Reducing Post Traumatic StressNCT02144779
Family Communication and Support in the Pediatric Intensive Care Unit
A study testing Assigned to palliative care team in people with Reducing Post Traumatic Stress, run by Ross Hays at 1 site in United States.
Trial summary
This project is evaluating the effect of a standardized communication intervention in the pediatric intensive care unit (PICU) on long-term distress of family members of children in the PICU for 5 days or longer. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Reducing Post Traumatic Stress
- What is being tested?
- Assigned to palliative care team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Oct 2015
- Phase
- Interventional
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 years or older
- actively involved in the life of the patient receiving care; and
- functionally fluent in English or Spanish.
Who cannot join
- discharge plan in place for patient before day 4
- previously received palliative care
- patient placed on extracorporeal membrane oxygenation (ECMO)
- no prior admission to ICU for same hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Childrens Hospital
Seattle, Washington, 98105
About this study
Official title: Improving Family Outcomes With a Communication Intervention in the Pediatric ICU
This project is evaluating the effect of a standardized communication intervention in the pediatric intensive care unit (PICU) on long-term distress of family members of children in the PICU for 5 days or longer. The study hypothesis is that intervention families will have lower (better) acute stress disorder scores when their child is discharged from the PICU and lower (better) post-traumatic stress disorder scores at 3-month follow-up, as compared to the control group families. The investigators will recruit 220 families (110 in each of the control and intervention groups). Families who are randomized to the intervention group will receive routine visits from members of the PACT (palliative care) team at least three times/week to address psychosocial needs, keep families informed about their child's health status, and offer emotional and instrumental support and resources. Families in the control group will receive usual care in the PICU. The intervention will end whenever the child is discharged from the PICU, which usually happens within 3 weeks of enrollment. The investigators will assess family outcomes at discharge from the PICU and 90 days after study enrollment. The investigators will conduct two additional activities to learn more about the processes of care for those in both the intervention and control groups. First, during the intervention, the investigators will recruit 30 families (15 in each group) and ask permission to audio-record the family care conferences to assess communication styles and gain greater insight into the differences in practice with or without the participation of the intervention team. The investigators will obtain additional consent from participants in these family conferences who are not otherwise enrolled in the study. Second, after completion of the 3-month follow-up interview, a sub-sample of a different 30 families (again, 15 in each group) will be invited to participate in qualitative interviews to debrief about their experience in the study and the intervention (for those in that group). This will be a one-time interview scheduled within 60 days of recruitment for this part of the project.
- Conditions
- Reducing Post Traumatic Stress
- Being tested
- Assigned to palliative care team, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned to palliative care teamBehavioural
Communication and Support through the palliative care team assigned to intervention participants.
Usual CareBehavioural
usual hospital care, not assigned to palliative care team
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | No treatment for this group Receives: Behavioral: Usual Care |
| Assigned to palliative care team | Experimental | The intervention group will be assigned to a palliative care team member that will facilitate communication and meetings between families and the medical team Receives: Behavioral: Assigned to palliative care team |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Traumatic Stress Disorder
PTSD will be measures using the Post Traumatic Stress Disorder (PCL-C) scale.
Measured: 90 days after baseline
Secondary outcomes (3)
Acute Stress Disorder
Will be measured using the Acute Stress Disorder Scale
Measured: Baseline, and up to 90 days after
Communication Satisfaction
Questions will be asked about family satisfaction with provider communication.
Measured: Baseline, and up to 90 days after
Conflict
Questions will be asked about conflict with providers.
Measured: Baseline and up to 90 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startSep 2009
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Reducing Post Traumatic StressStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ross Hays
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ross Hays, Seattle Children's Hospital
- Investigators
- Ross Hays, MD, Principal investigator, Seattle Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144779
- Sponsor's protocol ID
- 1RO1NRO11179
- Status last verified
- Nov 2015
- First submitted
- 14 May 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Doorenbos A, Lindhorst T, Starks H, Aisenberg E, Curtis JR, Hays R. Palliative care in the pediatric ICU: challenges and opportunities for family-centered practice. J Soc Work End Life Palliat Care. 2012;8(4):297-315. doi: 10.1080/15524256.2012.732461.
PubMed 23194167Doorenbos AZ, Starks H, Bourget E, McMullan DM, Lewis-Newby M, Rue TC, Lindhorst T, Aisenberg E, Oman N, Curtis JR, Hays R; Seattle Ethics in ECLS (SEE) Consortium; Clark JD, Baden HP, Brogan TV, Di Gennaro JL, Mazor R, Roberts JS, Turnbull J, Wilfond BS. Examining palliative care team involvement in automatic consultations for children on extracorporeal life support in the pediatric intensive care unit. J Palliat Med. 2013 May;16(5):492-5. doi: 10.1089/jpm.2012.0536. Epub 2013 Mar 29.
PubMed 23540309Iwata M, Han S, Hays R, Doorenbos AZ. Predictors of Depression and Anxiety in Family Members 3 Months After Child's Admission to a Pediatric ICU. Am J Hosp Palliat Care. 2019 Oct;36(10):841-850. doi: 10.1177/1049909119859517. Epub 2019 Jun 30.
PubMed 31256606Starks H, Doorenbos A, Lindhorst T, Bourget E, Aisenberg E, Oman N, Rue T, Curtis JR, Hays R. The Family Communication Study: A randomized trial of prospective pediatric palliative care consultation, study methodology and perceptions of participation burden. Contemp Clin Trials. 2016 Jul;49:15-20. doi: 10.1016/j.cct.2016.05.004. Epub 2016 Jun 1.
