Tendon InjuriesNCT03912168
Question Prompt List for Orthopaedic Conditions
A study testing Question Prompt List and 3 questions list in people with Tendon Injuries and Fracture, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether providing patients with a question prompt list (QPL) prior to their orthopaedic surgery clinic appointment improves their perceived involvement in care (PICs) score compared to being given 3 questions from the AskShareKnow model Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendon Injuries, Fracture, Arthritis
- What is being tested?
- Question Prompt List and 3 questions list
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2019to 22 Nov 2019
- 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
- common orthopaedic condition new patient
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Health Care
Redwood City, California, 94063
About this study
Official title: Does Giving a Question Prompt List to Patients With Orthopaedic Conditions Improve Their Perceived Involvement in Care? A Randomized Controlled Trial
The purpose of this study is to investigate whether providing patients with a question prompt list (QPL) prior to their orthopaedic surgery clinic appointment improves their perceived involvement in care (PICs) score compared to being given 3 questions from the AskShareKnow model
- Being tested
- Question Prompt List, 3 questions list
- Medical subject headings
- Tendon Injuries, Fractures, Bone, Arthritis, Sprains and Strains, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Question Prompt ListOther
Question prompt list for common orthopaedic conditions
3 questions listOther
3 questions from the AskShareKnow model
| Study group | Role | What they receive |
|---|---|---|
| Question Prompt List | Experimental | Not described Receives: Other: Question Prompt List |
| 3 questions list | Active comparator | Not described Receives: Other: 3 questions list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived involvement in care scale
The Perceived involvement in care scale PICS measures a patient's perceived involvement in their visit. it is a 13 item validated scale, scored 0-13, with higher scores indicating greater perceived involvement
Measured: Immediately after the clinical encounter, same day as clinical encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start12 Aug 2019
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tendon InjuriesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Kamal, Stanford University
- Investigators
- Robin N Kamal, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912168
- Sponsor's protocol ID
- 50238
- Status last verified
- Mar 2020
- First submitted
- 8 Apr 2019
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mariano DJ, Liu A, Eppler SL, Gardner MJ, Hu S, Safran M, Chou L, Amanatullah DF, Kamal RN. Does a Question Prompt List Improve Perceived Involvement in Care in Orthopaedic Surgery Compared with the AskShareKnow Questions? A Pragmatic Randomized Controlled Trial. Clin Orthop Relat Res. 2021 Feb 1;479(2):225-232. doi: 10.1097/CORR.0000000000001582.
PubMed 33239521
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Giving a Question Prompt List to Patients With Orthopaedic Conditions Improve Their Perceived Involvement in Care? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03912168
- Acronym / sponsor ID
- 50238
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 11 Apr 2019 (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 purpose of this study is to investigate whether providing patients with a question prompt list (QPL) prior to their orthopaedic surgery clinic appointment improves their perceived involvement in care (PICs) score compared to being given 3 questions from the AskShareKnow model
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Question Prompt List | Experimental | Other: Question Prompt List |
| 3 questions list | Active comparator | Other: 3 questions list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- common orthopaedic condition new patient
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Question Prompt ListQuestion prompt list for common orthopaedic conditions | Other | Question Prompt List |
| 3 questions list3 questions from the AskShareKnow model | Other | 3 questions list |
Primary outcome
Perceived involvement in care scale
Time frame: Immediately after the clinical encounter, same day as clinical encounter
The Perceived involvement in care scale PICS measures a patient's perceived involvement in their visit. it is a 13 item validated scale, scored 0-13, with higher scores indicating greater perceived involvement
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 19 Mar 2020.
- Derived from this study: PubMed 33239521Mariano DJ, Liu A, Eppler SL, Gardner MJ, Hu S, Safran M, Chou L, Amanatullah DF, Kamal RN. Does a Question Prompt List Improve Perceived Involvement in Care in Orthopaedic Surgery Compared with the AskShareKnow Questions? A Pragmatic Randomized Controlled Trial. Clin Orthop Relat Res. 2021 Feb 1;479(2):225-232. doi: 10.1097/CORR.0000000000001582.
- 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.
Robin N Kamal principal investigator
Stanford 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 Question Prompt List and 3 questions list in people with Tendon Injuries and Fracture, run by Stanford University 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 19 Mar 2020. 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?
Perceived involvement in care scale (time frame: Immediately after the clinical encounter, same day as clinical encounter). 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 NCT03912168, which also lists 1 linked publication.
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 19 Mar 2020.