Decision Making Support for Parents and Caregivers
Phase: NA
Conditions: Neonatal Critical Illness, Pediatric Critical Illness
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
 
Study Protocol: Decision Making Support for Parents and Caregivers 
 
 
 
 
Study Site: 
Duke University Hospital 
2301 Erwin Road 
Durham, NC 27710 
 
 
Principal Investigator: 
Monica Lemmon, MD 
Department of Pediatrics and Population Health Sciences 
DUMC 3936 
Durham, NC 27710 
 
 
 
 
 
 
 
 
 
 
 
 
 
ClinicalTrial.gov identifier: NCT05733975 
IRB: Pro00111995; March 20, 2023 
 

Study Title: Decision Making Support for Parents and Caregivers 
 
Short Title: Decision Making Support 
 
Study Objective.  
 
To determine the feasibility and acceptability of a tool to support decision making for parents 
of critically ill children. 
 
Study Overview.  
 
The feasibility study will use a single-arm design. All critically ill infants for whom a 
serious decision is anticipated will be screened for enrollment. We will enroll up to 40 
infants, their parent(s), and their clinician(s). A study team member will deliver the tool, 
discuss its use with parents, and answer parent questions as they arise. We will survey 
parents at baseline. Parents and clinicians will be surveyed and interviewed after utilizing 
the tool. 
 
Measures.  
 
Prior to implementation of this decision aid in a prospective randomized trial, we must 
first determine whether 1) study procedures are feasible and 2) the intervention is 
acceptable to parents and clinicians.  
 
Feasibility will be defined as 1) enrollment rate of ≥ 50% and 2) complete data collection 
rate of ≥ 80%. Parent and clinician acceptability will be measured using self-report survey 
measures, adapted from prior work. Additional outcomes will include preparation for 
decision making, parent decisional conflict, regret, and satisfaction, perception of feeling 
heard and understood, and psychological distress. Preparation for decision making will 
be measured using the PrepDM. Decisional conflict and regret will be measured by the 
Decisional Conflict Scale (DCS) and the Decisional Regret Scale (DRS); perception of 
feeling heard and understood will be measured by the Feeling Heard and Understood 
Scale (FHAU); parent psychological distress will be measured using PROMIS-29. 
 
Data collection.  
 
The infant’s chart will be reviewed and relevant data extracted. We will also document 
recruitment feasibility data. Parent baseline surveys will include demographic information 
and measures of psychological distress. Post-intervention surveys will be given to parents 
and clinicians following use of the tool. Clinician surveys will include measures of decision 
aid acceptability. Parent surveys will include measures of decision aid acceptability, 
decisional satisfaction, conflict and regret, perception of feeling heard and understood, 
preparation for decision making, and psychological distress.  
 
Parents and clinicians will be invited to complete semi-structured interviews, with content 
targeting acceptability of the decision aid. Survey data will be collected and stored via 
REDCap. Qualitative data will be analyzed using NVIVO. 
 
Study participants.  
 
Study participants will include infants, parents, and clinicians. Study team members will 
screen unit lists for potential eligible patients. 
 
Infant inclusion criteria will include 1) age < 1 year, 2) admission to a critical care unit, 
and 3) an anticipated serious health care decision, defined as 1) a decision about 

initiating, not initiating, or withdrawing life sustaining treatment or chronic life-sustaining 
treatment (e.g. tracheostomy) and/or 2) a decision about major surgery and/or medical 
therapy. 
 
All parents of eligible infants will be considered for inclusion. Parent exclusion criteria 
will include 1) age < 18 years, 2) hearing or speech impairment, and 3) non-English 
speakers. 
 
All clinicians of eligible infants will be considered for inclusion. 
 
Subject Recruitment and Compensation.  
 
We anticipate up to 40 infants, 60 parents, and 40 clinicians will be enrolled in this study. 
 
Patients and parents: We will recruit from the Duke Intensive Care Nursery, Pediatric 
Intensive Care Unit, and Pediatric Cardiac Intensive Care Unit. 
 
A study team member will communicate with the unit about 1) eligible patients and 
2) approaching the family about their willingness to speak with research staff about the 
study. A waiver of HIPPA authorization has been requested to allow identification of 
prospective participants. A member of the study team will approach eligible families to 
introduce the study to the family. For infants enrolled, parents will be compensated $100 for 
completion of all study procedures. Clinicians will be compensated $50 for completion of all 
study procedures. 
 
Study Intervention. 
 
The intervention includes a paper-based decision support tool. This decision guide includes 
content related to decisional awareness, values clarification, and a series of question 
prompts. This intervention will be introduced to participants by a study team member, who 
will remain available with parents as they review and complete the tool. The tool asks 
parents to consider which values matter most to them and to identify questions they would 
like to ask the clinical team. Following completion of the tool, a study team member will ask 
parents if they would like their answers shared with their clinical team. If the parent would 
like to share their responses, the study team member will share a copy of parent responses 
with clinicians caring for the patient and their family. 
 
Risk-benefit assessment 
 
Benefits. There will be no direct benefits to the participants in the study. The potential 
benefit to future parents and clinicians is substantial because of the potential for this 
study to lead to the development of interventions to improve shared decision making for 
infants and children with life-threatening conditions. Therefore, the risks of this study, 
which we anticipate to be minimal, are reasonable in relation to its anticipated benefits. 
 
Adverse events. The principal investigator or the clinical study staff will record and follow 
all adverse events that occur. Data describing adverse events will be collected and 
reported to the IRB. 
 
Confidentiality and data security. We believe this study poses minimal risks to participants. 
See additional sections for procedural information concerning data storage, privacy, 
confidentiality, and safety monitoring. 
 
Parent distress. It is possible that intervention delivery or study procedures, including 
participant interviews, could increase parent distress. Previous research has shown that 

interviews do not increase grief, and that families are glad to have participated in studies 
involving interviews about highly emotional topics. We will use several strategies to 
minimize the possibility of increasing distress, including 1) keeping the interview flexible 
so that when emotional responses such as anger or crying occur, the interviewer may 
offer rest breaks and direct the interview in and out of the sensitive area, and 2) providing 
immediate therapeutic intervention when needed. A study team member with interview 
experience or the study PI will perform the interviews. Should a parent become upset 
during an interview or survey completion, the study team member collecting the data will 
allow the parent to stop and encourage them to talk about their feelings. If a parent 
remains upset, the research staff member will stay with the parent and help them to 
contact the social worker or a community mental health professional about their concerns. 
As part of routine clinical care, a social worker is assigned to each patient and family. 
After each parent interview, parents will be reminded that if they have concerns they wish 
to discuss, they can contact their social worker, hospital chaplain or personal clergy, or 
community mental health professional. The parents will be given information on how to 
contact other resources if necessary or, if they prefer, the research staff will contact a 
professional for them. For concerns or questions about the study, parents will be given 
phone numbers for the investigators. 
 
Parent burden. We anticipate that tool completion will require 15-20 minutes of participant 
time. Parent interviews are expected to last approximately 30-45 minutes. Clinician 
interviews are expected to last approximately 15 - 30 minutes. This time commitment may be 
a burden for some participants.
 
Data and safety monitoring 
 
We believe this study will infer minimal risk to participants. Interval data analysis will be 
performed midway through study completion. Data monitoring, including ensuring audio-
recordings are transcribed in a timely manner, will be confirmed monthly by the principal 
investigator and/or study coordinator. For the audio recordings, we will use a Duke-
approved transcription service. For the purposes of our study, “de-identification” will 
involve the removal of all identifiers outlined by the HIPAA privacy rule. Qualitative 
software will be used to analyze de-identified transcripts. 
 
Analysis files will be permanently stored on the Duke Server. During the analysis phase, de-
identified analysis files may additionally be stored on Duke Box or a Duke University or 
Duke Health System computer, and uploaded to the Duke server daily. 
 
Consent process.  
 
The consent process will be completed by the principal investigator, clinical research 
coordinator, or clinical research specialist on the study team. There is no time limit to the 
consent discussion. We are open to answering any potential questions that may arise 
when we present the study information to parents or clinicians. 
 
The consent process will occur in the Neonatal Intensive Care Unit, the Pediatric 
Intensive Care Unit, or the Pediatric Cardiac Intensive Care Unit. The parent/legal 
guardian may be consented over the phone or by using an e-consent. The phone 
consent process will take place in those situations where attempts to find families in the 
neonatal intensive care unit have failed. With the use of phone consent or an e-consent 
all efforts will be made to provide a copy of the consent to parents either by fax or email 
before reading the consent. A telephone script will be used to introduce the study and 
then the consent form will be read to the parent or sent via email as an e-consent. 
 
 

 
 
To mitigate the risk of loss of confidentiality, all patient and clinician data will be fully de-
identified, with a participant ID number assigned in the place of any identifiers. This ID 
number will be linked to identifying information only in a secure, separate file for the 
duration of the study period and analysis, to allow follow-up clinical information to be 
collected as needed. 
 
Participants can contact the PI or members of the study team with any questions that 
arise. In addition, given that this study has multiple points of contact, participants will have 
additional opportunities to raise questions throughout the study period.  
 
We will maintain a high level of sensitivity to passive refusal, so prospective participants 
who do not show active interest will not be enrolled in the study. 
 
Privacy and confidentiality. 
 
All patient and physician data will be de-identified, with a participant ID number assigned 
in the place of any identifiers. This ID number will be linked to identifying information only 
in a secure, separate file for the duration of the study period and analysis, to allow follow-
up clinical information to be collected as needed. All recordings will be transcribed and 
de-identified. 
 
Audio-recordings, transcriptions, and other data will be securely stored on a Duke server 
accessible to the research team. Audio recordings will be reviewed by a Duke-approved 
transcription service to de-identify audio recordings. Paper documents will be kept in a 
locked cabinet in an access controlled area.