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Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery (SurgeryPal)

Primary Purpose

Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT (SurgeryPal)

Education

About this trial

This is an interventional treatment trial for Juvenile; Scoliosis focused on measuring Psychosocial Intervention, Spinal Fusion Surgery, Chronic Pain, Acute Pain, Adolescent, Randomized controlled trial

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Teen

12 to 18 years old at the time of enrollment
Undergoing scheduled spinal fusion surgery (eligible indications: juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis or kyphosis)

Parent/Caregiver

Parent or legal guardian of child who meets study criteria

Exclusion Criteria:

Teen

Does not speak or understand English
Has severe learning disability, cognitive impairment or intellectual delay (i.e. unable to read at 5th grade level)
Does not have access to a smart device (smartphone, iPad or tablet; Teens can borrow an iPad from the study team if one is available)
Recent psychiatric admission (in the past 30 days)
Severe systemic disease (neuromuscular scoliosis, cancer)
On a regular treatment regimen for a severe chronic medical condition
Prior major surgery (open surgery such as heart, lung, brain, abdominal surgery, or prior spine surgery)
Diagnosed chronic musculoskeletal pain condition (e.g. complex regional pain syndrome, fibromyalgia, widespread musculoskeletal pain)

Parent/Caregiver

Does not speak or understand English
Does not have access to a smart device (smartphone, iPad or tablet)

Sites / Locations

Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Pre-operative and Post-operative Education intervention

Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention

Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal)

Pre-operative and Post-operative CBT intervention (SurgeryPal)

Arm Description

This arm receives access to Patient Education intervention in the pre- and post-operative phases.

This arm receives access to CBT intervention in the pre-operative phase and Patient Education in the post-operative phase.

This arm receives access to Patient Education intervention during the pre-operative period and CBT intervention during the post-operative period.

This arm receives access to CBT intervention during the pre-operative and post-operative period.

Outcomes

Primary Outcome Measures

Post-surgical pain intensity and interference

The Brief Pain Inventory (BPI) has 2 scales: pain intensity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference. The 24 hour (short) version of this measure will be completed via REDCap daily for 14 days post-hospital discharge (beginning on day 1 after hospital discharge, and ending up to 3-weeks post-surgery).

Chronic pain intensity and interference

The Brief Pain Inventory (BPI) has 2 scales: pain intensity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference. The 24 hour (short) version of this measure will be completed via REDCap daily for 7 days at 3 months after the participant's surgery date.

Secondary Outcome Measures

Change in health-related quality of life

The Pediatric Quality of Life Inventory (Peds-QL) 15-item short form assesses several domains of functioning, including physical, social, emotional, and academic functioning. The PedsQL is widely used and demonstrates good reliability for both the parent and child self-report measures. Scale scores range from 0 to 100. Higher scores indicate fewer difficulties (better) health-related quality of life. Subscales of physical and psychosocial health will be used in analyses.

Change in opioid use

Youth will report medication use on the Brief Pain Inventory (BPI), including selecting medication name from a dropdown list (opioid, acetaminophen, anti-inflammatory, other). Number of days of opioid use will be used in analyses.

Change in opioid misuse

The American Psychiatric Association (APA) Adapted National Institute for Drug Abuse (NIDA) Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) Level 2 Tool (Teen Report) recommended by the National Institute on Drug Abuse for substance use screening in adolescents, will be used to assess alcohol, smoking, substance, and opioid use. Additional questions on reasons for misuse (e.g. to treat pain, to get high, etc.) and source of opioids (e.g. prescription, from a friend or relative) will be collected using the corresponding questions and response options used in the National Survey on Drug Use and Health.

Change in psychosocial distress

The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress Scales include an 8-item scale of anxiety that assesses fear (e.g., fearfulness), anxious misery (e.g., worry) and hyperarousal (e.g., nervousness) and 8-item scale of depressive symptoms that evaluates negative mood, view of self and social cognitions. Response options range from 1 (Never) to 5 (Almost Always). Raw scores for anxiety and depression are obtained by summing the corresponding items' response values, and range from 8 to 40 with higher scores indicating higher distress.

Change in mental health

Parents and teens will self-report on the Patient Health Questionnaire-4, a 4 item screening measure of general anxiety and depressive symptoms. Response options range from 0 (Not at all) to 3 (Nearly Every Day). Total scores are calculated by summing items, for a total score ranging from 0 to 12, with higher scores indicating greater anxiety and depressive symptoms.

Change in sleep quality

The Adolescent Sleep Wake Scale 10-item version (Teen Report) is a 10-item measure assesses self-reported sleep quality. Scale scores range from 1 to 6 with higher scores indicating better sleep quality. Four additional items assess sleep duration on weekdays and weekends.

