ICU Length of StayPIPRNsNCT03364933
Primary Intensivists and Primary Nurses to Decrease Pediatric ICU Length of Stay
A study testing Primary intensivist and nurses in people with ICU Length of Stay, run by Columbia University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ICU Length of Stay
- What is being tested?
- Primary intensivist and nurses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 3 Feb 2020
- 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
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
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.
Read the detailed description
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.
- Conditions
- ICU Length of Stay
- Being tested
- Primary intensivist and nurses
- Keywords
- Child, Critical Illness, Length of Stay, Satisfaction
- Medical subject headings
- Critical Illness, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary intensivist and nursesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary intensivist and nurses | Experimental | Patients randomized to the experimental arm will have a primary intensivist and a team of primary nurses assigned to them. Receives: Behavioral: Primary intensivist and nurses |
| Control | No intervention | Patients who are randomized to the control group will receive usual care and not be assigned a primary intensivist or nurses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PICU length of stay
Total number of days in which an individual stays in the PICU
Measured: Up to 2 years
Secondary outcomes (12)
Family satisfaction
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.
Measured: Up to 2 years
Provider satisfaction
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
Measured: Up to 2 years
Percentage of family meetings attended by a primary nurse
Number of meetings a nurse participated in divided by the number of meetings
Measured: Up to 2 years
Duration of invasive mechanical ventilation in those patients without chronic respiratory failure and who are on invasive mechanical ventilation from the time of enrollment
Measured in days.
Measured: Up to 2 years
Time to tracheotomy in those who undergo a tracheotomy
Measured in days.
Measured: Up to 2 years
Incidence of nursing-related KEEPSAFE reports recorded after enrollment
total number of reports that are recorded.
Measured: Up to 2 years
Timing of involvement of Patient Care Services
Measured in days.
Measured: Up to 2 years
Incidence of ICU-acquired infections after enrollment
Total number of ICU-acquired infections
Measured: Up to 2 years
Number of documented family meetings
Total number of family meetings.
Measured: Up to 2 years
Incidence of unplanned re-admissions to a PICU within 48 hours of PICU discharge
Total number of unplanned re-admissions to a PICU.
Measured: Up to 2 years
Percentage of primary intensivists who meet with families
Measured by total number of meeting divided by the number of weeks after enrollment.
Measured: Up to 2 years
Total number of shifts that are not being covered by a primary nurse,
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Feb 2018
- Primary completion3 Feb 2020
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Length of StayStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey D. Edwards, Columbia University
- Investigators
- Jeffrey Edwards, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364933
- Sponsor's protocol ID
- AAAR5445
- Acronym
- PIPRNs
- Status last verified
- Jul 2020
- First submitted
- 28 Nov 2017
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Intensivists and Primary Nurses to Decrease Pediatric ICU Length of Stay
- ClinicalTrials.gov ID
- NCT03364933
- Acronym / sponsor ID
- PIPRNs / AAAR5445
- Conditions
- ICU Length of Stay
- Keywords
- Child, Critical Illness, Length of Stay, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 7 Dec 2017 (actual)
- 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 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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary intensivist and nurses | Experimental | Behavioral: Primary intensivist and nursesPatients randomized to the experimental arm will have a primary intensivist and a team of primary nurses assigned to them. |
| Control | No intervention | –Patients who are randomized to the control group will receive usual care and not be assigned a primary intensivist or nurses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- PICU patients of any age who
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Primary intensivist and nursesPrimary 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. | Behavioural | Primary intensivist and nurses |
Primary outcome
PICU length of stay
Time frame: Up to 2 years
Total number of days in which an individual stays in the PICU
12 secondary outcomes
Family satisfaction
Time frame: Up to 2 years
Provider satisfaction
Time frame: Up to 2 years
Percentage of family meetings attended by a primary nurse
Time frame: Up to 2 years
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
Time to tracheotomy in those who undergo a tracheotomy
Time frame: Up to 2 years
Incidence of nursing-related KEEPSAFE reports recorded after enrollment
Time frame: Up to 2 years
Timing of involvement of Patient Care Services
Time frame: Up to 2 years
Incidence of ICU-acquired infections after enrollment
Time frame: Up to 2 years
Number of documented family meetings
Time frame: Up to 2 years
Incidence of unplanned re-admissions to a PICU within 48 hours of PICU discharge
Time frame: Up to 2 years
Percentage of primary intensivists who meet with families
Time frame: Up to 2 years
Total number of shifts that are not being covered by a primary nurse,
Time frame: Up to 2 years
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 27 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Jeffrey Edwards, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary intensivist and nurses in people with ICU Length of Stay, run by Columbia University 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 1 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 27 Jul 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?
PICU length of stay (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2020.