Clinical trial NCT03152045: Teaching Improved Communication To Adolescents and Clinicians
Official title: Teaching Improved Communication To Adolescents and Clinicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication Improvement Between Adolescent and Clinician
Keywords: communication between adolescent patients and their clinician
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2017-05-12
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional: to evaluate the effect of Feedback Guides on clinician-adolescent communication about hight-risk behaviors.

Control: standard of care
Primary purpose: OTHER

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.

Detailed description: The investigators propose a randomized pilot trial across two health systems, Duke University and University of Michigan to evaluate the effect of Feedback Guides on clinician-adolescent communication about high-risk behaviors.

* The investigators consent clinicians prior to any patient recruitment.
* When a patient aged 12-21 years arrives for an annual visit and is a patient of a consented clinician, the front desk staff will provide the teen with an iPad tablet.
* As part of standard clinical care, all teens will complete the Rapid Assessment for Adolescent Preventive Services (RAAPS) questionnaire on the tablet privately (either in waiting room or in clinic room while waiting for the provider).
* The patient and parent will then review a study explanation and informed consent on the tablet and sign electronically if they agree to participate. The study clinician will review the informed consent with the patient and answer any questions.
* Participating teens will then complete a brief baseline survey and those randomized to the intervention arm will print the visit conversation guides using a wireless study printer connected to the tablet. The guides will print in a designated nursing area and clinic staff will add the printed guides to visit-related paperwork for the patient and clinician to use during the visit.
* The teen patient audio records the encounter on the tablet.
* The patient completes post-visit patient survey on tablet.
* The clinician completes a post-visit survey on paper.
* The patient returns tablet to clinic staff.
* The iPad will be connected to a study workstation, where the iTunes application will be used to transfer the audio file from the Voice Memos app to the workstation and then to it's final destination on the file server. Once the transfer has been confirmed, using iTunes, the audio file will be deleted from both the iPad and the workstation, including any residual versions of the audio file.
* Three months after the encounter, staff will provide participating patients a link to a REDCap survey (not the survey itself). The link will be sent using the preferred method selected by the patient through a question in the baseline survey - email or short message service (SMS). To protect the confidentiality of the responses, we will also provide the participant a code to access the REDCap follow-up survey. This will prevent others from accessing the survey results.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Feasibility as measured by recruitment number
timeFrame: 9 months
Secondary outcomes:
measure: Acceptability
timeFrame: 9 months
Other outcomes:
measure: Patient perceived provider empathy as measure by a summed 10-question scale
timeFrame: 10 minutes
measure: Patient perceived autonomy support using a 15 question scale
timeFrame: 10 minutes
measure: Patient's self rated participation in the encounter
timeFrame: 10 minutes
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center - Cancer Prevention, Detection and Control
state: North Carolina
Study officials:
affiliation: Duke University
name: Kathryn Pollak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.