Communication Improvement Between Adolescent and ClinicianTicTacNCT03152045
Teaching Improved Communication To Adolescents and Clinicians
A study testing Communication Intervention in people with Communication Improvement Between Adolescent and Clinician, run by Duke University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Communication Improvement Between Adolescent and Clinician
- What is being tested?
- Communication Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Sep 2017to 29 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All English-speaking adolescent patients
- cognitively able to participate
Who cannot join
- Adolescents less than 12 years of age
- Adolescents over 21 years of age
- cognitively unable to participate.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27705
Duke University Medical Center - Cancer Prevention, Detection and Control
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Being tested
- Communication Intervention
- Keywords
- communication between adolescent patients and their clinician
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Communication Intervention |
| Standard Of Care | No intervention | Investigators will compare patients randomized into the intervention group to those who receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (1)
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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start25 Sep 2017
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Communication Improvement Between Adolescent and ClinicianStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Kathryn Pollak, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152045
- Sponsor's protocol ID
- Pro00078439
- Acronym
- TicTac
- Status last verified
- Oct 2018
- First submitted
- 2 May 2017
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified web-based surveys from the University of Michigan will be available to Duke researchers through REDCap.
Publications
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.
PubMed 20230518
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Improved Communication To Adolescents and Clinicians
- ClinicalTrials.gov ID
- NCT03152045
- Acronym / sponsor ID
- TicTac / Pro00078439
- Keywords
- communication between adolescent patients and their clinician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional: to evaluate the effect of Feedback Guides on clinician-adolescent communication about hight-risk behaviors. Control: standard of care
| Arm | Type | Receives |
|---|---|---|
| Communication Intervention | Experimental | Behavioral: Communication InterventionInvestigators 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. |
| Standard Of Care | No intervention | –Investigators will compare patients randomized into the intervention group to those who receive standard of care. |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All English-speaking adolescent patients
- cognitively able to participate
Key exclusion criteria (3 listed)
- Adolescents less than 12 years of age
- Adolescents over 21 years of age
- cognitively unable to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication InterventionIn 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. | Behavioural | Communication Intervention |
Primary outcome
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.
1 secondary outcome
Acceptability
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Results publication: PubMed 20230518Hoglund 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. De-identified web-based surveys from the University of Michigan will be available to Duke researchers through REDCap.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Pollak, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Intervention in people with Communication Improvement Between Adolescent and Clinician, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by recruitment number (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03152045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.