通过基于技术的干预和护理协调促进哮喘指南和管理 (PRAGMATIC)
2025年10月3日 更新者：Montefiore Medical Center
本研究的总体目标是在现实世界的城市初级保健办公室环境中测试多方面和多层次的提示干预对改善提供者提供的基于指南的哮喘护理和降低患有持续性或慢性疾病的城市儿童的哮喘发病率的有效性。不受控制的哮喘。
研究概览
详细说明
研究人员将进行一项整群随机试验，比较干预措施与强化常规护理 (eUC) 在 20 家布朗克斯诊所的服务对象为 5,000 多名患有持续性或未控制哮喘的 2-12 岁儿童。 11 个 eUC 实践将收到指南信息并评估儿童的哮喘严重程度和控制情况，但不会提供积极的干预措施。 实践将在 4 年内分 4 波加入研究（每年 4-6 次实践）。 将使用电子健康记录 (EHR) 数据和基于实践的哮喘严重程度筛查评估提供者对所有 2-12 岁患有持续性或不受控制的哮喘的患者（约 5,000 名）的指南的采用和护理利用，以及干预和 eUC 实践控制。 研究人员还将从两个研究组中随机抽取 512 名患有持续性/不受控制的哮喘儿童的看护者，以系统地评估看护者报告的儿童发病率结果，并获得 EHR 中没有的措施。
干预包括遵循国家哮喘指南的 EHR 学术细节和针对持续性或未控制哮喘患者的外展工作人员护理协调。
研究类型
介入性
注册 (实际的)
530
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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The Bronx、New York、美国、10467
- Children's Hospital at Montefiore, Albert Einstein College of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
2年 至 12年 (孩子)
接受健康志愿者
不
描述
纳入标准：
下面列出的标准将适用于来自 eMPI 和 eUC 实践的约 5,000 名儿童：
- 医生诊断的哮喘（基于 EHR）。
- 根据临床评估，持续或不受控制的哮喘。 根据 NHLBI 指南，以下任何一项：在过去一个月中，> 2 天/周出现哮喘症状，> 2 天/周使用急救药物，> 2 天/月出现夜间症状，或过去 > 2 次发作需要全身性皮质类固醇的一年。
- 2 岁和 12 岁，包括在内。
额外的纳入标准将适用于 512 名儿童的子集，他们的照料者将接受采访以获得照料者报告的发病率结果：
- 看护人能够说和理解英语或西班牙语。 无法阅读的参与者将符合条件，因为所有调查都将由研究人员口头进行。
- 主要照顾者的同意，照顾者允许孩子参加以及孩子（> 7 岁）的同意。 如果有符合条件的兄弟姐妹，则只会随机抽取一名儿童。
排除标准：
- 孩子有其他重要的医疗条件，例如先天性心脏病、囊性纤维化或其他慢性肺病，这些可能会干扰哮喘相关措施的评估。
额外的排除标准将适用于上述 512 名儿童/看护人的子集：
- 无法使用电话进行后续调查。
- 寄养儿童或其他无法获得监护人同意的情况。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：增强型多方面提示干预 (eMPI)
增强型 MPI 计划 (eMPI) 由创新的多层次和基于团队的策略组成，使提供者能够有效且高效地采用哮喘护理指南。
eMPI 在就诊时使用基于指南的提示来支持提供者的决策，增加他们建议纠正措施（即预防性药物处方）以改善哮喘管理的可能性。
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多层次实施战略的核心要素包括： 直接支持提供者在实践中提供基于指南的护理；增强 eMPI 的可行性和可持续性；让诊所工作人员参与推广和支持指南的使用；建立对基于指南的护理的责任感和承诺；促进提供商对指南的理解、接受和使用 |
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无干预：强化日常护理 (eUC) 实践
参与者将收到国家哮喘教育和预防计划 (NAEPP) 指南和家庭教育资源的审查包。
作为最佳实践护理的一部分，将在每次就诊时评估儿童的哮喘严重程度和控制水平，但不会提供主动干预措施。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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采取 1 项或多项基于指南的纠正措施的参与者的百分比
大体时间：干预后立即，最长 1 年
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报告电子健康记录 (EHR) 中记录的、采取了 1 项或多项基于指南的纠正措施（即控制药物处方或调整、触发评估）的参与者的百分比。
结果总结为研究组采取了 1 项或多项基于指南的纠正措施的参与者数量/百分比。
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干预后立即，最长 1 年
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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无症状天数 (SFD)
大体时间：基线以及 3 个月、6 个月、9 个月和 12 个月的随访评估
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研究组在基线和 12 个月的随访评估期间每 3 个月总结一次过去 14 天内无症状的天数。
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基线以及 3 个月、6 个月、9 个月和 12 个月的随访评估
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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小儿哮喘护理人员生活质量问卷 (PACQLQ)
大体时间：每 3 个月一次，最多 12 个月一次
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照顾者哮喘相关的生活质量
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每 3 个月一次，最多 12 个月一次
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医疗保健利用：因哮喘急诊就诊的次数
大体时间：每 3 个月一次，最多 12 个月一次
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因哮喘急诊就诊的次数
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每 3 个月一次，最多 12 个月一次
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医疗保健利用：哮喘住院人数
大体时间：每 3 个月一次，最多 12 个月一次
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因哮喘住院人数
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每 3 个月一次，最多 12 个月一次
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marina Reznik, MD, MS、Montefiore Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, Rubin HR. Why don't physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999 Oct 20;282(15):1458-65. doi: 10.1001/jama.282.15.1458.
- Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
- MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison of methods to test mediation and other intervening variable effects. Psychol Methods. 2002 Mar;7(1):83-104. doi: 10.1037/1082-989x.7.1.83.
- Akinbami LJ, Moorman JE, Simon AE, Schoendorf KC. Trends in racial disparities for asthma outcomes among children 0 to 17 years, 2001-2010. J Allergy Clin Immunol. 2014 Sep;134(3):547-553.e5. doi: 10.1016/j.jaci.2014.05.037. Epub 2014 Aug 1.
- Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.
- Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 1998 Aug-Sep;1(1):2-4. No abstract available.
- Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ. 2009 May 12;180(10):E47-57. doi: 10.1503/cmaj.090523. Epub 2009 Apr 16. No abstract available.
- Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56.
- Imai K, Keele L, Tingley D. A general approach to causal mediation analysis. Psychol Methods. 2010 Dec;15(4):309-34. doi: 10.1037/a0020761.
- Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.
- Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 Sep 24;290(12):1624-32. doi: 10.1001/jama.290.12.1624.
- Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C.
- Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001 Nov-Dec;20(6):64-78. doi: 10.1377/hlthaff.20.6.64.
- Webber MP, Carpiniello KE, Oruwariye T, Lo Y, Burton WB, Appel DK. Burden of asthma in inner-city elementary schoolchildren: do school-based health centers make a difference? Arch Pediatr Adolesc Med. 2003 Feb;157(2):125-9. doi: 10.1001/archpedi.157.2.125.
- Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
- Claudio L, Stingone JA, Godbold J. Prevalence of childhood asthma in urban communities: the impact of ethnicity and income. Ann Epidemiol. 2006 May;16(5):332-40. doi: 10.1016/j.annepidem.2005.06.046. Epub 2005 Oct 20.
- Reznik M, Silver EJ, Cao Y. Evaluation of MDI-spacer utilization and technique in caregivers of urban minority children with persistent asthma. J Asthma. 2014 Mar;51(2):149-54. doi: 10.3109/02770903.2013.854379. Epub 2013 Oct 22.
- Reznik M, Jaramillo Y, Wylie-Rosett J. Demonstrating and assessing metered-dose inhaler-spacer technique: pediatric care providers' self-reported practices and perceived barriers. Clin Pediatr (Phila). 2014 Mar;53(3):270-6. doi: 10.1177/0009922813512521. Epub 2013 Dec 12.
- Smith LA, Hatcher-Ross JL, Wertheimer R, Kahn RS. Rethinking race/ethnicity, income, and childhood asthma: racial/ethnic disparities concentrated among the very poor. Public Health Rep. 2005 Mar-Apr;120(2):109-16. doi: 10.1177/003335490512000203.
- Allen FC, Vargas PA, Kolodner K, Eggleston P, Butz A, Huss K, Malveaux F, Rand CS. Assessing pediatric clinical asthma practices and perceptions: a new instrument. J Asthma. 2000 Feb;37(1):31-42. doi: 10.3109/02770900009055426.
- Szefler SJ, Mitchell H, Sorkness CA, Gergen PJ, O'Connor GT, Morgan WJ, Kattan M, Pongracic JA, Teach SJ, Bloomberg GR, Eggleston PA, Gruchalla RS, Kercsmar CM, Liu AH, Wildfire JJ, Curry MD, Busse WW. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial. Lancet. 2008 Sep 20;372(9643):1065-72. doi: 10.1016/S0140-6736(08)61448-8.
- Gupta RS, Weiss KB. The 2007 National Asthma Education and Prevention Program asthma guidelines: accelerating their implementation and facilitating their impact on children with asthma. Pediatrics. 2009 Mar;123 Suppl 3:S193-8. doi: 10.1542/peds.2008-2233J.
- Bloom B, Jones LI, Freeman G. Summary health statistics for U.S. children: National Health Interview Survey, 2012. Vital Health Stat 10. 2013 Dec;(258):1-81.
- Blaakman S, Tremblay PJ, Halterman JS, Fagnano M, Borrelli B. Implementation of a community-based secondhand smoke reduction intervention for caregivers of urban children with asthma: process evaluation, successes and challenges. Health Educ Res. 2013 Feb;28(1):141-52. doi: 10.1093/her/cys070. Epub 2012 Jun 20.
- Juniper EF, Guyatt GH, Feeny DH, Ferrie PJ, Griffith LE, Townsend M. Measuring quality of life in the parents of children with asthma. Qual Life Res. 1996 Feb;5(1):27-34. doi: 10.1007/BF00435966.