Change in pain catastrophizing

The Pain Catastrophizing Scale - Child Version and Parent Version is a Self-report 13 item measures that assess child pain catastrophizing and parent's catastrophizing about child's pain, respectively. Total scores range from 0 to 52 with higher scores indicating greater pain catastrophizing.

Global pain severity

The Patient Global Impression of Severity Scale (PGIS), Teen Report is a 1-item measure that assesses adolescent's self-reported global impression of pain severity. Response options range from 0 (none) to 3 (severe) with higher scores indicating higher pain severity.

Full Information

NCT ID

NCT04637802

First Posted

November 6, 2020

Last Updated

August 9, 2022

Sponsor

Seattle Children's Hospital

Collaborators

Duke University, University of Utah, Vanderbilt University, Johns Hopkins University, Connecticut Children's Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04637802

Brief Title

Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

Acronym

SurgeryPal

Official Title

Effectiveness of an mHealth Psychosocial Intervention to Prevent Transition From Acute to Chronic Postsurgical Pain in Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 29, 2020 (Actual)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seattle Children's Hospital

Collaborators

Duke University, University of Utah, Vanderbilt University, Johns Hopkins University, Connecticut Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).

Detailed Description

Major musculoskeletal surgeries are associated with particularly high prevalence of both acute and chronic post-surgical pain (CPSP), with 80% of youth reporting intense acute pain after hospital discharge, and up to half reporting CPSP up to one year after spine surgery. Interventions to improve recovery and reduce pain after surgery have potential to interrupt a negative trajectory of suffering and disability associated with chronic pain. Our specific aims are: Primary: (1) Determine effectiveness of a pre-operative mHealth psychosocial intervention to improve acute pain outcomes in adolescents undergoing major musculoskeletal surgery, (2) Determine effectiveness of a post-operative mHealth psychosocial intervention to improve chronic pain outcomes at 3 months in adolescents undergoing major musculoskeletal surgery, (3) Determine the combined effects of pre- and post-operative psychosocial intervention on chronic pain outcomes. Secondary: (1) Determine effectiveness of pre-operative psychosocial intervention to reduce opioid use during the 14 days following hospital discharge, (2) Determine effectiveness of psychosocial intervention to improve health-related quality of life following surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis;Congenital, Kyphosis, Spondylolisthesis

Keywords

Psychosocial Intervention, Spinal Fusion Surgery, Chronic Pain, Acute Pain, Adolescent, Randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

Randomized and double-blinded controlled trial of cognitive-behavioral intervention vs education at two phases (pre-operative and post-operative)

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pre-operative and Post-operative Education intervention

Arm Type

Active Comparator

Arm Description

This arm receives access to Patient Education intervention in the pre- and post-operative phases.

Arm Title

Pre-operative CBT intervention (SurgeryPal), Post-operative Education intervention

Arm Type

Experimental

Arm Description

This arm receives access to CBT intervention in the pre-operative phase and Patient Education in the post-operative phase.

Arm Title

Pre-operative Education intervention, Post-operative CBT intervention (SurgeryPal)

Arm Type

Experimental

Arm Description

This arm receives access to Patient Education intervention during the pre-operative period and CBT intervention during the post-operative period.

Arm Title

Pre-operative and Post-operative CBT intervention (SurgeryPal)

Arm Type

Experimental

Arm Description

This arm receives access to CBT intervention during the pre-operative and post-operative period.

Intervention Type

Behavioral

Intervention Name(s)

CBT (SurgeryPal)

Intervention Description

The SurgeryPal intervention is a cognitive-behavioral program for youth undergoing major surgery. SurgeryPal is delivered in two 4-week phases: the pre-operative phase, and the post-operative phase. Each phase consists of 3 separate treatment modules for youth and parents, which teach cognitive and behavioral coping skills to target known psychosocial and behavioral risk factors (i.e. anxiety/distress and sleep disturbance) for poorer postsurgical outcomes, and provide training in pain self-management skills. Pre-operative modules include: 1) Preparing for surgery, 2) Coping with stress before surgery, and 3) Getting ready for the hospital. Postoperative modules include: 1) Coping at home after surgery, 2) Return to activities and school, and 3) Long-term recovery. Modules are self-guided and interactive, and focus on phases of preparation and recovery from surgery. The goal of the program is to reduce pain and enhance quality of life following surgery in youth.

Intervention Type

Behavioral

Intervention Name(s)

Education

Intervention Description

The patient education website will serve as the active comparator. The purpose is to control for time, attention, and online usage. Youth and parents will be provided access to an education website containing information about pediatric surgery at the same time interval as the active intervention; however, there will be no exposure to cognitive and behavioral coping skills. Similar to the CBT condition, the presurgery period of Education will be administered for one month prior to surgery and the postsurgery period will be administered for one month after the post-discharge assessment.

Primary Outcome Measure Information:

Title

Post-surgical pain intensity and interference

Description

Time Frame

Up to 3 weeks post-surgery

Title

Chronic pain intensity and interference

Description

The Brief Pain Inventory (BPI) has 2 scales: pain intensity (4 items) and pain interference (7 items). Items are averaged to yield scale scores, ranging from 0 to 10, with higher scores indicating greater pain intensity or interference. The 24 hour (short) version of this measure will be completed via REDCap daily for 7 days at 3 months after the participant's surgery date.

Time Frame

3 months post-surgery

Secondary Outcome Measure Information:

Title

Change in health-related quality of life

Description

Time Frame

Baseline, 3-months post-surgery, 6-months post-surgery

Title

Change in opioid use

Description

Time Frame

Baseline, Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery

Title

Change in opioid misuse

Description

Time Frame

Baseline, 3-months post-surgery, 6-months post-surgery

Title

Change in psychosocial distress

Description

Time Frame

Baseline, 3-months post-surgery, 6-months post-surgery

Title

Change in mental health

Description

Time Frame

Baseline, 3-months post-surgery, 6-months post-surgery

Title

Change in sleep quality

Description

Time Frame

Baseline, 3-months post-surgery, 6-months post-surgery

Title

Change in pain catastrophizing

Description

Time Frame

Baseline, 3-months post-surgery

Title

Global pain severity

Description

Time Frame

Up to 3 weeks post-surgery, 3-months post-surgery, 6-months post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Teen 12 to 18 years old at the time of enrollment Undergoing scheduled spinal fusion surgery (eligible indications: juvenile/adolescent idiopathic scoliosis, congenital scoliosis, spondylolisthesis or kyphosis) Parent/Caregiver Parent or legal guardian of child who meets study criteria Exclusion Criteria: Teen Does not speak or understand English Has severe learning disability, cognitive impairment or intellectual delay (i.e. unable to read at 5th grade level) Does not have access to a smart device (smartphone, iPad or tablet; Teens can borrow an iPad from the study team if one is available) Recent psychiatric admission (in the past 30 days) Severe systemic disease (neuromuscular scoliosis, cancer) On a regular treatment regimen for a severe chronic medical condition Prior major surgery (open surgery such as heart, lung, brain, abdominal surgery, or prior spine surgery) Diagnosed chronic musculoskeletal pain condition (e.g. complex regional pain syndrome, fibromyalgia, widespread musculoskeletal pain) Parent/Caregiver Does not speak or understand English Does not have access to a smart device (smartphone, iPad or tablet)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jennifer Rabbitts, MD

Phone

206-884-1361

jennifer.rabbitts@seattlechildrens.org

First Name & Middle Initial & Last Name or Official Title & Degree

Tonya Palermo, PhD

Phone

206-884-4208

tonya.palermo@seattlechildrens.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Rabbitts, MD

Organizational Affiliation

Seattle Children's Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tonya Palermo, PhD

Organizational Affiliation

Seattle Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Rabbitts

First Name & Middle Initial & Last Name & Degree

Jennifer Rabbitts, MD

First Name & Middle Initial & Last Name & Degree

Tonya Palermo, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

A releasable database for underlying primary data for publications will be made broadly available on the NIH HEAL Initiative central data repository. The database will be produced and will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act (HIPAA). The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. In accordance with policies of the NIH, the DCC will send the releasable database to the entity determined by the NIH or specific institute to be the repository for data created under the HEAL initiative. The DCC is able to produce a relational database export, or use SAS or SPSS data sets. The DCC will accompany the database with full documentation so that individual investigators will be able to effectively use the data.

IPD Sharing Time Frame

After last subject enrollment and all follow up procedures have been completed, the HEAL Pain Management Effectiveness Research Network Data Coordinating Center (DCC) at the University of Utah will prepare a final study database for the trial, which will then be used for statistical analyses and publication of findings from the trial. The policies for release of this database are in accordance with the HEAL Data Sharing policy as determined by the NIH. Our preliminary plan is to release the underlying primary database at the time of publication of the primary manuscript. The primary publication from the dataset will be made publicly available immediately without any embargo period through the Creative Commons Generic License in accordance with the HEAL Public Access guidance. Additional secondary publications will be deposited electronically within 4 weeks of acceptance into PubMed Central.

IPD Sharing Access Criteria

Access to the releasable database housed in the NIH-assigned repository will be in accordance with procedures and regulations of the NIH or specific institute. The DCC will not provide any support for investigators using the releasable database.

Citations:

PubMed Identifier

34330321

Citation

Rabbitts JA, Zhou C, de la Vega R, Aalfs H, Murray CB, Palermo TM. A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial. Trials. 2021 Jul 30;22(1):506. doi: 10.1186/s13063-021-05421-3. Erratum In: Trials. 2021 Sep 21;22(1):646.

Results Reference

derived

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Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

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