OSA-18 in Children With Mild Obstructive Sleep Apnea: Can it be a Helpful Decision Making Tool?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- Decisional Conflict Scale (DCS)
Study Overview
Brief Summary
The concept is a novel research idea that incorporates the potential impact of patient quality of life (QOL) on decision-making for treatment of mild obstructive sleep apnea (OSA). Our hypothesis is that in children with mild OSA there is significant conflict with parental decision-making; in the absence of significant sleep apnea, there is limited research regarding comparative efficacy of various treatment options. The impact of a QOL questionnaire can be a significant deciding factor and may help guide management decisions in such situations.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Parent/caregiver of child with an initial diagnosis mild obstructive sleep apnea defined as polysomnography AHI score between 1 and 5
- •Parent/caregiver of child between 3 and 12 years of age
- •Parent/caregiver of child who has been diagnosed with tonsillar hypertrophy grade 2 or higher
Exclusion Criteria
- •Parent/caregiver of child diagnosed with a syndromic or known neurologic condition and/or multiple (more than two) medical cardiac or respiratory medical conditions
- •Parent/caregiver of child who has previously underwent tonsillectomy
Arms & Interventions
OSA-18 Case Group
Case group participants will be given the OSA-18 survey at the start of their consultation. OSA-18 is an 18-item questionnaire that collects information about 5 subscales that are considered to be elements in quality of life: sleep disturbance, physical symptoms, emotional symptoms, daytime function, and caregiver concerns. The score is calculated that ranges from 18 (no impact on quality of life) to 126 (major negative impact).
Upon completion of OSA-18, scores are tabulated and relayed to families through a decisional aid. The score and the aid, which explains treatment options, risks and benefits will be used to guide discussion throughout the consultation.
After the consultation is complete and the provider leaves the room, families will be given a decisional conflict scale survey. All surveys will remain anonymous by using a unique study identifier. Forms will be placed in a locked box by parents prior to departure from the exam room.
Intervention: OSA-18 Survey (Other)
OSA-18 Case Group
Case group participants will be given the OSA-18 survey at the start of their consultation. OSA-18 is an 18-item questionnaire that collects information about 5 subscales that are considered to be elements in quality of life: sleep disturbance, physical symptoms, emotional symptoms, daytime function, and caregiver concerns. The score is calculated that ranges from 18 (no impact on quality of life) to 126 (major negative impact).
Upon completion of OSA-18, scores are tabulated and relayed to families through a decisional aid. The score and the aid, which explains treatment options, risks and benefits will be used to guide discussion throughout the consultation.
After the consultation is complete and the provider leaves the room, families will be given a decisional conflict scale survey. All surveys will remain anonymous by using a unique study identifier. Forms will be placed in a locked box by parents prior to departure from the exam room.
Intervention: Decisional Conflict (DCS) (Other)
Control Group
During the consultation, families will be given a printed form, "decisional aid," which is given to families to explain treatment options as well as their risks and benefits. The consultation will proceed as normal according to standard of care with the aid being used to guide conversation.
After the consultation is complete and the provider leaves the room, families will be given a decisional conflict scale survey to complete. All surveys will remain anonymous and only a unique study identification number will be placed on the surveys to correctly match each survey. Forms will be placed in a locked box by parents prior to departure from the exam room.
Intervention: Decisional Conflict (DCS) (Other)
Outcomes
Primary Outcomes
Decisional Conflict Scale (DCS)
Time Frame: Through clinical visit, an average of 30 minutes
The Decisional Conflict Scale (DCS) is a survey administered to both the experimental and active comparator evaluating the degree of conflict a caregiver feels when determining a treatment option. The minimum score is 0 (indicating no decisional conflict) and the maximum score is 100 (indicating significant decisional conflict).
Secondary Outcomes
- Race/Ethnicity of child and parent/legal guardian(Through clinical visit, an average of 30 minutes)
- Gender of child and parent/legal guardian(Through clinical visit, an average of 30 minutes)
- BMI Z-score(Through clinical visit, an average of 30 minutes)
- BMI percentile(Through clinical visit, an average of 30 minutes)
- Polysomnography (PSG) (Sleep Study Data), AHI(Through study completion, and average of 3 months)
- Polysomnography (PSG) (Sleep Study Data), OAHI(Through study completion, and average of 3 months)
- Polysomnography (PSG) (Sleep Study Data), high CO2 occurrences(Through study completion, and average of 3 months)
- Polysomnography (PSG) (Sleep Study Data), minimum oxygen saturation(Through study completion, and average of 3 months)
- Age of child and parent/legal guardian(Through clinical visit, an average of 30 minutes)
- Parent/legal guardian identified health care literacy and comfort completing medical forms.(Through clinical visit, an average of 30 minutes)
- Selected Treatment Option(Through clinical visit, an average of 30 minutes)
Investigators
Nancy Grover
Attending Otolaryngologist, Assistant Professor of Otolaryngology
Connecticut Children's Medical Center