An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS)

NCT ID: NCT03730259

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 659 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-12
• Study Completion Date: 2023-11-30

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.

Conditions

Anxiety; Pain; Postoperative Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

WebTIPS

A Tailored Program for Perioperative Anxiety and Pain (WebTIPS) aims at reducing perioperative anxiety and pain in children via an internet and mobile platform with short message service (SMS) two-way communication between a healthcare provider and patient/parent. The Web-based Tailored Intervention Preparation for Surgery (WebTIPS) program is developed using the conceptual framework of the Triple Aim that evaluates the intervention within the context of clinical efficacy, improved child and parent surgical experience, and reduced resource utilization during the surgical episode.

Group Type: EXPERIMENTAL

Web-based Tailored Intervention Preparation for Surgery

Intervention Type: OTHER

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.

Control

Subjects in this attention control group, the Web-based Information (WebINFO) group will not be provided tailored content or access to two-way communication. Instead, this group will only receive basic information regarding the management of perioperative anxiety and postoperative pain via the internet and/or mobile platform.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Web-based Tailored Intervention Preparation for Surgery

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.

Intervention Type: OTHER

Other Intervention Names

WebTIPS

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Zeev Kain

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeev Kain, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care

Locations

CHOC Children's Hospital

Orange, California, United States

Seattle Children's Hospital

Seattle, Washington, United States

Countries

United States

Other Identifiers

1R01HD091286-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R01HD091286-01A1 [#2019-5130]

Identifier Type: -

Identifier Source: org_study_id