Surrogate Decision Maker, After Death of PatientPhase 1/2NCT01902784
The Surrogate Project (Surrogate Storytelling)
A Phase 1/2 study testing Storytelling Interview in people with Surrogate Decision Maker, After Death of Patient, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surrogate Decision Maker, After Death of Patient
- What is being tested?
- Storytelling Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Nov 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Screening/Re-contact
- Ineligible patients will:
- be less than 18 years old
- prisoners
- be of other legal concern, such as malpractice
- Ineligible surrogates will:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Surrogate Project - Aim 2: Pilot Randomized Controlled Trial
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.
- Being tested
- Storytelling Interview
- Keywords
- Intensive Care Unit patients and families, Surrogate decision making, Life Sustaining Treatments (LST)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storytelling InterviewBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Storytelling Interview |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-6 weeks after patient death (during or after participation in study intervention interview)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months +/- 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surrogate Decision Maker, After Death of PatientStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Amber Barnato, MD, MPH, MS, University of Pittsburgh
- Investigators
- Amber E Barnato, MD MPH MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902784
- Sponsor's protocol ID
- PRO13040209
- Status last verified
- Jun 2017
- First submitted
- 16 Jul 2013
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surrogate Project - Aim 2: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01902784
- Acronym / sponsor ID
- PRO13040209
- Keywords
- Intensive Care Unit patients and families, Surrogate decision making, Life Sustaining Treatments (LST)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Jun 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Storytelling Interview | Experimental | Behavioral: Storytelling InterviewParticipants 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). |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Screening/Re-contact (1st phase)
- Eligible patients 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
Key exclusion criteria (12 listed)
- Screening/Re-contact
- Ineligible patients will:
- Ineligible surrogates will:
- For Assignment to Intervention/Control
- have fully and permanently regained decision-making capacity and therefore no longer require a surrogate to make treatment decisions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Storytelling Interview | Behavioural | Storytelling Interview |
Primary outcome
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.
9 secondary outcomes
Research approach rates (participant interest)
Time frame: start of recruitment - 6 months
Randomization
Time frame: 2- 6 weeks after patient death
Experience of participation
Time frame: 6 months (end of study participation)
Burdensomeness of participation
Time frame: 6 months (end of study participation)
Participation regret
Time frame: 6 months (end of study participation)
enrollment rate
Time frame: start of recruitment - end of study
completion of intervention session
Time frame: 2 - 6 weeks after patient death
follow up questionnaire completion
Time frame: 3 months +/- 9 days
follow up questionnaire completion
Time frame: 6 months +/- 18 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber E Barnato, MD MPH MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Storytelling Interview in people with Surrogate Decision Maker, After Death of Patient, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute referral to mental health services (time frame: 2-6 weeks after patient death (during or after participation in study intervention interview)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.