Clinical trial NCT02146573: Pediatric Continuity Care Intensivist
Official title: Pediatric Continuity Care Intensivist: Role Implementation and Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Intensive Care Units, Pediatric
Communication
Health personnel
Decision making
Critical Care
Length of Stay
Iatrogenic Disease
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Eligibility criteria: Inclusion Criteria:

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

1. 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
2. Parent/guardian ≥ 18 years old
3. Parent/guardian is English-speaking
4. Child \<18 years old at time of enrollment
5. Child has been admitted to the PICU at CHOP for ≥7 days
6. Medical team believed that patient will remain in the PICU for at least another seven days

Exclusion Criteria:

CCI Provider

1. Any medical care provider who is not an attending physician (e.g., Pediatric critical care residents, nurses, and fellows)

UC Provider

1. Any medical care provider who is not an attending physician (e.g., Pediatric critical care residents, nurses, and fellows)
2. Attending physician who is enrolled in the study as a CCI

Parent-Patient Dyads

1. Parent or guardian who has previously participated in the CCI study in a previous hospitalization (in either usual care or intervention arm)
2. Parent or guardian of a child who has already been hospitalized in the PICU \>7 days at the onset of the study.
3. Child ≥18 years of age at time of enrollment
4. Child has previously participated in the CCI study in a previous PICU stay (in either usual care or intervention arm)
5. Child has been hospitalized in the PICU \>7 days at the onset of the study
6. Child already has a "primary" attending
7. 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.
8. 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.

Primary outcomes:
measure: Difference in patient length of stay in the PICU between usual care and intervention arm
timeFrame: up to 600 days
Secondary outcomes:
measure: Difference in number of new technological dependence patients acquire during hospitalization between usual care and intervention arms
timeFrame: up to 600 days
measure: Difference in patient hospital-acquired conditions between usual care and intervention arm
timeFrame: up to 600 days
measure: Difference in patient length of time on sedation medicines between usual care and intervention arm
timeFrame: up to 600 days
measure: Difference in patients' new or progressive multiple organ dysfunction syndrome between usual care and intervention arm
timeFrame: up to 600 days
measure: Difference in patient organ failure free days between usual care and intervention arm
timeFrame: up to 600 days
measure: Difference in patient ventilator free days between usual care and intervention arm
timeFrame: up to 600 days
measure: Difference in change in parent preferences for shared decision-making from baseline to patient discharge between usual care and intervention arm
timeFrame: baseline, up to 600 days
measure: Difference in change in parent preferences for control in decision-making from baseline to patient discharge between usual care and intervention arm
timeFrame: baseline, up to 600 days
measure: Affects of Parent attachment style on communication preferences
timeFrame: baseline
measure: Difference in change in parental levels of anxiety and depression from baseline to patient discharge between usual care and intervention arm
timeFrame: baseline, up to 600 days
measure: Difference in change in parental levels of positive and negative affect from baseline to patient discharge between usual care and intervention arm
timeFrame: baseline, up to 600 days
measure: Difference in change in parental levels of anger from baseline to patient discharge between usual care and intervention arm
timeFrame: baseline, up to 600 days
measure: Difference in change in parental levels of hope from baseline to patient discharge between usual care and intervention arm
timeFrame: baseline, up to 600 days
measure: Difference in change in Parent/family satisfaction with decision-making from baseline to patient discharge between usual care and intervention arm
timeFrame: baseline, up to 600 days
measure: Difference in parent/family satisfaction with communication with their child's PICU physicians between usual care and intervention arm
timeFrame: up to 600 days
measure: Difference in change in parent self-report of medical communication competence from baseline to patient discharge between usual care and intervention arm
timeFrame: baseline, up to 600 days
measure: Difference in change in parent assessment of physician communication competency from baseline to patient discharge between usual care and intervention arm
timeFrame: baseline, up to 600 days
measure: Comparison of physician burnout between intervention and control group from baseline up to 600 days
timeFrame: baseline, up to 600 days
measure: Physician satisfaction with the communication training and with the CCI experience.
timeFrame: up to 600 days
measure: Evaluation of CCI provider experience in role of CCI and its feasibility of larger implementation
timeFrame: up to 600 days
measure: Comparison of physician comfort with end-of-life communication between intervention and control group from baseline up to 600 days
timeFrame: baseline, up to 600 days
measure: Difference in timing of patient's limitations of interventions to death between usual care and intervention arm
timeFrame: up to 600 days
measure: Frequency of palliative care consultation between usual care and intervention arm
timeFrame: up to 600 days
measure: Physician competency in communication with families via objective structured clinical examination (OSCE) evaluation
timeFrame: up to 600 days
measure: Comparison of physician self-reported communication competency between intervention and control group
timeFrame: baseline, up to 600 days
measure: Correlation between amount of CCI contact and parent and patient level outcomes
timeFrame: baseline, up to 600 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jennifer K Walter, MD, PhD, MS
role: PRINCIPAL_INVESTIGATOR
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