Use of the ‘patient journey’ model in the internet-based pre-fitting counseling of a person with hearing disability: lessons from a failed clinical trial

BMC Ear, Nose and Throat Disorders

Thomas Lunner¹  Gerhard Andersson²  Jerker Rönnberg³  Vinaya Manchaiah³ 

[1] Eriksholm Research Centre, Oticon A/S, 20 Rørtangvej, Snekkersten, Denmark;Department of Clinical Neuroscience, Division of Psychiatry, Karolinska Institutet, Stockholm, Sweden;Linnaeus Centre HEAD, Swedish Institute for Disability Research, Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden

关键词: Treatment compliancy;    Dropouts;    Failed clinical trial;    Pre-fitting counseling;    Patient journey;    Hearing disability;   

Others  :  862668
DOI  :  10.1186/1472-6815-14-3

 received in 2013-07-29, accepted in 2014-04-02,  发布年份 2014

【 摘 要 】

Background

Persons with a hearing impairment have various experiences during their ‘journey’ through hearing loss. In our previous studies we have developed ‘patient journey’ models of person with hearing impairment and their communication partners (CPs). The study was aimed to evaluate the effectiveness of using the patient journey model in the internet-based pre-fitting counseling of a person with hearing disability (ClinicalTrials.gov Protocol Registration System: NCT01611129, registered 2012 May 14).

Method

The study employed a randomized controlled trial (RCT) with waiting list control (WLC) design. Even though we had intended to recruit 158 participants, we only managed to recruit 80 participants who were assigned to one of two groups: (1) Intervention group; and (2) WLC. Participants from both groups completed a 30 day internet-based counseling program (group 2 waited for a month before intervention) based on the ‘patient journey’ model. Various outcome measures which focus on self-reported hearing disability, self-reported depression and anxiety, readiness to change and self-reported hearing disability acceptance were administered pre- and post-intervention.

Results

The trial results suggest that the intervention was not feasible. Treatment compliancy was one of the main problems with a high number of dropouts. Only 18 participants completed both pre- and post-intervention outcome measures. Their results were included in the analysis. Results suggest no statistically significant differences among groups over time in all four measures.

Conclusions

Due to the limited sample size, no concrete conclusions can be drawn about the hypotheses from the current study. Furthermore, possible reasons for failure of this trial and directions for future research are discussed.

【 授权许可】

   
2014 Manchaiah et al.; licensee BioMed Central Ltd.

【 图 表 】

【 参考文献 】

• [1]Kochkin S, MarkeTrak V: ‘Why my hearing aids are in the drawer’: the consumers perspectives. Hearing J 2000, 53:34-42.
• [2]Knudsen LV, Oberg M, Nielsen C, Naylor G, Kramer SE: Factors influencing help-seeking, hearing-aid uptake, hearing aid use and satisfaction with hearing aids: a review of literature. Trends Amplif 2010, 14(3):127-154.
• [3]Hannula S, Bloigu R, Majamma K, Sorri M, Mäki-Torkko E: Self-reported hearing problems among older adults: prevalence and comparison to measured hearing impairment. J Am Acad Audiol 2011, 22:550-559.
• [4]Stephens D, Kramer SE: Living with Hearing Difficulties: The process of enablement. Chichester: Wiley; 2009.
• [5]Dillion H: Hearing aids. Turramurra, Australia: Boomerang Press; 2001.
• [6]Kelly TB, Tolson D, Day T, McColgan G, Kroll T, Maclaren W: Older people’s views on what they need to successfully adjust to life with a hearing aid. Health Soc Care Com 2013, 21(3):293-302.
• [7]Brooks DN: Counselling and its effect on hearing aid use. Scand Audiol 1979, 8:101-107.
• [8]Brooks DN, Johnson DI: Pre-issue assessment and counseling as a component of hearing-aid provision. Brit J Audiol 1981, 15:13-19.
• [9]Kemker B, Holmes AE: Analysis of pre-fitting versus postfitting hearing aid orientation using the Glasgow Hearing Aid Benefit Profile (GHABP). J Am Acad Audiol 2004, 15:311-323.
• [10]Norman M, George CR, McCarthy D: The effect of pre-fitting counseling on the outcome of hearing aid fitting. Scand Audiol 1994, 23:257-263.
• [11]Öberg M, Andersson G, Wänström G, Lunner T: The effect of sound awareness pre-fitting intervention: a randomized controlled trial. Audiol Med 2008, 6:129-140.
• [12]Cummings JN, Sproull L, Kiesler SB: Beyond hearing: where real-world and online support meet. Group Dyn-Theor Res Pr 2002, 6(1):78-88.
• [13]Laplante-Lévesque A, Pichora-Fuller MK, Gangé J-P: Providing an internet-based audiological counseling program to new hearing aid users: a qualitative study. Int J Audiol 2006, 45:697-706.
• [14]Thorén E, Sevensson M, Törnqvist A, Andersson G, Carlbring P, Lunner T: Rehabilitative online education versus internet discussion group for hearing aid users: a randomized controlled trial. J Am Acad Audiol 2011, 22:274-285.
• [15]Lundberg M, Andersson G, Lunner T: A randomized, controlled trial of the short-terms effects of complementing education program for hearing aid users with telephone conversations. J Am Acad Audiol 2011, 22(10):654-662.
• [16]Baker MG, Graham L: The journey: Parkinson’s disease. Br Med J 2004, 329:611-614.
• [17]Janz NK, Becker MH: The health belief model: a decade later. Health Educ Q 1984, 11:1-47.
• [18]Layton A, Moss F, Morgan G: Mapping out the patient’s journey: experiences of developing pathways of care. Qual Health Care 1998, 7:S30-S36.
• [19]Macdonald N, Shapiro A, Bender C, Paolantonio M, Coombs J: Experiences and perspectives on the GIST patient journey. Patient Prefer Adher 2012, 5:653-662.
• [20]Chisholm N, Gillet G: The patient’s journey: living with locked-in syndrome. Br Med J 2005, 331:94-97.
• [21]Levenson R: A Patient’s journey: whooping cough. Br Med J 2004, 334:532-533.
• [22]Oliver S, Bosworth A, Airoldi M, Bumyna H, Callum A, Dixon J, Home D, Lax I, O’Brien A, Redmond A, Ryan S, Scott DG, Steuer A, Tanner L: Exploring the healthcare journey of patients with rheumatoid arthritis: a mapping project - implications for practice. Musculoskel Care 2008, 6:247-266.
• [23]Simpson C, Franks C, Morrison C, Lempp H: The patient’s journey: rheumatoid arthritis. Br Med J 2005, 331:887-889.
• [24]Manchaiah VKC, Stephens D, Meredith R: The patient journey of adults with hearing impairment: the patients’ view. Clin Otolaryngol 2011, 36:227-234.
• [25]Manchaiah VKC, Stephens D: The patient journey: living with hearing impairment. J Acad Rehabil Audiol 2011, 44:29-40.
• [26]Manchaiah VKC, Stephens D: The patient journey of adults with sudden-onset acquired hearing impairment: a pilot study. J Laryngol Otol 2012, 126(5):475-481.
• [27]Manchaiah VKC, Stephens D, Lunner T: Journey of communication partners of person with hearing impairment. Int J Otolaryngol 2013, 2013:1-11. doi: 10.1155/2013/707910
• [28]Manchaiah VKC, Stephens D, Andersson G, Rönnberg J, Lunner T: Use of the ‘patient journey’ model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial. Trials 2013, 4(1):25.
• [29]Andersson G, Bergström J, Buhrman M, Carlbring P, Holländare F, Kaldo V, Nilsson-Ihrfelt E, Paxling B, Ström L, Waara J: Development of a new approach to guided self-help via the internet: the Swedish experience. J Technol Hum Serv 2008, 26:161-181.
