Back to resultsPediatric Continuity Care Intensivist (CCI)
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuity Care Intensivist Communication Training
Continuity Care Intensivist (CCI) Provider Program
Sponsored by
About this trial
This is an interventional health services research trial for Critical Illness focused on measuring Intensive Care Units, Pediatric, Communication, Health personnel, Decision making, Critical Care, Length of Stay, Iatrogenic Disease
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
- 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
1. 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.
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CCI Provider for Parent-patient dyad
Usual Care for Parent-patient dyad
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Difference in number of new technological dependence patients acquire during hospitalization between usual care and intervention arms
We will measure new technology dependence like tracheostomy, gastrostomy tube, long term ventilation, bipap using VPS during the PICU hospitalization.
Difference in patient hospital-acquired conditions between usual care and intervention arm
Using VPS, investigators will track hospital acquired infections like catheter associated urinary tract infections and ventilator associated pneumonias
Difference in patient length of time on sedation medicines between usual care and intervention arm
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.
Difference in patients' new or progressive multiple organ dysfunction syndrome between usual care and intervention arm
Investigators will use the VPS designation of multiple organ dysfunction syndrome to characterize system failures like respiratory, renal, cardiac failure.
Difference in patient organ failure free days between usual care and intervention arm
Investigators will use the VPS designation of organ failure for systems like renal, respiratory and cardiac.
Difference in patient ventilator free days between usual care and intervention arm
Investigators will use the VPS designation for days up to 90 that the patient remains off of mechanical ventilation.
Difference in change in parent preferences for shared decision-making from baseline to patient discharge between usual care and intervention arm
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.
Difference in change in parent preferences for control in decision-making from baseline to patient discharge between usual care and intervention arm
The Control Preferences Scale for Pediatrics (CPS-P), a validated tool, will be used to measure parent's preferences for control in decision-making.
Affects of Parent attachment style on communication preferences
The Relationship Questionnaire, a validated measure, will be used to measure parent relationship style, which is based on attachment theory.
Difference in change in parental levels of anxiety and depression from baseline to patient discharge between usual care and intervention arm
Parental levels of hospital anxiety and depression will be measured using the Hospital Anxiety and Depression scale (HADS).
Difference in change in parental levels of positive and negative affect from baseline to patient discharge between usual care and intervention arm
Parental levels of positive and negative affect will be measured using the Positive and Negative Affect Scale (PANAS), a validated tool.
Difference in change in parental levels of anger from baseline to patient discharge between usual care and intervention arm
Parent levels of anger will be measured using PROMIS bank v1.1- Anger scale.
Difference in change in parental levels of hope from baseline to patient discharge between usual care and intervention arm
Parental levels of hope will be measured using the Hope Scale, a validated tool.
Difference in change in Parent/family satisfaction with decision-making from baseline to patient discharge between usual care and intervention arm
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.
Difference in parent/family satisfaction with communication with their child's PICU physicians between usual care and intervention arm
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.
Difference in change in parent self-report of medical communication competence from baseline to patient discharge between usual care and intervention arm
The Medical Communication Competence Scale, a partially validated tool, will be used to measure parent self-reported competency with communication.
Difference in change in parent assessment of physician communication competency from baseline to patient discharge between usual care and intervention arm
The Communication Assessment Tool (CAT), a validated tool, will be used to measure parent perceptions of physician competence in interpersonal and communication skills.
Comparison of physician burnout between intervention and control group from 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.
Physician satisfaction with the communication training and with the CCI experience.
Questions written for this study that have been written and piloted will assess the physicians' satisfaction and perceived usefulness of the communication training.
Evaluation of CCI provider experience in role of CCI and its feasibility of larger implementation
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.
Comparison of physician comfort with end-of-life communication between intervention and control group from 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.
Difference in timing of patient's limitations of interventions to death between usual care and intervention arm
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.
Frequency of palliative care consultation between usual care and intervention arm
Medical chart review to determine request for and consultation performed by Pediatric Advanced Care Team (palliative care consultation service) will be measured and compared.
Physician competency in communication with families via objective structured clinical examination (OSCE) evaluation
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.
Comparison of physician self-reported communication competency between intervention and control group
The Medical Communication Competence Scale, a partially validated measure will be used to assess physician self-reported competency.
Correlation between amount of CCI contact and parent and patient level outcomes
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.
Full Information
NCT ID
NCT02146573
First Posted
May 19, 2014
Last Updated
September 14, 2020
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT02146573
Brief Title
Pediatric Continuity Care Intensivist
Acronym
CCI
Official Title
Pediatric Continuity Care Intensivist: Role Implementation and Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Intensive Care Units, Pediatric, Communication, Health personnel, Decision making, Critical Care, Length of Stay, Iatrogenic Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CCI Provider for Parent-patient dyad
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care for Parent-patient dyad
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Continuity Care Intensivist Communication Training
Other Intervention Name(s)
CCI Communication Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Continuity Care Intensivist (CCI) Provider Program
Other Intervention Name(s)
CCI Provider
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference in patient length of stay in the PICU between usual care and intervention arm
Description
Length of stay as measured by the Virtual PICU system (VPS) in the PICU.
