ClinicalTrials.gov
ClinicalTrials.gov Menu

Teaching Improved Communication To Adolescents and Clinicians (TicTac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03152045
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Communication Improvement Between Adolescent and Clinician Behavioral: Communication Intervention Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Interventional: to evaluate the effect of Feedback Guides on clinician-adolescent communication about hight-risk behaviors.

Control: standard of care

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Teaching Improved Communication To Adolescents and Clinicians
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: Standard Of Care
Investigators will compare patients randomized into the intervention group to those who receive standard of care.



Primary Outcome Measures :
  1. Feasibility as measured by recruitment number [ Time Frame: 9 months ]
    We will consider the intervention feasible if we recruit 20 adolescent patients and up to 10 clinicians per site.


Secondary Outcome Measures :
  1. Acceptability [ Time Frame: 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


Other Outcome Measures:
  1. Patient perceived provider empathy as measure by a summed 10-question scale [ Time Frame: 10 minutes ]
    We will assess patient perceived provider empathy with a summed 10-question scale (α=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)).

  2. Patient perceived autonomy support using a 15 question scale [ Time Frame: 10 minutes ]
    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).

  3. Patient's self rated participation in the encounter [ Time Frame: 10 minutes ]
    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")



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152045


Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Kathryn I Pollak, PhD    919-681-4757    kathryn.pollak@duke.edu   
Principal Investigator: Kathryn I Pollak, PhD         
Duke University Medical Center - Cancer Prevention, Detection and Control Recruiting
Durham, North Carolina, United States, 27710
Contact: Kathryn I Pollak, Ph.D.    919-668-4376    kathryn.pollak@duke.edu   
Principal Investigator: Kathryn I Pollak, PhD         
Sponsors and Collaborators
Duke University
University of Michigan
Investigators
Principal Investigator: Kathryn Pollak, PhD Duke University

Additional Information:
Publications of Results:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03152045     History of Changes
Other Study ID Numbers: Pro00078439
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified web-based surveys from the University of Michigan will be available to Duke researchers through REDCap.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
communication between adolescent patients and their clinician