Impact of an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes on decisional conflict--study protocol for a randomized controlled trial

Catherine H Yu, Noah M Ivers, Dawn Stacey, Jeremy Rezmovitz, Deanna Telner, Kevin Thorpe, Susan Hall, Marc Settino, David M Kaplan, Michael Coons, Sumeet Sodhi, Joanna Sale, Sharon E Straus, Catherine H Yu, Noah M Ivers, Dawn Stacey, Jeremy Rezmovitz, Deanna Telner, Kevin Thorpe, Susan Hall, Marc Settino, David M Kaplan, Michael Coons, Sumeet Sodhi, Joanna Sale, Sharon E Straus

Abstract

Background: Competing health concerns present real obstacles to people living with diabetes and other chronic diseases as well as to their primary care providers. Guideline implementation interventions rarely acknowledge this, leaving both patients and providers feeling overwhelmed by the volume of recommended actions. Interprofessional (IP) shared decision-making (SDM) with the use of decision aids may help to set treatment priorities. We developed an evidence-based SDM intervention for patients with diabetes and other conditions that was framed by the IP-SDM model and followed a user-centered approach. Our objective in the present study is to pilot an IP-SDM and goal-setting toolkit following the Knowledge-to-Action Framework to assess (1) intervention fidelity and the feasibility of conducting a larger trial and (2) impact on decisional conflict, diabetes distress, health-related quality of life and patient assessment of chronic illness care.

Methods/design: A two-step, parallel-group, clustered randomized controlled trial (RCT) will be conducted, with the primary goal being to assess intervention fidelity and the feasibility of conducting a larger RCT. The first step is a provider-directed implementation only; the second (after a 6-month delay) involves both provider- and patient-directed implementation. Half of the clusters will be assigned to receive the IP-SDM toolkit, and the other will be assigned to be mailed a diabetes guidelines summary. Individual interviews with patients, their family members and health care providers will be conducted upon trial completion to explore toolkit use. A secondary purpose of this trial is to gather estimates of the toolkit's impact on decisional conflict. Secondary outcomes include diabetes distress, quality of life and chronic illness care, which will be assessed on the basis of patient-completed questionnaires of validated scales at baseline and at 6 and 12 months. Multilevel hierarchical regression models will be used to account for the clustered nature of the data.

Discussion: An individualized approach to patients with multiple chronic conditions using SDM and goal setting is a desirable strategy for achieving guideline-concordant treatment in a patient-centered fashion. Our pilot trial will provide insights regarding strategies for the routine implementation of such interventions in clinical practice, and it will offer an assessment of the impact of this approach.

Trial registration: Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015.

