AzTrials
AzTrials

Pain, ChronicRISE-OKNCT05037682

Pain and Opioid Management in Older Adults

A study testing Dissemination and Implementation Research in people with Pain, Chronic and Opioid Use Disorder, run by University of Oklahoma at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Chronic, Opioid Use Disorder
What is being tested?
Dissemination and Implementation Research
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,035 participants
Where
1 siteUnited States
Study dates
30 Sep 2020to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Timothy VanWagoner, PhD contact

(405) 271-3480

Timothy-VanWagoner@ouhsc.edu

Juell Homco, PhD, MPH contact

(918) 660-3808

juell-homco@ouhsc.edu

United States1 site, 1 recruiting

  • Oklahoma Clinical and Translational Science Institute

    Oklahoma City, Oklahoma, 73104

    Timothy VanWagoner, PhD, 405-271-3480, timothy-vanwagoner@ouhsc.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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:
  2. 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);
  3. 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
  4. 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.
  5. 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:
  6. 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
  7. Through ongoing observation and analysis, identify facilitators and barriers to program implementation to accelerate convergence on effective and replicable methods.
  8. Conduct a multi-dimensional and comprehensive evaluation of the impact of the RISE-OK program, including the measurement of the following outcomes:
  9. 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);
  10. 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;
  11. 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
  12. 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.
  13. Disseminate innovative approaches and products developed by the RISE-OK project in several ways:
  14. Community-based dissemination (community-based and professional health organizations);
  15. 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).
Being tested
Dissemination and Implementation Research
Keywords
Pain Management, Opioid Use Disorder in Older Adults, Implementation Science, Primary Care Practice Improvement
Medical subject headings
Chronic Pain, Opioid-Related Disorders, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dissemination and Implementation ResearchOther

    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.

Study groups in NCT05037682
Study groupRoleWhat they receive
Primary Care PracticesOtherDissemination and Implementation Research
Receives: Other: Dissemination and Implementation Research

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to 17 months

  2. 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

    Measured: Baseline to 17 months

  3. Morphine Milligram Equivalent (MME)

    Change in mean opioid Morphine Milligram Equivalent (MMEs) at the practice level

    Measured: Baseline to 17 months

Secondary outcomes (27)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: 17 months

  3. Pain-Function Interference

    3-item Pain-Enjoyment-General Activity (PEG) score

    Measured: Baseline

  4. Pain-Function Interference

    3-item Pain-Enjoyment-General Activity (PEG) score

    Measured: Month 5

  5. Pain-Function Interference

    3-item Pain-Enjoyment-General Activity (PEG) score

    Measured: Month 8

  6. Pain-Function Interference

    3-item Pain-Enjoyment-General Activity (PEG) score

    Measured: Month 12

  7. Pain-Function Interference

    3-item Pain-Enjoyment-General Activity (PEG) score

    Measured: Month 17

  8. 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).

    Measured: Baseline

  9. 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).

    Measured: Month 17

  10. Polypharmacy Risk

    % of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids

    Measured: Baseline

  11. Polypharmacy Risk

    % of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids

    Measured: Month 5

  12. Polypharmacy Risk

    % of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids

    Measured: Month 8

  13. Polypharmacy Risk

    % of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids

    Measured: Month 12

  14. Polypharmacy Risk

    % of Patients also on psychotropics, sedative-hypnotics, muscle relaxants, or cannabionoids

    Measured: Month 17

  15. Diversification of Pain Therapy

    Number (and Type) of pharmacological and non-pharmacological treatment types

    Measured: Baseline

  16. Diversification of Pain Therapy

    Number (and Type) of pharmacological and non-pharmacological treatment types

    Measured: Month 5

  17. Diversification of Pain Therapy

    Number (and Type) of pharmacological and non-pharmacological treatment types

    Measured: Month 8

  18. Diversification of Pain Therapy

    Number (and Type) of pharmacological and non-pharmacological treatment types

    Measured: Month 12

  19. Diversification of Pain Therapy

    Number (and Type) of pharmacological and non-pharmacological treatment types

    Measured: Month 17

  20. Chronic Opioid Therapy Statistics: Eligible Patients

    Number of patients 60+ years of age on chronic opioids

    Measured: Baseline

  21. Chronic Opioid Therapy Statistics: Eligible Patients

    Number of patients 60+ years of age on chronic opioids

    Measured: Month 17

  22. 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.

    Measured: Baseline

  23. 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.

