Teaching Improved Communication To Adolescents and Clinicians

Communication Improvement Between Adolescent and Clinician Clinical Trial

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Official title:

Teaching Improved Communication To Adolescents and Clinicians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152045
• Other study ID #: Pro00078439
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: October 29, 2018

Study information

• Verified date: October 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 29, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communication Improvement Between Adolescent and Clinician

Intervention

Behavioral:
• Communication Intervention
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Duke University Medical Center - Cancer Prevention, Detection and Control	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Höglund 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient perceived provider empathy as measure by a summed 10-question scale	We will assess patient perceived provider empathy with a summed 10-question scale (a=0.95; e.g., "Thinking about your visit with your doctor, how was your doctor at fully understanding your concerns?" (1= Not at all good and 5= Extremely good)).	10 minutes
Other	Patient perceived autonomy support using a 15 question scale	We will assess patient autonomy support using a 15 question scale (a=0.95;e.g., "I feel that my physician has provided me choices and potions" (1=Strongly disagree and 5=Strongly agree).	10 minutes
Other	Patient's self rated participation in the encounter	We will assess patient's self rated participation in the encounter using a five-point Likert-type scale (i.e., 1 "Not at all good" - 5 "Extremely good")	10 minutes
Primary	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	Acceptability	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	9 months

External Links

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