Clinical trial NCT03828669: Recovery Toolkits: Assessment of Pragmatic Behavioral Pain Medicine Delivered In Hospital After Surgery
Official title: Recovery Toolkits: An Observational Assessment of Nurse-Delivered, Pragmatic, Behavioral Pain Medicine for Post-Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Surgical Pain
Keywords: behavioral medicine
pain
perioperative
enhanced recovery after surgery
surgery
intervention
post-operative pain
opioid
digital
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-02-04
Enrollment: 649
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-surgical inpatients (spine, neurosurgery, and other specialties)

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.

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).

Eligibility criteria: Inclusion Criteria:

* Everyone

Exclusion Criteria:

* None, though Recovery Toolkits are English language

Primary outcomes:
measure: Satisfaction with Recovery Toolkits
timeFrame: 10 minute survey administered at hospital discharge
measure: Likelihood to recommend
timeFrame: 10 minute survey administered at hospital discharge
Secondary outcomes:
measure: Binary Opioid Use
timeFrame: Duration of inpatient hospital stay
measure: Average Pain
timeFrame: Duration of inpatient hospital stay
measure: Opioid Daily Dose
timeFrame: 5 minuute survey administered 1 month after surgery
measure: Opioid use
timeFrame: 5 minute survey administered 1 month after surgery
measure: Average Pain Intensity
timeFrame: 5 minute survey administered 1 month after surgery
measure: Opioid use
timeFrame: 5 minute survey administered 1 month after surgery
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Beth Darnall, PhD
role: PRINCIPAL_INVESTIGATOR
References: