Musculoskeletal DiseasesNCT04947878
Development and Validation of an Orthopedic Visit Prompt List
A study testing Prompt list in people with Musculoskeletal Diseases, run by University of Texas at Austin at 1 site in United States.
Trial summary
Investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Prompt list
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 1 Sep 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18+)
- Orthopedic visit
Who cannot join
- Patients who are illiterate.
- Patients who do not speak English.
Trial locations and contacts
1 site in 1 country.
About this study
Investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.
Read the detailed description
Visiting a doctor with a musculoskeletal problem can be quite a daunting experience for patients. A visit question prompt list may help to empower patients and increase their role in active decision-making. Previous studies have shown that patient activation is correlated with a disability, pain intensity, and satisfaction with treatment. Perceived empathy is strongly associated with satisfaction among people with arm problems. A list that prompts patients to ask about things that matter to them, might improve their connection with the surgeon and their perceived empathy. The investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Prompt list
- Keywords
- Orthopedics
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prompt listOther
The patients in the intervention group will review a prompt list before their visit.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | will not review a prompt list before their visit. |
| Prompt list | Experimental | The patients in the intervention group will review a prompt list before their visit. Receives: Other: Prompt list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale
Questionnaire assessing decision conflict
Measured: Baseline
Secondary outcomes (3)
Jefferson Scale of Patient's Perceptions of Physician Empathy
Patient perceived of physician empathy as measured by the JSPPE
Measured: Baseline
Patient Activation Measure-13
Patient activation as measured by PAM-13
Measured: Baseline
Satisfaction scale
Questionnaire measuring to what degree patients are satisfied with the care they received.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jul 2021
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All new, adult (18+ years old) patients seeing an orthopedic surgeon for a consultation will be invited to enroll. Randomization will be done through an Excel random number generator. The patients in the intervention group will review a prompt list before their visit. The research assistant will shadow the surgeon to count the amount of questions they ask during their visit. Patients in both groups will fill out a survey entailing demographics, the Decisional Conflict Scale, the JSPPE, the PAM score and a satisfaction scale at the end of the visit.
- Masking
- None (open label)
- Enrolment
- 128 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, PhD, Principal investigator, The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947878
- Sponsor's protocol ID
- 2017-02-0122
- Status last verified
- Sep 2021
- First submitted
- 13 Jun 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Orthopedic Visit Prompt List
- ClinicalTrials.gov ID
- NCT04947878
- Acronym / sponsor ID
- 2017-02-0122
- Conditions
- Musculoskeletal Diseases
- Keywords
- Orthopedics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 1 Jul 2021 (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.
Investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.
Detailed description
Visiting a doctor with a musculoskeletal problem can be quite a daunting experience for patients. A visit question prompt list may help to empower patients and increase their role in active decision-making. Previous studies have shown that patient activation is correlated with a disability, pain intensity, and satisfaction with treatment. Perceived empathy is strongly associated with satisfaction among people with arm problems. A list that prompts patients to ask about things that matter to them, might improve their connection with the surgeon and their perceived empathy. The investigators are interested to see whether patients who received a visit question prompt list before the consultation ask more questions, feel more actively involved in their healthcare, and think of their surgeon as being more empathetic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All new, adult (18+ years old) patients seeing an orthopedic surgeon for a consultation will be invited to enroll. Randomization will be done through an Excel random number generator. The patients in the intervention group will review a prompt list before their visit. The research assistant will shadow the surgeon to count the amount of questions they ask during their visit. Patients in both groups will fill out a survey entailing demographics, the Decisional Conflict Scale, the JSPPE, the PAM score and a satisfaction scale at the end of the visit.
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –will not review a prompt list before their visit. |
| Prompt list | Experimental | Other: Prompt listThe patients in the intervention group will review a prompt list before their visit. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (18+)
- Orthopedic visit
Key exclusion criteria (2 listed)
- Patients who are illiterate.
- Patients who do not speak English.
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 |
|---|---|---|
| Prompt listThe patients in the intervention group will review a prompt list before their visit. | Other | Prompt list |
Primary outcome
Decisional Conflict Scale
Time frame: Baseline
Questionnaire assessing decision conflict
3 secondary outcomes
Jefferson Scale of Patient's Perceptions of Physician Empathy
Time frame: Baseline
Patient Activation Measure-13
Time frame: Baseline
Satisfaction scale
Time frame: Baseline
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 28 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Musculoskeletal Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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, PhD principal investigator
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 Prompt list in people with Musculoskeletal Diseases, 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 28 Sep 2021. 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?
Decisional Conflict Scale (time frame: Baseline). 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 28 Sep 2021.