PROMNCT06078137
Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates
A study testing Usual PROMs and new PROMs strategy in people with PROM, run by University of Texas at Austin at 1 site in United States.
Trial summary
in clinical practice has been curbed by issues related to the variability in use of these tools for decision-making, and universally poor completion rates over time. Patients may not see the relevance of responding to questions about their health, and the results may not be reviewed by the clinician or presented and… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- PROM
- What is being tested?
- Usual PROMs and new PROMs strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All new 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.
United States1 site
University of Texas Health Austin
Austin, Texas, 78701
About this study
Official title: Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates, Decision Support, and Patient Experience: A Hybrid Effectiveness-Implementation Study
in clinical practice has been curbed by issues related to the variability in use of these tools for decision-making, and universally poor completion rates over time. Patients may not see the relevance of responding to questions about their health, and the results may not be reviewed by the clinician or presented and visualized with the patient. The questions may seem impersonal (e.g. too general and not directly assessing their individual goals, motivations, aspirations), irrelevant (e.g., asking about symptoms of depression when a person is seeking musculoskeletal specialty care) and insensitive (e.g., asking about sensitive subjects at the outset thereby disengaging the individual), and redundant or awkward (e.g., presenting questions that seem very similar or administered in strange orders). Finally, PROMs may also confer some burden (e.g., long PROM questionnaires often used for research may be unnecessarily burdensome for patient care), and provide logistical challenges (e.g., difficulties in administering the tools at the right time points), adding to a poor patient experience.
Read the detailed description
The investigator sought to assess the impact of an enhanced and more personalized PROM strategy to overcome these barriers by providing i) a primer ahead of PROMs administration, ii) simple 3-part survey capturing capability, comfort, and calm, iii) a short distress and misconception survey, iv) goal setting question, v) summary sheet of PRO scores, and vi) a commitment intervention. Patients will subsequently be requested to complete the CollaboRATE survey, JSPPE survey, and questions about their experience in relation to the new format of surveys (only if they were in the intervention group) before receiving a text message reminder around 6-weeks followed by a set of deprioritization questions and the 3-part capability, comfort, and calm survey.
- Conditions
- PROM
- Being tested
- Usual PROMs and new PROMs strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual PROMs and new PROMs strategyOther
Patients randomized to intervention receive both usual PROMs and new PROMs strategy
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients randomized to intervention receive both usual Patient reported outcome measure (PROM) and new PROMs strategy (on the technology platform for English speakers and on REDCap/Qualtrix for Spanish Speakers) done after rooming. Receives: Other: Usual PROMs and new PROMs strategy |
| Control group | No intervention | Patients go through the registration process which includes PROMs completion using Ipads. Enrolled in the room at the end of the visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text
We will assess the completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text.
Measured: through study completion, an average of 6 weeks
Completion of answered text
We will assess the completion response rate.
Measured: through study completion, an average of 6 weeks
Completion of deprioritization options 1 or 2 at 6-week follow-up via text or email
"1 = I got what I needed" "2 = I didn't receive anything useful" "3 = I'm still receiving care"
Measured: through study completion, an average of 6 weeks
Jefferson Scale of Patient's Perceptions of Physician Empathy
The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.
Measured: through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Sep 2023
- Primary completion1 Jan 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PROMStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- 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
- Principal investigator, David Ring, University of Texas at Austin
- Investigators
- David Ring, MD, Principal investigator, Professor of orthopedic surgery at The university of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078137
- Sponsor's protocol ID
- STUDY00001696
- Status last verified
- Jun 2026
- First submitted
- 28 Sep 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Enhanced Patient Reported Outcome Measurement (PROM) Strategy on PROM Completion Rates, Decision Support, and Patient Experience: A Hybrid Effectiveness-Implementation Study
- ClinicalTrials.gov ID
- NCT06078137
- Acronym / sponsor ID
- STUDY00001696
- Conditions
- PROM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 11 Oct 2023 (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.
in clinical practice has been curbed by issues related to the variability in use of these tools for decision-making, and universally poor completion rates over time. Patients may not see the relevance of responding to questions about their health, and the results may not be reviewed by the clinician or presented and visualized with the patient. The questions may seem impersonal (e.g. too general and not directly assessing their individual goals, motivations, aspirations), irrelevant (e.g., asking about symptoms of depression when a person is seeking musculoskeletal specialty care) and insensitive (e.g., asking about sensitive subjects at the outset thereby disengaging the individual), and redundant or awkward (e.g., presenting questions that seem very similar or administered in strange orders). Finally, PROMs may also confer some burden (e.g., long PROM questionnaires often used for research may be unnecessarily burdensome for patient care), and provide logistical challenges (e.g., difficulties in administering the tools at the right time points), adding to a poor patient experience.
Detailed description
The investigator sought to assess the impact of an enhanced and more personalized PROM strategy to overcome these barriers by providing i) a primer ahead of PROMs administration, ii) simple 3-part survey capturing capability, comfort, and calm, iii) a short distress and misconception survey, iv) goal setting question, v) summary sheet of PRO scores, and vi) a commitment intervention. Patients will subsequently be requested to complete the CollaboRATE survey, JSPPE survey, and questions about their experience in relation to the new format of surveys (only if they were in the intervention group) before receiving a text message reminder around 6-weeks followed by a set of deprioritization questions and the 3-part capability, comfort, and calm survey.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Usual PROMs and new PROMs strategyPatients randomized to intervention receive both usual Patient reported outcome measure (PROM) and new PROMs strategy (on the technology platform for English speakers and on REDCap/Qualtrix for Spanish Speakers) done after rooming. |
| Control group | No intervention | –Patients go through the registration process which includes PROMs completion using Ipads. Enrolled in the room at the end of the visit. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All new patients English and Spanish speakers
Key exclusion criteria (1 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 |
|---|---|---|
| Usual PROMs and new PROMs strategyPatients randomized to intervention receive both usual PROMs and new PROMs strategy | Other | Intervention Group |
Primary outcome
Completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text
Time frame: through study completion, an average of 6 weeks
We will assess the completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text.
Completion of answered text
Time frame: through study completion, an average of 6 weeks
We will assess the completion response rate.
Completion of deprioritization options 1 or 2 at 6-week follow-up via text or email
Time frame: through study completion, an average of 6 weeks
"1 = I got what I needed" "2 = I didn't receive anything useful" "3 = I'm still receiving care"
Jefferson Scale of Patient's Perceptions of Physician Empathy
Time frame: through study completion, an average of 6 weeks
The Jefferson Scale of Patient's Perceptions of Physician Empathy includes five 7-point scale questions and higher scores indicated greater perceived clinician empathy.
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 9 Jun 2026.
- 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.
David Ring, MD principal investigator
Professor of orthopedic surgery at The 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 Usual PROMs and new PROMs strategy in people with PROM, 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 1 inclusion and 1 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 9 Jun 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?
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?
Completion of 3-survey patient-reported outcome measure at 6-week follow-up via Text (time frame: through study completion, an average of 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.