This project has results

Testing a Program to Support Decision Making among Parents of Children in the PICU

Results Summary and Professional Abstract

Results Summary

Download this abstract: English (pdf) | Español (pdf)

What was the research about?

The pediatric intensive care unit, or PICU, takes care of children who are seriously ill. These children may be recovering from surgery or have an infection or a life-threatening illness. Their parents may have to make hard choices about health care, life support, or end-of-life care.

In this study, the research team created and tested a program for parents in the PICU, called PICU Supports. In this program, trained counselors offered parents help and support when making choices about care. The team wanted to learn if parents in the program felt more satisfied with the process of making decisions than parents who received a brochure about the PICU.

What were the results?

Parents in PICU Supports and parents who received the brochure didn’t differ in how satisfied they were with the process of making decisions. In addition, parents in the two groups didn’t report differences in

Amount of regret about choices they made for their child’s care in the PICU
Worry, sadness, or stress
Quality of life
Perceptions of how well PICU staff worked together and communicated with families
Satisfaction with care

Who was in the study?

The study included 442 parents of 382 children in the PICU. All children received care at two children’s hospitals in Chicago, Illinois. Of the parents, 54 percent were white, 18 percent were black, 3 percent were Asian, 13 percent were other races, and 11 percent didn’t report a race. The average parent age was 35, 71 percent were women, and 9 percent didn’t report their gender. The average patient age was 5. The most common reasons for children being in the PICU were breathing problems and care after surgery. All children received PICU care for more than one day.

What did the research team do?

The research team worked with parents of children in the PICU and people who work in the PICU to design PICU Supports.

The research team then assigned families to one of two groups by chance: PICU Supports or the PICU brochure. For those in PICU Supports, a trained counselor met with families each weekday. The counselor also offered to hold weekly meetings for parents with PICU staff. They gave parents other resources as needed, such as a list of common questions for the doctor and a PICU handbook.

The second group received a brochure about the PICU. It had information about PICU staff, how to visit the PICU, a list of terms often used in the PICU, and ways parents could be involved in their child’s care.

The research team asked parents in both groups to fill out a survey three to five weeks after leaving the PICU.

Parents of children who had been in the PICU and healthcare professionals helped plan the study.

What were the limits of the study?

The study enrolled fewer families than planned. Fewer than 60 percent of parents filled out the survey three to five weeks after leaving the PICU. Parents who filled out surveys differed from those who didn’t in terms of education, race, ethnicity, age, marriage status, and gender. Also, PICU staff were aware of PICU Supports, which may have changed the way they talked with all parents in the study. As a result, it may have been hard to detect differences between the PICU Supports group and the brochure group.

Future research could compare other ways of supporting parents in the PICU as they make choices about their child’s care.

How can people use the results?

Hospitals can use the results when considering ways to support parents of children in the PICU.

Professional Abstract

Objective

To test the effect of a navigator-based communication support program versus an informational brochure on satisfaction with decision making among parents of children in the pediatric intensive care unit (PICU)

Study Design

Design Elements	Description
Design	Randomized controlled trial
Population	442 parents of 382 children under the age of 18 who were receiving PICU care for more than 1 day
Interventions/ Comparators	PICU Supports Informational brochure about the PICU
Outcomes	Primary: parent satisfaction with decision making Secondary: parent satisfaction with care, decision regret, anxiety, depression, posttraumatic stress, health-related quality of life, perception of the healthcare team’s communication and collaboration
Timeframe	3- to 5-week follow-up for primary outcome

This randomized controlled trial tested the effect of PICU Supports, a navigator-based communication-support program, on parent satisfaction with decision making following PICU discharge. The research team designed PICU Supports, with input from parents of children in the PICU and PICU healthcare providers, to help parents making decisions related to health care, life support, and end-of-life care.

The research team randomly assigned families to receive either PICU Supports or an informational brochure. In PICU Supports, navigators, who were trained counselors, offered to meet with families each weekday. They also offered weekly meetings with parents and PICU staff and provided materials to parents as needed, such as a list of frequently asked questions and a PICU handbook. Navigators provided support to parents for decision making, managing emotions, and transitioning out of the PICU. In the second group, families received an informational brochure about the PICU, including a description of PICU staff, parking and visitation procedures, a glossary of terms often used in the PICU, and suggestions about how parents could participate in their child’s care.

The study included 442 parents of 382 PICU patients under the age of 18 receiving care from one of two children’s hospitals in Chicago, Illinois. Of the parents, 54% were white, 18% were black, 3% were Asian, and 13% were other races; 11% did not report their race. The average parent age was 35, and 71% were female; 9% did not report their gender. The average patient age was 5. The most common reasons for admission to the PICU were acute respiratory illness (37%) and postoperative care (31%).

Parents completed a survey to assess study outcomes three to five weeks after discharge from the PICU.

Parents of children who had been in the PICU and clinicians gave input about recruitment and study design.

Results

Three to five weeks after patient discharge from the PICU, parents in PICU Supports and parents who received the informational brochure did not differ significantly on satisfaction with decision making. Of parents in PICU Supports, 60% rated satisfaction with decision making as excellent compared with 56% of parents who received the informational brochure.

The two groups also did not differ significantly in secondary outcomes.

Limitations

The study did not enroll as many families as planned, and fewer than 60% of parents in the study returned surveys. Parents who returned surveys differed in education, race, ethnicity, age, marriage status, and gender from parents who did not return surveys. The healthcare teams were aware of PICU Supports, which may have changed communication with all parents in the study, making it difficult to detect differences between groups.

Conclusions and Relevance

In this study, parents in PICU Supports were not more satisfied with decision making than parents who received the informational brochure.

Future Research Needs

Future research could compare different ways of providing decision-making support to PICU families.

This project's final research report is expected to be available by April 2020.

Journal Articles

Pediatrics

Provider Perspectives on Use of Medical Marijuana in Children With Cancer

Journal of Patient Experience

The Process and Impact of Stakeholder Engagement in Developing a Pediatric Intensive Care Unit Communication and Decision-Making Intervention.

Journal of Patient Experience

The Process and Impact of Stakeholder Engagement in Developing a Pediatric Intensive Care Unit Communication and Decision-Making Intervention

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.

Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:

The reviewers asked that the researchers refer to the Four Supports study in the abstract. The researchers adapted that model for use in their PCORI-funded study. The researchers said they left the name of that intervention out intentionally because while it provided a preliminary framework, the intervention developed for this study differed substantially in content and structure, thanks to the work of the stakeholders. The reviewers insisted that the abstract still indicate that the intervention under study was a modification, and the researchers added a statement to that effect.
The reviewers expressed concern that the stakeholder parents who helped develop the intervention were not representative of the study population. The researchers added a table to the report listing the names and experience of the eight parent stakeholders. The researchers acknowledged that the stakeholders were not ethnically diverse and may overrepresent cases where children died. The researchers added comments about the representation of parents as well as other stakeholders to their study limitations section.
Given the lack of significant results at 3-5 weeks postdischarge, the reviewers wondered about the durability of the intervention and whether more pronounced results might be seen at other time points. The researchers suggested that measuring at an earlier time point could be more helpful and added a sentence to the report saying that they plan to conduct analyses of outcomes at the time of PICU discharge.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

Kelly N. Michelson, BA, MD, MPH

Project Status

Completed; PCORI Public and Professional Abstracts Posted

Project Title

Improving Communication in the Pediatric Intensive Care Unit for Patients Facing Life-Changing Decisions

Board Approval Date

September 2013

Project End Date

July 2019

Organization

Ann and Robert H. Lurie Children's Hospital of Chicago

Year Awarded

2013

State

Illinois

Year Completed

2019

Project Type

Research Project

Health Conditions

Other or Non-Disease Specific

Intervention Strategies

Care Coordination
Patient Navigation
Shared Decision Making
Other Health Services Interventions
Training and Education Interventions

Populations

Children -- 18 and under
Individuals with Multiple Chronic/co-morbid Conditions
Low Income
Racial/Ethnic Minorities

Funding Announcement

Communication and Dissemination Research

Project Budget

$1,854,139

Study Registration Information

HSRP20143438

NCT02333396

Page Last Updated:

July 31, 2019