This concept is a novel research idea that incorporates the potential impact of patient
quality of life (QOL) on decision making for treatment of mild sleep apnea in children
between the ages of 3yrs to <16 years. Previous studies have shown that parents of
children with mild OSA experience similar decisional conflict (DC) to those with a more
severe disease. The investigators believe it is important to provide caregivers with
tools that can aid in decision making and potentially reduce DC when choosing between
more than one treatment option, considering research on some of these options is also
recent and somewhat limited.
Children with mild OSA may be offered watchful waiting, surgery or medical therapy for
initial management. Although surgery results in resolution/improvement in symptoms in the
majority of children with mild OSA, recent data also shows encouraging success rates
after medical management. A well-designed RCT has also shown that untreated children with
non-severe OSA show normalization of PSG with watchful waiting, although they continued
to have higher OSA18 scores as compared to those who underwent surgery. This implies that
there is a continuing impact on quality of life and warrants inclusion of this
information early on in the decision-making process.
When presented with these data, some parents face a conflict deciding between management
options and/or may be reluctant to pursue the recommended management option. This is
known as "decisional conflict" and is frequently accompanied by emotional distress, which
can lead to delays in decision making.
The hypothesis is that in children with mild OSA there is significant conflict in
parental decision making, and, in the absence of significant sleep apnea, impact on QOL
can be a statistically significant deciding factor and may help guide management
decisions in such situations. Investigators propose to use OSA 18, a validated
questionnaire that determines the effects of obstructive sleep apnea on pediatric quality
of life, and subsequently measure caregivers' decision-making processes through a
decisional conflict scale survey. Investigators believe that using this questionnaire may
impact decision making for such patients and help reduce the DC.
This will be a randomized controlled trial (RCT).
Identification and Recruitment: Convenience sampling will be used for this study. The
clinic lists will be scanned weekly by a member of the study team to identify patients
with mild OSA. Consecutive patients/ families, meeting inclusion criteria will be invited
to participate. Participants will be approached by a member of the study team on the day
of visit or within 1 week of the visit by a telephone call to enlist participation.
Consent/Assent: Verbal consent will be obtained through the phone call and confirmed on
the day of clinic visit and documented in the consent documentation form which will be
locked away in a secure cabinet and also documented on the network drive. A secure REDCap
database will also be used to document verbal consent in the instance that recruitment
was done telephonically. Verbal consent will be obtained at the time of recruitment by a
study team member. The team member will introduce the study and explain the purpose, the
procedures, and how participants are randomly assigned to a group.
Retention: Participation last through the completion of all surveys. The surveys take
approximately 5 minutes to complete.
Protocol:
At the start of the visit, families who consented to participate will be given a
demographics questionnaire asking about age, race/ethnicity, and health literacy. BMI and
sleep study data will also be recorded by a study team member. Following this survey,
participants will follow the protocol for the group they are randomly assigned to, either
case or control.
Case Group:
If in case group, parents will be asked to complete the OSA18 questionnaire. The total
score along with category: mild, moderate or severe will be presented to the families
along with scores for various domains. Families will then be provided with a printed
form, "decision aid," at the time of consultation with various management options,
detailing evidence based risks and benefits for each option. In the case group, this will
include the OSA 18 total scores at the bottom this will also help standardized the
discussion by the provider.
The decisional conflict scale (DCS) will be filled out at conclusion of visit after the
provider has left the room. The DCS is a 16-item survey in which participants are asked
to respond to statements related to their decision on a five-point ordinal Likert scale:
0) strongly agree, 1) agree, 2) neither agree nor disagree, 3) disagree, and 4) strongly
disagree. Scores are summed, divided by16, and multiplied by 25. Scores range from 0,
signifying that the respondent has complete certainty about the best choice, to 100,
which signifies that the respondent feels extremely uncertain about the best choice. The
validation study indicates that a score ≥ 25 signifies a decisional conflict.
Control Group: Families in the control group will be provided with a printed form,
"decision aid," at the time of consultation with various management options, detailing
evidence based risks and benefits for each option.
The decisional conflict scale (DCS) will be filled out at conclusion of visit after the
provider has left the room. The DCS is a 16-item survey in which participants are asked
to respond to statements related to their decision on a five-point ordinal Likert scale:
0) strongly agree, 1) agree, 2) neither agree nor disagree, 3) disagree, and 4) strongly
disagree. Scores are summed, divided by16, and multiplied by 25. Scores range from 0,
signifying that the respondent has complete certainty about the best choice, to 100,
which signifies that the respondent feels extremely uncertain about the best choice. The
validation study indicates that a score ≥ 25 signifies a decisional conflict.
Responses from all participants will be stored securely in a de-identifiable manner.
