Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial

Lene Maria Ørts, Anders Løkke, Anne-Louise Bjerregaard, Helle Terkildsen Maindal, Annelli Sandbæk, Lene Maria Ørts, Anders Løkke, Anne-Louise Bjerregaard, Helle Terkildsen Maindal, Annelli Sandbæk

Abstract

Background: Early detection of lung diseases can help to reduce their severity. Lung diseases are among the most frequently occurring and serious diseases worldwide; nonetheless, many patients remain undiagnosed. Preventive health checks including spirometry can detect lung diseases at early stages; however, recruitment for health checks remains a challenge, and little is known about what motivates the attendance. The aim of the study is to examine whether focused information on spirometry in the invitation compared to general information will impact the attendance rate in preventive health checks.

Methods/design: This randomized, controlled trial tests the effect of information on spirometry embedded in the Check your Health Preventive Program (CHPP). The CHPP is an open-label, household cluster-randomized, controlled trial offering a preventive health check to 30- to -49-year-olds in a Danish municipality from 2012 to 2017 (n = 26,216). During 2015-2016, 4356 citizens aged 30-49 years will be randomized into two groups. The intervention group receives an invitation which highlights the value and contents of spirometry as part of a health check and information about lung diseases. The comparison group receives a standard invitation containing practical information and specifies the contents of the general health check. Outcomes are (1) differences in attendance rates measured by the proportion of citizens attending each of the two study groups and (2) proportion of persons at risk defined by smoking status and self-reported lung symptoms in the study groups. The proportion of participants with abnormal spirometry assessed at the preventive health check will be compared between the two study groups.

Discussion: The results from the present study will inform future recruitment strategies to health checks. The developed material on content, value, and information about lung disease is feasible and transferable to other populations, making it easy to implement if effective.

Trial registration: ClinicalTrials.gov: NCT02615769 . Registered on 25 November 2015.

Keywords: Attendance; Preventive health check; Spirometry.

Figures

Fig. 1
Fig. 1
Flowchart of participants in the Check your Health Preventive Program [20] and the present trial. R1 household randomization into five groups of equal size, R2 household randomization into the intervention group or comparison group in the present study before sending of the invitations

