Communication BarriersNCT07897877
Examining the Impact of a Patient Communication Pathway in the Critical Care Setting on Patient Experience and Nursing Staff's Perceptions of Usability
A study testing Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk) in people with Communication Barriers, run by University of Colorado, Denver.
Trial summary
The purpose of this study is to assess how an evidence-based communication protocol combined with Vidatalk can impact patient ICU experience and how usable this approach is perceived by nursing staff. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication Barriers
- What is being tested?
- Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over age of 18
- RN or Nursing Assistant
- Speaks and writes in English
- At least 18 years of age
- English speaking (Tool only validated in English)
- Intubated and ventilated for more than 12 hours
Show all 9Show fewer
- Not intubated more than 7 days
- Discharge from ICU status for 24 hours
- Oriented to person, place, time and situation at time of consent
Who cannot join
- Under the age of 18
- Not an RN or Nursing Assistant
- Does not or cannot speak or write in English
- Under 18 years of age
- Does not speak English
- Intubated and ventilated for less than 12 hours
Show all 9Show fewer
- Intubated and ventilated for over 7 days
- Discharged from ICU status for less than 24 hours
- Discharged from the hospital at time of consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to assess how an evidence-based communication protocol combined with Vidatalk can impact patient ICU experience and how usable this approach is perceived by nursing staff.
Read the detailed description
Research environments are highly controlled and regulated, which can cause unforeseen challenges when bringing evidenced-based practices into clinical practice. These challenges include the development of unforeseen barriers and unexpected or inaccurate perceptions of the new practices. With UCHealth University of Colorado Hospital recently adopting an evidence-based communication protocol and Vidatalk as the standard of care, the research team aims to assess how staff perceive the usability of these strategies as that might inform future implementation in other UCHealth ICUs. Furthermore, the research team would intends to assess patient's experiences of the ICU setting in both environments where the evidence-based communication protocol and Vidatalk are the standard of care in comparison to UCHealth ICU settings which still apply traditional communication methods (e.g., white boards, picture boards). This would allow for additional insight to how these strategies affect patient's perceptions of the ICU environment and their nursing care.
- Conditions
- Communication Barriers
- Being tested
- Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk)
- Keywords
- communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk)Other
Evidence-based communication protocol designed by Speech Language Pathologists has been implemented as a local standard of care in addition to associated low and high-tech communication approaches (i.e. Vidatalk) which are selected based upon the patient's assessment
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk) Receives: Other: Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk) |
| Control | No intervention | Routine communication techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care Experience Questionnaire (ICEQ)
Assessment of patient's intensive care experience measured by the Intensive Care Experience Questionnaire (ICEQ). This is a 31-item scale which uses a 5-point Likert scale. Scores can range from 31-155. Higher scores mean that participant's had more positive experiences within the intensive care unit setting.
Measured: From enrollment through completion of baseline survey (i.e., Intensive Care Experience Questionnaire). As this is a cross-sectional survey, participant's completion is finished upon completing survey.
System Usability Scale (SUS)
Assessment of nursing staff's perception of usability regarding evidenced-based communication protocol and associated low and high-tech communication approaches (i.e. Vidatalk). The System Usability Scale is a 10-item survey which uses a 5-point Likert scale. Scores can range from 0-100. Higher scores on the survey indicate that participants had increase perceptions of ease of use, decrease perceptions of cumbersomeness, and increased confidence with use.
Measured: From enrollment through completion of survey at baseline (i.e., System Usability Scale). As this is a cross-sectional survey, participant's completion is finished upon completing survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Communication BarriersStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One unit has currently implemented the evidence-based communication protocol plus Vidatalk and one unit has yet to implement this approach. The unit with the evidence-based communication protocol and Vidatalk will be in the intervention unit and the other unit without this approach will be the control unit.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maureen Varty, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897877
- Sponsor's protocol ID
- 26-1386
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartlett G, Blais R, Tamblyn R, Clermont RJ, MacGibbon B. Impact of patient communication problems on the risk of preventable adverse events in acute care settings. CMAJ. 2008 Jun 3;178(12):1555-62. doi: 10.1503/cmaj.070690.
PubMed 18519903Brooke, J. (1996). SUS - A quick and dirty usability scale. Usability Evaluation in Industry, 189-194
Brooke, J. (2013). SUS: A retrospective. Journal of Usability Studies, 8(2), 29-40.
Broyles LM, Tate JA, Happ MB. Use of augmentative and alternative communication strategies by family members in the intensive care unit. Am J Crit Care. 2012 Mar;21(2):e21-32. doi: 10.4037/ajcc2012752.
PubMed 22381993Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.
PubMed 36309746Danielis M, Povoli A, Mattiussi E, Palese A. Understanding patients' experiences of being mechanically ventilated in the Intensive Care Unit: Findings from a meta-synthesis and meta-summary. J Clin Nurs. 2020 Jul;29(13-14):2107-2124. doi: 10.1111/jocn.15259. Epub 2020 Apr 20.
