Pain and Opioid Management in Older Adults

NCT ID: NCT05037682

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1035 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2024-09-30

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.

Detailed Description

The project's specific aims are:

1. Building upon existing guidelines and tools that the investigators' collaborative has developed and implemented for pain and opioid management (POM), refine and tailor care processes, implementation support strategies, and shared decision support resources to the specific needs of older adults in primary care settings, using a systematic approach, including:

1. Conduct a rapid, iterative process, through which a diverse healthcare professional expert panel adapts and enhances existing POM approaches and tools to older adult patients (POMOA);

2. Implement a subsequent formative process, through which a patient and caregiver community advisory board ensures that the tailored POM approach and resources are acceptable, usable, context-sensitive and value-added for older adults and their caregivers; and

3. Assemble tailored resources to create a POMOA Toolkit from which primary care practices can select sets of resources based on their specific needs, guided by academic detailers and practice facilitators.

2. Over a 2-year period, help a minimum of 36 Oklahoma primary care practices implement a person-centered, goal-oriented, and community-linked approach to pain management, tailored to older adults. The implementation approach will include the following:

1. Using benchmarking and performance feedback, academic detailing, practice facilitation, and technology support, help practices integrate the tailored POMOA approach and resources into their workflows, focusing on improving patient functioning, self-efficacy, and the optimization of pain management; and

2. Through ongoing observation and analysis, identify facilitators and barriers to program implementation to accelerate convergence on effective and replicable methods.

3. Conduct a multi-dimensional and comprehensive evaluation of the impact of the RISE-OK program, including the measurement of the following outcomes:

1. Patient-Centered Outcomes: Patient health-related quality of life and functioning (PROMIS-29), self- efficacy for pain management using a modified Arthritis Self-Efficacy scale (ASES), pain interference (Pain-Enjoyment-General Activity), and functional goal attainment (Goal Attainment Scaling);

2. Care Quality Outcomes: Patient utilization of opioid medications (morphine milligram equivalents) and alternative therapies in older adults, change in prescribing patterns, and diversification of pharmacological and non-pharmacological pain therapies;

3. Care Process Outcomes: Impact of the program on practice-level care process outcomes (chronic opioid therapy registry use; systematic chronic opioid therapy visits; pain impact/interference measurement, pain management and risk/benefit conversations; naloxone prescription; tapering practices; patient/caregiver education; shared decision-making; referrals/community service linkages; medication assisted therapy utilization); and

4. Qualitative Outcomes: Healthcare professional, health system leadership, patient, and caregiver perceptions of the utility, effectiveness and generalizability of the RISE-OK program, explored via semi-structured interviews, exit surveys, and in-depth program implementation process observations.

4. Disseminate innovative approaches and products developed by the RISE-OK project in several ways:

1. Community-based dissemination (community-based and professional health organizations);

2. Academic dissemination (presentations, workshops, papers, Agency for Healthcare Research and Quality's communication professionals); Web-based and social networking-based dissemination (e.g., Research-to-Practice Exchange).

Conditions

Pain, Chronic; Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Primary Care Practices

Dissemination and Implementation Research

Group Type: OTHER

Dissemination and Implementation Research

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Crawford, MD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Oklahoma Clinical and Translational Science Institute

Oklahoma City, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Timothy VanWagoner, PhD

Role: CONTACT

Timothy-VanWagoner@ouhsc.edu

(405) 271-3480

Juell Homco, PhD, MPH

Role: CONTACT

juell-homco@ouhsc.edu

(918) 660-3808

Facility Contacts

Timothy VanWagoner, PhD

Role: primary

timothy-vanwagoner@ouhsc.edu

405-271-3480

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Related Links

https://wonder.cdc.gov/

CDC WONDER Database \[Internet\] 2017

https://data.cms.gov/tools

Medicare Part D Opioid Prescribing Mapping Tool \[Internet\] 2017

Other Identifiers

12359

Identifier Type: -

Identifier Source: org_study_id