An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Anxiety, Anxiety, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 2 - 7 |
| Updated: | 11/8/2018 |
| Start Date: | December 2019 |
| End Date: | November 2022 |
| Contact: | Haydee Cortes, B.A. |
| Email: | cortesh@uci.edu |
| Phone: | 714-480-0039 |
An Innovative Tailored Intervention for Improving Children's Postoperative Recovery
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 2-7 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.
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 2-7 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.
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.
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.
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
We found this trial at
2
sites
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4800 Sand Point Way NE
Seattle, Washington 98105
Seattle, Washington 98105
(206) 987-2000
Phone: 206-987-2704
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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