Pain and Opioid Management in Older Adults

Pain, Chronic Clinical Trial

— RISE-OK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05037682
• Other study ID #: 12359
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: Timothy VanWagoner, PhD
• Phone: (405) 271-3480
• Email: Timothy-VanWagoner[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1035
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use Disorder
• Opioid-Related Disorders
• Pain, Chronic
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Oklahoma Clinical and Translational Science Institute	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

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* Note: There are 53 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Morphine Milligram Equivalent (MME)	Change in mean opioid Morphine Milligram Equivalent (MMEs) at the practice level	Baseline to 17 months
Secondary	Self-Efficacy	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.	Baseline
Secondary	Self-Efficacy	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.	17 months
Secondary	Pain-Function Interference	3-item Pain-Enjoyment-General Activity (PEG) score	Baseline
Secondary	Pain-Function Interference	3-item Pain-Enjoyment-General Activity (PEG) score	Month 5
Secondary	Pain-Function Interference	3-item Pain-Enjoyment-General Activity (PEG) score	Month 8
Secondary	Pain-Function Interference	3-item Pain-Enjoyment-General Activity (PEG) score	Month 12
Secondary	Pain-Function Interference	3-item Pain-Enjoyment-General Activity (PEG) score	Month 17
Secondary	Pain-Related Goal Attainment	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).	Baseline
Secondary	Pain-Related Goal Attainment	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).	Month 17
Secondary	Polypharmacy Risk	% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids	Baseline
Secondary	Polypharmacy Risk	% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids	Month 5
Secondary	Polypharmacy Risk	% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids	Month 8
Secondary	Polypharmacy Risk	% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids	Month 12
Secondary	Polypharmacy Risk	% of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids	Month 17
Secondary	Diversification of Pain Therapy	Number (and Type) of pharmacological and non-pharmacological treatment types	Baseline
Secondary	Diversification of Pain Therapy	Number (and Type) of pharmacological and non-pharmacological treatment types	Month 5
Secondary	Diversification of Pain Therapy	Number (and Type) of pharmacological and non-pharmacological treatment types	Month 8
Secondary	Diversification of Pain Therapy	Number (and Type) of pharmacological and non-pharmacological treatment types	Month 12
Secondary	Diversification of Pain Therapy	Number (and Type) of pharmacological and non-pharmacological treatment types	Month 17
Secondary	Chronic Opioid Therapy Statistics: Eligible Patients	Number of patients 60+ years of age on chronic opioids	Baseline
Secondary	Chronic Opioid Therapy Statistics: Eligible Patients	Number of patients 60+ years of age on chronic opioids	Month 17
Secondary	Chronic Opioid Therapy Statistics: Visit Addressing Pain Management	% of patients on chronic opioids that were seen at a visit addressing pain management in the 6 months prior to Baseline.	Baseline
Secondary	Chronic Opioid Therapy Statistics: Visit Addressing Pain Management	% 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.	Month 17
Secondary	Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis	% of patients on chronic opioids with a chronic pain diagnosis	Baseline
Secondary	Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis	% of patients on chronic opioids with a chronic pain diagnosis	Month 17
Secondary	Chronic Opioid Therapy Statistics: High Risk Patients	% of patients on chronic opioids with MME>50 and benzo	Baseline
Secondary	Chronic Opioid Therapy Statistics: High Risk Patients	% of patients on chronic opioids with MME>50 and benzo	Month 17

External Links

•   CDC WONDER Database [Internet] 2017
•   U.S. Opioid Prescribing Rate Maps [Internet] 2017