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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03828669
Other study ID # IDCP18RT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 25, 2019
Est. completion date February 16, 2021

Study information

Verified date July 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 649
Est. completion date February 16, 2021
Est. primary completion date February 16, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Everyone Exclusion Criteria: - None, though Recovery Toolkits are English language

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
United States Stanford Hospital Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Satisfaction with Recovery Toolkits 6-point scale 10 minute survey administered at hospital discharge
Primary Likelihood to recommend 5-point scale 10 minute survey administered at hospital discharge
Secondary Binary Opioid Use Average Morphine Equivalent Daily Dose Duration of inpatient hospital stay
Secondary Average Pain Average of all pain ratings (0-10 numeric rating scale) Duration of inpatient hospital stay
Secondary Opioid Daily Dose Morphine Equivalent Daily Dose 5 minuute survey administered 1 month after surgery
Secondary Opioid use Binary question about continued opioid use (yes/no) 5 minute survey administered 1 month after surgery
Secondary Average Pain Intensity Rating on 0-10 numeric rating scale 5 minute survey administered 1 month after surgery
Secondary Opioid use Morphine Equivalent Daily Dose 5 minute survey administered 1 month after surgery
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