Osteo Arthritis KneeNCT03102580
Development of an Osteoarthritis (OA) Care Plan to Improve Process and Quality of OA Treatment Decisions
A study testing OA Care Plan in people with Osteo Arthritis Knee and Osteoarthritis, Hip, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
Knee and hip osteoarthritis (OA) is the most common cause of disability in the U.S. and affects more than 60% of adults over 65 years. As the burden of knee and hip OA increases among aging adults, more patients are deciding to have joint replacement surgery. Read more about this study
- Who is it for?
- Ages 40 to 99 years
- Conditions the study is for
- Osteo Arthritis Knee, Osteoarthritis, Hip
- What is being tested?
- OA Care Plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,713 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All new patients to participating surgeon's practice for the purpose of evaluation of knee or hip OA are possible participants.
- Patients must be 40 years of age or older and able to provide informed consent.
Who cannot join
- Inflammatory arthritis, such as rheumatoid or psoriatic arthritis
- Recent knee or hip injury as purpose for visit
- Pregnant women
- Prisoners
- Non-English speaking subjects- As we are refining and testing a web-based system intervention that provides individualized patient OA Care plans to improved shared decision making between patients and providers, for research purposes we must assure that the 'counseling' between the surgeon and patient will be in their native language. Once we have identified what materials work at the end of the study, we will translate materials into Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Patient Osteoarthritis Care Plan To Inform Optimal Treatment
Knee and hip osteoarthritis (OA) is the most common cause of disability in the U.S. and affects more than 60% of adults over 65 years. As the burden of knee and hip OA increases among aging adults, more patients are deciding to have joint replacement surgery. However, no clear guidelines exist for patients to determine if or when to undergo total joint replacement (TJR).
The investigators plan to develop a web-based system that will provide individualized patient OA Care Plans that will help patients make informed decisions about how to treat their arthritis. The investigators will be using this system with patients to see if they find it useful.
The investigators believe that the OA Care plan will improve the process and quality of OA treatment decisions and the quality of OA care.
Read the detailed description
The investigators propose to prospectively randomize orthopedists, with their patients, to receive (or not) a real-time, web-based system intervention: the OA Care plan. The OA Care plan will include individualized, patient-centric information: (1) trended patient-reported OA pain and function, (2) tailored estimates of likely TJR benefits and risks based on a contemporary US cohort of 25,000 TJR patients (FORCE-TJR Registry), (3) evidence-based information for non-operative care, and (4) individual patient goals.
Specific Aims include:
Aim 1. Patients and their Caregivers/Trusted Others will refine the design, content, and usability of a real-time, web-based individual OA Care plan to guide TJR and non-operative OA care decisions.
Aim 2. Randomize 26 orthopedists, and their patients, to receive the OA Care plan at the time of orthopedic consultation (intervention) vs. usual care (control) and compare (a) OA care decision process and quality and (b) quality of OA care as measured by pain relief and functional gain in the two arms at 6 and 12 months after the decision, and assess the impact of decision quality on quality of OA care.
Aim 3. Randomize 36 orthopedists, and their patients, to receive the OA Care plan plus peer, family, and primary care physician support (OA Care plan+Support; intervention) vs. the OA Care plan alone and compare the quality of OA care decision and quality of care (pain relief, functional gain) in the two arms.
Based on the components of the Chronic Care Model, this technology-delivered, individualized OA Care plan will enable patients and clinicians to make treatment decisions based on patient symptoms, goals, and comparative effectiveness evidence. The investigators hypothesize that OA Care plan users, as compared to usual care, will report greater decision quality for both TJR or non-operative care, and better quality of care (less OA pain, greater function). Further, the investigators anticipate incremental effectiveness of the OA Care plan+Support (peer, family, and primary care support) on the same outcomes. Study results will guide future OA Care plan implementation to assure optimal healthcare for patients with advanced knee and hip OA. Finally, lessons learned from the evaluation of this automated patient-centric decision support system can be extended beyond OA and TJR to other elective surgical procedures to engage informed patients to make optimal individual decisions.
- Conditions
- Osteo Arthritis Knee, Osteoarthritis, Hip
- Being tested
- OA Care Plan
- Keywords
- Shared Decision Making
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OA Care PlanOther
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.
| Study group | Role | What they receive |
|---|---|---|
| OA Care Plan Intervention | Experimental | 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. Receives: Other: OA Care Plan |
| Usual care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Decision Conflict Scale With ASK vs Usual Care
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.
Measured: 1 month post decision
Secondary outcomes (2)
Differences in Pain Relief at 6 Months After Enrollment
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.
Measured: 6 month followup
Difference in Functional Gain at 6 Months
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.
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 Nov 2017
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Surgeon offices will be randomized to Usual Care or Intervention sites. During Aim 2, after completing the surveys in the clinic, usual care patients and surgeons will have the ability to see PRO scores, but will NOT receive feedback (no OA Care Plan). This is the current standard of care in orthopedic clinics. For intervention sites, the patient and surgeon will receive the OA Care Plan. During Aim 3, Usual Care sites will receive the OA Care Plan, and Intervention sites will receive the Enhanced OA Care Plan, including access to Patient Peer Support website and PCP reports (currently under development). All surgeons that used the OA Care plan in Aim 2 will be invited to participate in the Enhanced OA Care plan in Aim 3.