Time Frame
up to 600 days
Secondary Outcome Measure Information:
Title
Difference in number of new technological dependence patients acquire during hospitalization between usual care and intervention arms
Description
We will measure new technology dependence like tracheostomy, gastrostomy tube, long term ventilation, bipap using VPS during the PICU hospitalization.
Time Frame
up to 600 days
Title
Difference in patient hospital-acquired conditions between usual care and intervention arm
Description
Using VPS, investigators will track hospital acquired infections like catheter associated urinary tract infections and ventilator associated pneumonias
Time Frame
up to 600 days
Title
Difference in patient length of time on sedation medicines between usual care and intervention arm
Description
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.
Time Frame
up to 600 days
Title
Difference in patients' new or progressive multiple organ dysfunction syndrome between usual care and intervention arm
Description
Investigators will use the VPS designation of multiple organ dysfunction syndrome to characterize system failures like respiratory, renal, cardiac failure.
Time Frame
up to 600 days
Title
Difference in patient organ failure free days between usual care and intervention arm
Description
Investigators will use the VPS designation of organ failure for systems like renal, respiratory and cardiac.
Time Frame
up to 600 days
Title
Difference in patient ventilator free days between usual care and intervention arm
Description
Investigators will use the VPS designation for days up to 90 that the patient remains off of mechanical ventilation.
Time Frame
up to 600 days
Title
Difference in change in parent preferences for shared decision-making from baseline to patient discharge between usual care and intervention arm
Description
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.
Time Frame
baseline, up to 600 days
Title
Difference in change in parent preferences for control in decision-making from baseline to patient discharge between usual care and intervention arm
Description
The Control Preferences Scale for Pediatrics (CPS-P), a validated tool, will be used to measure parent's preferences for control in decision-making.
Time Frame
baseline, up to 600 days
Title
Affects of Parent attachment style on communication preferences
Description
The Relationship Questionnaire, a validated measure, will be used to measure parent relationship style, which is based on attachment theory.
Time Frame
baseline
Title
Difference in change in parental levels of anxiety and depression from baseline to patient discharge between usual care and intervention arm
Description
Parental levels of hospital anxiety and depression will be measured using the Hospital Anxiety and Depression scale (HADS).
Time Frame
baseline, up to 600 days
Title
Difference in change in parental levels of positive and negative affect from baseline to patient discharge between usual care and intervention arm
Description
Parental levels of positive and negative affect will be measured using the Positive and Negative Affect Scale (PANAS), a validated tool.
Time Frame
baseline, up to 600 days
Title
Difference in change in parental levels of anger from baseline to patient discharge between usual care and intervention arm
Description
Parent levels of anger will be measured using PROMIS bank v1.1- Anger scale.
Time Frame
baseline, up to 600 days
Title
Difference in change in parental levels of hope from baseline to patient discharge between usual care and intervention arm
Description
Parental levels of hope will be measured using the Hope Scale, a validated tool.
Time Frame
baseline, up to 600 days
Title
Difference in change in Parent/family satisfaction with decision-making from baseline to patient discharge between usual care and intervention arm
Description
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.
Time Frame
baseline, up to 600 days
Title
Difference in parent/family satisfaction with communication with their child's PICU physicians between usual care and intervention arm
Description
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.
Time Frame
up to 600 days
Title
Difference in change in parent self-report of medical communication competence from baseline to patient discharge between usual care and intervention arm
Description
The Medical Communication Competence Scale, a partially validated tool, will be used to measure parent self-reported competency with communication.
Time Frame
baseline, up to 600 days
Title
Difference in change in parent assessment of physician communication competency from baseline to patient discharge between usual care and intervention arm
Description
The Communication Assessment Tool (CAT), a validated tool, will be used to measure parent perceptions of physician competence in interpersonal and communication skills.
Time Frame
baseline, up to 600 days
Title
Comparison of physician burnout between intervention and control group from baseline up to 600 days
Description
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.
Time Frame
baseline, up to 600 days
Title
Physician satisfaction with the communication training and with the CCI experience.
Description
Questions written for this study that have been written and piloted will assess the physicians' satisfaction and perceived usefulness of the communication training.
Time Frame
up to 600 days
Title
Evaluation of CCI provider experience in role of CCI and its feasibility of larger implementation
Description
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.
Time Frame
up to 600 days
Title
Comparison of physician comfort with end-of-life communication between intervention and control group from baseline up to 600 days
Description
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.
Time Frame
baseline, up to 600 days
Title
Difference in timing of patient's limitations of interventions to death between usual care and intervention arm
Description
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.
Time Frame
up to 600 days
Title
Frequency of palliative care consultation between usual care and intervention arm
Description
Medical chart review to determine request for and consultation performed by Pediatric Advanced Care Team (palliative care consultation service) will be measured and compared.
Time Frame
up to 600 days
Title
Physician competency in communication with families via objective structured clinical examination (OSCE) evaluation
Description
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.
Time Frame
up to 600 days
Title
Comparison of physician self-reported communication competency between intervention and control group
Description
The Medical Communication Competence Scale, a partially validated measure will be used to assess physician self-reported competency.
Time Frame
baseline, up to 600 days
Title
Correlation between amount of CCI contact and parent and patient level outcomes
Description
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.
Time Frame
baseline, up to 600 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
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
1. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer K Walter, MD, PhD, MS
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
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