Critical IllnessCCINCT02146573
Pediatric Continuity Care Intensivist
A study testing Continuity Care Intensivist Communication Training and Continuity Care Intensivist (CCI) Provider Program in people with Critical Illness, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study will implement and evaluate the effects of a pediatric continuity care intensivist program. This study will determine the impact of an additional pediatric intensive care unit (PICU) intensivist on outcomes at the patient and family level. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- What is being tested?
- Continuity Care Intensivist Communication Training and Continuity Care Intensivist (CCI) Provider Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- CCI Provider
- 1. Pediatric Intensive Care Unit Attending Physician who volunteers to serve in the role of CCI.
- Usual Care (UC) Provider
- 1. Any Pediatric Intensive Care Unit Attending Physician who is not enrolled as a CCI.
- Parent-Patient Dyads
- Parent/guardian of a child who has been admitted to the Children's Hospital of Philadelphia (CHOP) PICU for ≥7 days after onset of the study
Show all 11Show fewer
- Parent/guardian ≥ 18 years old
- Parent/guardian is English-speaking
- Child <18 years old at time of enrollment
- Child has been admitted to the PICU at CHOP for ≥7 days
- Medical team believed that patient will remain in the PICU for at least another seven days
Who cannot join
- CCI Provider
- 1. Any medical care provider who is not an attending physician (e.g., Pediatric critical care residents, nurses, and fellows)
- UC Provider
- Any medical care provider who is not an attending physician (e.g., Pediatric critical care residents, nurses, and fellows)
- Attending physician who is enrolled in the study as a CCI
- Parent-Patient Dyads
Show all 14Show fewer
- Parent or guardian who has previously participated in the CCI study in a previous hospitalization (in either usual care or intervention arm)
- Parent or guardian of a child who has already been hospitalized in the PICU >7 days at the onset of the study.
- Child ≥18 years of age at time of enrollment
- Child has previously participated in the CCI study in a previous PICU stay (in either usual care or intervention arm)
- Child has been hospitalized in the PICU >7 days at the onset of the study
- Child already has a "primary" attending
- Child has a sibling that has already been enrolled in the study. This child will be ineligible for the study but will be assigned to the same care as the child who is or was enrolled in the study.
- If contact was not established for enrollment by 14 days after admission, then the patient was no longer considered eligible for enrollment to maintain comparability of length of stay at enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pediatric Continuity Care Intensivist: Role Implementation and Randomized Control Trial
This study will implement and evaluate the effects of a pediatric continuity care intensivist program. This study will determine the impact of an additional pediatric intensive care unit (PICU) intensivist on outcomes at the patient and family level. It will also evaluate the training program to prepare the continuity care intensivist (CCI).
Read the detailed description
This randomized controlled trial will implement and evaluate the effects of a pediatric continuity care intensivist (CCI) program. The study will evaluate how effective the modified communication training for providers is to perform this new role. The primary outcome for the study is whether a CCI will affect several patient level outcomes for patients who have been admitted to the PICU longer than 7 days. Patient length of stay, hospital acquired conditions, time to limitations of interventions and new medical technology will be assessed comparing the intervention and usual care arms. The study will also determine the impact of the CCI program on parent/family satisfaction with provider communication and decision-making for their child.
- Conditions
- Critical Illness
- Being tested
- Continuity Care Intensivist Communication Training, Continuity Care Intensivist (CCI) Provider Program
- Keywords
- Intensive Care Units, Pediatric, Communication, Health personnel, Decision making, Critical Care, Length of Stay, Iatrogenic Disease
- Medical subject headings
- Critical Illness, Communication, Iatrogenic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuity Care Intensivist Communication TrainingBehavioural
Also called CCI Communication Training
Physicians enrolled in the intervention arm will complete a two to three part communication training. Survey measures of communication competency and burnout will be administered at baseline, after training, and at the end of the study. After the communication training, physicians will undergo an OSCE assessment with a simulated patient to evaluate communication skills. At the end of the study, CCI providers will receive surveys that assess the experience and challenges of the role, repeat surveys assessing competency with communication and frequency of engaging families in goals of care conversations, in addition to a follow-up focus group that will assess their experience with the intervention, the time required and the potential tradeoffs in other duties required by them to participate as a CCI.
Continuity Care Intensivist (CCI) Provider ProgramBehavioural
Also called CCI Provider
After undergoing CCI training, CCI providers will fulfill a standardized role with parent-patient dyads:
- CCI will meet with families on a regular basis and at change of physician of record throughout their entire PICU hospitalization.
- Help patients/families navigate decisions in concert with preferences and beliefs
- Help patients/families and other care providers look at "bigger picture"; trajectory of illness, goals, and hopes for the patient.
- Serve as point person for active intensivists on service and other specialists
- Help resolve conflict when multiple providers have different opinions on course of action
| Study group | Role | What they receive |
|---|---|---|
| CCI Provider for Parent-patient dyad | Experimental | Parents and patients are randomly assigned to a Continuity Care Intensivist (CCI) Provider who has received specialized communication training. The parent-patient dyad will receive standardized care from the CCI throughout their time in the PICU in addition to being assigned a rotating physician of record. Receives: Behavioral: Continuity Care Intensivist Communication Training; Behavioral: Continuity Care Intensivist (CCI) Provider Program |
| Usual Care for Parent-patient dyad | No intervention | Patients and parents randomly assigned to usual care in the PICU which includes the rotation of the physician of record approximately every 7 days. There is no standardized process by which patients may be assigned a primary attending who would follow them throughout their stay. In the usual care arm it may never happen that they are assigned a primary intensivist, regardless of the length of their hospitalization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in patient length of stay in the PICU between usual care and intervention arm
Length of stay as measured by the Virtual PICU system (VPS) in the PICU.
Measured: up to 600 days
Secondary outcomes (26)
Difference in number of new technological dependence patients acquire during hospitalization between usual care and intervention arms
We will measure new technology dependence like tracheostomy, gastrostomy tube, long term ventilation, bipap using VPS during the PICU hospitalization.
Measured: up to 600 days
Difference in patient hospital-acquired conditions between usual care and intervention arm
Using VPS, investigators will track hospital acquired infections like catheter associated urinary tract infections and ventilator associated pneumonias
Measured: up to 600 days
Difference in patient length of time on sedation medicines between usual care and intervention arm
Investigators will track the length of time on sedation medications used during intubations and when there is other medical equipment like chest tubes that it is not safe for patients to be moving. These medications include midazolam and fentanyl among others.
Measured: up to 600 days
Difference in patients' new or progressive multiple organ dysfunction syndrome between usual care and intervention arm
Investigators will use the VPS designation of multiple organ dysfunction syndrome to characterize system failures like respiratory, renal, cardiac failure.
Measured: up to 600 days
Difference in patient organ failure free days between usual care and intervention arm
Investigators will use the VPS designation of organ failure for systems like renal, respiratory and cardiac.
Measured: up to 600 days
Difference in patient ventilator free days between usual care and intervention arm
Investigators will use the VPS designation for days up to 90 that the patient remains off of mechanical ventilation.
Measured: up to 600 days
Difference in change in parent preferences for shared decision-making from baseline to patient discharge between usual care and intervention arm
A decision-analysis method will be used to administer and measure parental preferences for shared decision-making. Validation of the measure is completed but not yet published by the principal investigator.
Measured: baseline, up to 600 days
Difference in change in parent preferences for control in decision-making from baseline to patient discharge between usual care and intervention arm
The Control Preferences Scale for Pediatrics (CPS-P), a validated tool, will be used to measure parent's preferences for control in decision-making.
