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NCT05166356 Clinical Trial

Determinants and Effects in the Use of NOHARM Pain Management

Surgical Procedure, Unspecified Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05166356
Other study ID # 21-007898
Secondary ID UH3AG067593-03
Status Active, not recruiting
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date August 31, 2024

Study information
Verified date May 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 372
Est. completion date August 31, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Aim 1 Characteristics of high and low fidelity users of the intervention 3 months post-surgery
Primary 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
Primary 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
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