Virtual Communication in the Hospital: Impact on Patients and Surrogates

NCT05395039 | Withdrawn

• 2 other identifiers: 10893K24AG053794
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Communication; Anxiety; Depression; Distress, Emotional

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  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

  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

  6-8 weeks after discharge, 6 months after discharge

• Measure complicated grief for study participants of patients who died at 6 months after discharge

  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 daily during the first week and twice a week thereafter for the duration of the hospital stay, up to 1 year

Other Outcomes (5)

• Measure the change in observable and/or reported level of pain in patients of participants in the intervention group.

  Pre/post observations of pain will occur at the time of study intervention, typically within 1 hour.

• Measure the change in observable and/or reported level of distress in patients in the intervention group before and after study intervention

  Pre/post observations of distress will occur at the time of study intervention, typically within 1 hour of each other.

• Measure the change in blood pressure in patients in the intervention group before and after study intervention

  Pre/post observations of blood pressure will occur at the time of study intervention, typically within 1 hour of each other.

Study Arms (2)

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.

Other: VCHIPS

Interventions

VCHIPS OTHER

Participants in this group will have the opportunity to receive virtual visits with the patient during the hospital stay, led by a study nurse.

VCHIPS: Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patient:
• 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

You may not qualify if:

• Patient:
• Less than 65 years old
• Incarcerated individuals (e.g. prisoners)
• Lack of cognitive impairment
• Terminal wean/ actively dying
• Surrogate:
• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator
• Indiana University Health: collaborator
• Regenstrief Institute, Inc.: collaborator

Study Sites (1)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Communication; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Behavioral Symptoms

Study Officials

• Alexia M Torke, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Associate Division Chief

Model Details: Intervention Group: VCHIPS Control Group: Usual care

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 27, 2022
• Study Start (Estimated): March 31, 2027
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)