Measured: baseline, up to 600 days
Affects of Parent attachment style on communication preferences
The Relationship Questionnaire, a validated measure, will be used to measure parent relationship style, which is based on attachment theory.
Measured: baseline
Difference in change in parental levels of anxiety and depression from baseline to patient discharge between usual care and intervention arm
Parental levels of hospital anxiety and depression will be measured using the Hospital Anxiety and Depression scale (HADS).
Measured: baseline, up to 600 days
Difference in change in parental levels of positive and negative affect from baseline to patient discharge between usual care and intervention arm
Parental levels of positive and negative affect will be measured using the Positive and Negative Affect Scale (PANAS), a validated tool.
Measured: baseline, up to 600 days
Difference in change in parental levels of anger from baseline to patient discharge between usual care and intervention arm
Parent levels of anger will be measured using PROMIS bank v1.1- Anger scale.
Measured: baseline, up to 600 days
Difference in change in parental levels of hope from baseline to patient discharge between usual care and intervention arm
Parental levels of hope will be measured using the Hope Scale, a validated tool.
Measured: baseline, up to 600 days
Difference in change in Parent/family satisfaction with decision-making from baseline to patient discharge between usual care and intervention arm
Parent satisfaction with decision-making will measured through several question items designed to assess parent satisfaction with making decisions during their child's PICU visit. This measure was developed through extensive literature review and has been evaluated for face validity through cognitive interviewing and pilot testing with parents and families of children admitted to the ICU.
Measured: baseline, up to 600 days
Difference in parent/family satisfaction with communication with their child's PICU physicians between usual care and intervention arm
The Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU), a validated tool, will be used to measure parent satisfaction with communication with their child's PICU physician.
Measured: up to 600 days
Difference in change in parent self-report of medical communication competence from baseline to patient discharge between usual care and intervention arm
The Medical Communication Competence Scale, a partially validated tool, will be used to measure parent self-reported competency with communication.
Measured: baseline, up to 600 days
Difference in change in parent assessment of physician communication competency from baseline to patient discharge between usual care and intervention arm
The Communication Assessment Tool (CAT), a validated tool, will be used to measure parent perceptions of physician competence in interpersonal and communication skills.
Measured: baseline, up to 600 days
Comparison of physician burnout between intervention and control group from baseline up to 600 days
The Maslach Stress and Burnout Inventory, a validated tool, will be used to measure the three aspects of the burnout syndrome: emotional exhaustion, depersonalization, and lack of personal accomplishment.
Measured: baseline, up to 600 days
Physician satisfaction with the communication training and with the CCI experience.
Questions written for this study that have been written and piloted will assess the physicians' satisfaction and perceived usefulness of the communication training.
Measured: up to 600 days
Evaluation of CCI provider experience in role of CCI and its feasibility of larger implementation
Both open ended survey questions and focus groups will be qualitatively analyzed to determine the benefits and burdens for providers of serving in the CCI role.
Measured: up to 600 days
Comparison of physician comfort with end-of-life communication between intervention and control group from baseline up to 600 days
Physician comfort with end-of-life communication will be measured through several question items developed to assess how physicians feel about engaging in end of life discussions. The measure was developed through extensive literature review and has been evaluated for face validity through cognitive interviewing and pilot testing with PICU physicians.
Measured: baseline, up to 600 days
Difference in timing of patient's limitations of interventions to death between usual care and intervention arm
As measured by a chart review of timing of limitations of interventions including do not resuscitate (DNR)/ do not intubate (DNI) and other limitations like no escalation of care will be described and the time to event of death will be compared.
Measured: up to 600 days
Frequency of palliative care consultation between usual care and intervention arm
Medical chart review to determine request for and consultation performed by Pediatric Advanced Care Team (palliative care consultation service) will be measured and compared.
Measured: up to 600 days
Physician competency in communication with families via objective structured clinical examination (OSCE) evaluation
CCI providers will be evaluated using a simulated patient and scored using a validated tool for communication skills including empathy in an encounter in the end-of-life setting.
