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Completed

NCT Number: NCT02146573

Pediatric Continuity Care Intensivist

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).

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Key information

Conditions

Critical Illness Behavior Communication Disease Attributes Iatrogenic Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

CCI Provider

  • Pediatric Intensive Care Unit Attending Physician who volunteers to serve in the role of CCI.

Usual Care (UC) Provider

  • 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
  • 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

Exclusion criteria

CCI Provider

  • 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

  • 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.

Treatment and study plan

Continuity Care Intensivist Communication Training

Behavioral

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.

Other names: CCI Communication Training

Continuity Care Intensivist (CCI) Provider Program

Behavioral

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

Other names: CCI Provider

Primary outcomes

  1. 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.

Secondary outcomes

  1. Difference in number of new technological dependence patients acquire during hospitalization between usual care and intervention arms

    Time frame: up to 600 days

    We will measure new technology dependence like tracheostomy, gastrostomy tube, long term ventilation, bipap using VPS during the PICU hospitalization.

  2. Difference in patient hospital-acquired conditions between usual care and intervention arm

    Time frame: up to 600 days

    Using VPS, investigators will track hospital acquired infections like catheter associated urinary tract infections and ventilator associated pneumonias

  3. Difference in patient length of time on sedation medicines between usual care and intervention arm

    Time frame: up to 600 days

    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.

  4. Difference in patients' new or progressive multiple organ dysfunction syndrome between usual care and intervention arm

    Time frame: up to 600 days

    Investigators will use the VPS designation of multiple organ dysfunction syndrome to characterize system failures like respiratory, renal, cardiac failure.

  5. Difference in patient organ failure free days between usual care and intervention arm

    Time frame: up to 600 days

    Investigators will use the VPS designation of organ failure for systems like renal, respiratory and cardiac.

  6. Difference in patient ventilator free days between usual care and intervention arm

    Time frame: up to 600 days

    Investigators will use the VPS designation for days up to 90 that the patient remains off of mechanical ventilation.

  7. 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

    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.

  8. 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

    The Control Preferences Scale for Pediatrics (CPS-P), a validated tool, will be used to measure parent's preferences for control in decision-making.

  9. Affects of Parent attachment style on communication preferences

    Time frame: baseline

    The Relationship Questionnaire, a validated measure, will be used to measure parent relationship style, which is based on attachment theory.

  10. 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

    Parental levels of hospital anxiety and depression will be measured using the Hospital Anxiety and Depression scale (HADS).

  11. 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

    Parental levels of positive and negative affect will be measured using the Positive and Negative Affect Scale (PANAS), a validated tool.

  12. 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

    Parent levels of anger will be measured using PROMIS bank v1.1- Anger scale.

  13. 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

    Parental levels of hope will be measured using the Hope Scale, a validated tool.

  14. 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

    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.

  15. 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

    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.

  16. 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

    The Medical Communication Competence Scale, a partially validated tool, will be used to measure parent self-reported competency with communication.

  17. 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

    The Communication Assessment Tool (CAT), a validated tool, will be used to measure parent perceptions of physician competence in interpersonal and communication skills.

  18. Comparison of physician burnout between intervention and control group from baseline up to 600 days

    Time frame: 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.

  19. Physician satisfaction with the communication training and with the CCI experience.

    Time frame: up to 600 days

    Questions written for this study that have been written and piloted will assess the physicians' satisfaction and perceived usefulness of the communication training.

  20. Evaluation of CCI provider experience in role of CCI and its feasibility of larger implementation

    Time frame: up to 600 days

    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.

  21. 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

    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.

  22. Difference in timing of patient's limitations of interventions to death between usual care and intervention arm

    Time frame: up to 600 days

    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.

  23. Frequency of palliative care consultation between usual care and intervention arm

    Time frame: up to 600 days

    Medical chart review to determine request for and consultation performed by Pediatric Advanced Care Team (palliative care consultation service) will be measured and compared.

  24. Physician competency in communication with families via objective structured clinical examination (OSCE) evaluation

    Time frame: up to 600 days

    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.

  25. Comparison of physician self-reported communication competency between intervention and control group

    Time frame: baseline, up to 600 days

    The Medical Communication Competence Scale, a partially validated measure will be used to assess physician self-reported competency.

  26. Correlation between amount of CCI contact and parent and patient level outcomes

    Time frame: baseline, up to 600 days

    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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

Pediatric Continuity Care Intensivist: Role Implementation and Randomized Control Trial

Acronym: CCI

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 26, 2014
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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