Clinical trial NCT05395039: Virtual Communication in the Hospital: Impact on Patients and Surrogates
Official title: Communication in the Hospital: Impact on Patients With Alzheimer's Disease and Other Causes of Cognitive Impairments and Their Surrogate Decision Makers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Communication
Anxiety
Depression
Distress, Emotional
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
name: Indiana University Health
name: Regenstrief Institute, Inc.
First posted: 2022-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group: VCHIPS Control Group: Usual care
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
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
timeFrame: 6-8 weeks after discharge, 6 months after discharge
Secondary outcomes:
measure: Measure change in participant depression among study participants using the PHQ-8 at baseline, 6-8 weeks after discharge, and 6 months after discharge
timeFrame: Baseline, 6-8 weeks after discharge, 6 months after discharge
measure: Measure change in anxiety among study participants using the GAD-7 at baseline, 6-8 weeks after discharge, and 6 months after discharge
timeFrame: Baseline, 6-8 weeks after discharge, 6 months after discharge
measure: 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
timeFrame: 6-8 weeks after discharge, 6 months after discharge
measure: Measure complicated grief for study participants of patients who died at 6 months after discharge
timeFrame: 6 months after death
measure: Measure change in participants' ratings of communication quality over time for the duration of the patient's hospital stay
timeFrame: 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:
measure: Measure the change in observable and/or reported level of pain in patients of participants in the intervention group.
timeFrame: Pre/post observations of pain will occur at the time of study intervention, typically within 1 hour.
measure: Measure the change in observable and/or reported level of distress in patients in the intervention group before and after study intervention
timeFrame: Pre/post observations of distress will occur at the time of study intervention, typically within 1 hour of each other.
measure: Measure the change in blood pressure in patients in the intervention group before and after study intervention
timeFrame: Pre/post observations of blood pressure will occur at the time of study intervention, typically within 1 hour of each other.
measure: Measure the change in heart rate in patients in the intervention group before and after study intervention
timeFrame: Pre/post observations of heart rate will occur at the time of study intervention, typically within 1 hour of each other.
measure: Measure the change in respiratory rate in patients in the intervention group before and after study intervention
timeFrame: Pre/post observations of respiratory rate will occur at the time of study intervention, typically within 1 hour of each other.
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Alexia M Torke, MD
role: PRINCIPAL_INVESTIGATOR
References: