Brief educational video plus telecare to enhance recovery for older emergency department patients with acute musculoskeletal pain: study protocol for the BETTER randomized controlled trial

Timothy F Platts-Mills, Samuel A McLean, Morris Weinberger, Sally C Stearns, Montika Bush, Brittni B Teresi, Karen Hurka-Richardson, Kurt Kroenke, Robert D Kerns, Mark A Weaver, Francis J Keefe, Timothy F Platts-Mills, Samuel A McLean, Morris Weinberger, Sally C Stearns, Montika Bush, Brittni B Teresi, Karen Hurka-Richardson, Kurt Kroenke, Robert D Kerns, Mark A Weaver, Francis J Keefe

Abstract

Background: Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, reducing the transition from acute to chronic pain is a public health priority. In this paper, we report the protocol for the Brief EducaTional Tool to Enhance Recovery (BETTER) trial. This trial compares two versions of an intervention to usual care for preventing the transition from acute to chronic MSP among older adults in the emergency department (ED).

Methods: Three hundred sixty patients from the ED will be randomized to one of three arms: full intervention (an interactive educational video about pain medications and recovery-promoting behaviors, a telecare phone call from a nurse 48 to 72 h after discharge from the ED, and an electronic communication containing clinical information to the patient's primary care provider); video-only intervention (the interactive educational video but no telecare or primary care provider communication); or usual care. Data collection will occur at baseline and at 1 week and 1, 3, 6, and 12 months after study enrollment. The primary outcome is a composite measure of pain severity and interference. Secondary outcomes include physical function, overall health, opioid use, healthcare utilization, and an assessment of the economic value of the intervention.

Discussion: This trial is the first patient-facing ED-based intervention aimed at helping older adults to better manage their MSP and reduce their risk of developing chronic pain. If effective, future studies will examine the effectiveness of implementation strategies.

Trial registration: ClinicalTrials.gov NCT04118595 . Registered on 8 October 2019.

Keywords: Emergency medicine; Geriatrics; Musculoskeletal pain; Shared decision making.

Conflict of interest statement

The authors declare they have no competing interests.

Figures

Fig. 1
Fig. 1
Conceptual model of shared decision-making during usual care and during the intervention for the proposed study. Bidirectional arrows represent a decision-making interaction between the patient and provider. Broken arrows between patients and providers indicate communication by patients who have not received education on pain management approaches
Fig. 2
Fig. 2
Description of the three components of the full intervention for the BETTER trial. Light gray text describes additional interactions between patients and provider that may be indirectly influenced by the intervention
Fig. 3
Fig. 3
Incremental cost-effectiveness ratio

References

    1. Control CD. Prevention. Prevalence of self-reported arthritis or chronic joint symptoms among adults--United States, 2001. MMWR Morb Mortal Wkly Rep. 2002;51(42):948.
    1. Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014;95(5):986–995.
    1. Steingrimsdottir OA, Landmark T, Macfarlane GJ, Nielsen CS. Defining chronic pain in epidemiological studies: a systematic review and meta-analysis. Pain. 2017;158(11):2092–2107.
    1. Naik AD, Schulman-Green D, McCorkle R, Bradley EH, Bogardus ST. Will older persons and their clinicians use a shared decision-making instrument? J Gen Intern Med. 2005;20:640-3.
    1. Leveille SG, Jones RN, Kiely DK, Hausdorff JM, Shmerling RH, Guralnik JM, et al. Chronic musculoskeletal pain and the occurrence of falls in an older population. JAMA. 2009;302(20):2214–2221.
    1. Patel KV, Guralnik JM, Dansie EJ, Turk DC. Prevalence and impact of pain among older adults in the United States: findings from the 2011 National Health and Aging Trends Study. Pain. 2013;154(12):2649–2657.
    1. Johannes CB, Le TK, Zhou X, Johnston JA, Dworkin RH. The prevalence of chronic pain in United States adults: results of an internet-based survey. J Pain. 2010;11(11):1230–1239.
    1. Solomon DH, Rassen JA, Glynn RJ, Lee J, Levin R, Schneeweiss S. The comparative safety of analgesics in older adults with arthritis. Arch Intern Med. 2010;170(22):1968–1976.
    1. Chang YP. Factors associated with prescription opioid misuse in adults aged 50 or older. Nurs Outlook. 2018;66(2):112–120.
    1. Gurcay E, Bal A, Eksioglu E, Hasturk AE, Gurcay AG, Cakci A. Acute low back pain: clinical course and prognostic factors. Disabil Rehabil. 2009;31(10):840–845.
    1. Platts-Mills TF, Flannigan SA, Bortsov AV, Smith S, Domeier RM, Swor RA, et al. Persistent pain among older adults discharged home from the emergency department after motor vehicle crash: a prospective cohort study. Ann Emerg Med. 2016;67(2):166–176.
    1. Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesthesia. 2008;101(1):77–86.
    1. National Institutes of H. Grand Challenge on Chronic Pain : National Institute of Health; [Available from: .
    1. Control CfD, Prevention Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009;58(16):421–426.
    1. Katz J, Seltzer ZE. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009;9(5):723–744.
    1. Henschke N, Maher CG, Refshauge KM, Herbert RD, Cumming RG, Bleasel J, et al. Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study. BMJ. 2008;337:a171.
    1. Morrison RS, Flanagan S, Fischberg D, Cintron A, Siu AL. A novel interdisciplinary analgesic program reduces pain and improves function in older adults after orthopedic surgery. J Am Geriatr Soc. 2009;57(1):1–10.
    1. McLean SA, Clauw DJ, Abelson JL, Liberzon I. The development of persistent pain and psychological morbidity after motor vehicle collision: integrating the potential role of stress response systems into a biopsychosocial model. Psychosom Med. 2005;67(5):783–790.
    1. McLean SA. The scientific journey to predicting and preventing postoperative pain: recalling Dr. Wall's stories along the way. Anesthesiology. 2013;119(6):1244–1246.
    1. Platts-Mills TF, Esserman DA, Brown DL, Bortsov AV, Sloane PD, McLean SA. Older US emergency department patients are less likely to receive pain medication than younger patients: results from a national survey. Ann Emerg Med. 2012;60(2):199–206.
    1. Beaudoin FL, Merchant RC, Clark MA. Prevalence and detection of prescription opioid misuse and prescription opioid use disorder among emergency department patients 50 years of age and older: performance of the Prescription Drug Use Questionnaire, Patient Version Am J Geriatr Psychiatry 2016;24(8):627–636.
    1. Platts-Mills TF, Burke GF, Lee YM, Swor RA, Zaleski EZ, Clauw DJ, et al. Pain and interference of pain with function and mood in elderly adults involved in a motor vehicle collision: a pilot study. Exp Aging Res. 2012;38(3):330–343.
    1. Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997;44:681-92.
    1. Holland WC, Hunold KM, Mangipudi SA, Rittenberg AM, Yosipovitch N, Platts-Mills TF. A prospective evaluation of shared decision-making regarding analgesics selection for older emergency department patients with acute musculoskeletal pain. Acad Emerg Med Off J Soc Acad Emerg Med. 2016;23(3):306–314.
    1. Isaacs CG, Kistler C, Hunold KM, Pereira GF, Buchbinder M, Weaver MA, et al. Shared decision-making in the selection of outpatient analgesics for older individuals in the emergency department. J Am Geriatr Soc. 2013;61(5):793–798.
    1. Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain inventory. Ann Acad Med Singap. 1994;23(2):129–138.
    1. Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, et al. Report of the NIH task force on research standards for chronic low back pain. Phys Ther. 2015;95(2):e1–e18.
    1. Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009;18(7):873–880.
    1. Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003;41(11):1284–1292.
    1. Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007;146(5):317–325.
    1. Vaglio J, Conard M, Poston W, O'Keefe J, Haddock C, House J et al. Testing the performance of the ENRICHD Social Support Instrument in cardiac patients. Health Qual Life Outcomes. 2004;2:24.
    1. Degner LF, Sloan JA, Venkatesh P. The control preferences scale. Can J Nurs Res. 1997;29(3):21–43.
    1. McWilliams LA, Kowal J, Wilson KG. Development and evaluation of short forms of the Pain Catastrophizing Scale and the Pain Self-efficacy Questionnaire. Eur J Pain. 2015;19(9):1342–1349.