- Cloutier MM, Hall CB, Wakefield DB, Bailit H. Use of asthma guidelines by primary care providers to reduce hospitalizations and emergency department visits in poor, minority, urban children. J Pediatr. 2005 May;146(5):591-7. doi: 10.1016/j.jpeds.2004.12.017.
- Halterman JS, Riekert K, Bayer A, Fagnano M, Tremblay P, Blaakman S, Borrelli B. A pilot study to enhance preventive asthma care among urban adolescents with asthma. J Asthma. 2011 Jun;48(5):523-30. doi: 10.3109/02770903.2011.576741.
- Halterman JS, Szilagyi PG, Fisher SG, Fagnano M, Tremblay P, Conn KM, Wang H, Borrelli B. Randomized controlled trial to improve care for urban children with asthma: results of the School-Based Asthma Therapy trial. Arch Pediatr Adolesc Med. 2011 Mar;165(3):262-8. doi: 10.1001/archpediatrics.2011.1.
- Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care; Smedley BD, Stith AY, Nelson AR, editors. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. Washington (DC): National Academies Press (US); 2003. Available from http://www.ncbi.nlm.nih.gov/books/NBK220358/
- Flores G, Snowden-Bridon C, Torres S, Perez R, Walter T, Brotanek J, Lin H, Tomany-Korman S. Urban minority children with asthma: substantial morbidity, compromised quality and access to specialists, and the importance of poverty and specialty care. J Asthma. 2009 May;46(4):392-8. doi: 10.1080/02770900802712971.
- Wisnivesky JP, Lorenzo J, Lyn-Cook R, Newman T, Aponte A, Kiefer E, Halm EA. Barriers to adherence to asthma management guidelines among inner-city primary care providers. Ann Allergy Asthma Immunol. 2008 Sep;101(3):264-70. doi: 10.1016/S1081-1206(10)60491-7.
- Okelo SO, Butz AM, Sharma R, Diette GB, Pitts SI, King TM, Linn ST, Reuben M, Chelladurai Y, Robinson KA. Interventions to modify health care provider adherence to asthma guidelines: a systematic review. Pediatrics. 2013 Sep;132(3):517-34. doi: 10.1542/peds.2013-0779. Epub 2013 Aug 26.
- Cabana MD, Ebel BE, Cooper-Patrick L, Powe NR, Rubin HR, Rand CS. Barriers pediatricians face when using asthma practice guidelines. Arch Pediatr Adolesc Med. 2000 Jul;154(7):685-93. doi: 10.1001/archpedi.154.7.685.
- Frey SM, Fagnano M, Halterman JS. Caregiver education to promote appropriate use of preventive asthma medications: what is happening in primary care? J Asthma. 2016;53(2):213-9. doi: 10.3109/02770903.2015.1075549. Epub 2015 Aug 18.
- Okelo SO, Butz AM, Sharma R, Diette GB, Pitts SI, King TM, Linn ST, Reuben M, Chelladurai Y, Robinson KA. Interventions to Modify Health Care Provider Adherence to Asthma Guidelines [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 May. Report No.: 13-EHC022-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK144097/
- Okelo SO, Siberry GK, Solomon BS, Bilderback AL, Yamazaki M, Hetzler T, Ferrell CL, Dhepyasuwan N, Serwint JR; CORNET Investigators. Asthma treatment decisions by pediatric residents do not consistently conform to guidelines or improve with level of training. Acad Pediatr. 2014 May-Jun;14(3):287-93. doi: 10.1016/j.acap.2013.12.008. Epub 2014 Mar 12.
- Shiffman RN, Freudigman Md, Brandt CA, Liaw Y, Navedo DD. A guideline implementation system using handheld computers for office management of asthma: effects on adherence and patient outcomes. Pediatrics. 2000 Apr;105(4 Pt 1):767-73. doi: 10.1542/peds.105.4.767.
- Eccles M, McColl E, Steen N, Rousseau N, Grimshaw J, Parkin D, Purves I. Effect of computerised evidence based guidelines on management of asthma and angina in adults in primary care: cluster randomised controlled trial. BMJ. 2002 Oct 26;325(7370):941. doi: 10.1136/bmj.325.7370.941.
- Lesho EP, Myers CP, Ott M, Winslow C, Brown JE. Do clinical practice guidelines improve processes or outcomes in primary care? Mil Med. 2005 Mar;170(3):243-6. doi: 10.7205/milmed.170.3.243.
- Mitchell EA, Didsbury PB, Kruithof N, Robinson E, Milmine M, Barry M, Newman J. A randomized controlled trial of an asthma clinical pathway for children in general practice. Acta Paediatr. 2005 Feb;94(2):226-33. doi: 10.1111/j.1651-2227.2005.tb01896.x.
- Halterman JS, Fisher S, Conn KM, Fagnano M, Lynch K, Marky A, Szilagyi PG. Improved preventive care for asthma: a randomized trial of clinician prompting in pediatric offices. Arch Pediatr Adolesc Med. 2006 Oct;160(10):1018-25. doi: 10.1001/archpedi.160.10.1018.
- Martens JD, van der Weijden T, Severens JL, de Clercq PA, de Bruijn DP, Kester AD, Winkens RA. The effect of computer reminders on GPs' prescribing behaviour: a cluster-randomised trial. Int J Med Inform. 2007 Dec;76 Suppl 3:S403-16. doi: 10.1016/j.ijmedinf.2007.04.005. Epub 2007 Jun 14.
- Bell LM, Grundmeier R, Localio R, Zorc J, Fiks AG, Zhang X, Stephens TB, Swietlik M, Guevara JP. Electronic health record-based decision support to improve asthma care: a cluster-randomized trial. Pediatrics. 2010 Apr;125(4):e770-7. doi: 10.1542/peds.2009-1385. Epub 2010 Mar 15.
- Cho SH, Jeong JW, Park HW, Pyun BY, Chang SI, Moon HB, Kim YY, Choi BW. Effectiveness of a computer-assisted asthma management program on physician adherence to guidelines. J Asthma. 2010 Aug;47(6):680-6. doi: 10.3109/02770903.2010.481342.
- Davis AM, Cannon M, Ables AZ, Bendyk H. Using the electronic medical record to improve asthma severity documentation and treatment among family medicine residents. Fam Med. 2010 May;42(5):334-7.
- de Vries TW, van den Berg PB, Duiverman EJ, de Jong-van den Berg LT. Effect of a minimal pharmacy intervention on improvement of adherence to asthma guidelines. Arch Dis Child. 2010 Apr;95(4):302-4. doi: 10.1136/adc.2008.145581. Epub 2009 Apr 23.
- Ragazzi H, Keller A, Ehrensberger R, Irani AM. Evaluation of a practice-based intervention to improve the management of pediatric asthma. J Urban Health. 2011 Feb;88 Suppl 1(Suppl 1):38-48. doi: 10.1007/s11524-010-9471-3.
- Shapiro A, Gracy D, Quinones W, Applebaum J, Sarmiento A. Putting guidelines into practice: improving documentation of pediatric asthma management using a decision-making tool. Arch Pediatr Adolesc Med. 2011 May;165(5):412-8. doi: 10.1001/archpediatrics.2011.49.
- Halterman JS, Fagnano M, Tremblay PJ, Fisher SG, Wang H, Rand C, Szilagyi P, Butz A. Prompting asthma intervention in Rochester-uniting parents and providers (PAIR-UP): a randomized trial. JAMA Pediatr. 2014 Oct;168(10):e141983. doi: 10.1001/jamapediatrics.2014.1983. Epub 2014 Oct 6.
- Bloom B, Cohen RA, Freeman G. Summary health statistics for U.S. children: National Health Interview Survey, 2007. Vital Health Stat 10. 2009 Jan;(239):1-80.
- Cabana MD, Lara M, Shannon J. Racial and ethnic disparities in the quality of asthma care. Chest. 2007 Nov;132(5 Suppl):810S-817S. doi: 10.1378/chest.07-1910.
- Reznik M, Bauman LJ, Okelo SO, Halterman JS. Asthma identification and medication administration forms in New York City schools. Ann Allergy Asthma Immunol. 2015 Jan;114(1):67-68.e1. doi: 10.1016/j.anai.2014.10.006. Epub 2014 Oct 24. No abstract available.
- Wu AC, Smith L, Bokhour B, Hohman KH, Lieu TA. Racial/Ethnic variation in parent perceptions of asthma. Ambul Pediatr. 2008 Mar-Apr;8(2):89-97. doi: 10.1016/j.ambp.2007.10.007.
- Halterman JS, Auinger P, Conn KM, Lynch K, Yoos HL, Szilagyi PG. Inadequate therapy and poor symptom control among children with asthma: findings from a multistate sample. Ambul Pediatr. 2007 Mar-Apr;7(2):153-9. doi: 10.1016/j.ambp.2006.11.007.
- Capo-Ramos DE, Duran C, Simon AE, Akinbami LJ, Schoendorf KC. Preventive asthma medication discontinuation among children enrolled in fee-for-service Medicaid. J Asthma. 2014 Aug;51(6):618-26. doi: 10.3109/02770903.2014.895010. Epub 2014 Mar 20.
- Cabana MD, Bruckman D, Meister K, Bradley JF, Clark N. Documentation of asthma severity in pediatric outpatient clinics. Clin Pediatr (Phila). 2003 Mar;42(2):121-5. doi: 10.1177/000992280304200204.
- Biksey T, Zickmund S, Wu F. Disparities in risk communication: a pilot study of asthmatic children, their parents, and home environments. J Natl Med Assoc. 2011 May;103(5):388-91. doi: 10.1016/s0027-9684(15)30334-5.
- Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D, World Health O, Galen, AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008;63 Suppl 86:8-160.
- Diaz J, Farzan S. Clinical implications of the obese-asthma phenotypes. Immunol Allergy Clin North Am. 2014 Nov;34(4):739-51. doi: 10.1016/j.iac.2014.07.008.
