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The Surrogate Project (Surrogate Storytelling)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01902784
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : June 15, 2017
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Amber Barnato, MD, MPH, MS, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE July 16, 2013
First Posted Date  ICMJE July 18, 2013
Last Update Posted Date June 15, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
Acute referral to mental health services [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2013)
  • Research approach rates (participant interest) [ Time Frame: 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.
  • Randomization [ Time Frame: 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 [ Time Frame: 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.
  • Burdensomeness of participation [ Time Frame: 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.
  • Participation regret [ Time Frame: 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 [ Time Frame: 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.
  • completion of intervention session [ Time Frame: 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.
  • follow up questionnaire completion [ Time Frame: 3 months +/- 9 days ]
    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.
  • follow up questionnaire completion [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 16, 2013)
  • Limit missing data [ Time Frame: throughout study ]
    We will assess rates of missing data throughout data collection. A rate of 5% or lower missing data will be considered acceptable.
  • Participant distress after traumatic life event [ Time Frame: 2-4 weeks after patient death (baseline questionnaire) ]
    We will summarize range and distribution of participant distress after a traumatic life event with the Impact of Events Scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.
  • Participant distress after traumatic life event [ Time Frame: 3 months after patient death ]
    We will summarize range and distribution of participant distress after a traumatic life event with the Impact of Events Scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.
  • Participant distress after traumatic life event [ Time Frame: 6 months after patient death ]
    We will summarize range and distribution of participant distress after a traumatic life event with the Impact of Events Scale. Because this is a pilot trial, we will not conduct formal tests of efficacy.
  • Participant anxiety symptoms [ Time Frame: 2-4 weeks after patient death (baseline questionnaire) ]
    We will summarize range and distribution of participant anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS). Because this is a pilot trial, we will not conduct formal tests of efficacy.
  • Participant anxiety symptoms [ Time Frame: 3 months after patient death ]
    We will summarize range and distribution of participant anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS). Because this is a pilot trial, we will not conduct formal tests of efficacy.
  • Participant anxiety symptoms [ Time Frame: 6 months after patient death ]
    We will summarize range and distribution of participant anxiety symptoms with the Hospital Anxiety and Depression Scale (HADS). Because this is a pilot trial, we will not conduct formal tests of efficacy.
  • Participant depression symptoms [ Time Frame: 2-4 weeks after patient death (baseline questionnaire) ]
    We will summarize range and distribution of participant depression symptoms with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9). Because this is a pilot trial, we will not conduct formal tests of efficacy.
  • Participant depression symptoms [ Time Frame: 3 months after patient death ]
    We will summarize range and distribution of participant depression symptoms with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9). Because this is a pilot trial, we will not conduct formal tests of efficacy.
  • Participant depression symptoms [ Time Frame: 6 months after patient death ]
    We will summarize range and distribution of participant depression symptoms with the Hospital Anxiety and Depression Scale (HADS) and the Primary Care Evaluation of Mental Disorders: Patient Health Questionnaire (PRIME-MD PHQ-9). Because this is a pilot trial, we will not conduct formal tests of efficacy.
  • Complicated grief symptoms [ Time Frame: 6 months (+/- 3 weeks) after patient death ]
    We will assess whether surrogate participants are experiencing symptoms of complicated grief through administration of the Inventory of Complicated Grief during the final follow-up questionnaire at 6 months. Responses will be summarized to better understand how this population may be experiencing symptoms of complicated grief.
  • Subjective Units of Distress [ Time Frame: 2-6 weeks after patient death (during & after completion of study intervention interview) ]
    We will ask participants to rate their present level of distress with the Subjective Units of Distress Scale (SUDS) based on a scale of 0-100, where 0 is absolutely calm and 100 is the worst distress imaginable, during and after their participation in the study intervention interview. Less than 20% of participants experiencing very high levels of distress (SUDS > 70) after the interview will be considered successful and an indicator of acceptable safety. Note: This is a projected level of acceptability with a subjective measure. Our multidisciplinary team will continue to evaluate the safety of participation throughout study.
  • Decision regret [ Time Frame: 6 months (+/- 3 weeks) after patient death ]
    We will assess whether surrogate participants are experiencing regret over their decisions in the Intensive Care Unit (ICU) for their deceased loved one through administration of the Decision Regret Scale during the final follow-up questionnaire at 6 months. Responses will be summarized to better understand how this population may be experiencing symptoms of complicated grief.
  • Decision regret [ Time Frame: 3 months (+/- 3 weeks) after patient death ]
    We will assess whether surrogate participants are experiencing regret over their decisions in the Intensive Care Unit (ICU) for their deceased loved one through administration of the Decision Regret Scale. Responses will be summarized to better understand how this population may be experiencing symptoms of complicated grief.
  • Decision regret [ Time Frame: 2-4 weeks after patient death (baseline questionnaire) ]
    We will assess whether surrogate participants are experiencing regret over their decisions in the Intensive Care Unit (ICU) for their deceased loved one through administration of the Decision Regret Scale. Responses will be summarized to better understand how this population may be experiencing symptoms of complicated grief.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Surrogate Project (Surrogate Storytelling)
Official Title  ICMJE Surrogate Project - Aim 2: Pilot Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Surrogate Decision Maker, After Death of Patient
Intervention  ICMJE Behavioral: Storytelling Interview
Study Arms  ICMJE
  • Experimental: 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).

    Intervention: Behavioral: Storytelling Interview
  • No Intervention: Monitoring of well-being
    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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2014)
115
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2013)
300
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01902784
Other Study ID Numbers  ICMJE PRO13040209
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amber Barnato, MD, MPH, MS, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Icahn School of Medicine at Mount Sinai
Investigators  ICMJE
Principal Investigator: Amber E Barnato, MD MPH MS University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP