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

NCT ID: NCT03828669

Last Updated: 2021-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

649 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-25

Study Completion Date

2021-02-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Surgical Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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

Intervention Type BEHAVIORAL

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Everyone

Exclusion Criteria

* None, though Recovery Toolkits are English language
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Beth Darnall

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Beth Darnall, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford Hospital

Palo Alto, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IDCP18RT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Perioperative Pain Self-Management Program Trial
NCT04979429 ACTIVE_NOT_RECRUITING NA
Preventing Pain After Heart Surgery
NCT01480765 COMPLETED PHASE4