Trial Outcomes & Findings for Development of an Osteoarthritis (OA) Care Plan to Improve Process and Quality of OA Treatment Decisions (NCT NCT03102580)

Last Updated: 2026-02-02

Results Overview

The Decision Conflict Scale (DCS) is a validated self-report instrument that assesses uncertainty in healthcare decision making. The DCS consists of 16 items, each rated on a 5-point Likert scale. Scores are summed and transformed to a total score from 0 (no conflict) to 100 (high conflict). Lower scores indicate less decisional conflict (better outcome), and higher scores reflect greater decisional conflict (worse outcome). Mean (standard deviation) DCS scores are reported by study arm/group.

Recruitment status

COMPLETED

Study phase

Target enrollment

5713 participants

Primary outcome timeframe

1 month post decision

Results posted on

2026-02-02

Participant Flow

The study recruited diverse settings and patients by (1) location, (2) practice type, and (3) patient volume. Thirteen sites and 36 surgeons enrolled 5713 patients. Sites were situated in 11 states, 6 were non-academic sites (50%). Patients were \> 40 years of age and provided consent in English or Spanish; had a primary diagnosis of OA in a hip or knee and reported moderate or severe pain or functional limitation on the joint-specific standardized PROs included in the ASK assessment.

Participant milestones

Participant milestones
Measure	OA Care Plan Intervention For intervention sites, the patient and surgeon received the OA Care Plan with Patient Reported Outcomes, feedback reports, and risk factors for shared decision making.	Usual Care As collection of Patient Reported Outcomes (PROs) is considered standard of care in orthopedics (CMS mandate, Bundled Payment requirements, and reporting for Qualified Clinical Data Registry requirement for example), usual care patients and surgeons will view PRO scores as presented in the electronic health record.
Phase 1 STARTED	1764	1236
Phase 1 COMPLETED	1764	1236
Phase 1 NOT COMPLETED	0	0
Phase 2 STARTED	2713	0
Phase 2 COMPLETED	2713	0
Phase 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Development of an Osteoarthritis (OA) Care Plan to Improve Process and Quality of OA Treatment Decisions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OA Care Plan Intervention n=4477 Participants For intervention sites, the patient and surgeon will receive the OA Care Plan (currently under development). The OA Care plan with have Patient Reported Outcomes, feedback reports, and risk factors for shared decision making. OA Care Plan: Patient and surgeon will receive the OA Care Plan (currently under development). This Care Plan will inform Shared Decision for treatment of moderate to sever OA, including surgical and non-surgical options.	Usual Care n=1236 Participants As collection of Patient Reported Outcomes (PROs) is considered standard of care in orthopedics (CMS mandate, Bundled Payment requirements, and reporting for Qualified Clinical Data Registry requirement for example), usual care patients and surgeons will have the ability to see PRO scores.	Total n=5713 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 9.2 • n=41 Participants	65.7 years STANDARD_DEVIATION 9.9 • n=1581 Participants	66.6 years STANDARD_DEVIATION 9.4 • n=4626 Participants
Sex: Female, Male Female	2739 Participants n=41 Participants	756 Participants n=1581 Participants	3495 Participants n=4626 Participants
Sex: Female, Male Male	1738 Participants n=41 Participants	480 Participants n=1581 Participants	2218 Participants n=4626 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=41 Participants	3 Participants n=1581 Participants	12 Participants n=4626 Participants
Race (NIH/OMB) Asian	22 Participants n=41 Participants	6 Participants n=1581 Participants	28 Participants n=4626 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=41 Participants	1 Participants n=1581 Participants	5 Participants n=4626 Participants
Race (NIH/OMB) Black or African American	335 Participants n=41 Participants	93 Participants n=1581 Participants	428 Participants n=4626 Participants
Race (NIH/OMB) White	3916 Participants n=41 Participants	1082 Participants n=1581 Participants	4998 Participants n=4626 Participants
Race (NIH/OMB) More than one race	88 Participants n=41 Participants	23 Participants n=1581 Participants	111 Participants n=4626 Participants
Race (NIH/OMB) Unknown or Not Reported	103 Participants n=41 Participants	28 Participants n=1581 Participants	131 Participants n=4626 Participants
Mean OA Pain - Knee/Hip Injury and Osteoarthritis Outcome Score (KOOS/HOOS)	41.4 score on a scale STANDARD_DEVIATION 15.5 • n=41 Participants	39.3 score on a scale STANDARD_DEVIATION 16.9 • n=1581 Participants	41.0 score on a scale STANDARD_DEVIATION 15.9 • n=4626 Participants

PRIMARY outcome

Timeframe: 1 month post decision

Population: Patients \>40 years of age with knee or hip osteoarthritis and initial evaluation by orthopedic surgeon.

