The Surrogate Project (Surrogate Storytelling)

NCT ID: NCT01902784

Last Updated: 2017-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-11-30

Brief Summary

Research Protocol Abstract:

This is a phase II controlled trial (RCT) of a "storytelling" intervention compared to no treatment among surrogates who have participated in a decision to limit life-sustaining treatment in the ICU for an incapacitated loved one. Subjects will be sequentially assigned to "storytelling" (a facilitated elicitation of the experience 2-4 weeks after bereavement) or no treatment with follow up "monitoring of well-being". Subjects will receive print bereavement brochures at 1 week, and undergo telephone symptom assessment at 2-weeks, 3-months, and 6-months after bereavement.

Conditions

Surrogate Decision Maker, After Death of Patient

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Storytelling Interview

Participants assigned to receive the intervention will participate in an interview with a trained interventionist who will facilitate the telling of their 'story' - the personal experience they went through as a surrogate decision-maker for a loved one in the intensive care unit (ICU), who subsequently died after decisions were made to limit life-sustaining treatments (LST).

These participants will be evaluated with questionnaires at baseline, 3 months, and 6 months after the death of their loved one (ICU patient).

Group Type: EXPERIMENTAL

Storytelling Interview

Intervention Type: BEHAVIORAL

Monitoring of well-being

Participants assigned to the Monitoring of well-being group will receive follow up phone calls from study staff and be evaluated with questionnaires at baseline, 3 months, and 6 months after the death of their loved one (ICU patient).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Storytelling Interview

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Screening/Re-contact (1st phase)

• Eligible patients will:

• lack decision-making capacity
• have a surrogate decision maker (family member or friend)

Eligible surrogates will:

• be 18 years of age or older
• self-identify as having primary decision-making authority for the patient
• live within approximately 50miles or less of the University of Pittsburgh
• be able to conduct a 1hr interview in English

• Court-appointed power of attorney will be excluded, as they are not expected to experience the same emotional distress as a family member or friend of a critically ill patient.

For Assignment to Intervention/Control (2nd phase)

• Eligible surrogates will:

• have previously given consent for study staff to follow their loved one's course in the hospital and to be re-contacted
• have participated in decision making about limitation of life-sustaining treatments (LST) for their loved one (ICU patient)
• have had their loved one (ICU patient) die in the hospital

Exclusion Criteria

Screening/Re-contact

• Ineligible patients will:

• be less than 18 years old
• prisoners
• be of other legal concern, such as malpractice
• Ineligible surrogates will:

• be less than 18 years old
• be unable to complete a 1-hour interview and questionnaires in English
• For Assignment to Intervention/Control

Ineligible patients will:

• have fully and permanently regained decision-making capacity and therefore no longer require a surrogate to make treatment decisions
• be discharged from hospital alive

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Amber Barnato, MD, MPH, MS

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amber E Barnato, MD MPH MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO13040209

Identifier Type: -

Identifier Source: org_study_id