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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Storytelling Interview | Experimental | 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). |
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| Monitoring of well-being | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Storytelling Interview | Behavioral |
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| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Limit missing data | We will assess rates of missing data throughout data collection. A rate of 5% or lower missing data will be considered acceptable. | throughout study |
| Participant distress after traumatic life event |
Inclusion Criteria:
Screening/Re-contact (1st phase)
Eligible patients will:
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
For Assignment to Intervention/Control (2nd phase)
Eligible surrogates will:
Exclusion Criteria:
Screening/Re-contact
Ineligible patients will:
Ineligible surrogates will:
For Assignment to Intervention/Control
Ineligible patients will:
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| Name | Affiliation | Role |
|---|---|---|
| Amber E Barnato, MD MPH MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| 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 |
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.
| 2-4 weeks after patient death (baseline questionnaire) |
| Participant distress after traumatic life event | 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. | 3 months after patient death |
| Participant distress after traumatic life event | 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. | 6 months after patient death |
| Participant anxiety symptoms | 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. | 2-4 weeks after patient death (baseline questionnaire) |
| Participant anxiety symptoms | 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. | 3 months after patient death |
| Participant anxiety symptoms | 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. | 6 months after patient death |
| Participant depression symptoms | 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. | 2-4 weeks after patient death (baseline questionnaire) |
| Participant depression symptoms | 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. | 3 months after patient death |
| Participant depression symptoms | 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. | 6 months after patient death |
| Complicated grief symptoms | 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. | 6 months (+/- 3 weeks) after patient death |
| Subjective Units of Distress | 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. | 2-6 weeks after patient death (during & after completion of study intervention interview) |
| Decision regret | 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. | 6 months (+/- 3 weeks) after patient death |
| Decision regret | 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. | 3 months (+/- 3 weeks) after patient death |
| Decision regret | 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. | 2-4 weeks after patient death (baseline questionnaire) |