- Scadding G, Walker S. Poor asthma control?--then look up the nose. The importance of co-morbid rhinitis in patients with asthma. Prim Care Respir J. 2012 Jun;21(2):222-8. doi: 10.4104/pcrj.2012.00035.
- Lee MG, Cross KJ, Yang WY, Sutton BS, Jiroutek MR. Frequency of asthma education in primary care in the years 2007-2010. J Asthma. 2016;53(2):220-6. doi: 10.3109/02770903.2015.1087024. Epub 2015 Sep 18.
- McMullen A, Yoos HL, Anson E, Kitzmann H, Halterman JS, Arcoleo KS. Asthma care of children in clinical practice: do parents report receiving appropriate education? Pediatr Nurs. 2007 Jan-Feb;33(1):37-44.
- Conn KM, Halterman JS, Lynch K, Cabana MD. The impact of parents' medication beliefs on asthma management. Pediatrics. 2007 Sep;120(3):e521-6. doi: 10.1542/peds.2006-3023.
- Mitchell SJ, Bilderback AL, Okelo SO. Racial Disparities in Asthma Morbidity Among Pediatric Patients Seeking Asthma Specialist Care. Acad Pediatr. 2016 Jan-Feb;16(1):64-7. doi: 10.1016/j.acap.2015.06.010. Epub 2015 Aug 29.
- James CV, Rosenbaum S. Paying for quality care: implications for racial and ethnic health disparities in pediatric asthma. Pediatrics. 2009 Mar;123 Suppl 3:S205-10. doi: 10.1542/peds.2008-2233L.
- Tsuyuki RT, Sin DD, Sharpe HM, Cowie RL, Nilsson C, Man SF; Alberta Strategy to Help Manage Asthma (ASTHMA) Investigators. Management of asthma among community-based primary care physicians. J Asthma. 2005 Apr;42(3):163-7.
- Butz AM, Walker J, Land CL, Vibbert C, Winkelstein M. Improving asthma communication in high-risk children. J Asthma. 2007 Nov;44(9):739-45. doi: 10.1080/02770900701595683.
- Kattan M, Crain EF, Steinbach S, Visness CM, Walter M, Stout JW, Evans R 3rd, Smartt E, Gruchalla RS, Morgan WJ, O'Connor GT, Mitchell HE. A randomized clinical trial of clinician feedback to improve quality of care for inner-city children with asthma. Pediatrics. 2006 Jun;117(6):e1095-103. doi: 10.1542/peds.2005-2160.
- Vernacchio L, Francis ME, Epstein DM, Santangelo J, Trudell EK, Reynolds ME, Risko W. Effectiveness of an asthma quality improvement program designed for maintenance of certification. Pediatrics. 2014 Jul;134(1):e242-8. doi: 10.1542/peds.2013-2643. Epub 2014 Jun 16.
- Richman MJ, Poltawsky JS. Partnership for excellence in asthma care: evidence-based disease management. Stud Health Technol Inform. 2000;76:107-21.
- Baker R, Fraser RC, Stone M, Lambert P, Stevenson K, Shiels C. Randomised controlled trial of the impact of guidelines, prioritized review criteria and feedback on implementation of recommendations for angina and asthma. Br J Gen Pract. 2003 Apr;53(489):284-91.
- Coleman CI, Reddy P, Laster-Bradley NM, Dorval S, Munagala B, White CM. Effect of practitioner education on adherence to asthma treatment guidelines. Ann Pharmacother. 2003 Jul-Aug;37(7-8):956-61. doi: 10.1345/aph.1C506.
- Schneider A, Wensing M, Biessecker K, Quinzler R, Kaufmann-Kolle P, Szecsenyi J. Impact of quality circles for improvement of asthma care: results of a randomized controlled trial. J Eval Clin Pract. 2008 Apr;14(2):185-90. doi: 10.1111/j.1365-2753.2007.00827.x. Epub 2007 Dec 13.
- Daniels EC, Bacon J, Denisio S, Fry YW, Murray V, Quarshie A, Rust G. Translation squared: improving asthma care for high-disparity populations through a safety net practice-based research network. J Asthma. 2005 Jul-Aug;42(6):499-505. doi: 10.1081/JAS-67598.
- Frankowski BL, Keating K, Rexroad A, Delaney T, McEwing SM, Wasko N, Lynn S, Shaw J. Community collaboration: concurrent physician and school nurse education and cooperation increases the use of asthma action plans. J Sch Health. 2006 Aug;76(6):303-6. doi: 10.1111/j.1746-1561.2006.00117.x. No abstract available.
- Yawn BP, Bertram S, Wollan P. Introduction of Asthma APGAR tools improve asthma management in primary care practices. J Asthma Allergy. 2008 Aug 31;1:1-10. doi: 10.2147/jaa.s3595.
- Bender BG, Dickinson P, Rankin A, Wamboldt FS, Zittleman L, Westfall JM. The Colorado Asthma Toolkit Program: a practice coaching intervention from the High Plains Research Network. J Am Board Fam Med. 2011 May-Jun;24(3):240-8. doi: 10.3122/jabfm.2011.03.100171.
- Lob SH, Boer JH, Porter PG, Nunez D, Fox P. Promoting best-care practices in childhood asthma: quality improvement in community health centers. Pediatrics. 2011 Jul;128(1):20-8. doi: 10.1542/peds.2010-1962. Epub 2011 Jun 13.
- Evans D, Sheares BJ, Vazquez TL. Educating health professionals to improve quality of care for asthma. Paediatr Respir Rev. 2004 Dec;5(4):304-10. doi: 10.1016/j.prrv.2004.07.007.
- Lozano P, Finkelstein JA, Carey VJ, Wagner EH, Inui TS, Fuhlbrigge AL, Soumerai SB, Sullivan SD, Weiss ST, Weiss KB. A multisite randomized trial of the effects of physician education and organizational change in chronic-asthma care: health outcomes of the Pediatric Asthma Care Patient Outcomes Research Team II Study. Arch Pediatr Adolesc Med. 2004 Sep;158(9):875-83. doi: 10.1001/archpedi.158.9.875.
- Glasgow RE, Nutting PA, King DK, Nelson CC, Cutter G, Gaglio B, Rahm AK, Whitesides H, Amthauer H. A practical randomized trial to improve diabetes care. J Gen Intern Med. 2004 Dec;19(12):1167-74. doi: 10.1111/j.1525-1497.2004.30425.x.
- Mason T, Wilkinson GW, Nannini A, Martin CM, Fox DJ, Hirsch G. Winning policy change to promote community health workers: lessons from massachusetts in the health reform era. Am J Public Health. 2011 Dec;101(12):2211-6. doi: 10.2105/AJPH.2011.300402. Epub 2011 Oct 20.
- Margellos-Anast H, Gutierrez MA, Whitman S. Improving asthma management among African-American children via a community health worker model: findings from a Chicago-based pilot intervention. J Asthma. 2012 May;49(4):380-9. doi: 10.3109/02770903.2012.660295. Epub 2012 Feb 21.
- Campbell JD, Brooks M, Hosokawa P, Robinson J, Song L, Krieger J. Community Health Worker Home Visits for Medicaid-Enrolled Children With Asthma: Effects on Asthma Outcomes and Costs. Am J Public Health. 2015 Nov;105(11):2366-72. doi: 10.2105/AJPH.2015.302685. Epub 2015 Aug 13.
- Reznik M, Silver EJ, Jaramillo Y. A Randomized Trial of a Community Health Worker (CHW) Led Asthma Intervention: Preliminary Findings. 2014 Pediatric Academic Societies and Asian Society for Pediatric Research Joint Meeting, Vancouver, BC, Canada May 3-6, 2014.
- Peretz PJ, Matiz LA, Findley S, Lizardo M, Evans D, McCord M. Community health workers as drivers of a successful community-based disease management initiative. Am J Public Health. 2012 Aug;102(8):1443-6. doi: 10.2105/AJPH.2011.300585. Epub 2012 Apr 19.
- Fisher-Owens SA, Boddupalli G, Thyne SM. Telephone case management for asthma: an acceptable and effective intervention within a diverse pediatric population. J Asthma. 2011 Mar;48(2):156-61. doi: 10.3109/02770903.2011.554938.
- Garbutt JM, Sylvia S, Rook S, Schmandt M, Ruby-Ziegler C, Luby J, Strunk RC. Peer training to improve parenting and childhood asthma management skills: a pilot study. Ann Allergy Asthma Immunol. 2015 Feb;114(2):148-9. doi: 10.1016/j.anai.2014.10.023. Epub 2014 Dec 15. No abstract available.
- Garbutt JM, Yan Y, Highstein G, Strunk RC. A cluster-randomized trial shows telephone peer coaching for parents reduces children's asthma morbidity. J Allergy Clin Immunol. 2015 May;135(5):1163-70.e1-2. doi: 10.1016/j.jaci.2014.09.033. Epub 2014 Oct 30.
- Rapkin BD, Weiss ES, Lounsbury DW, Thompson HS, Goodman RM, Schechter CB, Merzel C, Shelton RC, Blank AE, Erb-Downward J, Williams A, Valera P, Padgett DK. Using the interactive systems framework to support a quality improvement approach to dissemination of evidence-based strategies to promote early detection of breast cancer: planning a comprehensive dynamic trial. Am J Community Psychol. 2012 Dec;50(3-4):497-517. doi: 10.1007/s10464-012-9518-6.
- Rapkin B.D., Trickett E.J. Comprehensive Dynamic Trial Designs for Behavioral Prevention Research with Communities: Overcoming Inadequacies of the Randomized Controlled Trial Paradigm. In Community Interventions and AIDS. Eds. Trickett E.J. and Pequegnat W. Oxford University Press. 2005:249-277University Press. 2005:249-277.
