Physician-Patient RelationsNCT06490224
Measuring and Displaying the Subjective
A study testing Relevant Patient Reported Outcome Measures (PROMs) and My Whole Health Map in people with Physician-Patient Relations and Communication Research, run by University of Texas at Austin at 1 site in United States.
Trial summary
The investigators developed a brief set of subjective health measures designed to feel more relevant to patients seeking musculoskeletal specialty care, presented the scores to patients and clinicians using an easy-to-understand visual display, and measured whether or not this process harmed patient experience. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Physician-Patient Relations, Communication Research
- What is being tested?
- Relevant Patient Reported Outcome Measures (PROMs) and My Whole Health Map
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2023to 6 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All new and return patients
- English and Spanish speakers
Who cannot join
- Cognitive deficiency precluding PROM completion
- Language other than English or Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Subjective Aspects of Health be Measured and Visually Displayed Without Harming Patient Experience: A Randomized Control Trial
The investigators developed a brief set of subjective health measures designed to feel more relevant to patients seeking musculoskeletal specialty care, presented the scores to patients and clinicians using an easy-to-understand visual display, and measured whether or not this process harmed patient experience.
Read the detailed description
Musculoskeletal patient-reported outcome measures (PROMs; measures of levels of discomfort and incapability) were originally designed as tools for clinical research as were other self-reported measures of the subjective aspects of illness such as mental health measures. PROMs and mental health measures are increasingly used in clinical practice with individual patients. A few areas for improvement are noted in the use of questionnaires in musculoskeletal specialty care, including relevancy, understandability, and their confusing use in heath strategies. The investigators sought to assess the impact of an enhanced and more personalized self-reported health measurement strategy to address some of these opportunities by developing a brief set of items addressing levels of discomfort, incapability, mental, and social health designed to feel relevant to musculoskeletal specialty care and resulting in an easy-to-understand display that can be a communication tool for patients and clinicians.
- Being tested
- Relevant Patient Reported Outcome Measures (PROMs), My Whole Health Map
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relevant Patient Reported Outcome Measures (PROMs)Behavioural
Depending on the participant's complaint: Hip disability and osteoarthritis outcome score JR (HOOS JR), Knee disability and osteoarthritis outcome score JR (KOOS JR), Quick Disabilities of the Arm, Shoulder, and Hand, Quick Disabilities of the Arm, Shoulder, and Hand (QUICKDASH), Patient Health Questionnaire 9 (PHQ-9), General Anxiety Disorder-7 (GAD7), Patient Self-Efficacy Questionnaire (PSEQ-2), Patient-Reported Outcomes Measurement Information System (PROMIS Global 10)
My Whole Health MapOther
Short visual map of responses to 10 questions of subjective measures.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Usual patient reported outcome measures Receives: Behavioral: Relevant Patient Reported Outcome Measures (PROMs) |
| Experimental | Experimental | Usual patient reported outcome measures + new visual display of responses to subjective health questions Receives: Behavioral: Relevant Patient Reported Outcome Measures (PROMs); Other: My Whole Health Map |
What is being measured
The primary outcome is the main question the study is designed to answer.
CollaboRATE survey
Quality of shared decision-making (Numerical scale from 1-27; Higher scores equal better outcome)
Measured: Immediately after the intervention
Jefferson Scale Patient Perceptions of Physician Empathy (JSPPPE)
Patient perceived clinician empathy (Numerical scale from 1-35; Higher scores equal better outcome)
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start19 Nov 2023
- Primary completion27 Feb 2024
- Study completion6 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physician-Patient RelationsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prakash Jayakumar, MD. PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490224
- Sponsor's protocol ID
- PROM Prototyping
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Neil W. Wagle MM (2017) Implementing Patient-Reported Outcome Measures. NEJM Catal
Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.
PubMed 23768763Amini M, Oemrawsingh A, Verweij LM, Lingsma HF, Hazelzet JA, Eijkenaar F, van Leeuwen N. Facilitators and barriers for implementing patient-reported outcome measures in clinical care: An academic center's initial experience. Health Policy. 2021 Sep;125(9):1247-1255. doi: 10.1016/j.healthpol.2021.07.001. Epub 2021 Jul 8.