    Measured: Month 17

  24. Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis

    % of patients on chronic opioids with a chronic pain diagnosis

    Measured: Baseline

  25. Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis

    % of patients on chronic opioids with a chronic pain diagnosis

    Measured: Month 17

  26. Chronic Opioid Therapy Statistics: High Risk Patients

    % of patients on chronic opioids with MME>50 and benzo

    Measured: Baseline

  27. Chronic Opioid Therapy Statistics: High Risk Patients

    % of patients on chronic opioids with MME>50 and benzo

    Measured: Month 17

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2021
  2. Study start30 Sep 2020
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
1,035 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05037682
Sponsor's protocol ID
12359
Acronym
RISE-OK
Status last verified
Mar 2024
First submitted
12 Jul 2021
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Murthy VH. Ending the Opioid Epidemic - A Call to Action. N Engl J Med. 2016 Dec 22;375(25):2413-2415. doi: 10.1056/NEJMp1612578. Epub 2016 Nov 9. No abstract available.

    PubMed 27959718

  • Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.

    PubMed 28033313

  • Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3.

    PubMed 26720857

  • Levy S. Youth and the Opioid Epidemic. Pediatrics. 2019 Feb;143(2):e20182752. doi: 10.1542/peds.2018-2752. Epub 2019 Jan 2.

    PubMed 30602544

  • Huhn AS, Strain EC, Tompkins DA, Dunn KE. A hidden aspect of the U.S. opioid crisis: Rise in first-time treatment admissions for older adults with opioid use disorder. Drug Alcohol Depend. 2018 Dec 1;193:142-147. doi: 10.1016/j.drugalcdep.2018.10.002. Epub 2018 Oct 18.

    PubMed 30384321

  • Jones MR, Novitch MB, Sarrafpour S, Ehrhardt KP, Scott BB, Orhurhu V, Viswanath O, Kaye AD, Gill J, Simopoulos TT. Government Legislation in Response to the Opioid Epidemic. Curr Pain Headache Rep. 2019 May 1;23(6):40. doi: 10.1007/s11916-019-0781-1.

    PubMed 31044343

  • Volkow ND, Collins FS. The Role of Science in Addressing the Opioid Crisis. N Engl J Med. 2017 Jul 27;377(4):391-394. doi: 10.1056/NEJMsr1706626. Epub 2017 May 31. No abstract available.

    PubMed 28564549

  • Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies--tackling the opioid-overdose epidemic. N Engl J Med. 2014 May 29;370(22):2063-6. doi: 10.1056/NEJMp1402780. Epub 2014 Apr 23. No abstract available.

    PubMed 24758595

  • Liebschutz JM, Xuan Z, Shanahan CW, LaRochelle M, Keosaian J, Beers D, Guara G, O'Connor K, Alford DP, Parker V, Weiss RD, Samet JH, Crosson J, Cushman PA, Lasser KE. Improving Adherence to Long-term Opioid Therapy Guidelines to Reduce Opioid Misuse in Primary Care: A Cluster-Randomized Clinical Trial. JAMA Intern Med. 2017 Sep 1;177(9):1265-1272. doi: 10.1001/jamainternmed.2017.2468.

    PubMed 28715535

  • Parchman ML, Von Korff M, Baldwin LM, Stephens M, Ike B, Cromp D, Hsu C, Wagner EH. Primary Care Clinic Re-Design for Prescription Opioid Management. J Am Board Fam Med. 2017 Jan 2;30(1):44-51. doi: 10.3122/jabfm.2017.01.160183.

    PubMed 28062816

  • West NA, Dart RC. Prescription opioid exposures and adverse outcomes among older adults. Pharmacoepidemiol Drug Saf. 2016 May;25(5):539-44. doi: 10.1002/pds.3934. Epub 2015 Dec 13.

    PubMed 26660909

  • Buckeridge D, Huang A, Hanley J, Kelome A, Reidel K, Verma A, Winslade N, Tamblyn R. Risk of injury associated with opioid use in older adults. J Am Geriatr Soc. 2010 Sep;58(9):1664-70. doi: 10.1111/j.1532-5415.2010.03015.x.

    PubMed 20863326

  • Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.

    PubMed 25581257

  • Edwards RR, Dworkin RH, Sullivan MD, Turk DC, Wasan AD. The Role of Psychosocial Processes in the Development and Maintenance of Chronic Pain. J Pain. 2016 Sep;17(9 Suppl):T70-92. doi: 10.1016/j.jpain.2016.01.001.

    PubMed 27586832

  • Qadeer RA, Shanahan L, Ferro MA. Chronic disruptive pain in emerging adults with and without chronic health conditions and the moderating role of psychiatric disorders: Evidence from a population-based cross-sectional survey in Canada. Scand J Pain. 2017 Oct;17:30-36. doi: 10.1016/j.sjpain.2017.07.009. Epub 2017 Jul 26.

    PubMed 28850370

Questions about this trial

What is this clinical trial studying?

A study testing Dissemination and Implementation Research in people with Pain, Chronic and Opioid Use Disorder, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Timothy VanWagoner, PhD ((405) 271-3480, Timothy-VanWagoner@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-Related Quality of Life and Functioning: Physical Health Summary Score (time frame: Baseline to 17 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05037682, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in