The Surrogate Project (Surrogate Storytelling)

Study Overview
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Brief Summary
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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.

Official Title
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Surrogate Project - Aim 2: Pilot Randomized Controlled Trial

Conditions
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Surrogate Decision Maker, After Death of Patient

Intervention / Treatment
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* Behavioral: Storytelling Interview


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Storytelling Interview<br>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). | Behavioral: Storytelling Interview<br> <br> |
| No Intervention: Monitoring of well-being<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute referral to mental health services | 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. | 2-6 weeks after patient death (during or after participation in study intervention interview) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Research approach rates (participant interest) | 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. | start of recruitment - 6 months | 
| Randomization | 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. | 2- 6 weeks after patient death | 
| Experience of 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. | 6 months (end of study participation) | 
| Burdensomeness of 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. | 6 months (end of study participation) | 
| Participation regret | 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. | 6 months (end of study participation) | 
| enrollment rate | 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. | start of recruitment - end of study | 
| completion of intervention session | 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. | 2 - 6 weeks after patient death | 
| follow up questionnaire completion | We will record the number of participants who complete the 3-month follow up questionnaire. A completion rate of 80% or greater will be considered successful and an indicator of study feasibility. | 3 months +/- 9 days | 
| follow up questionnaire completion | 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. | 6 months +/- 18 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Unit patients and families, Surrogate decision making, Life Sustaining Treatments (LST)