Clinical trial NCT01902784: The Surrogate Project (Surrogate Storytelling)
Official title: Surrogate Project - Aim 2: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Surrogate Decision Maker, After Death of Patient
Keywords: Intensive Care Unit patients and families
Surrogate decision making
Life Sustaining Treatments (LST)
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2013-07-18
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Acute referral to mental health services
timeFrame: 2-6 weeks after patient death (during or after participation in study intervention interview)
Secondary outcomes:
measure: Research approach rates (participant interest)
timeFrame: start of recruitment - 6 months
measure: Randomization
timeFrame: 2- 6 weeks after patient death
measure: Experience of participation
timeFrame: 6 months (end of study participation)
measure: Burdensomeness of participation
timeFrame: 6 months (end of study participation)
measure: Participation regret
timeFrame: 6 months (end of study participation)
measure: enrollment rate
timeFrame: start of recruitment - end of study
measure: completion of intervention session
timeFrame: 2 - 6 weeks after patient death
measure: follow up questionnaire completion
timeFrame: 3 months +/- 9 days
measure: follow up questionnaire completion
timeFrame: 6 months +/- 18 days
Other outcomes:
measure: Limit missing data
timeFrame: throughout study
measure: Participant distress after traumatic life event
timeFrame: 2-4 weeks after patient death (baseline questionnaire)
measure: Participant distress after traumatic life event
timeFrame: 3 months after patient death
measure: Participant distress after traumatic life event
timeFrame: 6 months after patient death
measure: Participant anxiety symptoms
timeFrame: 2-4 weeks after patient death (baseline questionnaire)
measure: Participant anxiety symptoms
timeFrame: 3 months after patient death
measure: Participant anxiety symptoms
timeFrame: 6 months after patient death
measure: Participant depression symptoms
timeFrame: 2-4 weeks after patient death (baseline questionnaire)
measure: Participant depression symptoms
timeFrame: 3 months after patient death
measure: Participant depression symptoms
timeFrame: 6 months after patient death
measure: Complicated grief symptoms
timeFrame: 6 months (+/- 3 weeks) after patient death
measure: Subjective Units of Distress
timeFrame: 2-6 weeks after patient death (during & after completion of study intervention interview)
measure: Decision regret
timeFrame: 6 months (+/- 3 weeks) after patient death
measure: Decision regret
timeFrame: 3 months (+/- 3 weeks) after patient death
measure: Decision regret
timeFrame: 2-4 weeks after patient death (baseline questionnaire)
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Amber E Barnato, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References: