NCT03828669

Brief Summary

Behavioral pain medicine is largely absent from perioperative pathways, and on post-surgical recovery units. The goal of this project was to develop and implement "Recovery Toolkits", physical branded bags presented to patients after surgery. The "Recovery Toolkits" include a descriptive brochure and orientation to the contents of the bag. "Recovery Toolkits" include a behavioral pain medicine self-help book, an app with a downloadable pain management audiofile, earbuds, and a pen. Patients on each unit have access to iPads where they may view a digital behavioral pain medicine program ("My Surgical Success"), consisting of three 15-minute video learning modules. The "Recovery Toolkits" are psychologist-developed and nurse-delivered to every patient on the surgical recovery units. This pragmatic project seeks to understand:

  1. 1.Nurse perceived value of the intervention
  2. 2.Burden to nurses to deliver the intervention to all patients
  3. 3.Patient engagement with the Recovery Toolkits
  4. 4.Patient perceived value of the Recovery Toolkits
  5. 5.Patient satisfaction with pain care
  6. 6.Impact of Recovery Toolkits on pain and opioid use in hospital and at one-month discharge relative to a pre-Recovery Toolkit program cohort of patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
649

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

2.1 years

First QC Date

January 29, 2019

Last Update Submit

July 7, 2021

Conditions

Post Surgical Pain

Keywords

behavioral medicinepainperioperativeenhanced recovery after surgerysurgeryinterventionpost-operative painopioiddigital

Outcome Measures

Primary Outcomes (2)

  • Satisfaction with Recovery Toolkits

    6-point scale

    10 minute survey administered at hospital discharge

  • Likelihood to recommend

    5-point scale

    10 minute survey administered at hospital discharge

Secondary Outcomes (6)

  • Binary Opioid Use

    Duration of inpatient hospital stay

  • Average Pain

    Duration of inpatient hospital stay

  • Opioid Daily Dose

    5 minuute survey administered 1 month after surgery

  • Opioid use

    5 minute survey administered 1 month after surgery

  • Average Pain Intensity

    5 minute survey administered 1 month after surgery

  • +1 more secondary outcomes

Study Arms (2)

Usual Care

Prior to the roll-out of the Recovery Toolkit program, all post-surgical patients receiving current standard of care are given pain care surveys at hospital discharge. Survey questions ask about pain, and satisfaction with pain care. The investigators will conduct chart review for pain and opioid use.

Recovery Toolkit

After launch of the Recovery Toolkit program on Jan 25, all post-surgical patients will be offered a Recovery Toolkit by a unit nurse. A pain survey will be administered at hospital discharge to assess about pain in the hospital, satisfaction with pain care, whether they received a Toolkit, use of the Toolkit, and likelihood to recommend the Toolkit. The investigators will conduct chart review for pain and opioid use.

Behavioral: Recovery Toolkits

Interventions

Recovery ToolkitsBEHAVIORAL

Recovery Toolkits are presented to patients in a branded bag and include a brochure, a self-help behavioral pain medicine book, a downloadable app, earbuds, and access to digital behavioral medicine (the "My Surgical Success" program including online educational videos)

Recovery Toolkit

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Post-surgical inpatients (spine, neurosurgery, and other specialties)

You may qualify if:

  • Everyone

You may not qualify if:

  • None, though Recovery Toolkits are English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Hospital

Palo Alto, California, 94034, United States

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Beth Darnall, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 29, 2019

First Posted

February 4, 2019

Study Start

January 25, 2019

Primary Completion

February 16, 2021

Study Completion

February 16, 2021

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)