NCT03152045

Brief Summary

The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention aimed at improving how adolescent patients and their clinicians communicate about behavior change.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 25, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2018

Completed
Last Updated

December 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

May 2, 2017

Last Update Submit

December 7, 2018

Conditions

Keywords

communication between adolescent patients and their clinician

Outcome Measures

Primary Outcomes (1)

  • Feasibility as measured by recruitment number

    We will consider the intervention feasible if we recruit 20 adolescent patients and up to 10 clinicians per site.

    9 months

Secondary Outcomes (1)

  • Acceptability

    9 months

Other Outcomes (3)

  • Patient perceived provider empathy as measure by a summed 10-question scale

    10 minutes

  • Patient perceived autonomy support using a 15 question scale

    10 minutes

  • Patient's self rated participation in the encounter

    10 minutes

Study Arms (2)

Communication Intervention

EXPERIMENTAL

Investigators are testing the feasibility, acceptability, and preliminary efficacy of a systems intervention that asks adolescents to report their risk behaviors before their encounter. Both clinicians and patients will receive a Feedback Guide that gives them tips on effective ways to communicate about these behaviors.

Behavioral: Communication Intervention

Standard Of Care

NO INTERVENTION

Investigators will compare patients randomized into the intervention group to those who receive standard of care.

Interventions

In this study, Investigators are testing the feasibility, acceptability, and preliminary efficacy of a systems intervention that asks adolescents to report their risk behaviors before their encounter. Both clinicians and patients will receive a Feedback Guide that gives them tips on effective ways to communicate about these behaviors.

Communication Intervention

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All English-speaking adolescent patients
  • cognitively able to participate

You may not qualify if:

  • Adolescents less than 12 years of age
  • Adolescents over 21 years of age
  • cognitively unable to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Duke University Medical Center - Cancer Prevention, Detection and Control

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Hoglund AT, Winblad U, Arnetz B, Arnetz JE. Patient participation during hospitalization for myocardial infarction: perceptions among patients and personnel. Scand J Caring Sci. 2010 Sep;24(3):482-9. doi: 10.1111/j.1471-6712.2009.00738.x.

Related Links

Study Officials

  • Kathryn Pollak, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Interventional: to evaluate the effect of Feedback Guides on clinician-adolescent communication about hight-risk behaviors. Control: standard of care
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 12, 2017

Study Start

September 25, 2017

Primary Completion

October 29, 2018

Study Completion

October 29, 2018

Last Updated

December 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

De-identified web-based surveys from the University of Michigan will be available to Duke researchers through REDCap.

Locations