Clinical trial NCT05037682: Pain and Opioid Management in Older Adults
Official title: Addressing Opioid Use Disorder in the Elderly Through Primary Care Innovation: Pain and Opioid Management in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Opioid Use Disorder
Keywords: Pain Management
Opioid Use Disorder in Older Adults
Implementation Science
Primary Care Practice Improvement
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2021-09-08
Enrollment: 1035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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.

Primary outcomes:
measure: Health-Related Quality of Life and Functioning: Physical Health Summary Score
timeFrame: Baseline to 17 months
measure: Health-Related Quality of Life and Functioning: Mental Health Summary Score
timeFrame: Baseline to 17 months
measure: Morphine Milligram Equivalent (MME)
timeFrame: Baseline to 17 months
Secondary outcomes:
measure: Self-Efficacy
timeFrame: Baseline
measure: Self-Efficacy
timeFrame: 17 months
measure: Pain-Function Interference
timeFrame: Baseline
measure: Pain-Function Interference
timeFrame: Month 5
measure: Pain-Function Interference
timeFrame: Month 8
measure: Pain-Function Interference
timeFrame: Month 12
measure: Pain-Function Interference
timeFrame: Month 17
measure: Pain-Related Goal Attainment
timeFrame: Baseline
measure: Pain-Related Goal Attainment
timeFrame: Month 17
measure: Polypharmacy Risk
timeFrame: Baseline
measure: Polypharmacy Risk
timeFrame: Month 5
measure: Polypharmacy Risk
timeFrame: Month 8
measure: Polypharmacy Risk
timeFrame: Month 12
measure: Polypharmacy Risk
timeFrame: Month 17
measure: Diversification of Pain Therapy
timeFrame: Baseline
measure: Diversification of Pain Therapy
timeFrame: Month 5
measure: Diversification of Pain Therapy
timeFrame: Month 8
measure: Diversification of Pain Therapy
timeFrame: Month 12
measure: Diversification of Pain Therapy
timeFrame: Month 17
measure: Chronic Opioid Therapy Statistics: Eligible Patients
timeFrame: Baseline
measure: Chronic Opioid Therapy Statistics: Eligible Patients
timeFrame: Month 17
measure: Chronic Opioid Therapy Statistics: Visit Addressing Pain Management
timeFrame: Baseline
measure: Chronic Opioid Therapy Statistics: Visit Addressing Pain Management
timeFrame: Month 17
measure: Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis
timeFrame: Baseline
measure: Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis
timeFrame: Month 17
measure: Chronic Opioid Therapy Statistics: High Risk Patients
timeFrame: Baseline
measure: Chronic Opioid Therapy Statistics: High Risk Patients
timeFrame: Month 17
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Clinical and Translational Science Institute
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Steven Crawford, MD
role: PRINCIPAL_INVESTIGATOR
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