Study Summary
This study is evaluating whether a program of pain management can help reduce opioid use in older adults.
Eligible Conditions
- Opioid Use Disorder
- Chronic Pain
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 9 Secondary · Reporting Duration: Month 17
17 months
Self-Efficacy
Baseline to 17 months
Health-Related Quality of Life and Functioning: Mental Health Summary Score
Health-Related Quality of Life and Functioning: Physical Health Summary Score
Morphine Milligram Equivalent (MME)
Month 17
Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis
Chronic Opioid Therapy Statistics: Eligible Patients
Chronic Opioid Therapy Statistics: High Risk Patients
Pain
Pain management
Pain-Function Interference
Pain-Related Goal Attainment
Polypharmacy Risk
Trial Safety
Safety Progress
Trial Design
0 Treatment Group
1035 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 17
Who is running the clinical trial?
Agency for Healthcare Research and Quality (AHRQ)FED
364 Previous Clinical Trials
7,008,620 Total Patients Enrolled
University of OklahomaLead Sponsor
422 Previous Clinical Trials
96,143 Total Patients Enrolled
Steven Crawford, MDPrincipal InvestigatorUniversity of Oklahoma
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- Wolff JL, Starfield B, Anderson G. Prevalence, expenditures, and complications of multiple chronic conditions in the elderly. Arch Intern Med. 2002 Nov 11;162(20):2269-76. doi: 10.1001/archinte.162.20.2269.
- Nagykaldi Z, Mold JW, Robinson A, Niebauer L, Ford A. Practice facilitators and practice-based research networks. J Am Board Fam Med. 2006 Sep-Oct;19(5):506-10. doi: 10.3122/jabfm.19.5.506.
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- 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.
- Grumbach K, Mold JW. A health care cooperative extension service: transforming primary care and community health. JAMA. 2009 Jun 24;301(24):2589-91. doi: 10.1001/jama.2009.923. No abstract available.
- 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.
- Wenger NS, Solomon DH, Roth CP, MacLean CH, Saliba D, Kamberg CJ, Rubenstein LZ, Young RT, Sloss EM, Louie R, Adams J, Chang JT, Venus PJ, Schnelle JF, Shekelle PG. The quality of medical care provided to vulnerable community-dwelling older patients. Ann Intern Med. 2003 Nov 4;139(9):740-7. doi: 10.7326/0003-4819-139-9-200311040-00008.
- Kastner M, Hayden L, Wong G, Lai Y, Makarski J, Treister V, Chan J, Lee JH, Ivers NM, Holroyd-Leduc J, Straus SE. Underlying mechanisms of complex interventions addressing the care of older adults with multimorbidity: a realist review. BMJ Open. 2019 Apr 3;9(4):e025009. doi: 10.1136/bmjopen-2018-025009.
- Reuben DB, Tinetti ME. Goal-oriented patient care--an alternative health outcomes paradigm. N Engl J Med. 2012 Mar 1;366(9):777-9. doi: 10.1056/NEJMp1113631. No abstract available.
- Maree RD, Marcum ZA, Saghafi E, Weiner DK, Karp JF. A Systematic Review of Opioid and Benzodiazepine Misuse in Older Adults. Am J Geriatr Psychiatry. 2016 Nov;24(11):949-963. doi: 10.1016/j.jagp.2016.06.003. Epub 2016 Jun 7.
- McCormack L, Sheridan S, Lewis M, Boudewyns V, Melvin CL, Kistler C, Lux LJ, Cullen K, Lohr KN. Communication and dissemination strategies to facilitate the use of health-related evidence. Evid Rep Technol Assess (Full Rep). 2013 Nov;(213):1-520. doi: 10.23970/ahrqepcerta213.
- Machado-Duque ME, Castano-Montoya JP, Medina-Morales DA, Castro-Rodriguez A, Gonzalez-Montoya A, Machado-Alba JE. Association between the use of benzodiazepines and opioids with the risk of falls and hip fractures in older adults. Int Psychogeriatr. 2018 Jul;30(7):941-946. doi: 10.1017/S1041610217002745. Epub 2017 Dec 10.
- 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.
- Liukas A, Kuusniemi K, Aantaa R, Virolainen P, Neuvonen M, Neuvonen PJ, Olkkola KT. Plasma concentrations of oral oxycodone are greatly increased in the elderly. Clin Pharmacol Ther. 2008 Oct;84(4):462-7. doi: 10.1038/clpt.2008.64.
- Mold J. Goal-Directed Health Care: Redefining Health and Health Care in the Era of Value-Based Care. Cureus. 2017 Feb 21;9(2):e1043. doi: 10.7759/cureus.1043.
- Mathis SM, Hagemeier N, Hagaman A, Dreyzehner J, Pack RP. A Dissemination and Implementation Science Approach to the Epidemic of Opioid Use Disorder in the United States. Curr HIV/AIDS Rep. 2018 Oct;15(5):359-370. doi: 10.1007/s11904-018-0409-9.
- Levy S. Youth and the Opioid Epidemic. Pediatrics. 2019 Feb;143(2):e20182752. doi: 10.1542/peds.2018-2752. Epub 2019 Jan 2.
- Le Roux C, Tang Y, Drexler K. Alcohol and Opioid Use Disorder in Older Adults: Neglected and Treatable Illnesses. Curr Psychiatry Rep. 2016 Sep;18(9):87. doi: 10.1007/s11920-016-0718-x.
- Kaufman A, Boren J, Koukel S, Ronquillo F, Davies C, Nkouaga C. Agriculture and Health Sectors Collaborate in Addressing Population Health. Ann Fam Med. 2017 Sep;15(5):475-480. doi: 10.1370/afm.2087.
- 2020. "Pain and Opioid Management in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05037682.
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