- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828669
Recovery Toolkits: Assessment of Pragmatic Behavioral Pain Medicine Delivered In Hospital After Surgery
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:
- Nurse perceived value of the intervention
- Burden to nurses to deliver the intervention to all patients
- Patient engagement with the Recovery Toolkits
- Patient perceived value of the Recovery Toolkits
- Patient satisfaction with pain care
- 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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94034
- Stanford hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Everyone
Exclusion Criteria:
- None, though Recovery Toolkits are English language
Study Plan
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.
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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.
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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)
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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
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6-point scale
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10 minute survey administered at hospital discharge
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Likelihood to recommend
Time Frame: 10 minute survey administered at hospital discharge
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5-point scale
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10 minute survey administered at hospital discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binary Opioid Use
Time Frame: Duration of inpatient hospital stay
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Average Morphine Equivalent Daily Dose
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Duration of inpatient hospital stay
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Average Pain
Time Frame: Duration of inpatient hospital stay
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Average of all pain ratings (0-10 numeric rating scale)
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Duration of inpatient hospital stay
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Opioid Daily Dose
Time Frame: 5 minuute survey administered 1 month after surgery
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Morphine Equivalent Daily Dose
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5 minuute survey administered 1 month after surgery
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Opioid use
Time Frame: 5 minute survey administered 1 month after surgery
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Binary question about continued opioid use (yes/no)
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5 minute survey administered 1 month after surgery
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Average Pain Intensity
Time Frame: 5 minute survey administered 1 month after surgery
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Rating on 0-10 numeric rating scale
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5 minute survey administered 1 month after surgery
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Opioid use
Time Frame: 5 minute survey administered 1 month after surgery
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Morphine Equivalent Daily Dose
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5 minute survey administered 1 month after surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDCP18RT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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