Exposure to Violent EventNCT02041182
Electronic Pre-visit Questionnaire to Prompt Discussions of Youth Violence in Primary Care
A study testing Pre-Visit Questionnaire in people with Exposure to Violent Event and Bullying, run by Rhode Island Hospital at 1 site in United States.
Trial summary
Pediatricians are supposed to talk about youth violence at all heath supervision visits, however these types of conversations rarely occur. There have been no studies assessing tools to prompt these discussions. Read more about this study
- Who is it for?
- Ages 13 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Exposure to Violent Event, Bullying
- What is being tested?
- Pre-Visit Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Feb 2014
- 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 13 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- adolescents ages 13-21
- presenting for annual physical exam
- provider is general pediatrician (micro-practice 1-8)
- parent present for consent (if under 18 years old)
Who cannot join
- non-English speaking
- developmental/neurologic delay
- no parent (if under 18 years old)
- presenting for sick visit or specialty clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
Hasbro Primary Care Clinics
Providence, Rhode Island, 02903
About this study
Official title: Use of an Electronic Pre-visit Questionnaire and Effect on Patient-provider Discussions of Youth Violence in Primary Care
Pediatricians are supposed to talk about youth violence at all heath supervision visits, however these types of conversations rarely occur. There have been no studies assessing tools to prompt these discussions. The goal of this study is to see if electronic pre-visit questionnaires (PVQs) prompt patient-provider discussion of youth violence (YV) in the primary care setting. Additionally, patient-provider characteristics are explored as mediators to youth violence discussions, as well as feasibility and acceptability of the PVQ by patients and providers.
Adolescents ages 13 to 21 who come to the Hasbro Primary Care Clinics for annual physicals will be recruited. A baseline phase was conducted to look at how often providers ask about health-related teen behaviors, assessed by exit survey. The experimental period will involve adolescents completing health-related behavior PVQ, given to their doctor prior to the visit. Exit survey will assess topics discussed. Experimental group will differ from control group based on PVQ containing extra questions about youth violence.
- Conditions
- Exposure to Violent Event, Bullying
- Being tested
- Pre-Visit Questionnaire
- Keywords
- youth violence, doctor-patient communication, health risk behaviors, pre-visit questionnaires
- Medical subject headings
- Bullying, Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Visit QuestionnaireBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Pre-visit Questionnaire | Experimental | Adolescents receive PVQ that includes questions about youth violence/bullying Receives: Behavioral: Pre-Visit Questionnaire |
| Control Pre-visit Questionnaire | Active comparator | Adolescents received PVQ without youth violence/bullying items Receives: Behavioral: Pre-Visit Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient-reported patient-provider discussions about youth violence
The intervention is implemented immediately prior to the primary care visit; the outcome is measured directly following the visit by exit survey
Measured: One time point (single day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exposure to Violent EventStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, HRSA/Maternal and Child Health Bureau
- Responsible party
- Sponsor
- Investigators
- Megan Ranney, MD MPH, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041182
- Sponsor's protocol ID
- APA-YIA-2013
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Electronic Pre-visit Questionnaire and Effect on Patient-provider Discussions of Youth Violence in Primary Care
- ClinicalTrials.gov ID
- NCT02041182
- Acronym / sponsor ID
- APA-YIA-2013
- Conditions
- Exposure to Violent Event, Bullying
- Keywords
- youth violence, doctor-patient communication, health risk behaviors, pre-visit questionnaires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, HRSA/Maternal and Child Health Bureau
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Jan 2014 (estimated)
- 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.
Pediatricians are supposed to talk about youth violence at all heath supervision visits, however these types of conversations rarely occur. There have been no studies assessing tools to prompt these discussions. The goal of this study is to see if electronic pre-visit questionnaires (PVQs) prompt patient-provider discussion of youth violence (YV) in the primary care setting. Additionally, patient-provider characteristics are explored as mediators to youth violence discussions, as well as feasibility and acceptability of the PVQ by patients and providers.
Adolescents ages 13 to 21 who come to the Hasbro Primary Care Clinics for annual physicals will be recruited. A baseline phase was conducted to look at how often providers ask about health-related teen behaviors, assessed by exit survey. The experimental period will involve adolescents completing health-related behavior PVQ, given to their doctor prior to the visit. Exit survey will assess topics discussed. Experimental group will differ from control group based on PVQ containing extra questions about youth violence.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Pre-visit Questionnaire | Experimental | Behavioral: Pre-Visit QuestionnaireAdolescents receive PVQ that includes questions about youth violence/bullying |
| Control Pre-visit Questionnaire | Active comparator | Behavioral: Pre-Visit QuestionnaireAdolescents received PVQ without youth violence/bullying items |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- adolescents ages 13-21
- presenting for annual physical exam
- provider is general pediatrician (micro-practice 1-8)
- parent present for consent (if under 18 years old)
Key exclusion criteria (4 listed)
- non-English speaking
- developmental/neurologic delay
- no parent (if under 18 years old)
- presenting for sick visit or specialty clinic
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 |
|---|---|---|
| Pre-Visit Questionnaire | Behavioural | Control Pre-visit Questionnaire, Intervention Pre-visit Questionnaire |
Primary outcome
Number of patient-reported patient-provider discussions about youth violence
Time frame: One time point (single day)
The intervention is implemented immediately prior to the primary care visit; the outcome is measured directly following the visit by exit survey
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 20 Aug 2014.
Related trials for Exposure to Violent Event
Enrolling by invitation
Evaluation of Violence Prevention Strategies to Prevent and Reduce Community Levels of Youth Violence
Violence, Exposure to Violent Event
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.
Megan Ranney, MD MPH principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Visit Questionnaire in people with Exposure to Violent Event and Bullying, run by Rhode Island Hospital 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 4 inclusion and 4 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 20 Aug 2014. 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?
Number of patient-reported patient-provider discussions about youth violence (time frame: One time point (single day)). 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 20 Aug 2014.