Recovery Toolkits: Assessment of Pragmatic Behavioral Pain Medicine Delivered In Hospital After Surgery

July 7, 2021 updated by: Beth Darnall, Stanford University

Recovery Toolkits: An Observational Assessment of Nurse-Delivered, Pragmatic, Behavioral Pain Medicine for Post-Surgical Patients

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. Nurse perceived value of the intervention
  2. Burden to nurses to deliver the intervention to all patients
  3. Patient engagement with the Recovery Toolkits
  4. Patient perceived value of the Recovery Toolkits
  5. Patient satisfaction with pain care
  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Stanford "Recovery Toolkit" program is delivered by nurses across multiple surgical recovery units and surgery types, including neurosurgery, spine, and orthopedic surgeries. All patients who enter the units are offered a "Recovery Toolkit", which is a physical and branded bag. The program includes the following elements: 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 all participating units 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.

At discharge, patients are asked to evaluate their pain care and perception about the "Recovery Toolkit" in a 10-item survey that includes items as to whether the patient received a "Recovery Toolkit" (yes/no), did they use the "Recovery Toolkit" (yes/no), their satisfaction with the "Recovery Toolkit" (6-point likert scale), and recommendation for continuing the program (5-point likert scale). Chart review will extract data for demographics, surgery type, existing pain conditions and comorbidities, pain intensity scores averaged over the duration of their inpatient stay, as well as total opioid use during hospital stay and a daily average for inpatient opioid use. At one month after surgery, patients who agreed to be contacted will be asked their average pain intensity (0-10), whether they are taking opioid medication (yes/no) and how much (morphine equivalent daily dose), whether they have used the Recovery Toolkit information (yes/no), and, if yes, to please rate the helpfulness of the Recovery Toolkit information (0-10).

Nurses will be surveyed to determine the level of burden to deliver the intervention (0-6), their perceived value of the intervention to their patients (0-6), and their assessment on whether the program should be continued/expanded (0-6).

Study Type

Observational

Enrollment (Actual)

649

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Palo Alto, California, United States, 94034
        • Stanford hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Everyone

Exclusion Criteria:

  • None, though Recovery Toolkits are English language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with Recovery Toolkits
Time Frame: 10 minute survey administered at hospital discharge
6-point scale
10 minute survey administered at hospital discharge
Likelihood to recommend
Time Frame: 10 minute survey administered at hospital discharge
5-point scale
10 minute survey administered at hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binary Opioid Use
Time Frame: Duration of inpatient hospital stay
Average Morphine Equivalent Daily Dose
Duration of inpatient hospital stay
Average Pain
Time Frame: Duration of inpatient hospital stay
Average of all pain ratings (0-10 numeric rating scale)
Duration of inpatient hospital stay
Opioid Daily Dose
Time Frame: 5 minuute survey administered 1 month after surgery
Morphine Equivalent Daily Dose
5 minuute survey administered 1 month after surgery
Opioid use
Time Frame: 5 minute survey administered 1 month after surgery
Binary question about continued opioid use (yes/no)
5 minute survey administered 1 month after surgery
Average Pain Intensity
Time Frame: 5 minute survey administered 1 month after surgery
Rating on 0-10 numeric rating scale
5 minute survey administered 1 month after surgery
Opioid use
Time Frame: 5 minute survey administered 1 month after surgery
Morphine Equivalent Daily Dose
5 minute survey administered 1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2019

Primary Completion (Actual)

February 16, 2021

Study Completion (Actual)

February 16, 2021

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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