Pain and Opioid Management in Older Adults

NCT05037682 | Recruiting

• 1 other identifier: 12359
• Study Type: interventional
• Target: 1,035
• Locations: 1 country
• Sites: 1

Brief Summary

The extent and depth of the ongoing opioid crisis are well known and many interventions are under way in the United States and other countries to alleviate its devastating impact on individuals and the society. To address specific challenges of pain and opioid management (POM) in older and vulnerable adults, the investigators will design and implement a multi-faceted, person-centered, and scalable opioid use disorder (OUD) management program in Oklahoma primary care practices. The investigators expect that the rigorously designed and evidence-based program will establish and disseminate innovative solutions for pain and opioid management in high-risk, older and vulnerable populations living with chronic pain. The proposed initiative will help primary care practices optimize pain management approaches in older adults through an integrated and trans-disciplinary application of innovations in multi-modal pain management, pain mechanism-based pharmacotherapy, patient goal-oriented care, implementation science, evidence-based quality improvement methodology, and community-engaged design.

Conditions

Pain, Chronic; Opioid Use Disorder

Keywords

Pain Management; Opioid Use Disorder in Older Adults; Implementation Science; Primary Care Practice Improvement

Outcome Measures

Primary Outcomes (3)

• Health-Related Quality of Life and Functioning: Physical Health Summary Score

  Change in Patient-Reported Outcomes Measurement Information System Survey (PROMIS-29) Physical Health Summary Score

  Baseline to 17 months

• Health-Related Quality of Life and Functioning: Mental Health Summary Score

  Change in Patient-Reported Outcomes Measurement Information System Survey (PROMIS-29) Mental Health Summary Score

  Baseline to 17 months

• Morphine Milligram Equivalent (MME)

  Change in mean opioid Morphine Milligram Equivalent (MMEs) at the practice level

  Baseline to 17 months

Secondary Outcomes (27)

• Self-Efficacy

  Baseline

• Self-Efficacy

  17 months

• Pain-Function Interference

  Baseline

• Pain-Function Interference

  Month 5

• Pain-Function Interference

  Month 8

Study Arms (1)

Primary Care Practices

OTHER

Dissemination and Implementation Research

Other: Dissemination and Implementation Research

Interventions

Dissemination and Implementation Research OTHER

The study will employ a research and implementation design that attempts to balance scientific rigor, research good practices, primary care implementation preferences and numerous limitations related to the study context. A waitlist-controlled, staggered implementation study will be conducted with three groups of 15 practices introduced to the intervention in 3-month intervals, each baseline overlapping with interim measurements of care quality and process outcomes in concurrent groups in every 3 months, followed by a final data collection at the end of the intervention in months 16 and 17, including baseline measures plus semi-structured interviews. The groups and their sequence will not be randomized, but practice characteristics will be used to distribute them among the three groups based on location, type, size and patient mix to maximize the balance of practices among the groups.

Primary Care Practices

Eligibility Criteria

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

You may qualify if:

• For the Practice: Deliver primary care services to older adults. Be located in Oklahoma. Be willing to complete a pre- and post-practice characteristic and building blocks of primary care survey. Use an electronic health record.
• For Practice Clinicians: Be an MD, DO, PA, or APRN licensed to practice in Oklahoma. Be willing to complete a pre- and post- practice member survey. Be willing to work with the OPHIC external support personnel to use the performance measures.
• For Practice Staff: Be employed by the practice. Be willing to complete a pre- and post- practice member survey. Be willing to work with the OPHIC external support personnel to use performance measures to optimize pain management approaches in older adults.
• For Practice Patients: Be chronic pain patients aged 60 or older, or may be younger, but vulnerable due to disability, significant functional limitation or social deprivation. Be willing to complete PROMIS-29 surveys, participate in RISE-OK Project activities, and provide feedback on the RISE-OK program.

You may not qualify if:

• Practices: Does not provide primary care. Provides only urgent care and does not provide continuity of care or long-term follow-up care. Does not use an electronic health record.
• Clinicians: Do not provide primary care with continuity and chronic care follow-up. Planning to leave practice within the next 12 months, including if the clinician is planning to retire within the next 12 months.
• Practice Staff: Under 18 years of age.
• Patients: Not older adult chronic pain patients.

Sponsors & Collaborators

• University of Oklahoma: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Oklahoma Clinical and Translational Science Institute

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Related Publications (53)

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Related Links

• CDC WONDER Database \[Internet\] 2017
• Medicare Part D Opioid Prescribing Mapping Tool \[Internet\] 2017

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Steven Crawford, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy VanWagoner, PhD

CONTACT

(405) 271-3480; Timothy-VanWagoner@ouhsc.edu

Juell Homco, PhD, MPH

CONTACT

(918) 660-3808; juell-homco@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dissemination and Implementation Research (D\&I): Involves assisting primary care practices to address pain and opioid management in older adults. The D\&I model also involves Practice Assessment, Academic Detailing, Practice Facilitation, Health Information Technology Support, Performance Feedback and Benchmarking, and a Virtual Learning Community.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: September 8, 2021
• Study Start: September 30, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

US (1)