Recruiting

Pain Management

Sponsor:

University of Oklahoma

Code:

NCT05037682

Conditions

Pain, Chronic

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dissemination and Implementation Research

Study Details

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

Study ID

NCT05037682

Start date

Sep 30, 2020

Status verified date

Mar, 2024

Completion date

Sep 30, 2024

Anticipated

Primary completion date

Sep 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

1035 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Primary Care Practices

Dissemination and Implementation Research

Interventions

Dissemination and Implementation Research

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 outcome measure

  • Health-Related Quality of Life and Functioning: Physical Health Summary Score [ Time Frame: Baseline to 17 months ]
  • Health-Related Quality of Life and Functioning: Mental Health Summary Score [ Time Frame: Baseline to 17 months ]
  • Morphine Milligram Equivalent (MME) [ Time Frame: Baseline to 17 months ]

Central Contacts and Locations

Central contacts

Timothy VanWagoner, PhD

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

Juell Homco, PhD, MPH

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

Locations

Oklahoma Clinical and Translational Science Institute

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Timothy VanWagoner, PhD

405-271-3480timothy-vanwagoner@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Mar 6, 2024

Last verified

Mar, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2024-03-06.