Ankle PathologyNCT04654910
PROMIS and Patient Satisfaction
A study testing PROMIS Score Explanation in people with Ankle Pathology and Foot Pathology, run by University of Rochester at 1 site in United States.
Trial summary
The primary aim for this study is to determine if patient satisfaction and experience is improved with the active discussion/inclusion of PROMIS scores during new foot and ankle clinic patient visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Pathology, Foot Pathology
- What is being tested?
- PROMIS Score Explanation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 1 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18
- New patient at the foot and ankle clinic
Who cannot join
- Patients under the age of 18
- Patients presenting for a Follow up visit
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14618
About this study
Official title: Does Patient-Reported Outcome Measure Use in Clinic Visits Improve Patient Satisfaction and Experience? A Randomized, Controlled Trial
The primary aim for this study is to determine if patient satisfaction and experience is improved with the active discussion/inclusion of PROMIS scores during new foot and ankle clinic patient visits.
- Conditions
- Ankle Pathology, Foot Pathology
- Being tested
- PROMIS Score Explanation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROMIS Score ExplanationBehavioural
The surgeon completing the clinical visit with the participant will explain what the PROMIS tool is, the purpose of the tool and what the participant's scores mean using a script.
PlaceboBehavioural
Subjects will complete the PROMIS assessment but will not receive an explanation of the tool.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | enrolled subjects that do NOT receive explanation of PROMIS measures during visit. Receives: Behavioral: Placebo |
| Intervention | Active comparator | enrolled subjects that DO receive explanation of PROMIS measures during visit. Receives: Behavioral: PROMIS Score Explanation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pain interference domain measured by PROMIS
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100. Any result with higher a higher number is indicating higher pain interference effect.
Measured: baseline, before intervention
mean Patient Activation Measure (PAM)
Our primary outcome measure is the Patient Activation Measure (PAM). The PAM is a 13-item scale with a 5-point Likert response scale for all questions. Raw scores are scaled to a range of 0-100 with 100 being the highest activation in self- management.
Measured: baseline, after intervention
percent of participant who respond favorably on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG CAHPS)
We will assess scores on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG CAHPS) survey. This is a standardized tool to measure patients' perception of care provided by physicians in an office setting. Specifically, for our analysis will we focus specifically on the individual question to assess communication. We will compare the percentage of participants in the intervention versus control group who respond favorably to this question using a chi-square test of association.
Measured: baseline, after intervention
mean depression
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100. Any result with higher a higher number is indicating higher depression effect.
Measured: baseline, before intervention
mean physical function
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100. Any result with higher a higher number is indicating higher physical function effect.
Measured: baseline, before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start24 Feb 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle PathologyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- American Orthopaedic Foot and Ankle Society
- Responsible party
- Principal investigator, Judy Baumhauer, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654910
- Sponsor's protocol ID
- STUDY00005316
- Status last verified
- Apr 2023
- First submitted
- 3 Dec 2020
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participant data will not be available for other researchers. data is to remain in house at URMC.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Patient-Reported Outcome Measure Use in Clinic Visits Improve Patient Satisfaction and Experience? A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04654910
- Acronym / sponsor ID
- STUDY00005316
- Conditions
- Ankle Pathology, Foot Pathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- American Orthopaedic Foot and Ankle Society
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 4 Dec 2020 (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 primary aim for this study is to determine if patient satisfaction and experience is improved with the active discussion/inclusion of PROMIS scores during new foot and ankle clinic patient visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Placeboenrolled subjects that do NOT receive explanation of PROMIS measures during visit. |
| Intervention | Active comparator | Behavioral: PROMIS Score Explanationenrolled subjects that DO receive explanation of PROMIS measures during visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18
- New patient at the foot and ankle clinic
Key exclusion criteria (2 listed)
- Patients under the age of 18
- Patients presenting for a Follow up visit
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 |
|---|---|---|
| PROMIS Score ExplanationThe surgeon completing the clinical visit with the participant will explain what the PROMIS tool is, the purpose of the tool and what the participant's scores mean using a script. | Behavioural | Intervention |
| PlaceboSubjects will complete the PROMIS assessment but will not receive an explanation of the tool. | Behavioural | Control |
Primary outcome
mean pain interference domain measured by PROMIS
Time frame: baseline, before intervention
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100. Any result with higher a higher number is indicating higher pain interference effect.
mean Patient Activation Measure (PAM)
Time frame: baseline, after intervention
Our primary outcome measure is the Patient Activation Measure (PAM). The PAM is a 13-item scale with a 5-point Likert response scale for all questions. Raw scores are scaled to a range of 0-100 with 100 being the highest activation in self- management.
percent of participant who respond favorably on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG CAHPS)
Time frame: baseline, after intervention
We will assess scores on the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG CAHPS) survey. This is a standardized tool to measure patients' perception of care provided by physicians in an office setting. Specifically, for our analysis will we focus specifically on the individual question to assess communication. We will compare the percentage of participants in the intervention versus control group who respond favorably to this question using a chi-square test of association.
mean depression
Time frame: baseline, before intervention
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100. Any result with higher a higher number is indicating higher depression effect.
mean physical function
Time frame: baseline, before intervention
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores are typically between 20-80, but may be 0-100. Any result with higher a higher number is indicating higher physical function effect.
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 10 Apr 2023.
- Individual participant dataSharing planned: No. participant data will not be available for other researchers. data is to remain in house at URMC.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROMIS Score Explanation in people with Ankle Pathology and Foot Pathology, run by University of Rochester 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 10 Apr 2023. 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?
mean pain interference domain measured by PROMIS (time frame: baseline, before intervention). The study lists 5 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 10 Apr 2023.