- Reznik M, Bauman LJ. Barriers to Physical Activity in Schoolchildren with Asthma: A Parent Perspective Clinical and Translational Science 2012;5(2):168.
- Brown JV, Bakeman R, Celano MP, Demi AS, Kobrynski L, Wilson SR. Home-based asthma education of young low-income children and their families. J Pediatr Psychol. 2002 Dec;27(8):677-88. doi: 10.1093/jpepsy/27.8.677.
- Reznik M, Wylie-Rosett J, Kim M, Ozuah PO. A classroom-based physical activity intervention for urban kindergarten and first-grade students: a feasibility study. Child Obes. 2015 Jun;11(3):314-24. doi: 10.1089/chi.2014.0090. Epub 2015 Mar 6.
- Rinke ML, Chen AR, Bundy DG, Colantuoni E, Fratino L, Drucis KM, Panton SY, Kokoszka M, Budd AP, Milstone AM, Miller MR. Implementation of a central line maintenance care bundle in hospitalized pediatric oncology patients. Pediatrics. 2012 Oct;130(4):e996-e1004. doi: 10.1542/peds.2012-0295. Epub 2012 Sep 3.
- Rinke ML, Dietrich E, Kodeck T, Westcoat K. Operation care: a pilot case management intervention for frequent emergency medical system users. Am J Emerg Med. 2012 Feb;30(2):352-7. doi: 10.1016/j.ajem.2010.12.012. Epub 2011 Jan 26.
- Basu Roy U, Michel T, Carpenter A, Lounsbury DW, Sabino E, Stevenson AJ, Combs S, Jacobs J, Padgett D, Rapkin BD. Community-led cancer action councils in Queens, New York: process evaluation of an innovative partnership with the Queens library system. Prev Chronic Dis. 2014 Feb 6;11:130176. doi: 10.5888/pcd11.130176.
- Ockene JK, Zapka JG. Provider education to promote implementation of clinical practice guidelines. Chest. 2000 Aug;118(2 Suppl):33S-39S. doi: 10.1378/chest.118.2_suppl.33s.
- Halterman JS, McConnochie KM, Conn KM, Yoos HL, Callahan PM, Neely TL, Szilagyi PG. A randomized trial of primary care provider prompting to enhance preventive asthma therapy. Arch Pediatr Adolesc Med. 2005 May;159(5):422-7. doi: 10.1001/archpedi.159.5.422.
- Cabana MD, Slish KK, Evans D, Mellins RB, Brown RW, Lin X, Kaciroti N, Clark NM. Impact of Physician Asthma Care Education on patient outcomes. Health Educ Behav. 2014 Oct;41(5):509-17. doi: 10.1177/1090198114547510.
- Cabana MD, Slish KK, Evans D, Mellins RB, Brown RW, Lin X, Kaciroti N, Clark NM. Impact of physician asthma care education on patient outcomes. Pediatrics. 2006 Jun;117(6):2149-57. doi: 10.1542/peds.2005-1055.
- Clark NM, Gong M, Schork MA, Maiman LA, Evans D, Hurwitz ME, Roloff D, Mellins RB. A scale for Assessing Health Care Providers' Teaching and Communication Behavior regarding asthma. Health Educ Behav. 1997 Apr;24(2):245-56. doi: 10.1177/109019819702400211.
- Busse WW, Morgan WJ, Taggart V, Togias A. Asthma outcomes workshop: overview. J Allergy Clin Immunol. 2012 Mar;129(3 Suppl):S1-8. doi: 10.1016/j.jaci.2011.12.985.
- Schatz M, Zeiger RS, Drane A, Harden K, Cibildak A, Oosterman JE, Kosinski M. Reliability and predictive validity of the Asthma Control Test administered by telephone calls using speech recognition technology. J Allergy Clin Immunol. 2007 Feb;119(2):336-43. doi: 10.1016/j.jaci.2006.08.042. Epub 2006 Dec 27.
- Asmussen L, Olson LM, Grant EN, Fagan J, Weiss KB. Reliability and validity of the Children's Health Survey for Asthma. Pediatrics. 1999 Dec;104(6):e71. doi: 10.1542/peds.104.6.e71.
- Horne R WJ HM. The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication. Psych Health. 1999.
- Pak L, Allen PJ. The impact of maternal depression on children with asthma. Pediatr Nurs. 2012 Jan-Feb;38(1):11-9, 30.
- Otsuki M, Eakin MN, Arceneaux LL, Rand CS, Butz AM, Riekert KA. Prospective relationship between maternal depressive symptoms and asthma morbidity among inner-city African American children. J Pediatr Psychol. 2010 Aug;35(7):758-67. doi: 10.1093/jpepsy/jsp091. Epub 2009 Oct 22.
- Clark NM, Gong M, Schork MA, Evans D, Roloff D, Hurwitz M, Maiman L, Mellins RB. Impact of education for physicians on patient outcomes. Pediatrics. 1998 May;101(5):831-6. doi: 10.1542/peds.101.5.831.
