RECRUITING

A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Conditions

Grief Trauma Psychotherapy Critical Care

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2. Qualitative data will provide insights not captured by quantitative data. Hypothesis 3. Reductions in experiential avoidance will mediate reductions in grief and Post Traumatic Stress Disorder (PTSD) symptoms, highlighting it as important to target in future implementation.

Official Title

A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Quick Facts

Study Start:2022-10-11

Study Completion:2027-12-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05587517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients who, during their hospital stay, have been admitted to the ICU and are near EoL, as indicated by a modified "surprise question" whereby physicians are asked to identify patients whom they do not expect to survive the next 12 months. * Surrogate decision-makers of patients who were admitted to the ICU or step-down unit during their current admission/stay, or within 1 month of discharge from their last admission/stay. * Surrogate decision-makers are 18 years or older. * Surrogate decision-makers whom physicians or advance practice providers (i.e. physician assistants, nurse practitioners) indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts or by self-report of the surrogate. * Surrogate decision-makers must speak English. * Surrogate decision-makers must report "syndromal" levels of pre-loss grief (PG-12 score ≥ 25) or peritraumatic distress (PDI ≥ 23). * Surrogate decision makers will need to reside in a state in which an interventionist is licensed or otherwise be able to comply with current telehealth regulations. * Surrogate decision-makers will need to be willing to utilize a device (computer, tablet, phone) with internet. * Surrogate decision-makers who are able and willing to provide an emergency contact.	* Patients and surrogate decision-makers who do not meet the eligibility criteria. * Surrogate decision-makers who indicate the presence of cognitive impairment based on responses to the Ultra-Brief Confusion Assessment Method and/or significant psychiatric or cognitive disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent. * Surrogate-decision makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale. * Surrogate-decision makers who are unable to access a functional device for videoconferencing and decline the offer to use a study loner device.

Inclusion Criteria

Exclusion Criteria

* Patients who, during their hospital stay, have been admitted to the ICU and are near EoL, as indicated by a modified "surprise question" whereby physicians are asked to identify patients whom they do not expect to survive the next 12 months.
* Surrogate decision-makers of patients who were admitted to the ICU or step-down unit during their current admission/stay, or within 1 month of discharge from their last admission/stay.
* Surrogate decision-makers are 18 years or older.
* Surrogate decision-makers whom physicians or advance practice providers (i.e. physician assistants, nurse practitioners) indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts or by self-report of the surrogate.
* Surrogate decision-makers must speak English.
* Surrogate decision-makers must report "syndromal" levels of pre-loss grief (PG-12 score ≥ 25) or peritraumatic distress (PDI ≥ 23).
* Surrogate decision makers will need to reside in a state in which an interventionist is licensed or otherwise be able to comply with current telehealth regulations.
* Surrogate decision-makers will need to be willing to utilize a device (computer, tablet, phone) with internet.
* Surrogate decision-makers who are able and willing to provide an emergency contact.

* Patients and surrogate decision-makers who do not meet the eligibility criteria.
* Surrogate decision-makers who indicate the presence of cognitive impairment based on responses to the Ultra-Brief Confusion Assessment Method and/or significant psychiatric or cognitive disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent.
* Surrogate-decision makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale.
* Surrogate-decision makers who are unable to access a functional device for videoconferencing and decline the offer to use a study loner device.

Contacts and Locations

Study Contact

Holly Prigerson, PhD

CONTACT

212-746-1374

hgp2001@med.cornell.edu

Hillary Winoker, B.A.

CONTACT

646-962-7143

hiw4002@med.cornell.edu

Principal Investigator

Holly Prigerson, PhD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Wendy Lichtenthal, PhD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

United States

NewYork-Presbyterian Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

Holly Prigerson, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University
Wendy Lichtenthal, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-11

Study Completion Date2027-12-11

Study Record Updates

Study Start Date2022-10-11

Study Completion Date2027-12-11

Terms related to this study

Additional Relevant MeSH Terms

Grief
Trauma
Psychotherapy
Critical Care