Pediatric Continuity Care Intensivist

NCT02146573 | Completed

• 1 other identifier: IRB 14-010987
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief 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. It will also evaluate the training program to prepare the continuity care intensivist (CCI).

Conditions

Critical Illness

Keywords

Intensive Care Units, Pediatric; Communication; Health personnel; Decision making; Critical Care; Length of Stay; Iatrogenic Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 600 days

Secondary Outcomes (26)

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

  up to 600 days

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

  up to 600 days

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

  up to 600 days

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

  up to 600 days

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

  up to 600 days

Study Arms (2)

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.

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.

Interventions

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.

Also known as: CCI Communication Training

CCI Provider for Parent-patient dyad

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

Also known as: CCI Provider

CCI Provider for Parent-patient dyad

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

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MeSH Terms

Conditions

Critical Illness; Communication; Iatrogenic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Jennifer K Walter, MD, PhD, MS

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 26, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: September 16, 2020

Record last verified: 2020-09

Locations

US (1)