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The Surrogate Project (Surrogate Storytelling)

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University of Pittsburgh

Status and phase

Completed
Phase 2
Phase 1

Conditions

Surrogate Decision Maker, After Death of Patient

Treatments

Behavioral: Storytelling Interview

Study type

Interventional

Funder types

Other

Identifiers

NCT01902784
PRO13040209

Details and patient eligibility

About

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.

Enrollment

115 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

115 participants in 2 patient groups

Storytelling Interview
Experimental group
Description:
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).
Treatment:
Behavioral: Storytelling Interview
Monitoring of well-being
No Intervention group
Description:
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).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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