Determinants and Effects in the Use of NOHARM Pain Management

NCT05166356 | Completed

• 2 other identifiers: 21-007898UH3AG067593-03
• Study Type: observational
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to enrich the ongoing Non-pharmacological Pain Management After Surgery (NOHARM) pragmatic trial (NCT04570371) with a mixed methods analysis of patient and care team factors that affect the routine adoption, implementation, and meaningful and sustainable use of the NOHARM intervention.

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (3)

• Aim 1

  Characteristics of high and low fidelity users of the intervention

  3 months post-surgery

• Determinants of patient engagement with the intervention

  Measured by the NOHARM patient interview guide that asks the participant to list determinants for non-medication options of managing pain

  3 months post-surgery

• Sustainability of the NOHARM intervention

  Assessed using the Clinical Sustainability Assessment Tool (CSAT) that is a structured assessment of current capacity for sustainability across a range of specific organizational and contextual factors. Responses from the care team for this survey identify sustainability strengths and challenges. Questions use a scale of 1=to little or not extent and 7 = to a very great extent; scores are averaged for a total score with lower average scores indicating areas where practice capacity for sustainability could be improved.

  3 months post-surgery

Study Arms (2)

Patients

A sample of patients who received the NOHARM intervention after their surgery.

Care Team Members

Staff members who had patients on the NOHARM intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will all be patients who received the NOHARM intervention for a recent surgery.

You may qualify if:

• Participants eligible for this study will be patients on the NOHARM trial registry (e.g., patients that were automatically assigned to receive the NOHARM intervention as part of their surgical care) and/or their charts and members of their care teams, including nurses, doctors, physical therapists, nurse practitioners and physician assistants, and medical assistants.

You may not qualify if:

• Individuals not on the NOHARM trial registry.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55901, United States

Location

Related Publications (1)

• Minteer SA, Audeh CM, Tofthagen C, Sheffield KE, Cutshall SM, Tilburt JC, Cheville AL. Patients' peri-operative experiences with non-pharmacologic pain care techniques: a secondary qualitative analysis of the NOHARM trial. BMC Complement Med Ther. 2025 Oct 17;25(1):388. doi: 10.1186/s12906-025-05141-0.

  PMID: 41107758 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Andrea Cheville, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 21, 2021
• Study Start: March 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)