- Masking
- None (open label)
- Enrolment
- 5,713 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Franklin, Northwestern University
- Investigators
- Patricia D Franklin, MD MBA MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102580
- Sponsor's protocol ID
- IHS-1507-31714
- Other IDs
- PCORI IHS 1507-3174
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2017
- Last updated
- 2 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers
Publications
Centers for Disease Control and Prevention (CDC). Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation--United States, 2010-2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):869-73.
PubMed 24196662NIH Consensus Statement on total knee replacement. NIH Consens State Sci Statements. 2003 Dec 8-10;20(1):1-34.
PubMed 17308549Dowsey MM, Nikpour M, Dieppe P, Choong PF. Associations between pre-operative radiographic osteoarthritis severity and pain and function after total hip replacement : Radiographic OA severity predicts function after THR. Clin Rheumatol. 2016 Jan;35(1):183-9. doi: 10.1007/s10067-014-2808-7. Epub 2014 Oct 24.
PubMed 25339125Nguyen US, Ayers,D.C., Li,W., Harrold L, Franklin PD. Pre-operative Pain and Function: Profiles of Selected TKR Patients among US Surgeons. Amer Coll Rheum 2014.
Kurtz SM, Lau E, Ong K, Zhao K, Kelly M, Bozic KJ. Future young patient demand for primary and revision joint replacement: national projections from 2010 to 2030. Clin Orthop Relat Res. 2009 Oct;467(10):2606-12. doi: 10.1007/s11999-009-0834-6. Epub 2009 Apr 10.
PubMed 19360453Katz JN. Parachutes and Preferences--A Trial of Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1668-9. doi: 10.1056/NEJMe1510312. No abstract available.
PubMed 26488698Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.
PubMed 26488691Katz JN. Editorial: appropriateness of total knee arthroplasty. Arthritis Rheumatol. 2014 Aug;66(8):1979-81. doi: 10.1002/art.38688. No abstract available.
PubMed 24975039Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Cubukcu D, Sarsan A, Alkan H. Relationships between Pain, Function and Radiographic Findings in Osteoarthritis of the Knee: A Cross-Sectional Study. Arthritis. 2012;2012:984060. doi: 10.1155/2012/984060. Epub 2012 Nov 19.
PubMed 23209900Stern BZ, Pila S, Joseph LI, Rothrock NE, Franklin PD. Patients' perspectives on the benefits of feedback on patient-reported outcome measures in a web-based personalized decision report for hip and knee osteoarthritis. BMC Musculoskelet Disord. 2022 Aug 23;23(1):806. doi: 10.1186/s12891-022-05764-1.
PubMed 35999585
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Osteoarthritis Care Plan To Inform Optimal Treatment
- ClinicalTrials.gov ID
- NCT03102580
- Acronym / sponsor ID
- IHS-1507-31714
- Conditions
- Osteo Arthritis Knee, Osteoarthritis, Hip
- Keywords
- Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,713 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Posted 2 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee and hip osteoarthritis (OA) is the most common cause of disability in the U.S. and affects more than 60% of adults over 65 years. As the burden of knee and hip OA increases among aging adults, more patients are deciding to have joint replacement surgery. However, no clear guidelines exist for patients to determine if or when to undergo total joint replacement (TJR).
The investigators plan to develop a web-based system that will provide individualized patient OA Care Plans that will help patients make informed decisions about how to treat their arthritis. The investigators will be using this system with patients to see if they find it useful.
The investigators believe that the OA Care plan will improve the process and quality of OA treatment decisions and the quality of OA care.
Detailed description
The investigators propose to prospectively randomize orthopedists, with their patients, to receive (or not) a real-time, web-based system intervention: the OA Care plan. The OA Care plan will include individualized, patient-centric information: (1) trended patient-reported OA pain and function, (2) tailored estimates of likely TJR benefits and risks based on a contemporary US cohort of 25,000 TJR patients (FORCE-TJR Registry), (3) evidence-based information for non-operative care, and (4) individual patient goals.
Specific Aims include:
Aim 1. Patients and their Caregivers/Trusted Others will refine the design, content, and usability of a real-time, web-based individual OA Care plan to guide TJR and non-operative OA care decisions.
Aim 2. Randomize 26 orthopedists, and their patients, to receive the OA Care plan at the time of orthopedic consultation (intervention) vs. usual care (control) and compare (a) OA care decision process and quality and (b) quality of OA care as measured by pain relief and functional gain in the two arms at 6 and 12 months after the decision, and assess the impact of decision quality on quality of OA care.
Aim 3. Randomize 36 orthopedists, and their patients, to receive the OA Care plan plus peer, family, and primary care physician support (OA Care plan+Support; intervention) vs. the OA Care plan alone and compare the quality of OA care decision and quality of care (pain relief, functional gain) in the two arms.
Based on the components of the Chronic Care Model, this technology-delivered, individualized OA Care plan will enable patients and clinicians to make treatment decisions based on patient symptoms, goals, and comparative effectiveness evidence. The investigators hypothesize that OA Care plan users, as compared to usual care, will report greater decision quality for both TJR or non-operative care, and better quality of care (less OA pain, greater function). Further, the investigators anticipate incremental effectiveness of the OA Care plan+Support (peer, family, and primary care support) on the same outcomes. Study results will guide future OA Care plan implementation to assure optimal healthcare for patients with advanced knee and hip OA. Finally, lessons learned from the evaluation of this automated patient-centric decision support system can be extended beyond OA and TJR to other elective surgical procedures to engage informed patients to make optimal individual decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Surgeon offices will be randomized to Usual Care or Intervention sites. During Aim 2, after completing the surveys in the clinic, usual care patients and surgeons will have the ability to see PRO scores, but will NOT receive feedback (no OA Care Plan). This is the current standard of care in orthopedic clinics. For intervention sites, the patient and surgeon will receive the OA Care Plan. During Aim 3, Usual Care sites will receive the OA Care Plan, and Intervention sites will receive the Enhanced OA Care Plan, including access to Patient Peer Support website and PCP reports (currently under development). All surgeons that used the OA Care plan in Aim 2 will be invited to participate in the Enhanced OA Care plan in Aim 3.
| Arm | Type | Receives |
|---|---|---|
| OA Care Plan Intervention | Experimental | Other: OA Care PlanFor 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. |
| Usual care | No intervention | –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. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All new patients to participating surgeon's practice for the purpose of evaluation of knee or hip OA are possible participants.
- Patients must be 40 years of age or older and able to provide informed consent.
Key exclusion criteria (5 listed)
- Inflammatory arthritis, such as rheumatoid or psoriatic arthritis
- Recent knee or hip injury as purpose for visit
- Pregnant women
- Prisoners
- Non-English speaking subjects- As we are refining and testing a web-based system intervention that provides individualized patient OA Care plans to improved shared decision making between patients and providers, for research purposes we must assure that the 'counseling' between the surgeon and patient will be in their native language. Once we have identified what materials work at the end of the study, we will translate materials into Spanish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OA Care PlanPatient 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. | Other | OA Care Plan Intervention |
Primary outcome
Differences in Decision Conflict Scale With ASK vs Usual Care
Time frame: 1 month post decision
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.
2 secondary outcomes
Differences in Pain Relief at 6 Months After Enrollment
Time frame: 6 month followup
Difference in Functional Gain at 6 Months
Time frame: 6 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24196662Centers for Disease Control and Prevention (CDC). Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation--United States, 2010-2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):869-73.
- Background: PubMed 17308549NIH Consensus Statement on total knee replacement. NIH Consens State Sci Statements. 2003 Dec 8-10;20(1):1-34.
- Background: PubMed 25339125Dowsey MM, Nikpour M, Dieppe P, Choong PF. Associations between pre-operative radiographic osteoarthritis severity and pain and function after total hip replacement : Radiographic OA severity predicts function after THR. Clin Rheumatol. 2016 Jan;35(1):183-9. doi: 10.1007/s10067-014-2808-7. Epub 2014 Oct 24.
- BackgroundNguyen US, Ayers,D.C., Li,W., Harrold L, Franklin PD. Pre-operative Pain and Function: Profiles of Selected TKR Patients among US Surgeons. Amer Coll Rheum 2014.
- Background: PubMed 19360453Kurtz SM, Lau E, Ong K, Zhao K, Kelly M, Bozic KJ. Future young patient demand for primary and revision joint replacement: national projections from 2010 to 2030. Clin Orthop Relat Res. 2009 Oct;467(10):2606-12. doi: 10.1007/s11999-009-0834-6. Epub 2009 Apr 10.
- Background: PubMed 26488698Katz JN. Parachutes and Preferences--A Trial of Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1668-9. doi: 10.1056/NEJMe1510312. No abstract available.
- Background: PubMed 26488691Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.
- Background: PubMed 24975039Katz JN. Editorial: appropriateness of total knee arthroplasty. Arthritis Rheumatol. 2014 Aug;66(8):1979-81. doi: 10.1002/art.38688. No abstract available.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 23209900Cubukcu D, Sarsan A, Alkan H. Relationships between Pain, Function and Radiographic Findings in Osteoarthritis of the Knee: A Cross-Sectional Study. Arthritis. 2012;2012:984060. doi: 10.1155/2012/984060. Epub 2012 Nov 19.
- Derived from this study: PubMed 35999585Stern BZ, Pila S, Joseph LI, Rothrock NE, Franklin PD. Patients' perspectives on the benefits of feedback on patient-reported outcome measures in a web-based personalized decision report for hip and knee osteoarthritis. BMC Musculoskelet Disord. 2022 Aug 23;23(1):806. doi: 10.1186/s12891-022-05764-1.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia D Franklin, MD MBA MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OA Care Plan in people with Osteo Arthritis Knee and Osteoarthritis, Hip, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Decision Conflict Scale With ASK vs Usual Care (time frame: 1 month post decision). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102580, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.