Measured: up to 600 days
Comparison of physician self-reported communication competency between intervention and control group
The Medical Communication Competence Scale, a partially validated measure will be used to assess physician self-reported competency.
Measured: baseline, up to 600 days
Correlation between amount of CCI contact and parent and patient level outcomes
Investigators will categorize the extent of CCI contact and then determine if there is a correlation between amount of contact and parent and patient level outcomes.
Measured: baseline, up to 600 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer K Walter, MD, PhD, MS, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146573
- Sponsor's protocol ID
- IRB 14-010987
- Acronym
- CCI
- Status last verified
- Sep 2020
- First submitted
- 19 May 2014
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Board R, Ryan-Wenger N. Long-term effects of pediatric intensive care unit hospitalization on families with young children. Heart Lung. 2002 Jan-Feb;31(1):53-66. doi: 10.1067/mhl.2002.121246.
PubMed 11805751Balluffi A, Kassam-Adams N, Kazak A, Tucker M, Dominguez T, Helfaer M. Traumatic stress in parents of children admitted to the pediatric intensive care unit. Pediatr Crit Care Med. 2004 Nov;5(6):547-53. doi: 10.1097/01.PCC.0000137354.19807.44.
PubMed 15530191Needle JS, O'Riordan M, Smith PG. Parental anxiety and medical comprehension within 24 hrs of a child's admission to the pediatric intensive care unit*. Pediatr Crit Care Med. 2009 Nov;10(6):668-74; quiz 674. doi: 10.1097/PCC.0b013e3181a706c9.
PubMed 19451843Pochard F, Darmon M, Fassier T, Bollaert PE, Cheval C, Coloigner M, Merouani A, Moulront S, Pigne E, Pingat J, Zahar JR, Schlemmer B, Azoulay E; French FAMIREA study group. Symptoms of anxiety and depression in family members of intensive care unit patients before discharge or death. A prospective multicenter study. J Crit Care. 2005 Mar;20(1):90-6. doi: 10.1016/j.jcrc.2004.11.004.
PubMed 16015522Fauman KR, Pituch KJ, Han YY, Niedner MF, Reske J, LeVine AM. Predictors of depressive symptoms in parents of chronically ill children admitted to the pediatric intensive care unit. Am J Hosp Palliat Care. 2011 Dec;28(8):556-63. doi: 10.1177/1049909111403465. Epub 2011 Mar 30.
PubMed 21454321Nuss SL, Hinds PS, LaFond DA. Collaborative clinical research on end-of-life care in pediatric oncology. Semin Oncol Nurs. 2005 May;21(2):125-34; discussion 134-44. doi: 10.1016/j.soncn.2004.12.011.
PubMed 15991662Diaz-Caneja A, Gledhill J, Weaver T, Nadel S, Garralda E. A child's admission to hospital: a qualitative study examining the experiences of parents. Intensive Care Med. 2005 Sep;31(9):1248-54. doi: 10.1007/s00134-005-2728-8. Epub 2005 Jul 15.
PubMed 16021417Colville G, Darkins J, Hesketh J, Bennett V, Alcock J, Noyes J. The impact on parents of a child's admission to intensive care: integration of qualitative findings from a cross-sectional study. Intensive Crit Care Nurs. 2009 Apr;25(2):72-9. doi: 10.1016/j.iccn.2008.10.002. Epub 2008 Nov 18.
PubMed 19019677Back AL, Arnold RM, Baile WF, Fryer-Edwards KA, Alexander SC, Barley GE, Gooley TA, Tulsky JA. Efficacy of communication skills training for giving bad news and discussing transitions to palliative care. Arch Intern Med. 2007 Mar 12;167(5):453-60. doi: 10.1001/archinte.167.5.453.
PubMed 17353492Davidson JE, Powers K, Hedayat KM, Tieszen M, Kon AA, Shepard E, Spuhler V, Todres ID, Levy M, Barr J, Ghandi R, Hirsch G, Armstrong D; American College of Critical Care Medicine Task Force 2004-2005, Society of Critical Care Medicine. Clinical practice guidelines for support of the family in the patient-centered intensive care unit: American College of Critical Care Medicine Task Force 2004-2005. Crit Care Med. 2007 Feb;35(2):605-22. doi: 10.1097/01.CCM.0000254067.14607.EB.
PubMed 17205007Namachivayam P, Shann F, Shekerdemian L, Taylor A, van Sloten I, Delzoppo C, Daffey C, Butt W. Three decades of pediatric intensive care: Who was admitted, what happened in intensive care, and what happened afterward. Pediatr Crit Care Med. 2010 Sep;11(5):549-55. doi: 10.1097/PCC.0b013e3181ce7427.
PubMed 20124947Feudtner C, Christakis DA, Connell FA. Pediatric deaths attributable to complex chronic conditions: a population-based study of Washington State, 1980-1997. Pediatrics. 2000 Jul;106(1 Pt 2):205-9.
PubMed 10888693Azoulay E, Pochard F, Chevret S, Lemaire F, Mokhtari M, Le Gall JR, Dhainaut JF, Schlemmer B; French FAMIREA Group. Meeting the needs of intensive care unit patient families: a multicenter study. Am J Respir Crit Care Med. 2001 Jan;163(1):135-9. doi: 10.1164/ajrccm.163.1.2005117.
PubMed 11208638Johnson D, Wilson M, Cavanaugh B, Bryden C, Gudmundson D, Moodley O. Measuring the ability to meet family needs in an intensive care unit. Crit Care Med. 1998 Feb;26(2):266-71. doi: 10.1097/00003246-199802000-00023.
PubMed 9468163Curtis JR, Ciechanowski PS, Downey L, Gold J, Nielsen EL, Shannon SE, Treece PD, Young JP, Engelberg RA. Development and evaluation of an interprofessional communication intervention to improve family outcomes in the ICU. Contemp Clin Trials. 2012 Nov;33(6):1245-54. doi: 10.1016/j.cct.2012.06.010. Epub 2012 Jul 6.
PubMed 22772089
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Continuity Care Intensivist: Role Implementation and Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02146573
- Acronym / sponsor ID
- CCI / IRB 14-010987
- Conditions
- Critical Illness
- Keywords
- Intensive Care Units, Pediatric, Communication, Health personnel, Decision making, Critical Care, Length of Stay, Iatrogenic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 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 study will implement and evaluate the effects of a pediatric continuity care intensivist program. This study will determine the impact of an additional pediatric intensive care unit (PICU) intensivist on outcomes at the patient and family level. It will also evaluate the training program to prepare the continuity care intensivist (CCI).
Detailed description
This randomized controlled trial will implement and evaluate the effects of a pediatric continuity care intensivist (CCI) program. The study will evaluate how effective the modified communication training for providers is to perform this new role. The primary outcome for the study is whether a CCI will affect several patient level outcomes for patients who have been admitted to the PICU longer than 7 days. Patient length of stay, hospital acquired conditions, time to limitations of interventions and new medical technology will be assessed comparing the intervention and usual care arms. The study will also determine the impact of the CCI program on parent/family satisfaction with provider communication and decision-making for their child.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCI Provider for Parent-patient dyad | Experimental | Behavioral: Continuity Care Intensivist Communication Training, Behavioral: Continuity Care Intensivist (CCI) Provider ProgramParents and patients are randomly assigned to a Continuity Care Intensivist (CCI) Provider who has received specialized communication training. The parent-patient dyad will receive standardized care from the CCI throughout their time in the PICU in addition to being assigned a rotating physician of record. |
| Usual Care for Parent-patient dyad | No intervention | –Patients and parents randomly assigned to usual care in the PICU which includes the rotation of the physician of record approximately every 7 days. There is no standardized process by which patients may be assigned a primary attending who would follow them throughout their stay. In the usual care arm it may never happen that they are assigned a primary intensivist, regardless of the length of their hospitalization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- CCI Provider
- 1. Pediatric Intensive Care Unit Attending Physician who volunteers to serve in the role of CCI.
