RISE-OK: Pain and Opioid Management in Older Adults

Sponsor

University of Oklahoma (Other)

Overall Status

Recruiting

CT.gov ID

NCT05037682

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

1,035

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Chronic Opioid Use Disorder	Other: Dissemination and Implementation Research	N/A

Detailed Description

The project's specific aims are:

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:
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);
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
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.
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:
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
Through ongoing observation and analysis, identify facilitators and barriers to program implementation to accelerate convergence on effective and replicable methods.
Conduct a multi-dimensional and comprehensive evaluation of the impact of the RISE-OK program, including the measurement of the following outcomes:
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);
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;
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
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.
Disseminate innovative approaches and products developed by the RISE-OK project in several ways:
Community-based dissemination (community-based and professional health organizations);
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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1035 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Addressing Opioid Use Disorder in the Elderly Through Primary Care Innovation: Pain and Opioid Management in Older Adults

Actual Study Start Date :

Sep 30, 2020

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Primary Care Practices Dissemination and Implementation Research	Other: 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.

Arm

Intervention/Treatment

Other: Primary Care Practices

Dissemination and Implementation Research

Other: 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.

Outcome Measures

Primary Outcome Measures

Health-Related Quality of Life and Functioning: Physical Health Summary Score [Baseline to 17 months]
Change in Patient-Reported Outcomes Measurement Information System Survey (PROMIS-29) Physical Health Summary Score
Health-Related Quality of Life and Functioning: Mental Health Summary Score [Baseline to 17 months]
Change in Patient-Reported Outcomes Measurement Information System Survey (PROMIS-29) Mental Health Summary Score
Morphine Milligram Equivalent (MME) [Baseline to 17 months]
Change in mean opioid Morphine Milligram Equivalent (MMEs) at the practice level

Secondary Outcome Measures

Self-Efficacy [Baseline]
Arthritis Self-Efficacy Scale (ASES) Score. The Arthritis Self-Efficacy Scale has 20 items in 3 subscales: self-efficacy for managing pain (PSE), 5 items; self-efficacy for physical function (FSE), 9 items; and self-efficacy for controlling other systems (OSE), 6 items. Items are rated on a 1 (very uncertain) to 10 (very certain) rating scale. Higher scores indicate greater confidence or self-efficacy.
Self-Efficacy [17 months]
Arthritis Self-Efficacy Scale (ASES) Score. The Arthritis Self-Efficacy Scale has 20 items in 3 subscales: self-efficacy for managing pain (PSE), 5 items; self-efficacy for physical function (FSE), 9 items; and self-efficacy for controlling other systems (OSE), 6 items. Items are rated on a 1 (very uncertain) to 10 (very certain) rating scale. Higher scores indicate greater confidence or self-efficacy.
Pain-Function Interference [Baseline]
3-item Pain-Enjoyment-General Activity (PEG) score
Pain-Function Interference [Month 5]
3-item Pain-Enjoyment-General Activity (PEG) score
Pain-Function Interference [Month 8]
3-item Pain-Enjoyment-General Activity (PEG) score
Pain-Function Interference [Month 12]
3-item Pain-Enjoyment-General Activity (PEG) score
Pain-Function Interference [Month 17]
3-item Pain-Enjoyment-General Activity (PEG) score
Pain-Related Goal Attainment [Baseline]
Summary of 3-point Pain-Related Goal Attainment Scaling. Patients will rate their Pain-Related Goal Attainment using a 3-category response scale (somewhat less than expected (-1), expected goal achievement (0), and somewhat better than expected (+1).
Pain-Related Goal Attainment [Month 17]
Summary of 3-point Pain-Related Goal Attainment Scaling. Patients will rate their Pain-Related Goal Attainment using a 3-category response scale (somewhat less than expected (-1), expected goal achievement (0), and somewhat better than expected (+1).
Polypharmacy Risk [Baseline]
% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids
Polypharmacy Risk [Month 5]
% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids
Polypharmacy Risk [Month 8]
% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids
Polypharmacy Risk [Month 12]
% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids
Polypharmacy Risk [Month 17]
% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids
Diversification of Pain Therapy [Baseline]
Number (and Type) of pharmacological and non-pharmacological treatment types
Diversification of Pain Therapy [Month 5]
Number (and Type) of pharmacological and non-pharmacological treatment types
Diversification of Pain Therapy [Month 8]
Number (and Type) of pharmacological and non-pharmacological treatment types
Diversification of Pain Therapy [Month 12]
Number (and Type) of pharmacological and non-pharmacological treatment types
Diversification of Pain Therapy [Month 17]
Number (and Type) of pharmacological and non-pharmacological treatment types
Chronic Opioid Therapy Statistics: Eligible Patients [Baseline]
Number of patients 60+ years of age on chronic opioids
Chronic Opioid Therapy Statistics: Eligible Patients [Month 17]
Number of patients 60+ years of age on chronic opioids
Chronic Opioid Therapy Statistics: Visit Addressing Pain Management [Baseline]
% of patients on chronic opioids that were seen at a visit addressing pain management in the 6 months prior to Baseline.
Chronic Opioid Therapy Statistics: Visit Addressing Pain Management [Month 17]
% of patients on chronic opioids that were seen at a visit addressing pain management in the 6 months prior to Month 17 of the study.
Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis [Baseline]
% of patients on chronic opioids with a chronic pain diagnosis
Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis [Month 17]
% of patients on chronic opioids with a chronic pain diagnosis
Chronic Opioid Therapy Statistics: High Risk Patients [Baseline]
% of patients on chronic opioids with MME>50 and benzo
Chronic Opioid Therapy Statistics: High Risk Patients [Month 17]
% of patients on chronic opioids with MME>50 and benzo

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.