Determinants and Effects in the Use of NOHARM Pain Management

Active, not recruiting

• Conditions: Surgical Procedure, Unspecified

• Registration Number: NCT05166356
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-21
• Study Start: 2022-03-01
• Primary Completion: 2024-02-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 372

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.

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Exclusion Criteria

• Individuals not on the NOHARM trial registry.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aim 1	3 months post-surgery	Characteristics of high and low fidelity users of the intervention
Determinants of patient engagement with the intervention	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
Sustainability of the NOHARM intervention	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.

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States