References

    1. Yu CH, Stacey D, Sale J, Hall S, Kaplan DM, Ivers N, et al. Designing and evaluating an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes in clinical care – systematic decision aid development and study protocol. Implement Sci. 2014;9:16. doi: 10.1186/1748-5908-9-16.
    1. Joosten EA, DeFuentes-Merillas L, de Weert GH, Sensky T, van der Staak CP, de Jong CA. Systematic review of the effects of shared decision-making on patient satisfaction, treatment adherence and health status. Psychother Psychosom. 2008;77:219–26. doi: 10.1159/000126073.
    1. Légaré F, Ratté S, Gravel K, Graham ID. Barriers and facilitators to implementing shared decision-making in clinical practice: update of a systematic review of health professionals’ perceptions. Patient Educ Couns. 2008;73(3):526–35. doi: 10.1016/j.pec.2008.07.018.
    1. Peek ME, Wilson SC, Gorawara-Bhat R, Odoms-Young A, Quinn MT, Chin MH. Barriers and facilitators to shared decision-making among African-Americans with diabetes. J Gen Intern Med. 2009;24(10):1135–9. doi: 10.1007/s11606-009-1047-0.
    1. Légaré F, Stacey D, Graham ID, Elwyn G, Pluye P, Gagnon MP, et al. Advancing theories, models and measurement for an interprofessional approach to shared decision making in primary care: a study protocol. BMC Health Serv Res. 2008;8:2. doi: 10.1186/1472-6963-8-2.
    1. Légaré F, Ratté S, Stacey D, Kryworuchko J, Gravel K, Graham ID, et al. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2010;5:CD006732.
    1. Russell K, Hymans D. Interprofessional education for undergraduate students. Public Health Nurs. 1999;16(4):254–62. doi: 10.1046/j.1525-1446.1999.00254.x.
    1. van Dam HA, van der Horst F, van den Borne B, Ryckman R, Crebolder H. Provider–patient interaction in diabetes care: effects on patient self-care and outcomes. A systematic review. Patient Educ Couns. 2003;51(1):17–28. doi: 10.1016/S0738-3991(02)00122-2.
    1. Shojania KG, Ranji SR, McDonald KM, Grimshaw JM, Sundaram V, Rushakoff RJ, et al. Effects of quality improvement strategies for type 2 diabetes on glycemic control: a meta-regression analysis. JAMA. 2006;296(4):427–40. doi: 10.1001/jama.296.4.427.
    1. Tricco AC, Ivers NM, Grimshaw JM, Moher D, Turner L, Galipeau J, et al. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis. Lancet. 2012;379(9833):2252–61. doi: 10.1016/S0140-6736(12)60480-2.
    1. MacGregor K, Handley M, Wong S, Sharifi C, Gjeltema K, Schillinger D, et al. Behavior-change action plans in primary care: a feasibility study of clinicians. J Am Board Fam Med. 2006;19(3):215–23. doi: 10.3122/jabfm.19.3.215.
    1. Légaré F, Stacey D. An interprofessional approach to shared decision making: what it means and where next. In: Woodruff TK, Clayman ML, Waimey KE, editors. Oncofertility communication: sharing information and building relationships across disciplines. New York: Springer Science + Business Media; 2014. pp. 131–9.
    1. Coyne I, O’Mathúna DP, Gibson F, Shields L, Sheaf G. Interventions for promoting participation in shared decision-making for children with cancer. Cochrane Database Syst Rev. 2013;6:CD008970.
    1. Duncan E, Best C, Hagen S. Shared decision making interventions for people with mental health conditions. Cochrane Database Syst Rev. 2010;1:CD007297.
    1. Nannenga MR, Montori VM, Weymiller AJ, Smith SA, Christianson TJ, Bryant SC, et al. A treatment decision aid may increase patient trust in the diabetes specialist: the Statin Choice randomized trial. Health Expect. 2009;12:38–44. doi: 10.1111/j.1369-7625.2008.00521.x.
    1. Corser W, Holmes-Rovner M, Lein C, Gossain V. A shared decision-making primary care intervention for type 2 diabetes. Diabetes Educ. 2007;33(4):700–8. doi: 10.1177/0145721707304086.
    1. Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, et al. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009;169(17):1560–8. doi: 10.1001/archinternmed.2009.293.
    1. Weymiller AJ, Montori VM, Jones LA, Gafni A, Guyatt GH, Bryant SC, et al. Helping patients with type 2 diabetes mellitus make treatment decisions: Statin Choice randomized trial. Arch Intern Med. 2007;167:1076–82. doi: 10.1001/archinte.167.10.1076.
    1. Jones LA, Weymiller AJ, Shah N, Bryant SC, Christianson TJ, Guyatt GH, et al. Should clinicians deliver decision aids? Further exploration of the Statin Choice randomized trial results. Med Decis Making. 2009;29:468–74. doi: 10.1177/0272989X09333120.
    1. Edwards A, Thomas R, Williams R, Ellner AL, Brown P, Elwin G. Presenting risk information to people with diabetes: evaluating effects and preferences for different formats by a web-based randomised controlled trial. Patient Educ Couns. 2006;63:336–49. doi: 10.1016/j.pec.2005.12.016.
    1. Mann DM, Ponieman D, Montori VM, Arciniega J, McGinn T. The Statin Choice decision aid in primary care: a randomized trial. Patient Educ Couns. 2010;80:138–40. doi: 10.1016/j.pec.2009.10.008.
    1. Denig P, Schuling J, Haaijer-Ruskamp F, Voorham J. Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: pragmatic randomised controlled trial. BMJ. 2014;349:g5651. doi: 10.1136/bmj.g5651.
    1. Frost J, Anderson R, Argyle C, Daly M, Harris-Golesworthy F, Harris J, et al. A pilot randomised controlled trial of a preconsultation web-based intervention to improve the care quality and clinical outcomes of diabetes outpatients (DIAT) BMJ Open. 2013;3:e003396.
    1. Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, et al. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006;26(1):13–24. doi: 10.1002/chp.47.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi: 10.1136/bmj.a1655.
    1. Stacey D, Hill S. Patient-direct and patient-mediated KT interventions. In: Straus SE, Tetroe J, Graham ID, editors. Knowledge translation in health care: moving from evidence to practice. Chichester, UK: John Wiley & Sons; 2013. pp. 197–211.
    1. Elwyn G, Scholl I, Tietbohl C, Mann M, Edwards AG, Clay C, et al. “Many miles to go …”: a systematic review of the implementation of patient decision support interventions into routine clinical practice. BMC Med Inform Decis Mak. 2013;13 Suppl 2:S14. doi: 10.1186/1472-6947-13-S2-S14.
    1. Ontario Local Health Integration Network. . Accessed 15 June 2015.
    1. Légaré F, Stacey D, Brière N, Desroches S, Dumont S, Fraser K, et al. A conceptual framework for interprofessional shared decision making in home care: protocol for a feasibility study. BMC Health Serv Res. 2011;11:23. doi: 10.1186/1472-6963-11-23.
    1. Elwyn G, O’Connor A, Stacey D, Volk R, Edwards A, Coulter A, et al. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006;333:417. doi: 10.1136/.
    1. Légaré F, Stacey D, Pouliot S, Gauvin FP, Desroches S, Kryworuchko J, et al. Interprofessionalism and shared decision-making in primary care: a stepwise approach towards a new model. J Interprof Care. 2011;25(1):18–25. doi: 10.3109/13561820.2010.490502.
    1. O’Connor AM. User manual: decisional conflict scale. Ottawa, ON, Canada: Ottawa Hospital Research Institute; 1993.
    1. Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, et al. Assessing psychosocial distress in diabetes: development of the Diabetes Distress Scale. Diabetes Care. 2005;28(3):626–31. doi: 10.2337/diacare.28.3.626.
    1. Ware JE, Kosinski M, Keller SD. SF-36 physical and mental health summary scales: a user’s manual. Boston: The Health Institute; 1994.
    1. Glasgow RE, Whitesides H, Nelson CC, King DK. Use of the Patient Assessment of Chronic Illness Care (PACIC) with diabetic patients: relationship to patient characteristics, receipt of care, and self-management. Diabetes Care. 2005;28:2655–61. doi: 10.2337/diacare.28.11.2655.
    1. Francis J, Eccles MP, Johnston M, Walker AE, Grimshaw JM, Foy R, et al. Constructing questionnaires based on the theory of planned behavior: a manual for health services researchers. Newcastle upon Tyne, UK: Centre for Health Services Research, University of Newcastle upon Tyne; 2004.
    1. Elwyn G, Edwards A, Hood K, Robling M, Atwell C, Russell I, et al. Achieving involvement: process outcomes from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Fam Pract. 2004;21:337–46. doi: 10.1093/fampra/cmh401.
    1. Entwistle V, Prior M, Skea ZC, Francis JJ. Involvement in treatment decision-making: its meaning to people with diabetes and implications for conceptualisation. Soc Sci Med. 2008;66(2):362–75. doi: 10.1016/j.socscimed.2007.09.001.
    1. Murad MH, Shah ND, Van Houten HK, Ziegenfuss JY, Deming JR, Beebe TJ, et al. Individuals with diabetes preferred that future trials use patient-important outcomes and provide pragmatic inferences. J Clin Epidemiol. 2011;64(7):743–8. doi: 10.1016/j.jclinepi.2010.08.005.
    1. Gandhi GY, Murad MH, Fujiyoshi A, Mullan RJ, Flynn DN, Elamin MB, et al. Patient-important outcomes in registered diabetes trials. JAMA. 2008;299:2543–9. doi: 10.1001/jama.299.21.2543.
    1. Rubin RR, Peyrot M. Quality of life and diabetes. Diabetes Metab Res Rev. 1999;15(3):205–18. doi: 10.1002/(SICI)1520-7560(199905/06)15:3<205::AID-DMRR29>;2-O.
    1. O’Connor AM. Validation of a decisional conflict scale. Med Dec Making. 1995;15(1):25–30. doi: 10.1177/0272989X9501500105.
    1. Légaré F, O’Connor AM, Graham ID, Wells GA, Tremblay S. Impact of the Ottawa Decision Support Framework on the agreement and the difference between patients’ and physicians’ decisional conflict. Med Dec Making. 2006;26(4):373–90. doi: 10.1177/0272989X06290492.
    1. Deber RB, Kraetschmer N, Urowitz S, Sharpe N. Do people want to be autonomous patients? Preferred roles in treatment decision-making in several patient populations. Health Expect. 2007;10(3):248–58. doi: 10.1111/j.1369-7625.2007.00441.x.
    1. Levinson W, Kao A, Kuby A, Thisted RA. Not all patients want to participate in decision making: a national study of public preferences. J Gen Intern Med. 2005;20(6):531–5. doi: 10.1111/j.1525-1497.2005.04101.x.
    1. Arora NK, McHorney CA. Patient preferences for medical decision making: who really wants to participate? Med Care. 2000;38(3):335–41. doi: 10.1097/00005650-200003000-00010.
    1. Kuzel AJ. Sampling in qualitative inquiry. In: Crabtree BF, Miller WL, editors. Doing qualitative research. Thousand Oaks, CA: Sage Publications; 1999. pp. 33–45.
    1. Poland BD. Transcription quality as an aspect of rigor in qualitative research. Qual Inq. 1995;1(3):290–310. doi: 10.1177/107780049500100302.
    1. Kvale S. InterViews: an introduction to qualitative research interviewing. Thousand Oaks, CA: Sage Publications; 1996.
    1. Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011;10:CD001431.
    1. O’Connor AM, Bennett C, Stacey D, Barry MJ, Col NF, Eden KB, et al. Do patient decision aids meet effectiveness criteria of the International Patient Decision Aid Standards Collaboration? A systematic review and meta-analysis. Med Decis Making. 2007;27(5):554–74. doi: 10.1177/0272989X07307319.
    1. Bryman A. Quantity and quality in social research. Abingdon, UK: Routledge; 1988.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe