The Surrogate Project (Surrogate Storytelling)

Phase 1

Completed

• Conditions: Surrogate Decision Maker, After Death of Patient
• Interventions: Behavioral: Storytelling Interview

• Registration Number: NCT01902784
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-18
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Storytelling Interview	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).

Primary Outcome Measures

Name	Time	Method
Acute referral to mental health services	2-6 weeks after patient death (during or after participation in study intervention interview)	We will assess acute risk of self-harm (or harm to others) and subsequent required referrals to mental health crisis services in participants throughout the intervention interview. Trained clinicians conducting interviews will refer when needed and record the number of participants requiring this service.; Less than 5% of participants requiring an acute mental health crisis referral will be considered acceptable and an indicator of study safety.

Secondary Outcome Measures

Name	Time	Method
Burdensomeness of participation	6 months (end of study participation)	We will ask participants to report how burdensome they felt participation in this study was for them by asking whether they Strongly Agree, Agree, Neither agree nor disagree, Disagree, or Strongly disagree with this statement: "Participating in this study was burdensome."; 10% or fewer participants reporting that the study was burdensome, with a response of 'Strongly Agree' or 'Agree' will be considered successful and an indicator of study acceptability.
Research approach rates (participant interest)	start of recruitment - 6 months	We will record the number of eligible surrogate decision makers who agree to be approached by a study staff member to hear about this research project, when asked by a member of their patient's clinical team. These counts will be summarized to assess a percentage and rate of eligible surrogates who agree to research approach among those who are eligible.
Participation regret	6 months (end of study participation)	We will ask participants to report if they regret participation in this study by asking whether they Strongly Agree, Agree, Neither agree nor disagree, Disagree, or Strongly disagree with this statement: "I wish I hadn't agreed to participate in the study."; 10% or fewer participants reporting that they regret their participation in this study, with a response of 'Strongly Agree' or 'Agree' will be considered successful and an indicator of study acceptability.
enrollment rate	start of recruitment - end of study	We will assess enrollment rate by recording the number of eligible participants who consent to participate and do participate in the intervention or control. The rate of enrollment will compare the number in this consented, participating group with the overall number of eligible participants encountered.; We will consider an enrollment rate greater than 60% to be successful and an indicator of study feasibility.
follow up questionnaire completion	6 months +/- 18 days	We will record the number of participants who complete the 6-month follow up questionnaire.; A completion rate of 70% or greater will be considered successful and an indicator of study feasibility.
completion of intervention session	2 - 6 weeks after patient death	We will record the number of eligible participants randomly assigned to the intervention session who complete the intervention session. We will calculate a rate of completion for the intervention session.; A completion rate of 80% or greater will be considered successful and an indicator of study feasibility.
Randomization	2- 6 weeks after patient death	We will randomize participants who consent to participation in the 2nd portion of the study, after completion of a baseline questionnaire. Eligible participants will be randomized with equal numbers of participants in the intervention and control groups.; Randomization of 30 eligible participants to the intervention group and 30 to the control will be considered successful and an indicator of study feasibility.
Experience of participation	6 months (end of study participation)	We will ask participants to report their experience of study participation by asking them, "How did participation in this study make you feel?" Five (5) answer choices will be given: Much better, Better, Neither better nor worse, Worse, or Much worse.; 10% or fewer participants reporting that the study made them feel 'Worse' or 'Much Worse' will be considered successful and an indicator of study acceptability.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States