Hand InjuriesNCT04027569
PROMs To Improve Care- Standardized vs Patient Specific
A study testing Patient Specific Functional Scale and PROMIS PF in people with Hand Injuries, run by Stanford University.
Trial summary
To examine the impact of using 2 validated PROMs during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Hand Injuries
- What is being tested?
- Patient Specific Functional Scale and PROMIS PF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2040to Dec 2040
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hand surgery patients over age 18, english fluency and literacy, able to take informed consent
Who cannot join
- -
About this study
Official title: PROMs To Improve Care: A Pragmatic RCT on Standardized and Patient Specific PROMs on Outcomes After Hand Surgery
To examine the impact of using 2 validated PROMs during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes.
- Conditions
- Hand Injuries
- Being tested
- Patient Specific Functional Scale, PROMIS PF
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Specific Functional ScaleOther
A validated patient reported outcome measure that asks patients to write down activities and score them 0 to 10.
PROMIS PFOther
A computer adaptive, validated patient reported outcome measure that measures physical function on a 1 to 100.
| Study group | Role | What they receive |
|---|---|---|
| PSFS group | Active comparator | Patients in this arm will complete the patient specific functional scale (PSFS) during their visits Receives: Other: Patient Specific Functional Scale |
| PROMIS PF group | Experimental | Patients in this arm will complete the PROMIS Physical Function during their visits Receives: Other: PROMIS PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale (DCS)
DCS is a validated tool that measures patient uncertainty about decisions. it is scored 0 to 100, with higher scores indicating greater conflict about the decisions.
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 posted22 Jul 2019
- Study startNov 2040 (estimated)
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Why it stopped: Logistics (Research Staffing)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand 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
- 0 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, MD MBA, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027569
- Sponsor's protocol ID
- 52021
- Status last verified
- Apr 2025
- First submitted
- 18 Jul 2019
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMs To Improve Care: A Pragmatic RCT on Standardized and Patient Specific PROMs on Outcomes After Hand Surgery
- ClinicalTrials.gov ID
- NCT04027569
- Acronym / sponsor ID
- 52021
- Conditions
- Hand Injuries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistics (Research Staffing)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2040 (estimated)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 22 Jul 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.
To examine the impact of using 2 validated PROMs during the care of an orthopaedic condition on shared decision making, patient centered care, and patient outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSFS group | Active comparator | Other: Patient Specific Functional ScalePatients in this arm will complete the patient specific functional scale (PSFS) during their visits |
| PROMIS PF group | Experimental | Other: PROMIS PFPatients in this arm will complete the PROMIS Physical Function during their visits |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- hand surgery patients over age 18, english fluency and literacy, able to take informed consent
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 |
|---|---|---|
| Patient Specific Functional ScaleA validated patient reported outcome measure that asks patients to write down activities and score them 0 to 10. | Other | PSFS group |
| PROMIS PFA computer adaptive, validated patient reported outcome measure that measures physical function on a 1 to 100. | Other | PROMIS PF group |
Primary outcome
Decisional Conflict Scale (DCS)
Time frame: Immediately after the clinical encounter, same day as clinical encounter
DCS is a validated tool that measures patient uncertainty about decisions. it is scored 0 to 100, with higher scores indicating greater conflict about the decisions.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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, MD MBA principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Patient Specific Functional Scale and PROMIS PF in people with Hand Injuries, run by Stanford University.
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: withdrawn, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 (DCS) (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?
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 Apr 2025.