The Surrogate Project (Surrogate Storytelling)

Phase 2CompletedNCT01902784

University of Pittsburgh115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

115

Conditions

Surrogate Decision Maker, After Death of Patient

Interventions

Storytelling InterviewBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 2-6 weeks after patient death (during or after participation in study intervention interview)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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