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Completed

NCT Number: NCT05166356

Determinants and Effects in the Use of NOHARM Pain Management

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.

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Key information

Conditions

Surgical Procedure, Unspecified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55901, United States

About this study

Aim 1: Explore differences in patient engagement with the NOHARM intervention, use of non-pharm modalities, and clinical outcomes by key patient demographics, including surgical procedure type, gender, and opioid abuse risk. This aim will provide information about patient characteristics that may better predict who will use and/or benefit from the NOHARM intervention and who will not.

Aim 2: Qualitatively explore determinants of patient-level factors contributing to their ability to effectively engage with the NOHARM intervention in a diverse subgroups that adopt and use the intervention as intended and those that do not, respectively. This aim will provide information that helps us explain why some patients tend to use and/or benefit from NOHARM and others do not.

Aim 3: Characterize, using mixed methods, the relative fidelity and sustainability of implementation of NOHARM among ambulatory and inpatient surgical practices and test for associations with patient engagement and clinical outcomes. This aim will provide information about the characteristics of care teams that tend to adopt and maintain use of the NOHARM intervention and those that do not. It will also provide information about whether care teams play an important role in prompting patients to engage with and benefit from the NOHARM intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Individuals not on the NOHARM trial registry.

Treatment and study plan

Primary outcomes

  1. Aim 1

    Time frame: 3 months post-surgery

    Characteristics of high and low fidelity users of the intervention

  2. Determinants of patient engagement with the intervention

    Time frame: 3 months post-surgery

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

  3. Sustainability of the NOHARM intervention

    Time frame: 3 months post-surgery

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Describing the Determinants and Effects of Variation in the Adoption and Use of the NOHARM Pain Management Intervention Among Diverse Surgical Practices

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2021
Registry last updated
Oct 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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