PubMed 27263074
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Family Outcomes With a Communication Intervention in the Pediatric ICU
- ClinicalTrials.gov ID
- NCT02144779
- Acronym / sponsor ID
- 1RO1NRO11179
- Conditions
- Reducing Post Traumatic Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Ross HaysUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 May 2014 (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.
This project is evaluating the effect of a standardized communication intervention in the pediatric intensive care unit (PICU) on long-term distress of family members of children in the PICU for 5 days or longer. The study hypothesis is that intervention families will have lower (better) acute stress disorder scores when their child is discharged from the PICU and lower (better) post-traumatic stress disorder scores at 3-month follow-up, as compared to the control group families. The investigators will recruit 220 families (110 in each of the control and intervention groups). Families who are randomized to the intervention group will receive routine visits from members of the PACT (palliative care) team at least three times/week to address psychosocial needs, keep families informed about their child's health status, and offer emotional and instrumental support and resources. Families in the control group will receive usual care in the PICU. The intervention will end whenever the child is discharged from the PICU, which usually happens within 3 weeks of enrollment. The investigators will assess family outcomes at discharge from the PICU and 90 days after study enrollment. The investigators will conduct two additional activities to learn more about the processes of care for those in both the intervention and control groups. First, during the intervention, the investigators will recruit 30 families (15 in each group) and ask permission to audio-record the family care conferences to assess communication styles and gain greater insight into the differences in practice with or without the participation of the intervention team. The investigators will obtain additional consent from participants in these family conferences who are not otherwise enrolled in the study. Second, after completion of the 3-month follow-up interview, a sub-sample of a different 30 families (again, 15 in each group) will be invited to participate in qualitative interviews to debrief about their experience in the study and the intervention (for those in that group). This will be a one-time interview scheduled within 60 days of recruitment for this part of the project.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Usual CareNo treatment for this group |
| Assigned to palliative care team | Experimental | Behavioral: Assigned to palliative care teamThe intervention group will be assigned to a palliative care team member that will facilitate communication and meetings between families and the medical team |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 years or older
- actively involved in the life of the patient receiving care; and
- functionally fluent in English or Spanish.
Key exclusion criteria (4 listed)
- discharge plan in place for patient before day 4
- previously received palliative care
- patient placed on extracorporeal membrane oxygenation (ECMO)
- no prior admission to ICU for same hospitalization
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 |
|---|---|---|
| Assigned to palliative care teamCommunication and Support through the palliative care team assigned to intervention participants. | Behavioural | Assigned to palliative care team |
| Usual Careusual hospital care, not assigned to palliative care team | Behavioural | Usual care |
Primary outcome
Post Traumatic Stress Disorder
Time frame: 90 days after baseline
PTSD will be measures using the Post Traumatic Stress Disorder (PCL-C) scale.
3 secondary outcomes
Acute Stress Disorder
Time frame: Baseline, and up to 90 days after
Communication Satisfaction
Time frame: Baseline, and up to 90 days after
Conflict
Time frame: Baseline and up to 90 days after
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 20 Nov 2015.
- Background: PubMed 23194167Doorenbos A, Lindhorst T, Starks H, Aisenberg E, Curtis JR, Hays R. Palliative care in the pediatric ICU: challenges and opportunities for family-centered practice. J Soc Work End Life Palliat Care. 2012;8(4):297-315. doi: 10.1080/15524256.2012.732461.
- Background: PubMed 23540309Doorenbos AZ, Starks H, Bourget E, McMullan DM, Lewis-Newby M, Rue TC, Lindhorst T, Aisenberg E, Oman N, Curtis JR, Hays R; Seattle Ethics in ECLS (SEE) Consortium; Clark JD, Baden HP, Brogan TV, Di Gennaro JL, Mazor R, Roberts JS, Turnbull J, Wilfond BS. Examining palliative care team involvement in automatic consultations for children on extracorporeal life support in the pediatric intensive care unit. J Palliat Med. 2013 May;16(5):492-5. doi: 10.1089/jpm.2012.0536. Epub 2013 Mar 29.
- Derived from this study: PubMed 31256606Iwata M, Han S, Hays R, Doorenbos AZ. Predictors of Depression and Anxiety in Family Members 3 Months After Child's Admission to a Pediatric ICU. Am J Hosp Palliat Care. 2019 Oct;36(10):841-850. doi: 10.1177/1049909119859517. Epub 2019 Jun 30.
- Derived from this study: PubMed 27263074Starks H, Doorenbos A, Lindhorst T, Bourget E, Aisenberg E, Oman N, Rue T, Curtis JR, Hays R. The Family Communication Study: A randomized trial of prospective pediatric palliative care consultation, study methodology and perceptions of participation burden. Contemp Clin Trials. 2016 Jul;49:15-20. doi: 10.1016/j.cct.2016.05.004. Epub 2016 Jun 1.
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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.
Ross Hays, MD principal investigator
Seattle Childrens Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned to palliative care team in people with Reducing Post Traumatic Stress, run by Ross Hays 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 3 inclusion and 4 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 20 Nov 2015. 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.
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?
Post Traumatic Stress Disorder (time frame: 90 days after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02144779, which also lists 4 linked publications.
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 20 Nov 2015.