0-85
  • Able to consent

Exclusion Criteria:

  • Prior total knee replacement (TKR)
  • Prior consultation with orthopaedic surgeons for TKR
  • Prior experience with Joint Insights
  • Trauma condition or psoriatic/rheumatoid arthritis
  • Non-English or Non-Spanish speakers
  • BMI <20 or >46

Sites / Locations

  • UT Health Austin Musculoskeletal InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Joint Insights Decision Aid

Education Module Only

Arm Description

Participants view the entire Joint Insights decision aid for knee osteoarthritis including: Education Module with information about knee osteoarthritis and risks and benefits of various treatment options, Preferences and Values elicitation questions, and Personalized Risk/Benefit Report.

Participants view the Joint Insights Education Module only

Outcomes

Primary Outcome Measures

Patient perception of decision process and quality as measured by the Knee Decision Quality Instrument (Knee-DQI)
Patients are asked about whether they were offered a choice between treatments (yes/no), to what extent the pros and cons were discussed (a lot/some/a little/not at all), and whether the health care provider asked for their preferences (yes/no). Participants receive 1 point for a response of "yes" or "a lot/some." The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicated a more shared decision making process.

Secondary Outcome Measures

Concordance between patient preferences and actual outcomes
A binary (yes/no) measure of whether a patient's response to the Knee Decision Quality Instrument question #1.6 (asking whether a patient wants surgical or non-surgical treatment) matches the observed outcome of whether the patient had TKA within 6 months (based on medical record review). A "yes" indicates greater concordance.

