Clinical trial NCT04805554: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Patient perception of decision process and quality as measured by the Knee Decision Quality Instrument (Knee-DQI)
timeFrame: Immediately following enrollment visit
Secondary outcomes:
measure: Concordance between patient preferences and actual outcomes
timeFrame: 3 months and 6 months following enrollment visit
Other outcomes:
measure: Patient perception of the level of shared decision making as measured by the CollaboRATE survey
timeFrame: Immediately following enrollment visit
measure: Patient/provider satisfaction with discussion as measured by a numeric rating scale
timeFrame: Immediately following enrollment visit
measure: Total consultation time (minutes)
timeFrame: Enrollment visit
measure: Patient-reported overall health as measured by the PROMIS Global-10 tool
timeFrame: Change in overall health from baseline visit to 3 month and 6 month follow up
measure: Patient-reported capability level as measured by the KOOS JR tool
timeFrame: Change in limitations from baseline visit to 3 month and 6 month follow up
measure: Treatment selected/TKR rate
timeFrame: 3 months and 6 months after initial visit
measure: Patient perception of decisional conflict as measured by the Decisional Conflict Scale 10 (DCS-10)
timeFrame: Immediately following enrollment visit
measure: Patient perception of decision regret, as measured by the Decision Regret Scale (DRS)
timeFrame: 3 and 6 months following enrollment visit
Locations:
city: Austin
country: United States
facility: UT Health Austin Musculoskeletal Institute
state: Texas
Study officials:
References:
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.