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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT03828669
Collaborator
(none)
649
1
24.7
26.2

Study Details

Study Description

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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Recovery Toolkits

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 Design

Study Type:
Observational
Actual Enrollment :
649 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Recovery Toolkits: An Observational Assessment of Nurse-Delivered, Pragmatic, Behavioral Pain Medicine for Post-Surgical Patients
Actual Study Start Date :
Jan 25, 2019
Actual Primary Completion Date :
Feb 16, 2021
Actual Study Completion Date :
Feb 16, 2021

Arms and Interventions

Arm 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.

Behavioral: Recovery Toolkits
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)

Outcome Measures

Primary Outcome Measures

  1. Satisfaction with Recovery Toolkits [10 minute survey administered at hospital discharge]

    6-point scale

  2. Likelihood to recommend [10 minute survey administered at hospital discharge]

    5-point scale

Secondary Outcome Measures

  1. Binary Opioid Use [Duration of inpatient hospital stay]

    Average Morphine Equivalent Daily Dose

  2. Average Pain [Duration of inpatient hospital stay]

    Average of all pain ratings (0-10 numeric rating scale)

  3. Opioid Daily Dose [5 minuute survey administered 1 month after surgery]

    Morphine Equivalent Daily Dose

  4. Opioid use [5 minute survey administered 1 month after surgery]

    Binary question about continued opioid use (yes/no)

  5. Average Pain Intensity [5 minute survey administered 1 month after surgery]

    Rating on 0-10 numeric rating scale

  6. Opioid use [5 minute survey administered 1 month after surgery]

    Morphine Equivalent Daily Dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Everyone
Exclusion Criteria:
  • None, though Recovery Toolkits are English language

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford Hospital Palo Alto California United States 94034

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Beth Darnall, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beth Darnall, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier:
NCT03828669
Other Study ID Numbers:
  • IDCP18RT
First Posted:
Feb 4, 2019
Last Update Posted:
Jul 8, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beth Darnall, Principal Investigator, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2021