References

    1. Registry of Causes of Death. Available at: . Accessed 14 Oct 2015.
    1. Chronic obstructive pulmonary disease. Recommendations for early identification, follow-up, treatment and rehabilitation. Copenhagen, Denmark: The National Board of Health; 2007.
    1. Løkke A, Ulrik CS, Dahl R, et al. Detection of previously undiagnosed cases of COPD in a high-risk population identified in general practice. COPD. 2012;9(5):458–465. doi: 10.3109/15412555.2012.685118.
    1. Halding A-G, Heggdal K, Wahl A. Experiences of self-blame and stigmatisation for self-infliction among individuals living with COPD. Scand J Caring Sci. 2011;25(1):100–107. doi: 10.1111/j.1471-6712.2010.00796.x.
    1. Dryden R, Williams B, McCowan C, Themessl-Huber M. What do we know about who does and does not attend general health checks? Findings from a narrative scoping review. BMC Public Health. 2012;12(1):723. doi: 10.1186/1471-2458-12-723.
    1. Jepson R, Clegg A, Forbes C, Lewis R, Sowden A, Kleijnen J. The determinants of screening uptake and interventions for increasing uptake: a systematic review. Health Technol Assess. 2000;4(14):1–191.
    1. Kiernan M, Phillips K, Fair JM, King AC. Using direct mail to recruit Hispanic adults into a dietary intervention: an experimental study. Ann Behav Med. 2000;22(1):89–93. doi: 10.1007/BF02895172.
    1. Sallis A, Bunten A, Bonus A, James A, Chadborn T, Berry D. The effectiveness of an enhanced invitation letter on uptake of National Health Service Health Checks in primary care: a pragmatic quasi-randomised controlled trial. BMC Fam Pract. 2016;17(1):35. doi: 10.1186/s12875-016-0426-y.
    1. van Wonderen KE, Mohrs J, IJff M, Bindels PJE, ter Riet G. Two simple strategies (adding a logo or a senior faculty’s signature) failed to improve patient participation rates in a cohort study: randomized trial. J Clin Epidemiol. 2008;61(10):971–977. doi: 10.1016/j.jclinepi.2008.05.008.
    1. Martinson BC, Lazovich D, Lando HA, Perry CL, McGovern PG, Boyle RG. Effectiveness of monetary incentives for recruiting adolescents to an intervention trial to reduce smoking. Prev Med (Baltim) 2000;31(6):706–713. doi: 10.1006/pmed.2000.0762.
    1. Hewitson P, Ward AM, Heneghan C, Halloran SP, Mant D. Primary care endorsement letter and a patient leaflet to improve participation in colorectal cancer screening: results of a factorial randomised trial. Br J Cancer. 2011;105(4):475–480. doi: 10.1038/bjc.2011.255.
    1. Wardle J, Williamson S, McCaffery K, et al. Increasing attendance at colorectal cancer screening: testing the efficacy of a mailed, psychoeducational intervention in a community sample of older adults. Health Psychol. 2003;22(1):99–105. doi: 10.1037/0278-6133.22.1.99.
    1. Quaife SL, Ruparel M, Beeken RJ, et al. The Lung Screen Uptake Trial (LSUT): protocol for a randomised controlled demonstration lung cancer screening pilot testing a targeted invitation strategy for high risk and “hard-to-reach” patients. BMC Cancer. 2016;16(1):281. doi: 10.1186/s12885-016-2316-z.
    1. Lauritzen T, Leboeuf-Yde C, Lunde IM, Nielsen KD. Ebeltoft project: baseline data from a five-year randomized, controlled, prospective health promotion study in a Danish population. Br J Gen Pract. 1995;45(399):542–547.
    1. Lange P, Celli B, Agustí A, et al. Lung-function trajectories leading to chronic obstructive pulmonary disease. N Engl J Med. 2015;373(2):111–122. doi: 10.1056/NEJMoa1411532.
    1. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63(8):e1–e37. doi: 10.1016/j.jclinepi.2010.03.004.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148(4):295–309. doi: 10.7326/0003-4819-148-4-200802190-00008.
    1. Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661. doi: 10.1136/bmj.e5661.
    1. Maindal HT, Støvring H, Sandbaek A. Effectiveness of the population-based Check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial. Trials. 2014;15:341. doi: 10.1186/1745-6215-15-341.
    1. Schmidt M, Pedersen L, Sørensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014;29(8):541–549. doi: 10.1007/s10654-014-9930-3.
    1. Pedersen CB. The Danish Civil Registration System. Scand J Public Health. 2011;39(7 suppl):22–25. doi: 10.1177/1403494810387965.
    1. Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–233. doi: 10.1097/00005650-199603000-00003.
    1. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993;88(6):791–804. doi: 10.1111/j.1360-0443.1993.tb02093.x.
    1. Christensen AI. Den nationale sundhedsprofil 2010: Hvordan har du det? 2013.
    1. van der Molen T, Willemse BWM, Schokker S, ten Hacken NHT, Postma DS, Juniper EF. Development, validity and responsiveness of the Clinical COPD Questionnaire. Health Qual Life Outcomes. 2003;1:13. doi: 10.1186/1477-7525-1-13.
    1. Vestbo J, Hurd SS, Agusti AG, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013;187(4):347–365. doi: 10.1164/rccm.201204-0596PP.
    1. Vestbo J, Hurd SS, Rodriguez-Roisin R. The 2011 revision of the global strategy for the diagnosis, management and prevention of COPD (GOLD)—why and what? Clin Respir J. 2012;6(4):208–214. doi: 10.1111/crj.12002.
    1. Astrand I. Aerobic work capacity in men and women with special reference to age. Acta Physiol Scand Suppl. 1960;49(169):1–92.
    1. Statistican Denmark. No Title. (February 2016). . Accessed 13 Oct 2015
    1. Kildemoes HW, Sørensen HT, Hallas J. The Danish National Prescription Registry. Scand J Public Health. 2011;39(7 Suppl):38–41. doi: 10.1177/1403494810394717.
    1. Check your health preventive program. . Accessed 20 May 2016.
    1. Donner A, Klar N. Design and analysis of cluster randomization trials in health research. New York: Wiley; 2000.
    1. Mapstone J, Elbourne D, Roberts IG. Strategies to improve recruitment to research studies. Cochrane Database Syst Rev. 2007;2:MR000013.
    1. Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57(8):785–794. doi: 10.1016/j.jclinepi.2003.12.013.
    1. Little RJ, Agostino RD, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367(14):1355–60. doi:10.1056/NEJMsr1203730.
    1. Stata: Data Analysis and Statistical Software. . Accessed 24 Oct 2015.
    1. Kølner-augustson L, Thøgersen N, Faaborg TH, Weinreich UM. The majority of participants with abnormal spirometry at walk-in consult their general practitioner as recommended. Dan Med J. 2015;62:A5149.
    1. The Danish Lung Association. (Feb 2016). . Accessed 15 Feb 2016.

Source: PubMed

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