PubMed 32243007Happ MB, Garrett KL, Tate JA, DiVirgilio D, Houze MP, Demirci JR, George E, Sereika SM. Effect of a multi-level intervention on nurse-patient communication in the intensive care unit: results of the SPEACS trial. Heart Lung. 2014 Mar-Apr;43(2):89-98. doi: 10.1016/j.hrtlng.2013.11.010. Epub 2014 Feb 1.
PubMed 24495519Holm A, Dreyer P. Nurse-patient communication within the context of non-sedated mechanical ventilation: A hermeneutic-phenomenological study. Nurs Crit Care. 2018 Mar;23(2):88-94. doi: 10.1111/nicc.12297. Epub 2017 Jun 7.
PubMed 28593721Karlsen MW, Olnes MA, Heyn LG. Communication with patients in intensive care units: a scoping review. Nurs Crit Care. 2019 May;24(3):115-131. doi: 10.1111/nicc.12377. Epub 2018 Aug 1.
PubMed 30069988Kuruppu NR, Chaboyer W, Abayadeera A, Ranse K. Augmentative and alternative communication tools for mechanically ventilated patients in intensive care units: A scoping review. Aust Crit Care. 2023 Nov;36(6):1095-1109. doi: 10.1016/j.aucc.2022.12.009. Epub 2023 Feb 9.
PubMed 36774294LaValley M, Chavers-Edgar T, Wu M, Schlosser R, Koul R. Augmentative and Alternative Communication Interventions in Critical and Acute Care With Mechanically Ventilated and Tracheostomy Patients: A Scoping Review. Am J Speech Lang Pathol. 2024 Sep 18;33(5):2667-2686. doi: 10.1044/2024_AJSLP-23-00310. Epub 2024 Aug 13.
PubMed 39146218Radtke JV, Tate JA, Happ MB. Nurses' perceptions of communication training in the ICU. Intensive Crit Care Nurs. 2012 Feb;28(1):16-25. doi: 10.1016/j.iccn.2011.11.005. Epub 2011 Dec 14.
PubMed 22172745Rattray J, Johnston M, Wildsmith JA. The intensive care experience: development of the ICE questionnaire. J Adv Nurs. 2004 Jul;47(1):64-73. doi: 10.1111/j.1365-2648.2004.03066.x.
PubMed 15186469Roberts M, Bortolotto SJ, Weyant RA, Jock L, LaLonde T, Henderson A. The Experience of Acute Mechanical Ventilation From the Patient's Perspective. Dimens Crit Care Nurs. 2019 Jul/Aug;38(4):201-212. doi: 10.1097/DCC.0000000000000361.
PubMed 31145167Shin JW, Happ MB, Tate JA. VidaTalk patient communication application "opened up" communication between nonvocal ICU patients and their family. Intensive Crit Care Nurs. 2021 Oct;66:103075. doi: 10.1016/j.iccn.2021.103075. Epub 2021 Jun 12.
PubMed 34127362
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of a Patient Communication Pathway in the Critical Care Setting on Patient Experience and Nursing Staff's Perceptions of Usability
- ClinicalTrials.gov ID
- NCT07897877
- Acronym / sponsor ID
- 26-1386
- Conditions
- Communication Barriers
- Keywords
- communication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 2026 (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 study is to assess how an evidence-based communication protocol combined with Vidatalk can impact patient ICU experience and how usable this approach is perceived by nursing staff.
Detailed description
Research environments are highly controlled and regulated, which can cause unforeseen challenges when bringing evidenced-based practices into clinical practice. These challenges include the development of unforeseen barriers and unexpected or inaccurate perceptions of the new practices. With UCHealth University of Colorado Hospital recently adopting an evidence-based communication protocol and Vidatalk as the standard of care, the research team aims to assess how staff perceive the usability of these strategies as that might inform future implementation in other UCHealth ICUs. Furthermore, the research team would intends to assess patient's experiences of the ICU setting in both environments where the evidence-based communication protocol and Vidatalk are the standard of care in comparison to UCHealth ICU settings which still apply traditional communication methods (e.g., white boards, picture boards). This would allow for additional insight to how these strategies affect patient's perceptions of the ICU environment and their nursing care.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One unit has currently implemented the evidence-based communication protocol plus Vidatalk and one unit has yet to implement this approach. The unit with the evidence-based communication protocol and Vidatalk will be in the intervention unit and the other unit without this approach will be the control unit.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk)Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk) |
| Control | No intervention | –Routine communication techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over age of 18
- RN or Nursing Assistant
- Speaks and writes in English
- At least 18 years of age
- English speaking (Tool only validated in English)
Key exclusion criteria (9 listed)
- Under the age of 18
- Not an RN or Nursing Assistant
- Does not or cannot speak or write in English
- Under 18 years of age
- Does not speak English
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 |
|---|---|---|
| Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk)Evidence-based communication protocol designed by Speech Language Pathologists has been implemented as a local standard of care in addition to associated low and high-tech communication approaches (i.e. Vidatalk) which are selected based upon the patient's assessment | Other | Intervention |
Primary outcome
Intensive Care Experience Questionnaire (ICEQ)
Time frame: From enrollment through completion of baseline survey (i.e., Intensive Care Experience Questionnaire). As this is a cross-sectional survey, participant's completion is finished upon completing survey.