Outcome measures

Outcome measures
Measure	Usual Care n=4477 Participants As collection of Patient Reported Outcomes (PROs) is considered standard of care in orthopedics (CMS mandate, Bundled Payment requirements, and reporting for Qualified Clinical Data Registry requirement for example), usual care patients and surgeons will have the ability to see PRO scores.	OA Care Plan Intervention n=1236 Participants For intervention sites, the patient and surgeon will receive the OA Care Plan. The OA Care plan with have Patient Reported Outcomes, feedback reports, and risk factors for shared decision making. For usual care sites, the patient and surgeon will receive only the routine Patient Reported Outcome score as is available in the electronic health record.
Differences in Decision Conflict Scale With ASK vs Usual Care	25.1 Score on a scale Standard Deviation 7	26.0 Score on a scale Standard Deviation 8

SECONDARY outcome

Timeframe: 6 month followup

Pain relief was assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) for knee OA patients and the Hip disability and Osteoarthritis Outcome Score (HOOS) for hip OA patients. The HOOS/KOOS is a broadly used 100 point scale (0-100) with 100 reflecting the maximum score and best health status for OA patients. The items are combined into two health domains: Pain and ADL (function/activities of daily living). The pain and ADL domains are scored 0-100 independently (with 100 reflecting the best health status for either pain or ADL). The domains scores are not additive.

Outcome measures

Outcome measures
Measure	Usual Care n=1062 Participants As collection of Patient Reported Outcomes (PROs) is considered standard of care in orthopedics (CMS mandate, Bundled Payment requirements, and reporting for Qualified Clinical Data Registry requirement for example), usual care patients and surgeons will have the ability to see PRO scores.	OA Care Plan Intervention n=1554 Participants For intervention sites, the patient and surgeon will receive the OA Care Plan. The OA Care plan with have Patient Reported Outcomes, feedback reports, and risk factors for shared decision making. For usual care sites, the patient and surgeon will receive only the routine Patient Reported Outcome score as is available in the electronic health record.
Differences in Pain Relief at 6 Months After Enrollment	20.1 score on a scale Standard Deviation 8.5	18.9 score on a scale Standard Deviation 9.1

SECONDARY outcome

Timeframe: 6 month follow-up

Functional gain was assessed using the Activities of Daily Living (ADL) domain of the Knee injury and Osteoarthritis Outcome Score (KOOS) for knee OA, and the Hip disability and Osteoarthritis Outcome Score (HOOS) for hip OA. The HOOS/KOOS is a broadly used 100 point scale (0-100) with 100 reflecting the maximum score and best health status for OA patients. The items are combined into two health domains: Pain and ADL (function/activities of daily living). The pain and ADL domains are scored 0-100 independently (with 100 reflecting the best health status for either pain or ADL). The domains scores are not additive.

Outcome measures

Outcome measures
Measure	Usual Care n=1062 Participants As collection of Patient Reported Outcomes (PROs) is considered standard of care in orthopedics (CMS mandate, Bundled Payment requirements, and reporting for Qualified Clinical Data Registry requirement for example), usual care patients and surgeons will have the ability to see PRO scores.	OA Care Plan Intervention n=1554 Participants For intervention sites, the patient and surgeon will receive the OA Care Plan. The OA Care plan with have Patient Reported Outcomes, feedback reports, and risk factors for shared decision making. For usual care sites, the patient and surgeon will receive only the routine Patient Reported Outcome score as is available in the electronic health record.
Difference in Functional Gain at 6 Months	17.1 score on a scale Standard Deviation 8.9	18.2 score on a scale Standard Deviation 9.2

Adverse Events

OA Care Plan Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Patricia Franklin, MD (Professor, Medical Social Sciences and PI)

Northwestern University Feinberg School of Medicine

Phone: 312-503-4348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place