• [30]Manchaiah VKC: Health behaviour change in hearing healthcare: a discussion paper. Audiol Res 2012, 2(e4):12-16.
• [31]Gatehouse S, Noble W: The speech, spatial and qualities of hearing scale (SSQ). Int J Audiol 2004, 43:85-99.
• [32]Hickson L, Worrall L, Scarinci N: A randomized controlled trial evaluating the active communication education program for older people with hearing impairment. Ear Hear 2007, 28:212-230.
• [33]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychatr Scand 1983, 67(6):361-370.
• [34]Herrmann C: International experience with the hospital anxiety and depression scale - a review of validation data and clinical results. J Psychosom Res 1997, 42(1):17-41.
• [35]McConnaughy EN, Prochaska JO, Velicer WF: Stages of change in psychotherapy: measurement and sample profiles. Psychother-Theor Res Pr 1983, 20:368-375.
• [36]DiClemente CC, Prochaska J: Toward a comprehensive, transtheoretical model of change. In Treating Addictive Behaviors. 2nd edition. Edited by Miller W, Heather N. New York: Plenum Press; 1998:3-24.
• [37]Laplante-Lévesque A, Hickson L, Worral L: Stages of change in adults with acquired hearing impairment seeking help for the first time: application of the transtheoretical model in audiologic rehabilitation. Ear Hear 2013, 34(4):47-57.
• [38]Manchaiah VKC, Molander P, Rönnberg J, Andersson G, Lunner T: The acceptance of hearing disability among adults experiencing hearing difficulties: a cross-sectional study. BMJ Open 2014, 4:e004066. doi:10.1136/bmjopen-2013-004066
• [39]Hopewell S, London K, Clarke MJ, Oxmann AD, Dickersin K: Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Sys Rev 2009, 1:1-28.
• [40]Touloumi G, Pocock SJ, Babiker AG, Darbyshire JH: Impact of missing data due to selective droupouts in cohort studies and clinical trials. Epidemiol 2002, 13:347-355.
• [41]Kemmler G, Hummer M, Widschwendter C, Fleischhacker W: Drouout rates in placebo-controlled and active-control clinical trials of antipsychotic drugs. Arch Gen Psychatry 2005, 62:1305-1312.
• [42]Woodford J, Farrand P, Bessant M, Williams C: Recruitment into a guided internet based CBT (iCBT) intervention for depression: lesson learnt from the failure of a prevalence recruitment strategy. Contemp Clin Trials 2011, 32:641-648.
• [43]Zajicek J, Fox P: MS clinical trials: lessons from recent failures. Int MS J 2001, 8(3):97-103.
• [44]Lenney W, Perry S, Price D: Clinical trials and tribulations: the MASCOT study. Thorax 2011, 66(6):457-458.
• [45]Smyth RL: Lessons to be learnt from unsuccessful clinical trials. Thorax 2011, 66(6):459-460.
• [46]Nachtegaal J, Smith JH, Smith C, Bezemer PD, van Beek JHM, Festen JM, Kramer SE: The association between hearing status and psychosocial health before the age of 70 years: results from an internet-based national survey on hearing. Ear Hear 2009, 30(3):302-312.
• [47]Nachtegaal J, Kuik DJ, Anema JR, Goverts ST, Festen JM, Kramer SE: Hearing status, need for recovery after work, and psychosocial work characteristics: results from an internet-based national survey on hearing. Int J Audiol 2009, 48:684-691.
• [48]Weise C, Kleinstäuber M, Hesser H, Zetterqvist Westin V, Andersson G: Acceptance of tinnitus: validation of the tinnitus acceptance questionnaire. Cognit Behav Ther 2013, 42(2):100-115.
• [49]Andersson G, Ljótsson B, Weise C: Internet-delivered treatment to promote health. Curr Opin Psychiatr 2011, 24:168-172.
• [50]Henshaw H, Clark DPA, Kang S, Ferguson MA: Computer skills and internet use in adults aged 50–74 years: influence of hearing difficulties. J Med Internet Res 2012, 14(4):1-14.
• [51]Davis A, Smith P, Ferguson M, Stephens D, Gianopoulos I: Acceptability, benefit and costs of early screening for hearing disability: a study of potential screening tests and models. Health Technol Assess 2007, 11(42):1-294.
• [52]Whitehead LC: Methodological and ethical issues in internet-mediated research in the field of health: an integrated review of the literature. Soc Sci Med 2007, 65:782-791.
• [53]Glasgow RE, Nelson CC, Kearney KA: Reach, engagement, and retention in an internet-based weight loss program in a multi-site randomized controlled trial. J Med Internet Res 2007, 9:e11. doi:10.2196/jmir.9.2.e11
• [54]Beck J, Esser PJ, Herschel MB: Why clinical trials fail before they even they get started: the ‘Frontloading’ process. Qual Assur J 2004, 8:21-32.
• [55]McMurran M, Cox WM, Whitham D, Hegdes L: The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial. Trials 2013, 14:50. BioMed Central Full Text