An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS)
Condition: Anxiety; Pain; Postoperative Behavior
Study type: Interventional

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.
    

Intervention name(s): Web-based Tailored Intervention Preparation for Surgery
Intervention type(s): Other
Intervention description(s): A Tailored Internet-based Preparation Program for Perioperative Anxiety and Pain (WebTIPS) is developed using the conceptual framework of the Triple Aim that evaluates the intervention within the context of clinical efficacy, improved child and parent experience, and reduced resource utilization during the surgical episode. WebTIPS aims at reducing perioperative anxiety and pain in children via an internet-based platform with short message service (SMS) two-way communication between a healthcare provider and patient.
Other intervention name(s): WebTIPS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pediatric; Pain; Postoperative; General Anesthesia; Anesthesia Recovery Period; Patient Satisfaction; mobile health