PubMed 34311981
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Subjective Aspects of Health be Measured and Visually Displayed Without Harming Patient Experience: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06490224
- Acronym / sponsor ID
- PROM Prototyping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 19 Nov 2023 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 6 Apr 2024 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators developed a brief set of subjective health measures designed to feel more relevant to patients seeking musculoskeletal specialty care, presented the scores to patients and clinicians using an easy-to-understand visual display, and measured whether or not this process harmed patient experience.
Detailed description
Musculoskeletal patient-reported outcome measures (PROMs; measures of levels of discomfort and incapability) were originally designed as tools for clinical research as were other self-reported measures of the subjective aspects of illness such as mental health measures. PROMs and mental health measures are increasingly used in clinical practice with individual patients. A few areas for improvement are noted in the use of questionnaires in musculoskeletal specialty care, including relevancy, understandability, and their confusing use in heath strategies. The investigators sought to assess the impact of an enhanced and more personalized self-reported health measurement strategy to address some of these opportunities by developing a brief set of items addressing levels of discomfort, incapability, mental, and social health designed to feel relevant to musculoskeletal specialty care and resulting in an easy-to-understand display that can be a communication tool for patients and clinicians.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Relevant Patient Reported Outcome Measures (PROMs)Usual patient reported outcome measures |
| Experimental | Experimental | Behavioral: Relevant Patient Reported Outcome Measures (PROMs), Other: My Whole Health MapUsual patient reported outcome measures + new visual display of responses to subjective health questions |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All new and return patients
- English and Spanish speakers
Key exclusion criteria (2 listed)
- Cognitive deficiency precluding PROM completion
- Language other than English or 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 |
|---|---|---|
| Relevant Patient Reported Outcome Measures (PROMs)Depending on the participant's complaint: Hip disability and osteoarthritis outcome score JR (HOOS JR), Knee disability and osteoarthritis outcome score JR (KOOS JR), Quick Disabilities of the Arm, Shoulder, and Hand, Quick Disabilities of the Arm, Shoulder, and Hand (QUICKDASH), Patient Health Questionnaire 9 (PHQ-9), General Anxiety Disorder-7 (GAD7), Patient Self-Efficacy Questionnaire (PSEQ-2), Patient-Reported Outcomes Measurement Information System (PROMIS Global 10) | Behavioural | Control, Experimental |
| My Whole Health MapShort visual map of responses to 10 questions of subjective measures. | Other | Experimental |
Primary outcome
CollaboRATE survey
Time frame: Immediately after the intervention
Quality of shared decision-making (Numerical scale from 1-27; Higher scores equal better outcome)
Jefferson Scale Patient Perceptions of Physician Empathy (JSPPPE)
Time frame: Immediately after the intervention
Patient perceived clinician empathy (Numerical scale from 1-35; Higher scores equal better outcome)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- BackgroundNeil W. Wagle MM (2017) Implementing Patient-Reported Outcome Measures. NEJM Catal
- Background: PubMed 23768763Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.
- Background: PubMed 34311981Amini M, Oemrawsingh A, Verweij LM, Lingsma HF, Hazelzet JA, Eijkenaar F, van Leeuwen N. Facilitators and barriers for implementing patient-reported outcome measures in clinical care: An academic center's initial experience. Health Policy. 2021 Sep;125(9):1247-1255. doi: 10.1016/j.healthpol.2021.07.001. Epub 2021 Jul 8.
- Individual participant dataSharing planned: No
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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.
Prakash Jayakumar, MD. PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relevant Patient Reported Outcome Measures (PROMs) and My Whole Health Map in people with Physician-Patient Relations and Communication Research, run by University of Texas at Austin 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 2 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 8 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CollaboRATE survey (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. 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 NCT06490224, which also lists 3 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 8 Jul 2024.