CommunicationVCHIPSNCT05395039
Virtual Communication in the Hospital: Impact on Patients and Surrogates
A study testing VCHIPS in people with Communication and Anxiety, run by Indiana University at 1 site in United States.
Trial summary
This is a pilot study of scheduled video/audio conferences by clinical navigators on the experience of surrogate decision makers for hospitalized older adults with Alzheimer's disease (AD), delirium, and other causes of cognitive impairment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Communication, Anxiety, Depression
- What is being tested?
- VCHIPS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2027to 31 Mar 2027
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient:
- 65 years or older
- cognitive impairment due to ADRD, delirium, or other causes of cognitive impairment severe enough that they require a surrogate for all medical decisions
- must have a surrogate decision maker based on a previously executed healthcare representative form or based on Indiana statute.
- Surrogate:
- English-speaking
- Surrogate does not plan to be at patient's bedside every day
- surrogate is 18 or older
Who cannot join
- Patient:
- Less than 65 years old
- Incarcerated individuals (e.g. prisoners)
- Lack of cognitive impairment
- Terminal wean/ actively dying
- Surrogate:
Show all 12Show fewer
- Less than 18 years old
- Incarcerated individuals (e.g. prisoners)
- non-English speaking
- plans to be at patient's bedside every day
- has a care contract or flagged for security risk
- state-appointed guardians
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health
Indianapolis, Indiana, 46202
About this study
Official title: Communication in the Hospital: Impact on Patients With Alzheimer's Disease and Other Causes of Cognitive Impairments and Their Surrogate Decision Makers
This is a pilot study of scheduled video/audio conferences by clinical navigators on the experience of surrogate decision makers for hospitalized older adults with Alzheimer's disease (AD), delirium, and other causes of cognitive impairment. The purpose of this study is to learn more about the experiences of surrogate decision makers of hospitalized older adults when they cannot be physically present with the patient in the hospital. We will conduct a randomized pilot study of virtual visits to connect the surrogate decision makers of incapacitated, hospitalized older adults with AD, delirium, and related causes of cognitive impairment with the patient and clinicians.
Read the detailed description
As the COVID-19 pandemic exploded, hospitals across the globe completely excluded or severely limited family visitors. Thousands of patients have faced life-threatening illness or died without any loved ones at the bedside. Patients with AD were often unable to understand why their family members could not be present, leading to increased agitation. The calming presence that family often provide to hospitalized patients was missing. In addition to the tragedy for patients, family members were forced to address decisions about life-sustaining treatments without being able to see the patient or talk face to face with clinicians. As our knowledge of coronavirus transmission expanded, visitor restrictions have been relaxed in some cases but not eliminated. Urgent interventions are needed to mitigate the harm of these restrictions. While the future is uncertain, COVID-19 cases are rising across the country, suggesting that visitation will continue to be restricted. Additionally, our tertiary referral center often admits patients from across the state, limiting the ability of family members to be at the bedside. Harnessing virtual technologies has the potential to enhance surrogate/clinician communication and decision making during the pandemic and after.
Telehealth has greatly expanded the abilities of patients to see clinicians remotely or for clinician to clinician consultation, but prior to COVID-19 there were few interventions aimed at the family members of hospitalized patients. We feel we are poised to rapidly move along the NIH research pathway given that we are studying our early implementation. At the conclusion of this pilot, we will then conduct an effectiveness trial, followed by an embedded, pragmatic clinical trial.
- Conditions
- Communication, Anxiety, Depression, Distress, Emotional
- Being tested
- VCHIPS
- Medical subject headings
- Communication, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCHIPSOther
Participants in this group will have the opportunity to receive virtual visits with the patient during the hospital stay, led by a study nurse.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care: Control Group | No intervention | No interventions administered. Participant will receive usual care in the hospital. |
| VCHIPS: Intervention Group | Experimental | Individuals in this group will work with a study nurse to schedule the intervention. Receives: Other: VCHIPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure change in ratings of communication quality among study participants using the FICS at baseline, 6-8 weeks after patient discharge, and 6 months after patient discharge
Communication quality will be measured using the validated Family Inpatient Communication Survey (30 item scale)
Measured: 6-8 weeks after discharge, 6 months after discharge
Secondary outcomes (5)
Measure change in participant depression among study participants using the PHQ-8 at baseline, 6-8 weeks after discharge, and 6 months after discharge
Depression will be measured using the validated Patient Health Questionnaire (8 item)
Measured: Baseline, 6-8 weeks after discharge, 6 months after discharge
Measure change in anxiety among study participants using the GAD-7 at baseline, 6-8 weeks after discharge, and 6 months after discharge
Anxiety will be measured using the validated Generalized Anxiety Disorder-7
Measured: Baseline, 6-8 weeks after discharge, 6 months after discharge
Measure change in the impact of events among study participants using the IES-R at 6-8 weeks after discharge and 6 months after discharge
Impact of Events will be measured using the validated Impact of Events Scale
Measured: 6-8 weeks after discharge, 6 months after discharge
Measure complicated grief for study participants of patients who died at 6 months after discharge
Complicated grief will be measured using the validated Inventory of Complicated Grief
Measured: 6 months after death
Measure change in participants' ratings of communication quality over time for the duration of the patient's hospital stay
Communication quality will be measured from participants responses to texted survey questions (ecological momentary assessment) written by the study team. Participants will respond on a 5 point Likert scale.
