Virtual Communication in the Hospital: Impact on Patients and Surrogates

NCT ID: NCT05395039

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2026-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care: Control Group

No interventions administered. Participant will receive usual care in the hospital.

Group Type: NO_INTERVENTION

No interventions assigned to this group

VCHIPS: Intervention Group

Individuals in this group will work with a study nurse to schedule the intervention.

Group Type: EXPERIMENTAL

VCHIPS

Intervention Type: 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.

Interventions

VCHIPS

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Indiana University Health

OTHER

Sponsor Role: collaborator

Regenstrief Institute, Inc.

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Alexia M. Torke

Professor of Medicine, Associate Division Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexia M Torke, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University Health

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

K24AG053794

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10893

Identifier Type: -

Identifier Source: org_study_id