跳至主要内容
临床试验/NCT05395039
NCT05395039撤回不适用

Communication in the Hospital: Impact on Patients With Alzheimer's Disease and Other Causes of Cognitive Impairments and Their Surrogate Decision Makers

Indiana University2 个研究点 分布在 1 个国家开始时间: 2027年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • surrogate is 18 or older

排除标准

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

研究组 & 干预措施

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.

干预措施: VCHIPS (Other)

结局指标

主要结局

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

时间窗: 6-8 weeks after discharge, 6 months after discharge

Communication quality will be measured using the validated Family Inpatient Communication Survey (30 item scale)

次要结局

  • 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 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)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexia M. Torke

Professor of Medicine, Associate Division Chief

Indiana University

研究点 (2)

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