Measured: Communication quality will be measured daily during the first week and twice a week thereafter for the duration of the hospital stay, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start31 Mar 2027 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Why it stopped: Recruitment effort yielded no enrollments, so this study was stopped. We are re-evaluating the study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention Group: VCHIPS Control Group: Usual care
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH), Indiana University Health, Regenstrief Institute, Inc.
- Responsible party
- Principal investigator, Alexia M. Torke, Indiana University
- Investigators
- Alexia M Torke, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395039
- Sponsor's protocol ID
- 10893
- Other IDs
- K24AG053794
- Acronym
- VCHIPS
- Status last verified
- Mar 2026
- First submitted
- 15 Apr 2022
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication in the Hospital: Impact on Patients With Alzheimer's Disease and Other Causes of Cognitive Impairments and Their Surrogate Decision Makers
- ClinicalTrials.gov ID
- NCT05395039
- Acronym / sponsor ID
- VCHIPS / 10893
- Conditions
- Communication, Anxiety, Depression, Distress, Emotional
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment effort yielded no enrollments, so this study was stopped. We are re-evaluating the study design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH), Indiana University Health, Regenstrief Institute, Inc.
- Study start
- 31 Mar 2027 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 May 2022 (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.
This is a pilot study of scheduled video/audio conferences by clinical navigators on the experience of surrogate decision makers for hospitalized older adults with Alzheimer's disease (AD), delirium, and other causes of cognitive impairment. The purpose of this study is to learn more about the experiences of surrogate decision makers of hospitalized older adults when they cannot be physically present with the patient in the hospital. We will conduct a randomized pilot study of virtual visits to connect the surrogate decision makers of incapacitated, hospitalized older adults with AD, delirium, and related causes of cognitive impairment with the patient and clinicians.
Detailed description
As the COVID-19 pandemic exploded, hospitals across the globe completely excluded or severely limited family visitors. Thousands of patients have faced life-threatening illness or died without any loved ones at the bedside. Patients with AD were often unable to understand why their family members could not be present, leading to increased agitation. The calming presence that family often provide to hospitalized patients was missing. In addition to the tragedy for patients, family members were forced to address decisions about life-sustaining treatments without being able to see the patient or talk face to face with clinicians. As our knowledge of coronavirus transmission expanded, visitor restrictions have been relaxed in some cases but not eliminated. Urgent interventions are needed to mitigate the harm of these restrictions. While the future is uncertain, COVID-19 cases are rising across the country, suggesting that visitation will continue to be restricted. Additionally, our tertiary referral center often admits patients from across the state, limiting the ability of family members to be at the bedside. Harnessing virtual technologies has the potential to enhance surrogate/clinician communication and decision making during the pandemic and after.
Telehealth has greatly expanded the abilities of patients to see clinicians remotely or for clinician to clinician consultation, but prior to COVID-19 there were few interventions aimed at the family members of hospitalized patients. We feel we are poised to rapidly move along the NIH research pathway given that we are studying our early implementation. At the conclusion of this pilot, we will then conduct an effectiveness trial, followed by an embedded, pragmatic clinical trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention Group: VCHIPS Control Group: Usual care
| Arm | Type | Receives |
|---|---|---|
| Usual Care: Control Group | No intervention | –No interventions administered. Participant will receive usual care in the hospital. |
| VCHIPS: Intervention Group | Experimental | Other: VCHIPSIndividuals in this group will work with a study nurse to schedule the intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 65 years or older
- cognitive impairment due to ADRD, delirium, or other causes of cognitive impairment severe enough that they require a surrogate for all medical decisions
- must have a surrogate decision maker based on a previously executed healthcare representative form or based on Indiana statute.
- English-speaking
- Surrogate does not plan to be at patient's bedside every day
Key exclusion criteria (12 listed)
- Less than 65 years old
- Incarcerated individuals (e.g. prisoners)
- Lack of cognitive impairment
- Terminal wean/ actively dying
- Less than 18 years old
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 |
|---|---|---|
| VCHIPSParticipants in this group will have the opportunity to receive virtual visits with the patient during the hospital stay, led by a study nurse. | Other | VCHIPS: Intervention Group |
Primary outcome
Measure change in ratings of communication quality among study participants using the FICS at baseline, 6-8 weeks after patient discharge, and 6 months after patient discharge
Time frame: 6-8 weeks after discharge, 6 months after discharge
Communication quality will be measured using the validated Family Inpatient Communication Survey (30 item scale)
5 secondary outcomes
Measure change in participant depression among study participants using the PHQ-8 at baseline, 6-8 weeks after discharge, and 6 months after discharge
Time frame: Baseline, 6-8 weeks after discharge, 6 months after discharge
Measure change in anxiety among study participants using the GAD-7 at baseline, 6-8 weeks after discharge, and 6 months after discharge
Time frame: Baseline, 6-8 weeks after discharge, 6 months after discharge
Measure change in the impact of events among study participants using the IES-R at 6-8 weeks after discharge and 6 months after discharge
Time frame: 6-8 weeks after discharge, 6 months after discharge
Measure complicated grief for study participants of patients who died at 6 months after discharge
Time frame: 6 months after death
Measure change in participants' ratings of communication quality over time for the duration of the patient's hospital stay
Time frame: Communication quality will be measured daily during the first week and twice a week thereafter for the duration of the hospital stay, up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- 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. This study is not recruiting at the moment.
Alexia M Torke, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VCHIPS in people with Communication and Anxiety, run by Indiana University at 1 site 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 8 inclusion and 12 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: withdrawn, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Measure change in ratings of communication quality among study participants using the FICS at baseline, 6-8 weeks after patient discharge, and 6 months after patient discharge (time frame: 6-8 weeks after discharge, 6 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.