Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial

Aleida G Huppelschoten, Noortje T L van Duijnhoven, Rosella P M G Hermens, Chris Verhaak, Jan A M Kremer, Willianne L D M Nelen, Aleida G Huppelschoten, Noortje T L van Duijnhoven, Rosella P M G Hermens, Chris Verhaak, Jan A M Kremer, Willianne L D M Nelen

Abstract

Background: Beside traditional outcomes of safety and (cost-)effectiveness, the Institute of Medicine states patient-centeredness as an independent outcome indicator to evaluate the quality of healthcare. Providing patient-centered care is important because patients want to be heard for their ideas and concerns. Healthcare areas associated with high emotions and intensive treatment periods could especially benefit from patient-centered care. How care can become optimally improved in patient-centeredness is unknown. Therefore, we will conduct a study in the context of Dutch fertility care to determine the effects of a multifaceted approach on patient-centeredness, patients' quality of life (QoL) and levels of distress. Our aims are to investigate the effectiveness of a multifaceted approach and to identify determinants of a change in the level of patient-centeredness, patients' QoL and distress levels. This paper presents the study protocol.

Methods/design: In a cluster-randomized trial in 32 Dutch fertility clinics the effects of a multifaceted approach will be determined on the level of patient-centeredness (Patient-centredness Questionnaire - Infertility), patients' QoL (FertiQoL) and levels of distress (SCREENIVF). The multifaceted approach includes audit and feedback, educational outreach visits and patient-mediated interventions. Potential determinants of a change in patient-centeredness, patients' QoL and levels of distress will be collected by an addendum to the patients' questionnaire and a professionals' questionnaire. The latter includes the Organizational Culture Assessment Instrument about the clinic's culture as a possible determinant of an increase in patient-centered care.

Discussion: The study is expected to yield important new evidence about the effects of a multifaceted approach on levels of patient-centeredness, patients' QoL and distress in fertility care. Furthermore, determinants associated with a change in these outcome measures will be studied. With knowledge of these results, patient-centered care and thus the quality of healthcare can be improved. Moreover, the results of this study could be useful for similar initiatives to improve the quality of care delivery. The results of this project are expected at the end of 2013.

Trial registration: Clinicialtrials.gov NCT01481064.

Figures

Figure 1
Figure 1
Design of the study.

References

    1. Institute of Medicine. Crossing the Quality Chasm. A New Health System for the 21st Century. National Academy Press, Washington, DC; 2001.
    1. Bengoa R, Kawar R, Key P, Leatherman S, Massoud R, Saturno P. Quality of Care; A Process for Making Strategic Choices in Health Systems. WHO Press, Geneva; 2006.
    1. Keirns CC, Goold SD. Patient-centered care and preference-sensitive decision making. JAMA. 2009;302:1805–1806. doi: 10.1001/jama.2009.1550.
    1. Epstein RM, Fiscella K, Lesser CS, Stange KC. Why the nation needs a policy push on patient-centered health care. Health Aff. 2010;8:1489–1895.
    1. Levinson W, Roter DL, Mullooly JP, Dull VT, Frankel RM. Physician–patient communication: the relationship with malpractice claims among primary care physicians and surgeons. JAMA. 1997;277:553–559. doi: 10.1001/jama.1997.03540310051034.
    1. Mead N, Bower P. Patient-centred consultations and outcomes in primary care: a review of the literature. Patient Educ Couns. 2002;48:51–61. doi: 10.1016/S0738-3991(02)00099-X.
    1. Little P, Everitt H, Williamson I, Warner G, Moore M, Gould C, Ferrier K, Payne S. Observational study of effect of patient centeredness and positive approach on outcomes of general practice consultations. BMJ. 2001;323:908–911. doi: 10.1136/bmj.323.7318.908.
    1. Stewart M, Brown JB, Donner A, Mc Whinney IR, Oates J, Weston WW, Jordan J. The impact of patient-centered care on outcomes. J Fam Pract. 2000;49:796–804.
    1. Lewin S, Skea Z, Entwistle VA, Zwarenstein M, Dick J. Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev. 2001;4:CD003267. doi: 10.1002/14651858.
    1. Taylor A. ABC of subfertility. Extent of the problem. BMJ. 2003;327:434. doi: 10.1136/bmj.327.7412.434.
    1. Schmidt L, Münster K. Infertility, involuntary infecundity, and the seeking of medical advice in industrialized countries 1970–1992: a review of concepts, measurements and results. Hum Reprod. 1995;10:1407–1418.
    1. Bunting L, Boivin J. Decision-making about seeking medical advice in an Internet sample of women trying to get pregnant. Hum Reprod. 2007;22:1662–1668. doi: 10.1093/humrep/dem057.
    1. Verhaak CM, Smeenk JM, Evers AW, Kremer JA, Kraaimaat FW, Braat DD. Women’s emotional adjustment to IVF: a systematic review of 25 years of research. Hum Reprod Update. 2007;13:27–36.
    1. Chachamovich J, Chachamovich E, Ezer H, Fleck M, Knauth D, Passos E. Investigating quality of life and health-related quality of life in infertility: a systematic review. J Psychosom Obstet Gynaecol. 2010;31:101–110. doi: 10.3109/0167482X.2010.481337.
    1. Nelson CJ, Shindel AW, Naughton CK, Ohebshalom M, Mulhall JP. Prevalence and predictor of sexual problems, relationship stress, and depression in female partners of infertile couples. J Sex Med. 2008;5:1907–1914. doi: 10.1111/j.1743-6109.2008.00880.x.
    1. Drosdzol A, Skrzypulec V. Quality of life and sexual functioning of Polish infertile couples. Eur J Contracept Reprod Care. 2008;13:271–281. doi: 10.1080/13625180802049187.
    1. Brandes M, van der Steen JOM, Bokdam SB, Hamilton CJCM, de Bruin JP, Nelen WLDM, Kremer JAM. When and why do subfertile couples discontinue their fertility care? Hum Reprod. 2009;24:3127–3135. doi: 10.1093/humrep/dep340.
    1. Van Empel IWH, Aarts JWM, Cohlen BJ, Huppelschoten DA, Laven JSE, Nelen WLDM, Kremer JAM. Measuring patient-centredness, the neglected outcome in fertility care: a random multicentre validation study. Hum Reprod. 2010;10:2516–2526.
    1. Aarts JWM, Faber MJ, van Empel IWH, Scheenjes E, Nelen WLDM, Kremer JAM. Professionals’ perceptions of their patients’ experiences with fertility care. Hum Reprod. 2011;26:1119–1127. doi: 10.1093/humrep/der054.
    1. Proudfoot J, Jayasinghe UW, Holton C, Grimm J, Bubner T, Amoroso C, Beilby J, Harris MF. Team climate for innovation: what difference does it make in general practice? Int J Qual Health Care. 2007;19:164–169. doi: 10.1093/intqhc/mzm005.
    1. Bower P, Campbell S, Bojke C, Sibbald B. Team structure, team climate and the quality of care in primary care: an observational study. Qual Saf Health Care. 2003;12:273–279. doi: 10.1136/qhc.12.4.273.
    1. Wheelan SA, Burchill CN, Tilin F. The link between teamwork and patients’ outcomes in intensive care units. Am J Crit Care. 2003;12:527–534.
    1. Campbell SM, Hann M, Hacker J, Burns C, Oliver D, Thapar A, Mead N, Safran DG, Roland MO. Identifying predictors of high quality care in English general practice: observational study. BMJ. 2001;323:784–787. doi: 10.1136/bmj.323.7316.784.
    1. Elwyn G, Edwards A, Kinnersley P, Grol R. Shared decision making and the concept of equipoise: the competences of involving patients in healthcare choices. Br J Gen Pract. 2000;50:892–899.
    1. Grol R, Berwick DM, Wensing M. On the trail of quality and safety in health care. BMJ. 2008;336:74–76. doi: 10.1136/.
    1. Oxman A, Thomson MA, Davis DA, Haynes RB. No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. CMAJ. 1995;153:1423–1431.
    1. Boivin J, Takefman J, Braverman A. The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum Reprod. 2011;26:2084–2091. doi: 10.1093/humrep/der171.
    1. Aarts JWM, van Empel IVW, Boivin J, Nelen WL, Kremer JAM, Verhaak CM. Relation between quality of life and distress in infertility: a validation study of the FertiQoL. Hum Reprod. 2011;26:1112–1118. doi: 10.1093/humrep/der051.
    1. Zuidgeest M, Hendriks M, Kooman L, Spreeuwenberg P, Rademaker J. A comparison of a postal survey and mixed-mode survey using a questionnaire on patients’ experiences with breast care. J Med Internet Res. 2011;13:e68. doi: 10.2196/jmir.1241.
    1. Verhaak CM, Lintsen AME, Evers AWM, Braat DDM. Who is at risk of emotional problems and how do you know? Screening of women going for IVF treatment. Hum Reprod. 2010;25:1234–1240. doi: 10.1093/humrep/deq054.
    1. Spielberger CD. Manual for the State-trait Anxiety Scale. Consulting Psychologists Press, Palo Alto, CA; 1983.
    1. Van der Ploeg HM, Defares PB, Spielberger CD. Handleiding bij de Zelfbeoordelingsvragenlijst: een Nederlandse bewerking van de Spielberger State Trait Anxiety Inventory [Dutch Manual for the Speilberger State and Trait Anxiety Inventory] Swets & Zeitlinger, Lisse; 2000.
    1. Beck AT, Guth D, Steer RA, Ball R. Screening for major depression disorders in medical inpatients with the Beck Depression Inventory for primary care. Behav Res Ther. 1997;35:785–791. doi: 10.1016/S0005-7967(97)00025-9.
    1. Van Dam-Baggen R, Kraaimaat FW. De inventarisatielijst Sociale betrokkenheid (ISB): een zelfbeoordelingslijst om sociale steun te meten [The Inventarisation inventory to measure sociale integration: a self report inventory to assess social support] Gedragstherapie. 1992;25:27–45.
    1. Evers AW, Kraaimaat FW, van Lankveld W, Jongen PJ, Bijlsma JWJ. Beyond unfavorable thinking: the illness cognition questionnaire for chronic diseases. J Consult Clin Psychol. 2001;69:1026–1036.
    1. Verhaak CM, Smeenk JM, van Minnen A, Kremer JA, Kraaimaat FW. A longitudinal, prospective study on emotional adjustment before, during and after consecutive fertility treatment cycles. Hum Reprod. 2005;20:2253–2260. doi: 10.1093/humrep/dei015.
    1. Mourad SM, Hermens RPMG, Liefers J, Akkermans RP, Zielhuis GA, Adang E, Grol RPTM, Nelen WLDM, Kremer JAM. A multi-faceted strategy to improve the use of national fertility guidelines; a cluster-randomized controlled trial. Hum Reprod. 2011;26:817–826. doi: 10.1093/humrep/deq299.
    1. Haagen EC, Nelen WL, Hermens RP, Braat DD, Grol RP, Kremer JA. Barriers to physician adherence to a subfertility guideline. Hum Reprod. 2005;20:3301–3306. doi: 10.1093/humrep/dei220.
    1. Jamtvedt G, Young JM, Kristoffersen DT, O’Brien MA, Oxman AD. Audit and feedback: effects on professional practice and health care outcomes. Cochrane Database Syst Rev. 2006;2:D000259. doi: 10.1002/14651858.CD000259.pub2.
    1. Grimshaw JM, Thomas RE, MacLennan G, Fraser C, Ramsay CR, Vale L, Whitty P, Eccles MP, Matowe L, Shirran L, Wensing M, Dijkstra R, Donaldson C. Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004;8:iii–iv. 1–72.
    1. Hysong SJ. Meta-analysis: audit and feedback features impact effectiveness on care quality. Med Care. 2009;47:356–363. doi: 10.1097/MLR.0b013e3181893f6b.
    1. Wensing M, Van der Weijden T, Grol R. Implementing guidelines and innovations in general practice: which interventions are effective? J Gen Pract. 1998;48:991–997.
    1. Van Empel IWH, Hermens RPMG, Akkermans RP, Hollander KWP, Nelen WLDM, Kremer JAM. Organizational determinants of patient-centred fertility care: a multilevel analysis. Fert Steril. 2011;95:513–519. doi: 10.1016/j.fertnstert.2010.08.021.
    1. Mourad SM, Nelen WLDM, Akkermans RP, Vollebergh JHA, Grol RPTM, Hermens RPMG, Kremer JAM. Determinants of patients’ experiences and satisfaction with fertility care. Fert Steril. 2010;94:1254–1259. doi: 10.1016/j.fertnstert.2009.07.990.
    1. Cho SK, Kim D, Jun JB, Bae SC, Sung YK. Factors influencing quality of life (QOL) for Korean patients with rheumatoid arthritis (RA) Rheumatol Int. 2012. [Epub ahead of print]
    1. Nefs G, Pouwer F, Denollet J, Pop V. The course of depressive symptoms in primary care patients with type 2 diabetes: results from the Diabetes, Depression, Type D Personality Zuidoost-Brabant (DiaDDZoB) Study. Diabetologia. 2011;55:608–616.
    1. Quinn RE, Rohrbaugh J. A competing values approach to organizational effectiveness. Public Productivity Rev. 1981;5:122–140. doi: 10.2307/3380029.
    1. Cameron K, Freeman S. Culture, congruence, strength and type: relationship to effectiveness. Res Organ Change Dev. 1991;5:23–58.
    1. Cameron KS, Quinn RE, Degraff J, Thakor AV. Competing Values Leadership: Creating Value in Organizations. Edward Elgar, Cheltenham; 2006.
    1. Bosch M, Dijkstra R, Wensing M, van der Wijden T, Grol R. Organizational culture, team climate and diabetes care in small office-based practices. BMC Health Serv Res. 2008;8:180–187. doi: 10.1186/1472-6963-8-180.
    1. Hann M, Bower P, Campbell S, Marshall M, Reeves D. The association between culture, climate and quality of care in primary health care teams. Fam Pract. 2007;24:323–329. doi: 10.1093/fampra/cmm020.
    1. Mannion R, Harrison S, Jacobs R, Konteh F, Walshe K, Davies HT. From cultural cohesion to rules and competition: the trajectory of senior management culture in English NHS hospitals, 2001–2008. J R Soc Med. 2009;102:332–336. doi: 10.1258/jrsm.2009.090066.
    1. Scott T, Mannion R, Davies H, Marshall M. The quantitative measurement of organizational culture in health care: a review of the available instruments. Health Serv Res. 2003;38:923–945. doi: 10.1111/1475-6773.00154.
    1. Organizational Culture Assessment Instrument.
    1. Weiner BJ, Belden CM, Bergmire DM, Johnston M. The meaning and measurement of implementation science. Implement Sci. 2011;6:78–89. doi: 10.1186/1748-5908-6-78.
    1. Hulscher MEJL, Laurant MGH, Grol RPTM. Process evaluation on quality improvement interventions. Qual Saf Health Care. 2003;12:40–46. doi: 10.1136/qhc.12.1.40.
    1. Van der Veer SN, de Vos ML, Jager KJ, van der Voort PH, Peek N, Wester GP, Graafmans WC, de Keizer NF. Evaluating the effectiveness of a tailored multifaceted performance feedback intervention to improve the quality of care: protocol for a cluster randomized trial in intensive care. Implement Sci. 2011;6:119. doi: 10.1186/1748-5908-6-119.
    1. NHS Centre for Reviews and Dissemination and Nuffield Institute for Health. Implementing clinical guidelines. Can guidelines be used to improve clinical practice? Eff Health Care. 1994;1:1–12.
    1. Pill R, Stott NC, Rollnick SR, Rees M. A randomized controlled trial of an intervention designed to improve the care given in general practice to type II diabetic patients: patient outcomes and professional ability to change behavior. Fam Pract. 1998;15:229–235. doi: 10.1093/fampra/15.3.229.
    1. Lewis CC, Pantell RH, Sharp L. Increasing patient knowledge, satisfaction, and involvement: randomized trial of a communication intervention. Pediatrics. 1991;88:351–358.

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