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Completed

NCT Number: NCT03364933

Primary Intensivists and Primary Nurses to Decrease Pediatric ICU Length of Stay

This is a randomized control trial of PICU patients admitted for 7 days and expected to remain for at least another 3 days and who have a complex chronic condition. Patients will be randomized to usual care or usual care plus a primary intensivist and group of primary nurses (to facilitate passing of important patient information and informed, expedited decision-making). The primary research question is whether having a primary intensivist and nurses decreases PICU length of stay.

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Key information

Conditions

ICU Length of Stay Behavior Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

Long-stay intensive care unit (ICU) patients, or children who require prolonged hospitalization in the pediatric ICU (PICU), represent a minority of PICU patients but have a disproportionate impact on hospital resources and unfavorable outcomes, including morbidity, mortality, and repeated critical illness. These patients and their families have multifaceted needs (eg, tailored communication) that pose unique challenges to PICU providers and the parent-provider relationship. These experiences and needs are compounded and complicated by the transitory care that is typically provided by PICU. This transitory care may contribute to 1) patient/family dissatisfaction; 2) ineffective passing of important information day to day and week to week; and 3) delayed decision-making. These latter two potential consequences may, in turn, contribute to prolonged length of stay (LOS).

For these reasons, the investigators propose a randomized control trial to test whether primary intensivists and primary nurses can decrease PICU LOS for long-stay patients. A primary intensivist is one that remains a consistent physician-presence for the patient/family and PICU team throughout the child's PICU stay, despite changes in the intensivist(s) who orchestrates day-to-day management. Primary nurses are a team of PICU nurses who provide the all/most of the bedside care to the child. The investigators hypothesize that the long-stay PICU patients who are randomized to receive primary intensivists and nurses will have a statistically lower LOS than those patients who do not.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • PICU patients of any age who
  • have a complex chronic condition
  • have been admitted to the PICU for one week and are predicted by the PICU attending to continue to be admitted for at least another 3 days.

Exclusion criteria

-

Treatment and study plan

Primary intensivist and nurses

Behavioral

Primary intensivist will have no active role in the daily management of patients. The primary intensivist should facilitate decision-making, be a liaison between the patient/family and PICU team, and be a resource of information for all. Responsibilities of primary intensivist:

  • Weekly check-in with and availability to patient/family
  • Attendance at family meetings
  • Availability to PICU team

Primary nurses will be a team of up to 7 ICU nurses who will provide as much of the bedside care as possible. Responsibilities of primary nurses:

  • Maintain a primary nurse binder (paper format) for on-going communication about the patient among the team members; it will be their discretion what is information is communicated.
  • The Primary Nurse or delegate will be involved in all team/family meetings and will be expected/given an opportunity to speak during these meetings.

Primary outcomes

  1. PICU length of stay

    Time frame: Up to 2 years

    Total number of days in which an individual stays in the PICU

Secondary outcomes

  1. Family satisfaction

    Time frame: Up to 2 years

    In order to assess family satisfaction, families of all PICU patients (with PICU lengths of stay > 10 days) will be asked to complete a short anonymous questionnaire (Likert Scale) at the time of ICU discharge or within a few days when the patient is still hospitalized, if discharged late at night or over a weekend.

  2. Provider satisfaction

    Time frame: Up to 2 years

    In order assess provider satisfaction, all PICU attendings, fellows, and nurses will be verbally consented and asked to complete a short anonymous questionnaire (Likert Scale) at one of two time points-1) at the end of the study or 2) before the staff member leaves

  3. Percentage of family meetings attended by a primary nurse

    Time frame: Up to 2 years

    Number of meetings a nurse participated in divided by the number of meetings

  4. Duration of invasive mechanical ventilation in those patients without chronic respiratory failure and who are on invasive mechanical ventilation from the time of enrollment

    Time frame: Up to 2 years

    Measured in days.

  5. Time to tracheotomy in those who undergo a tracheotomy

    Time frame: Up to 2 years

    Measured in days.

  6. Incidence of nursing-related KEEPSAFE reports recorded after enrollment

    Time frame: Up to 2 years

    total number of reports that are recorded.

  7. Timing of involvement of Patient Care Services

    Time frame: Up to 2 years

    Measured in days.

  8. Incidence of ICU-acquired infections after enrollment

    Time frame: Up to 2 years

    Total number of ICU-acquired infections

  9. Number of documented family meetings

    Time frame: Up to 2 years

    Total number of family meetings.

  10. Incidence of unplanned re-admissions to a PICU within 48 hours of PICU discharge

    Time frame: Up to 2 years

    Total number of unplanned re-admissions to a PICU.

  11. Percentage of primary intensivists who meet with families

    Time frame: Up to 2 years

    Measured by total number of meeting divided by the number of weeks after enrollment.

  12. Total number of shifts that are not being covered by a primary nurse,

    Time frame: Up to 2 years

    The Bice-Boxerman Continuity of Care Index will be used to measure continuity compliance in terms of the total number of shifts not covered by a primary nurse.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Acronym: PIPRNs

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2017
Registry last updated
Jul 27, 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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