    1. Morris NS, MacLean CD, Chew LD, Littenberg B. The Single Item Literacy Screener: evaluation of a brief instrument to identify limited reading ability. BMC Fam Pract. 2006;7:21.
    1. Kaye AD, Cornett EM, Hart B, Patil S, Pham A, Spalitta M, et al. Novel pharmacological nonopioid therapies in chronic pain. Curr Pain Headache Rep. 2018;22(4):31.
    1. Guy W. ECDEU Assessment Manual for Psychopharmacology, Revised. US Department of Health,Education, and Welfare Publication (ADM). Rockville, MD: National Institute of Mental Health, 1976:76-338.
    1. Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010;80(1):94–99.
    1. Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004;99(3):699–709.
    1. Moul DE, PP, Miewald JM, Carey TJ, Buysse DJ. Preliminary study of the test-retest reliability and concurrent validities of the Pittsburgh Insomnia Rating Scale (PIRS) Sleep. 2002;25:A246–A247.
    1. Booth M, Booth M. Assessment of physical activity: an international perspective. Res Q Exerc Sport 71, S114-S120. Res Q Exerc Sport. 2000;71:S114–S120.
    1. Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014;312(3):240–248.
    1. Kroenke K, Theobald D, Wu J, Norton K, Morrison G, Carpenter J, et al. Effect of telecare management on pain and depression in patients with cancer: a randomized trial. JAMA. 2010;304(2):163–171.
    1. Kroenke K, Baye F, Lourens SG, Evans E, Weitlauf S, McCalley S, et al. Automated self-management (ASM) vs. ASM-enhanced collaborative care for chronic pain and mood symptoms: the CAMMPS randomized clinical trial. J Gen Intern Med. 2019;34(9):1806–1814.
    1. Kessler C, Shakeel F, Gene Hern H, Jones JS, Comes J, Kulstad C, et al. An algorithm for transition of care in the emergency department. Acad Emerg Med. 2013;20(6):605–610.
    1. Freedland KE, Mohr DC, Davidson KW, Schwartz JE. Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosom Med. 2011;73(4):323.
    1. Littell RC, Milliken GA, Stroup WW, Wolfinger RD, Schabenberger O. SAS for mixed models. 2. Cary, NC: SAS Institute; 2006.
    1. Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008;9(2):105–121.
    1. Drummond MF, McGuire A. Economic evaluation in health care: merging theory with practice. New York: OUP Oxford; 2001. .
    1. Drummond MF, Sculpher MJ, Claxton K, Stoddart GL, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford university press; 2015. .
    1. Gold MR. Cost-effectiveness in health and medicine. New York: Oxford university press; 1996. .
    1. Briggs A. Economics notes: handling uncertainty in economic evaluation. Br Med J. 1999;319(7202):120.
    1. Chaudhary MA, Stearns SC. Estimating confidence intervals for cost-effectiveness ratios: an example from a randomized trial. Stat Med. 1996;15(13):1447–1458.
    1. Platts-Mills TF, Hollowell AG, Burke GF, Zimmerman S, Dayaa JA, Quigley BR, et al. Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients. Trials. 2018;19(1):10.
    1. Carter MW, Yang BK, Davenport M, Kabel A. Increasing rates of opioid misuse among older adults visiting emergency departments. Innov Aging. 2019;3(1):igz002.
    1. Platts-Mills TF, Hunold KM, Bortsov AV, Soward AC, Peak DA, Jones JS, et al. More educated emergency department patients are less likely to receive opioids for acute pain. Pain. 2012;153(5):967–973.
    1. Platts-Mills TF, Quigley BR, Duronio JP, Hoover MV, Burgh ET, LaMantia MA, et al. Development and validation of a brief interactive educational video to improve outpatient treatment of older adults’ acute musculoskeletal pain. J Am Geriatr Soc. 2016;64(4):880–881.
    1. Smith RJ, Rhodes K, Paciotti B, Kelly S, Perrone J, Meisel ZF. Patient perspectives of acute pain management in the era of the opioid epidemic. Ann Emerg Med. 2015;66(3):246–252.
    1. Holbrook TL, Galarneau MR, Dye JL, Quinn K, Dougherty AL. Morphine use after combat injury in Iraq and post-traumatic stress disorder. N Engl J Med. 2010;362(2):110–117.
    1. Vitiello MV, McCurry SM, Shortreed SM, Balderson BH, Baker LD, Keefe FJ, et al. Cognitive-behavioral treatment for comorbid insomnia and osteoarthritis pain in primary care: the lifestyles randomized controlled trial. J Am Geriatr Soc. 2013;61(6):947–956.
    1. Keefe FJ, Blumenthal J, Baucom D, Affleck G, Waugh R, Caldwell DS, et al. Effects of spouse-assisted coping skills training and exercise training in patients with osteoarthritic knee pain: a randomized controlled study. Pain. 2004;110(3):539–549.
    1. Kroenke K, Bair MJ, Damush TM, et al. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009;301(20):2099–2110.
    1. Platts-Mills TF, Nicholson RJ, Richmond NL, Patel KV, Simonsick EM, Domeier RM, et al. Restricted activity and persistent pain following motor vehicle collision among older adults: a multicenter prospective cohort study. BMC Geriatr. 2016;16(1):1.
    1. Ettinger WH, Burns R, Messier SP, Applegate W, Rejeski WJ, Morgan T, et al. A randomized trial comparing aerobic exercise and resistance exercise with a health education program in older adults with knee osteoarthritis: the Fitness Arthritis and Seniors Trial (FAST) JAMA. 1997;277(1):25–31.
    1. Blyth FM, Noguchi N. Chronic musculoskeletal pain and its impact on older people. Best Pract Res Clin Rheumatol. 2017;31(2):160–168.
    1. Smith TO. Dainty JR, Williamson E, Martin KR. Association between musculoskeletal pain with social isolation and loneliness: analysis of the English Longitudinal Study of Ageing. Br J Pain. 2019;13(2):82–90.

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