Teaching Improved Communication To Adolescents and Clinicians

Not Applicable

Completed

• Conditions: Communication Improvement Between Adolescent and Clinician
• Interventions: Behavioral: Communication Intervention

• Registration Number: NCT03152045
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-12
• Study Start: 2017-09-25
• Status Verified: 2018-10
• Primary Completion: 2018-10-29
• Study Completion: 2018-10-29
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Communication Intervention	Communication Intervention	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.

Primary Outcome Measures

Name	Time	Method
Feasibility as measured by recruitment number	9 months	We will consider the intervention feasible if we recruit 20 adolescent patients and up to 10 clinicians per site.

Secondary Outcome Measures

Name	Time	Method
Acceptability	9 months	To determine acceptability, we will examine patients' reports of rated helpfulness of the intervention. To be deemed acceptable, 75% would have to rate it as a "4" or "5" on the 5-point scale

Trial Locations

Locations (2)

Duke University Medical Center - Cancer Prevention, Detection and Control; 🇺🇸 Durham, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States