NCT02041182

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 20, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

January 15, 2014

Last Update Submit

August 19, 2014

Conditions

Keywords

youth violencedoctor-patient communicationhealth risk behaviorspre-visit questionnaires

Outcome Measures

Primary Outcomes (1)

  • 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

    One time point (single day)

Study Arms (2)

Intervention Pre-visit Questionnaire

EXPERIMENTAL

Adolescents receive PVQ that includes questions about youth violence/bullying

Behavioral: Pre-Visit Questionnaire

Control Pre-visit Questionnaire

ACTIVE COMPARATOR

Adolescents received PVQ without youth violence/bullying items

Behavioral: Pre-Visit Questionnaire

Interventions

Control Pre-visit QuestionnaireIntervention Pre-visit Questionnaire

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • non-English speaking
  • developmental/neurologic delay
  • no parent (if under 18 years old)
  • presenting for sick visit or specialty clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasbro Primary Care Clinics

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

BullyingHealth Risk Behaviors

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial BehaviorHealth Behavior

Study Officials

  • Megan Ranney, MD MPH

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 20, 2014

Study Start

October 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

August 20, 2014

Record last verified: 2014-01

Locations