Full Information

First Posted
March 15, 2021
Last Updated
December 9, 2022
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT04805554
Brief Title
Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee
Official Title
Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Osteoarthritis (OA) of the knee constitutes a major public health problem. Treatment options for knee OA range from lifestyle changes to pharmacological management to total knee replacement surgery. As a "preference-sensitive" condition, management of OA of the knee is ideally suited for shared decision making (SDM), taking into consideration benefits, risks, and patients' health status, values, and goals. Patient-reported outcomes (PROs) reflect health status from the patient's perspective. For knee OA, relevant PROs include pain and other symptoms, functional status and limitations, and overall health. Prior research indicates that patients with higher baseline physical function and/or poor baseline mental health do not benefit as much from total knee replacement. Still, due to logistical challenges, costs, and disruptions in workflow, PROs have not yet achieved their full potential in clinical care. Musculoskeletal providers at Dell Medical School and UT Health Austin currently collect general and condition-specific PROs from every patient seen in their Musculoskeletal Institute. PROs are collected via an electronic interface and results are pulled into the Athena electronic health record (EHR). Given the promise of combining PRO data with clinical and demographic data, musculoskeletal providers at UT Health Austin have begun utilizing an innovative electronic PRO-based predictive analytic tool at the point of care to guide SDM in patients with knee OA. This project plans to evaluate the clinical effectiveness and impact of the PRO-guided predictive analytic SDM tool and process in a randomized controlled trial in Austin. Outcomes will include decision quality, as reported by patients; treatment decision (surgical vs. non-surgical); and decisional conflict and regret. Our project contributes to AHRQ's strategy to use health IT to improve quality and outcomes by evaluating a tool and process for the use of PRO data at the point of care. The model being tested puts patients at the center of their care by enabling them to participate in informed decision making by using their personal health data, preferences, and prognostic models. Knowledge gained will be critical to scaling and spreading use of this PRO-guided SDM tool among patients with knee OA nationally.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Joint Insights Decision Aid
Arm Type
Experimental
Arm Description
Participants view the entire Joint Insights decision aid for knee osteoarthritis including: Education Module with information about knee osteoarthritis and risks and benefits of various treatment options, Preferences and Values elicitation questions, and Personalized Risk/Benefit Report.
Arm Title
Education Module Only
Arm Type
Active Comparator
Arm Description
Participants view the Joint Insights Education Module only
Intervention Type
Other
Intervention Name(s)
Joint Insights decision aid
Intervention Description
The Joint Insights decision aid was developed by Dell Medical School faculty in collaboration with OM1, a health outcomes and predictive analytics company. This decision aid uses patient-report outcome measures (PROMs) - specifically, the PROMIS Global and the KOOS JR - along with patient clinical and demographic information (age, sex, race, ethnicity, chronic narcotic use, body mass index), in machine-learning-based predictive analytic models to provide personalized estimates of likely benefit or harm from total knee replacement surgery. The tool is designed to collect PROMs or pull in PROMs collected through other systems (e.g., an EHR or a third-party PROM platform). It also provides condition-specific education to patients with knee OA and allows a patient to reflect on and document their preferences and goals. The personalized risk/benefit report generated by the decision aid is meant to be discussed with the patient's provider to enhance shared decision making.
Primary Outcome Measure Information:
Title
Patient perception of decision process and quality as measured by the Knee Decision Quality Instrument (Knee-DQI)
Description
Patients are asked about whether they were offered a choice between treatments (yes/no), to what extent the pros and cons were discussed (a lot/some/a little/not at all), and whether the health care provider asked for their preferences (yes/no). Participants receive 1 point for a response of "yes" or "a lot/some." The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicated a more shared decision making process.
Time Frame
Immediately following enrollment visit
Secondary Outcome Measure Information:
Title
Concordance between patient preferences and actual outcomes
Description
A binary (yes/no) measure of whether a patient's response to the Knee Decision Quality Instrument question #1.6 (asking whether a patient wants surgical or non-surgical treatment) matches the observed outcome of whether the patient had TKA within 6 months (based on medical record review). A "yes" indicates greater concordance.
Time Frame
3 months and 6 months following enrollment visit
Other Pre-specified Outcome Measures:
Title
Patient perception of the level of shared decision making as measured by the CollaboRATE survey
Description
Patients are asked three questions, each on a scale of 0-9, about how much effort they perceived their medical provider to have made to help the patient understand their health issues, understand what is important to the patient, and incorporate what is important to the patient in choosing a treatment. The scores range from 0-27 and a higher score indicates greater perceived shared decision making.
Time Frame
Immediately following enrollment visit
Title
Patient/provider satisfaction with discussion as measured by a numeric rating scale
Description
Patients and providers rate their satisfaction with the discussion on a 10 point scale (single question) in which a higher score indicates greater satisfaction.
Time Frame
Immediately following enrollment visit
Title
Total consultation time (minutes)
Description
Duration of surgeon/patient consultation in minutes as measured by research assistant. Continuous variable, no set scale.
Time Frame
Enrollment visit
Title
Patient-reported overall health as measured by the PROMIS Global-10 tool
Description
Patients answer ten survey questions regarding their overall physical and mental health; the measure produces two sub-scores, one each for physical and mental health. The physical health sub-score is scored on a scale of 16.6 to 67.7, with higher scores indicating better physical health. The mental health sub-score is scored on a scale of 21.2 to 67.6 with higher scores indicating better mental health.
Time Frame
Change in overall health from baseline visit to 3 month and 6 month follow up
Title
Patient-reported capability level as measured by the KOOS JR tool
Description
Patients answer seven Likert-scale survey questions about their degree of stiffness, pain, and difficulty in performing everyday tasks. The tool is scored from 0-100 with higher scores indicating higher levels of capability or functionality.
Time Frame
Change in limitations from baseline visit to 3 month and 6 month follow up
Title
Treatment selected/TKR rate
Description
Treatment choice (arthroplasty vs non-surgical treatment). Categorical.
Time Frame
3 months and 6 months after initial visit
Title
Patient perception of decisional conflict as measured by the Decisional Conflict Scale 10 (DCS-10)
Description
The decisional conflict scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The likert scales are scored as 1-5, with the scoring reversed for negatively-phrased items. The mean is then taken and converted to a score ranging 0-100 with 100 being the least decision regret.10-item survey in which each item is scored as 0 (yes), 2 (unsure) or 4 (no). The items are summed, divided by 10, and multiplied by 25 to get a score ranging from 0-100 in which the patient is extremely uncertain about their decision.
Time Frame
Immediately following enrollment visit
Title
Patient perception of decision regret, as measured by the Decision Regret Scale (DRS)
Description
The Decision Regret Scale measures distress or remorse after a health care decision through five agree/disagree statements. The likert scales are scored as 1-5, with the scoring reversed for negatively-phrased items. The mean is then taken and converted to a score ranging 0-100 with 100 being the least decision regret.
Time Frame
3 and 6 months following enrollment visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: New patients Presumptive diagnosis of knee OA Aged 45 to 89 K-L Joint OA severity grade 3 to 4 (moderate to severe) KOOS JR score 0-85 Able to consent Exclusion Criteria: Prior total knee replacement (TKR) Prior consultation with orthopaedic surgeons for TKR Prior experience with Joint Insights Trauma condition or psoriatic/rheumatoid arthritis Non-English or Non-Spanish speakers BMI <20 or >46
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Uhler, MPH
Phone
512-495-5090
Email
lauren.uhler@austin.utexas.edu
Facility Information:
Facility Name
UT Health Austin Musculoskeletal Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Uhler
First Name & Middle Initial & Last Name & Degree
Kevin Bozic, MD, MBA

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35190439
Citation
Lin E, Uhler LM, Finley EP, Jayakumar P, Rathouz PJ, Bozic KJ, Tsevat J. Incorporating patient-reported outcomes into shared decision-making in the management of patients with osteoarthritis of the knee: a hybrid effectiveness-implementation study protocol. BMJ Open. 2022 Feb 21;12(2):e055933. doi: 10.1136/bmjopen-2021-055933.
Results Reference
derived

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Incorporating Patient-Reported Outcomes Into Shared Decision Making With Patients With Osteoarthritis of the Hip or Knee

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