- Usual Care (UC) Provider
- 1. Any Pediatric Intensive Care Unit Attending Physician who is not enrolled as a CCI.
- Parent-Patient Dyads
Key exclusion criteria (14 listed)
- CCI Provider
- 1. Any medical care provider who is not an attending physician (e.g., Pediatric critical care residents, nurses, and fellows)
- UC Provider
- Any medical care provider who is not an attending physician (e.g., Pediatric critical care residents, nurses, and fellows)
- Attending physician who is enrolled in the study as a CCI
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 |
|---|---|---|
| Continuity Care Intensivist Communication TrainingAlso: CCI Communication TrainingPhysicians enrolled in the intervention arm will complete a two to three part communication training. Survey measures of communication competency and burnout will be administered at baseline, after training, and at the end of the study. After the communication training, physicians will undergo an OSCE assessment with a simulated patient to evaluate communication skills. At the end of the study, CCI providers will receive surveys that assess the experience and challenges of the role, repeat surveys assessing competency with communication and frequency of engaging families in goals of care conversations, in addition to a follow-up focus group that will assess their experience with the intervention, the time required and the potential tradeoffs in other duties required by them to participate as a CCI. | Behavioural | CCI Provider for Parent-patient dyad |
| Continuity Care Intensivist (CCI) Provider ProgramAlso: CCI ProviderAfter undergoing CCI training, CCI providers will fulfill a standardized role with parent-patient dyads: * CCI will meet with families on a regular basis and at change of physician of record throughout their entire PICU hospitalization. * Help patients/families navigate decisions in concert with preferences and beliefs * Help patients/families and other care providers look at "bigger picture"; trajectory of illness, goals, and hopes for the patient. * Serve as point person for active intensivists on service and other specialists * Help resolve conflict when multiple providers have different opinions on course of action | Behavioural | CCI Provider for Parent-patient dyad |
Primary outcome
Difference in patient length of stay in the PICU between usual care and intervention arm
Time frame: up to 600 days
Length of stay as measured by the Virtual PICU system (VPS) in the PICU.
26 secondary outcomes
Difference in number of new technological dependence patients acquire during hospitalization between usual care and intervention arms
Time frame: up to 600 days
Difference in patient hospital-acquired conditions between usual care and intervention arm
Time frame: up to 600 days
Difference in patient length of time on sedation medicines between usual care and intervention arm
Time frame: up to 600 days
Difference in patients' new or progressive multiple organ dysfunction syndrome between usual care and intervention arm
Time frame: up to 600 days
Difference in patient organ failure free days between usual care and intervention arm
Time frame: up to 600 days
Difference in patient ventilator free days between usual care and intervention arm
Time frame: up to 600 days
Difference in change in parent preferences for shared decision-making from baseline to patient discharge between usual care and intervention arm
Time frame: baseline, up to 600 days
Difference in change in parent preferences for control in decision-making from baseline to patient discharge between usual care and intervention arm
Time frame: baseline, up to 600 days
Affects of Parent attachment style on communication preferences
Time frame: baseline
Difference in change in parental levels of anxiety and depression from baseline to patient discharge between usual care and intervention arm
Time frame: baseline, up to 600 days
Difference in change in parental levels of positive and negative affect from baseline to patient discharge between usual care and intervention arm
Time frame: baseline, up to 600 days
Difference in change in parental levels of anger from baseline to patient discharge between usual care and intervention arm
Time frame: baseline, up to 600 days
Difference in change in parental levels of hope from baseline to patient discharge between usual care and intervention arm
Time frame: baseline, up to 600 days
Difference in change in Parent/family satisfaction with decision-making from baseline to patient discharge between usual care and intervention arm
Time frame: baseline, up to 600 days
Difference in parent/family satisfaction with communication with their child's PICU physicians between usual care and intervention arm
Time frame: up to 600 days
Difference in change in parent self-report of medical communication competence from baseline to patient discharge between usual care and intervention arm
Time frame: baseline, up to 600 days
Difference in change in parent assessment of physician communication competency from baseline to patient discharge between usual care and intervention arm
Time frame: baseline, up to 600 days
Comparison of physician burnout between intervention and control group from baseline up to 600 days
Time frame: baseline, up to 600 days
Physician satisfaction with the communication training and with the CCI experience.
Time frame: up to 600 days
Evaluation of CCI provider experience in role of CCI and its feasibility of larger implementation
Time frame: up to 600 days
Comparison of physician comfort with end-of-life communication between intervention and control group from baseline up to 600 days
Time frame: baseline, up to 600 days
Difference in timing of patient's limitations of interventions to death between usual care and intervention arm
Time frame: up to 600 days
Frequency of palliative care consultation between usual care and intervention arm
Time frame: up to 600 days
Physician competency in communication with families via objective structured clinical examination (OSCE) evaluation
Time frame: up to 600 days
Comparison of physician self-reported communication competency between intervention and control group
Time frame: baseline, up to 600 days
Correlation between amount of CCI contact and parent and patient level outcomes
Time frame: baseline, up to 600 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 16 Sep 2020.
- Background: PubMed 11805751Board R, Ryan-Wenger N. Long-term effects of pediatric intensive care unit hospitalization on families with young children. Heart Lung. 2002 Jan-Feb;31(1):53-66. doi: 10.1067/mhl.2002.121246.
- Background: PubMed 15530191Balluffi A, Kassam-Adams N, Kazak A, Tucker M, Dominguez T, Helfaer M. Traumatic stress in parents of children admitted to the pediatric intensive care unit. Pediatr Crit Care Med. 2004 Nov;5(6):547-53. doi: 10.1097/01.PCC.0000137354.19807.44.
- Background: PubMed 19451843Needle JS, O'Riordan M, Smith PG. Parental anxiety and medical comprehension within 24 hrs of a child's admission to the pediatric intensive care unit*. Pediatr Crit Care Med. 2009 Nov;10(6):668-74; quiz 674. doi: 10.1097/PCC.0b013e3181a706c9.
- Background: PubMed 16015522Pochard F, Darmon M, Fassier T, Bollaert PE, Cheval C, Coloigner M, Merouani A, Moulront S, Pigne E, Pingat J, Zahar JR, Schlemmer B, Azoulay E; French FAMIREA study group. Symptoms of anxiety and depression in family members of intensive care unit patients before discharge or death. A prospective multicenter study. J Crit Care. 2005 Mar;20(1):90-6. doi: 10.1016/j.jcrc.2004.11.004.
- Background: PubMed 21454321Fauman KR, Pituch KJ, Han YY, Niedner MF, Reske J, LeVine AM. Predictors of depressive symptoms in parents of chronically ill children admitted to the pediatric intensive care unit. Am J Hosp Palliat Care. 2011 Dec;28(8):556-63. doi: 10.1177/1049909111403465. Epub 2011 Mar 30.
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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.
Jennifer K Walter, MD, PhD, MS principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuity Care Intensivist Communication Training and Continuity Care Intensivist (CCI) Provider Program in people with Critical Illness, run by Children's Hospital of Philadelphia 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 11 inclusion and 14 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 16 Sep 2020. 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?
Difference in patient length of stay in the PICU between usual care and intervention arm (time frame: up to 600 days). 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 NCT02146573, which also lists 34 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 16 Sep 2020.