- Maly RC, Leake B, Silliman RA. Breast cancer treatment in older women: impact of the patient-physician interaction. J Am Geriatr Soc. 2004 Jul;52(7):1138-45. doi: 10.1111/j.1532-5415.2004.52312.x.
- Maly RC, Leake B, Silliman RA. Health care disparities in older patients with breast carcinoma: informational support from physicians. Cancer. 2003 Mar 15;97(6):1517-27. doi: 10.1002/cncr.11211.
- Imai K, Keele L, Tingley D, Yamamoto T (2010). Causal Mediation Analysis Using R.
- Rubin, D.B. (1976) Inference and missing data. Biometrika, 63, 581-592.
- Finkelstein JA, Lozano P, Streiff KA, Arduino KE, Sisk CA, Wagner EH, Weiss KB, Inui TS. Clinical effectiveness research in managed-care systems: lessons from the Pediatric Asthma Care PORT. Patient Outcomes Research Team. Health Serv Res. 2002 Jun;37(3):775-89. doi: 10.1111/1475-6773.00048.
- Fuhlbrigge AL, Kitch BT, Paltiel AD, Kuntz KM, Neumann PJ, Dockery DW, Weiss ST. FEV(1) is associated with risk of asthma attacks in a pediatric population. J Allergy Clin Immunol. 2001 Jan;107(1):61-7. doi: 10.1067/mai.2001.111590.
- Jenkins HA, Cherniack R, Szefler SJ, Covar R, Gelfand EW, Spahn JD. A comparison of the clinical characteristics of children and adults with severe asthma. Chest. 2003 Oct;124(4):1318-24. doi: 10.1378/chest.124.4.1318.
- Sharek PJ, Mayer ML, Loewy L, Robinson TN, Shames RS, Umetsu DT, Bergman DA. Agreement among measures of asthma status: a prospective study of low-income children with moderate to severe asthma. Pediatrics. 2002 Oct;110(4):797-804. doi: 10.1542/peds.110.4.797.
- Bacharier LB MD, Lemanske RF, Schend V, Sorkness C, Strunk RC. Classifying asthma severity in children: is measuring lung function helpful? . J Allergy Clin Immunol. 2002.
- Spahn JD, Cherniack R, Paull K, Gelfand EW. Is forced expiratory volume in one second the best measure of severity in childhood asthma? Am J Respir Crit Care Med. 2004 Apr 1;169(7):784-6. doi: 10.1164/rccm.200309-1234OE. Epub 2004 Jan 30. No abstract available.
- Reznik M, Ball-Jones R, Ibarra J. The COVID-19 pandemic and asthma management: a family caregiver perspective. J Asthma. 2025 May;62(5):817-823. doi: 10.1080/02770903.2024.2447285. Epub 2025 Jan 8.
- Telzak A, Fiori KP, Chambers EC, Haughton J, Levano S, Reznik M. Unmet Social Needs and Pediatric Asthma Severity in an Urban Primary Care Setting. Acad Pediatr. 2023 Sep-Oct;23(7):1361-1367. doi: 10.1016/j.acap.2023.02.009. Epub 2023 Feb 27.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月7日
初级完成 (实际的)
2024年8月24日
研究完成 (实际的)
2024年8月24日
研究注册日期
首次提交
2017年2月16日
首先提交符合 QC 标准的
2017年2月23日
首次发布 (实际的)
2017年2月28日
研究记录更新
最后更新发布 (估计的)
2025年10月21日
上次提交的符合 QC 标准的更新
2025年10月3日
最后验证
2025年10月1日
更多信息
与本研究相关的术语
其他研究编号
- 2016-6258
- 1R01HL133789 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
在研究完成且主要研究目标手稿已发表后，研究人员将使用数据共享协议流程共享去识别化数据。
IPD 共享时间框架
根据 NIH 数据管理和共享 (DMS) 政策，IPD 数据的“及时发布和共享”将被考虑不晚于接受发布最终数据集的主要发现，并允许“合理的宽限期” （30-60 天）如政策中所述。
数据的可用期限长达 XX 年。
IPD 共享访问标准
对 BDC 的访问由 NHLBI 数据访问委员会 (DAC) 控制，该委员会使用基因型和表型数据库 (dbGaP) 权限基础设施。 要访问 BDC 中的受控访问数据，研究者必须在 dbGaP 中拥有已批准的数据访问请求 (DAR)。 DAC 将审查并批准（或拒绝）研究者提交的 DAR，以确保研究者遵守数据共享政策。
仅根据数据共享协议才向用户提供数据和相关文档，该协议要求：
- 接收者不得将数据传输给其他用户；
- 仅用于研究目的的数据；
- 承诺不为了识别任何个体主体的目的而操纵数据；
- 使用数据进行的拟议研究将由 IRB 审查；
- 承诺使用适当的计算机技术保护数据；
- 承诺在分析完成后销毁或归还数据。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
电子MPI的临床试验
-
The Cleveland ClinicDJO Incorporated完全的
-
University of TennesseeUnited States Naval Medical Center, San Diego; Walter Reed National Military Medical Center完全的