Clinical trial NCT03730259: An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS)
Official title: An Innovative Tailored Intervention for Improving Children's Postoperative Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Postoperative Behavior
Keywords: Pediatric
Pain
Postoperative
General Anesthesia
Anesthesia Recovery Period
Patient Satisfaction
mobile health
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-11-05
Enrollment: 659
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized trial is to examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) in reducing anxiety and improving the recovery process in children undergoing surgery. Two hospitals and all parent-child dyads and healthcare providers (HCPs) will be randomized to either a Web-based Tailored Intervention Preparation for Surgery (WebTIPS) Group or to a Web-based Information (WebINFO) Group, the attention control group. The WebTIPS group will receive the newly developed intervention with short message service (SMS) two-way communication between an HCP and patient, while the WebINFO Group will only receive an internet and mobile platform with information on the management of preoperative anxiety and perioperative pain. The aims of this study are to:

Primary aim:

Quality of Clinical Care:

Determine whether and to what extent WebTIPS is more effective than an attention control intervention in reducing preoperative anxiety among children ages 1-12 years old undergoing anesthesia and outpatient surgery.

Secondary aims:

Quality of Clinical Care:

1. Examine the impact of WebTIPS on Post-Anesthesia care unit based postoperative clinical recovery parameters, such as pain and emergence delirium.
2. Examine the impact of WebTIPS on home-based postoperative clinical recovery parameters such as pain, new onset behavioral changes and return to normal daily activity over 2 weeks.
3. Determine if the use of WebTIPS reduces parental preoperative anxiety.

Experience of Care:

Examine the effects of WebTIPS on parental satisfaction with the overall experience of the surgical episode.

Cost of Care/Resource Use:

Determine if WebTIPS modifies healthcare resource use, as measured by 30-day charges adjusted for Medicaid cost-to-charge ratios.

Detailed description: The proposed clustered two-arm single blind, randomized trial of two children's hospitals: CHOC Children's (CHOC) and Seattle Children's Hospital. Approximately 620 patients and their families will be recruited in total. This study will examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) aimed at reducing anxiety and improving the recovery process in children undergoing surgery via parent and child interactive preparation modules. Each study site will have a permuted block group assignment stratified by surgical severity. Within each surgical severity group, patients and their families will be randomized to either a Web-based Tailored Intervention Preparation for Surgery (WebTIPS) Group or to a Web-based Information (WebINFO) Group, the attention control group. The WebTIPS group will receive the newly developed interactive intervention with short message service (SMS) two-way communication between a clinician and patient. Conversely, the WebINFO Group will only receive an internet and mobile platform with information on the management of preoperative anxiety and postoperative pain. Objective measures of children's preoperative anxiety and postoperative recovery will be collected prior and during the experimental period.

Patients and their parents in the intervention group will learn through the internet and mobile platforms that implementing strategies and ways to adjust behavior, such as distraction and medical reinterpretation, directs the child's attention away from their own distress or fear. This group will also have access to a SMS messaging system to allow for patient/parent-provider two-way interaction and two-way sharing of information so health care providers learn about parents' coping styles.

Child's anxiety (assessed through the modified Yale Preoperative Anxiety Scale-mYPAS) during induction will be assessed at two points, a) entering the operation room (OR) and b) introduction of the anesthesia mask to the child. If parents accompanied the child into the OR, their anxiety will be rated as they leave the OR (state-trait anxiety inventory-STAI). Also, parents answer baseline questionnaires aimed at capturing demographics (e.g. age, sex), as well as parental coping (through the Miller behavioral style scale), and child temperament (through the emotional, activity, and shyness temperament survey). In the holding area and separation, a research assistant who is blinded to group assignment will rate child anxiety (mYPAS) and ask parent anxiety (STAI), and also assess child/parent anxiety at separation to the OR (mYPAS, STAI). Postoperative analgesic consumption, behavioral and recovery measures will also be collected.

Eligibility criteria: Inclusion Criteria:

Children:

* Children scheduled to undergo anesthesia and outpatient surgery.
* Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study.
* Only children who are in the normal range of development will be recruited for this study

Parents:

* Parents of children who are enrolled in the study.

Healthcare Providers:

* Anesthesia care providers in the two study hospitals
* Nurses who provide preoperative nursing care to children who are about to undergo surgery in the two study hospitals

Exclusion Criteria:

Children:

* Patients with health status defined by ASA status IV-V
* Children who are not in the normal range of development and who are visually impaired will be excluded from this study.
* Children with visual impairment.

Parents:

* Parents who refuse to be part of the study and whose children are not eligible for the study.
* Parents who are visually impaired.

Healthcare Providers:

* Anesthesiologists who refuse to be part of the study
* Nurses who refuse to be part of the study

Primary outcomes:
measure: Assess children's domains of behavior indicating anxiety [Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents]
timeFrame: Day of surgery (Holding Area, Separation, Entrance to operating room, and placement of the anesthesia mask)
Secondary outcomes:
measure: Change in children's postoperative pain using the Faces Pain Scale-Revised (FPS-R)
timeFrame: Every 15 minutes for 1-2 hours while patient is in the post-anesthesia care unit
measure: Assess Pediatric Anesthesia Emergence Delirium [Emergence status and Psychometric Evaluation in children]
timeFrame: Baseline (Post-Anesthesia Care Unit)
measure: Change in children's pain intensity using the Postoperative Pain Measure (PPPM)
timeFrame: Days 1-14 after surgery, twice a day
measure: Change in children's postoperative maladaptive behaviors using the Post-Hospitalization-Behavior-Questionnaire for Ambulatory Surgery
timeFrame: Days 5, 7, and 14 after surgery
measure: Change in children's return to normal activity using the Pediatric Quality of Life (PedsQL) questionnaire
timeFrame: Days 1-14 after surgery, twice a day
measure: State-Trait Anxiety Inventory (STAI) (parent self-report)
timeFrame: Day of surgery (Holding area, separation, & Operating room)
measure: Assess parent satisfaction outcomes using the National Research Council (NRC) Picker satisfaction survey
timeFrame: Day 30 after surgery
measure: Change in children's postoperative pain using the Faces, Legs, Arms, Cry and Consolability pain scale (FLACC)
timeFrame: Every 15 minutes for 1-2 hours while patient is in the post-anesthesia care unit
measure: Change in children's postoperative pain using the visual analog scale (VAS)
timeFrame: Every 15 minutes for 1-2 hours while patient is in the post-anesthesia care unit
measure: Change in children's pain intensity using the Faces Pain Scale-Revised (FPS-R)
timeFrame: Days 1-14 after surgery, twice a day
Other outcomes:
measure: Assess children's temperament using the Emotional, Activity, Sociability, and Impulsivity temperament scale (adjusting variable)
timeFrame: 5 days before surgery
measure: Assess parent behavioral coping and style using Miller Behavioral style scale (adjusting variable)
timeFrame: 5 days before surgery
Locations:
city: Orange
country: United States
facility: CHOC Children's Hospital
state: California
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care
name: Zeev Kain, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: