Orthopedic DisorderNCT03645135
Does Goal Elicitation Improve Patient Perceived Involvement
A study testing Goal elicitation in people with Orthopedic Disorder, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine if goal elicitation among orthopaedic patients improves their perceived involvement in care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Goal elicitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 19 Nov 2018
- 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
- New patients visiting the orthopaedic service
- English fluency and literacy
Who cannot join
- Returning patients
- Children
- Non-English speaking patients
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 Goal Elicitation Improve Patient Perceived Involvement?
The purpose of this study is to determine if goal elicitation among orthopaedic patients improves their perceived involvement in care.
Read the detailed description
This is a RCT with 2 intervention arms. In the first arm, the control arm, patients will be asked to complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care. The second arm, the intervention arm, will be asked to list 2 goals for their visit and complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care.
- Conditions
- Orthopedic Disorder
- Being tested
- Goal elicitation
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal elicitationOther
Patients will be asked to list 2 goals for their visit
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control group will be asked to complete a demographics survey and assess their perceived involvement in care after their visit |
| Goal elicitation | Experimental | Patients in the intervention group will be asked to list 2 goals for their visit. They will also be asked to complete a demographics survey and access their perceived involvement in care after their visit. Receives: Other: Goal elicitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Involvement in Care Scale (PICS)
PICS measures the following: doctor facilitation of patient involvement, level of information exchange, and patient participation in decision making. Scale: 0-13, higher score means higher perceived involvement.
Measured: Immediately after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Jul 2018
- Primary completion19 Nov 2018
- Study completion19 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies 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
- Model description
- Patients will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention. We will use a random block generator to assign participants to their study arm.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 90 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, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645135
- Sponsor's protocol ID
- 45823
- Status last verified
- Apr 2019
- First submitted
- 22 Aug 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared for this study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Goal Elicitation Improve Patient Perceived Involvement?
- ClinicalTrials.gov ID
- NCT03645135
- Acronym / sponsor ID
- 45823
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 19 Nov 2018 (actual)
- First posted
- 24 Aug 2018 (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 determine if goal elicitation among orthopaedic patients improves their perceived involvement in care.
Detailed description
This is a RCT with 2 intervention arms. In the first arm, the control arm, patients will be asked to complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care. The second arm, the intervention arm, will be asked to list 2 goals for their visit and complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Patients will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention. We will use a random block generator to assign participants to their study arm.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control group will be asked to complete a demographics survey and assess their perceived involvement in care after their visit |
| Goal elicitation | Experimental | Other: Goal elicitationPatients in the intervention group will be asked to list 2 goals for their visit. They will also be asked to complete a demographics survey and access their perceived involvement in care after their 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)
- New patients visiting the orthopaedic service
- English fluency and literacy
Key exclusion criteria (3 listed)
- Returning patients
- Children
- Non-English speaking patients
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 |
|---|---|---|
| Goal elicitationPatients will be asked to list 2 goals for their visit | Other | Goal elicitation |
Primary outcome
Perceived Involvement in Care Scale (PICS)
Time frame: Immediately after visit
PICS measures the following: doctor facilitation of patient involvement, level of information exchange, and patient participation in decision making. Scale: 0-13, higher score means higher 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 10 Apr 2019.
- Individual participant dataSharing planned: No. IPD will not be shared for this study.
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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 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 Goal elicitation in people with Orthopedic Disorder, 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 2 inclusion and 3 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 2019. 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 (PICS) (time frame: Immediately after visit). 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 2019.