Assessment of patient's intensive care experience measured by the Intensive Care Experience Questionnaire (ICEQ). This is a 31-item scale which uses a 5-point Likert scale. Scores can range from 31-155. Higher scores mean that participant's had more positive experiences within the intensive care unit setting.
System Usability Scale (SUS)
Time frame: From enrollment through completion of survey at baseline (i.e., System Usability Scale). As this is a cross-sectional survey, participant's completion is finished upon completing survey.
Assessment of nursing staff's perception of usability regarding evidenced-based communication protocol and associated low and high-tech communication approaches (i.e. Vidatalk). The System Usability Scale is a 10-item survey which uses a 5-point Likert scale. Scores can range from 0-100. Higher scores on the survey indicate that participants had increase perceptions of ease of use, decrease perceptions of cumbersomeness, and increased confidence with use.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 18519903Bartlett G, Blais R, Tamblyn R, Clermont RJ, MacGibbon B. Impact of patient communication problems on the risk of preventable adverse events in acute care settings. CMAJ. 2008 Jun 3;178(12):1555-62. doi: 10.1503/cmaj.070690.
- BackgroundBrooke, J. (1996). SUS - A quick and dirty usability scale. Usability Evaluation in Industry, 189-194
- BackgroundBrooke, J. (2013). SUS: A retrospective. Journal of Usability Studies, 8(2), 29-40.
- Background: PubMed 22381993Broyles LM, Tate JA, Happ MB. Use of augmentative and alternative communication strategies by family members in the intensive care unit. Am J Crit Care. 2012 Mar;21(2):e21-32. doi: 10.4037/ajcc2012752.
- Background: PubMed 36309746Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.
- Background: PubMed 32243007Danielis M, Povoli A, Mattiussi E, Palese A. Understanding patients' experiences of being mechanically ventilated in the Intensive Care Unit: Findings from a meta-synthesis and meta-summary. J Clin Nurs. 2020 Jul;29(13-14):2107-2124. doi: 10.1111/jocn.15259. Epub 2020 Apr 20.
- Background: PubMed 24495519Happ MB, Garrett KL, Tate JA, DiVirgilio D, Houze MP, Demirci JR, George E, Sereika SM. Effect of a multi-level intervention on nurse-patient communication in the intensive care unit: results of the SPEACS trial. Heart Lung. 2014 Mar-Apr;43(2):89-98. doi: 10.1016/j.hrtlng.2013.11.010. Epub 2014 Feb 1.
- Background: PubMed 28593721Holm A, Dreyer P. Nurse-patient communication within the context of non-sedated mechanical ventilation: A hermeneutic-phenomenological study. Nurs Crit Care. 2018 Mar;23(2):88-94. doi: 10.1111/nicc.12297. Epub 2017 Jun 7.
- Background: PubMed 30069988Karlsen MW, Olnes MA, Heyn LG. Communication with patients in intensive care units: a scoping review. Nurs Crit Care. 2019 May;24(3):115-131. doi: 10.1111/nicc.12377. Epub 2018 Aug 1.
- Background: PubMed 36774294Kuruppu NR, Chaboyer W, Abayadeera A, Ranse K. Augmentative and alternative communication tools for mechanically ventilated patients in intensive care units: A scoping review. Aust Crit Care. 2023 Nov;36(6):1095-1109. doi: 10.1016/j.aucc.2022.12.009. Epub 2023 Feb 9.
- Background: PubMed 39146218LaValley M, Chavers-Edgar T, Wu M, Schlosser R, Koul R. Augmentative and Alternative Communication Interventions in Critical and Acute Care With Mechanically Ventilated and Tracheostomy Patients: A Scoping Review. Am J Speech Lang Pathol. 2024 Sep 18;33(5):2667-2686. doi: 10.1044/2024_AJSLP-23-00310. Epub 2024 Aug 13.
- Background: PubMed 22172745Radtke JV, Tate JA, Happ MB. Nurses' perceptions of communication training in the ICU. Intensive Crit Care Nurs. 2012 Feb;28(1):16-25. doi: 10.1016/j.iccn.2011.11.005. Epub 2011 Dec 14.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based communication protocol associated low and high-tech communication approaches (i.e. Vidatalk) in people with Communication Barriers, run by University of Colorado, Denver.
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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maureen Varty, PhD, RN (720-848-6648, maureen.varty@uchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Care Experience Questionnaire (ICEQ) (time frame: From enrollment through completion of baseline survey (i.e., Intensive Care Experience Questionnaire). As this is a cross-sectional survey, participant's completion is finished upon completing survey.). The study lists 2 primary outcomes in all. 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 NCT07897877, which also lists 17 linked publications.
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 27 Oct 2026.