TY - JOUR
T1 - Non-pharmacological Options in Postoperative Hospital-Based and Rehabilitation Pain Management (NOHARM)
T2 - Protocol for a Stepped-Wedge Cluster-Randomized Pragmatic Clinical Trial
AU - Mayo Clinic NOHARM Research Team
AU - Redmond, Sarah
AU - Tilburt, Jon
AU - Cheville, Andrea
N1 - Funding Information:
Marcel Salive, MD, NIA; Theresa Cruz, PhD, National Institute of Child Health and Human Development (NICHD); and Scott Wright, MD, Mayo Clinic IRB; as well as the Biostatistics & Design as well as the Ethics & Regulatory Cores of the Healthcare Systems Collaboratory all provided invaluable feedback in the construction of this protocol. Becky Fulton, P.T., also played a valuable role in this work. We would like to acknowledge our dear colleague and friend, Dr. Aaron Leppin, for his thoughtful contributions to this manuscript and tireless commitment to the NOHARM trial until his passing on November 3, 2021. He is included in the group authorship because of his significant contribution to this work before his passing. This work was supported by the NIH through the NIH HEAL Initiative under award numbers UG3AG067593 and UH3AG067593 from the NIA and the National Institute of Neurological Disorders and Stroke (NINDS). This work also received logistical and technical support from the PRISM Resource Coordinating Center under award number U24AT010961 from the NIH through the NIH HEAL Initiative. The funders provided funding for the trial and Rapid Service Fee. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or its HEAL Initiative. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Dr. Sarah Redmond, the Mayo Clinic NOHARM Research Team, Dr. Andrea Cheville, and Dr. Jon Tilburt contributed to the study concept and design. Dr. Andrea Cheville and Dr. Jon Tilburt acquired funding for the study. Dr. Sarah Redmond prepared the first draft of this manuscript. All authors contributed to and approved of the final version of this manuscript. The Mayo Clinic NOHARM Research Team includes the following authors who provided substantial and equal contributions to this work: Matthew P. Abdel, M.D., Jeffrey Basford, M.D., Raenell Campbell, Robert Cima, M.D., Sue Custhall, APRN, CNS, D.N.P., Sean Dowdy, M.D., Halena Gazelka, M.D., Amanda Glasgow, M.H.A., Elizabeth Habermann, Ph.D., Ian Hargraves, Ph.D., Sarah Harper, Jane Hein, P.T., Jeph Herrin, Ph.D., Michael Hooten, M.D., Lina Ibarra Figueroa, P.T., D.P.T, Amanika Kumar, M.D., Susan Launder, M.S.N, RN, BMT-CN, Aaron L., Leppin, M.D., MSc, Mary McGough, Amanda Nelson, Joel Pacyna, M.A., Karin Pyan, Jewel Podratz, M.B.A., Cathi Rhodes, Marguerite Robinson, M.A., Angela Severson, Mark Stanfield, M.A., Kristi Swanson, M.S., Cindy Tofthagen, Ph.D., and Natalie Wegner. Dr. Sarah Redmond, Dr. Andrea Cheville, Dr. Jon Tilburt, and the Mayo Clinic NOHARM Study Team have nothing to disclose. The Mayo Clinic IRB reviewed and approved this protocol (IRB #20-004839). The IRB endorsed waiving individual patient and clinician consent, citing the intervention’s congruence with standard of care, practicability constraints, a robust practice engagement, and written endorsement plan as a substantive alternative authorization. This trial complies with the Helsinki Declaration of 1964 and its amendments. Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study. All study data will be kept confidential and conform to strict Mayo Clinic Policy Guidelines for handling protected health information (PHI). Collected data will be stored within Epic until its extraction for analyses at the end of the study. Extracted data will be transferred to Mayo Clinic research servers protected by password and encryption. Identifiable data will only be accessible by IRB-approved study personnel. If the Mayo Clinic IRB, NIA, or other governmental regulatory agencies need to access this data for audits, inspections, or monitoring purposes, access will be granted. Data shared outside the Mayo Clinic firewall will follow all Mayo Clinic guidelines and precautions (removing PHI, de-identification of data, and adding encryption). A version of this protocol and preliminary process data were accepted for presentation at the International Congress on Integrative Medicine and Health, May 23–26, 2020 in Phoenix, AZ.
Funding Information:
This work was supported by the NIH through the NIH HEAL Initiative under award numbers UG3AG067593 and UH3AG067593 from the NIA and the National Institute of Neurological Disorders and Stroke (NINDS). This work also received logistical and technical support from the PRISM Resource Coordinating Center under award number U24AT010961 from the NIH through the NIH HEAL Initiative. The funders provided funding for the trial and Rapid Service Fee. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or its HEAL Initiative.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/9
Y1 - 2022/9
N2 - Introduction: Opioids may be necessary for guideline-concordant acute perioperative pain management, but their use carries risks for unintended prolonged use and addiction. Guidelines recommend use of validated non-pharmacological pain care (NPPC) approaches in conjunction with prescribed opioids and other analgesics. Our protocol outlines a population-level, pragmatic trial that will test a bundled intervention comprised of an electronic health record (EHR) portal-based conversation guide, EHR clinical decision support (CDS), and a suite of self-management educational and support materials to encourage and advance NPPC use. Methods: We are conducting a stepped-wedge, cluster-randomized pragmatic trial spanning seven surgical specialties across six geographically diverse locations within the Mayo Clinic Enterprise. Thirty two surgical practices across six locations (Rochester, Minnesota; Mankato, Minnesota; La Crosse, Wisconsin; Eau Claire, Wisconsin; Phoenix, Arizona; Jacksonville, Florida) comprise 22 distinct practice clusters that are randomly assigned to one of five steps using constrained randomization. Steps “go live” by initiating the intervention at 7-month intervals between March 2021 and July 2023. Patients over 18 years of age who are scheduled for qualifying procedures within “live” consenting practices are sent a Healing After Surgery guide via their patient portals pre-operatively, directing them to identify their preferred NPPC modalities among 13 approaches. These selections create CDS options for care teams to support patients with self-management materials that reinforce safe NPPC use. Planned Outcomes: Patients’ clinical, demographic, and outcome data will be abstracted from the Epic EHR. Primary outcomes will be the Patient Reported Outcomes Measurement Information System (PROMIS) pain interference and physical functioning computer adaptive tests (CAT) collected at 1, 2, and 3 months postoperatively via the patient portal. We will mail printed versions of the 6-item PROMIS short forms to portal non-responders to minimize bias. Secondary outcomes will include the PROMIS anxiety CAT, opioid consumption, and self-reported NPPC use. Trial Registration: ClinicalTrials.gov identifier, NCT04570371.
AB - Introduction: Opioids may be necessary for guideline-concordant acute perioperative pain management, but their use carries risks for unintended prolonged use and addiction. Guidelines recommend use of validated non-pharmacological pain care (NPPC) approaches in conjunction with prescribed opioids and other analgesics. Our protocol outlines a population-level, pragmatic trial that will test a bundled intervention comprised of an electronic health record (EHR) portal-based conversation guide, EHR clinical decision support (CDS), and a suite of self-management educational and support materials to encourage and advance NPPC use. Methods: We are conducting a stepped-wedge, cluster-randomized pragmatic trial spanning seven surgical specialties across six geographically diverse locations within the Mayo Clinic Enterprise. Thirty two surgical practices across six locations (Rochester, Minnesota; Mankato, Minnesota; La Crosse, Wisconsin; Eau Claire, Wisconsin; Phoenix, Arizona; Jacksonville, Florida) comprise 22 distinct practice clusters that are randomly assigned to one of five steps using constrained randomization. Steps “go live” by initiating the intervention at 7-month intervals between March 2021 and July 2023. Patients over 18 years of age who are scheduled for qualifying procedures within “live” consenting practices are sent a Healing After Surgery guide via their patient portals pre-operatively, directing them to identify their preferred NPPC modalities among 13 approaches. These selections create CDS options for care teams to support patients with self-management materials that reinforce safe NPPC use. Planned Outcomes: Patients’ clinical, demographic, and outcome data will be abstracted from the Epic EHR. Primary outcomes will be the Patient Reported Outcomes Measurement Information System (PROMIS) pain interference and physical functioning computer adaptive tests (CAT) collected at 1, 2, and 3 months postoperatively via the patient portal. We will mail printed versions of the 6-item PROMIS short forms to portal non-responders to minimize bias. Secondary outcomes will include the PROMIS anxiety CAT, opioid consumption, and self-reported NPPC use. Trial Registration: ClinicalTrials.gov identifier, NCT04570371.
KW - Non-pharmacologic
KW - Opioids
KW - Pain care
KW - Postoperative recovery
UR - http://www.scopus.com/inward/record.url?scp=85133844655&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85133844655&partnerID=8YFLogxK
U2 - 10.1007/s40122-022-00393-x
DO - 10.1007/s40122-022-00393-x
M3 - Article
AN - SCOPUS:85133844655
SN - 2193-8237
VL - 11
SP - 1037
EP - 1053
JO - Pain and Therapy
JF - Pain and Therapy
IS - 3
ER -