Impact of MyDiabetesPlan, a Web-Based Patient Decision Aid on Decisional Conflict, Diabetes Distress, Quality of Life, and Chronic Illness Care in Patients With Diabetes: Cluster Randomized Controlled Trial

Catherine Yu, Dorothy Choi, Brigida A Bruno, Kevin E Thorpe, Sharon E Straus, Paul Cantarutti, Karen Chu, Paul Frydrych, Amy Hoang-Kim, Noah Ivers, David Kaplan, Fok-Han Leung, John Maxted, Jeremy Rezmovitz, Joanna Sale, Sumeet Sodhi-Helou, Dawn Stacey, Deanna Telner, Catherine Yu, Dorothy Choi, Brigida A Bruno, Kevin E Thorpe, Sharon E Straus, Paul Cantarutti, Karen Chu, Paul Frydrych, Amy Hoang-Kim, Noah Ivers, David Kaplan, Fok-Han Leung, John Maxted, Jeremy Rezmovitz, Joanna Sale, Sumeet Sodhi-Helou, Dawn Stacey, Deanna Telner

Abstract

Background: Person-centered care is critical for delivering high-quality diabetes care. Shared decision making (SDM) is central to person-centered care, and in diabetes care, it can improve decision quality, patient knowledge, and patient risk perception. Delivery of person-centered care can be facilitated with the use of patient decision aids (PtDAs). We developed MyDiabetesPlan, an interactive SDM and goal-setting PtDA designed to help individualize care priorities and support an interprofessional approach to SDM.

Objective: This study aims to assess the impact of MyDiabetesPlan on decisional conflict, diabetes distress, health-related quality of life, and patient assessment of chronic illness care at the individual patient level.

Methods: A two-step, parallel, 10-site cluster randomized controlled trial (first step: provider-directed implementation only; second step: both provider- and patient-directed implementation 6 months later) was conducted. Participants were adults 18 years and older with diabetes and 2 other comorbidities at 10 family health teams (FHTs) in Southwestern Ontario. FHTs were randomly assigned to MyDiabetesPlan (n=5) or control (n=5) through a computer-generated algorithm. MyDiabetesPlan was integrated into intervention practices, and clinicians (first step) followed by patients (second step) were trained on its use. Control participants received static generic Diabetes Canada resources. Patients were not blinded. Participants completed validated questionnaires at baseline, 6 months, and 12 months. The primary outcome at the individual patient level was decisional conflict; secondary outcomes were diabetes distress, health-related quality of life, chronic illness care, and clinician intention to practice interprofessional SDM. Multilevel hierarchical regression models were used.

Results: At the end of the study, the intervention group (5 clusters, n=111) had a modest reduction in total decisional conflicts compared with the control group (5 clusters, n=102; -3.5, 95% CI -7.4 to 0.42). Although there was no difference in diabetes distress or health-related quality of life, there was an increase in patient assessment of chronic illness care (0.7, 95% CI 0.4 to 1.0).

Conclusions: Use of goal-setting decision aids modestly improved decision quality and chronic illness care but not quality of life. Our findings may be due to a gap between goal setting and attainment, suggesting a role for optimizing patient engagement and behavioral support. The next steps include clarifying the mechanisms by which decision aids impact outcomes and revising MyDiabetesPlan and its delivery.

Trial registration: ClinicalTrials.gov NCT02379078; https://ichgcp.net/clinical-trials-registry/NCT02379078.

Keywords: decision aid; decisional conflict; diabetes distress; diabetes mellitus; goals of care; patient assessment of chronic illness care; quality of life; randomized clinical trials; shared decision making.

Conflict of interest statement

Conflicts of Interest: None declared.

©Catherine Yu, Dorothy Choi, Brigida A Bruno, Kevin E Thorpe, Sharon E Straus, Paul Cantarutti, Karen Chu, Paul Frydrych, Amy Hoang-Kim, Noah Ivers, David Kaplan, Fok-Han Leung, John Maxted, Jeremy Rezmovitz, Joanna Sale, Sumeet Sodhi-Helou, Dawn Stacey, Deanna Telner. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 30.09.2020.

Figures

Figure 1
Figure 1
CONSORT (Consolidated Standards of Reporting Trials) flow diagram. DM: diabetes mellitus; FHT: family health team.

References

    1. Santana MJ, Manalili K, Jolley RJ, Zelinsky S, Quan H, Lu M. How to practice person-centred care: a conceptual framework. Health Expect. 2018 Apr;21(2):429–40. doi: 10.1111/hex.12640.
    1. Williams JS, Walker RJ, Smalls BL, Hill R, Egede LE. Patient-centered care, glycemic control, diabetes self-care, and quality of life in adults with type 2 diabetes. Diabetes Technol Ther. 2016 Oct;18(10):644–9. doi: 10.1089/dia.2016.0079.
    1. Scholl I, Zill JM, Härter M, Dirmaier J. An integrative model of patient-centeredness - a systematic review and concept analysis. PLoS One. 2014;9(9):e107828. doi: 10.1371/journal.pone.0107828.
    1. Mullan RJ, Montori VM, Shah ND, Christianson TJH, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560–8. doi: 10.1001/archinternmed.2009.293.
    1. Rost KM, Flavin KS, Cole K, McGill JB. Change in metabolic control and functional status after hospitalization. Impact of patient activation intervention in diabetic patients. Diabetes Care. 1991 Oct;14(10):881–9. doi: 10.2337/diacare.14.10.881.
    1. Kashaf MS, McGill ET, Berger ZD. Shared decision-making and outcomes in type 2 diabetes: a systematic review and meta-analysis. Patient Educ Couns. 2017 Dec;100(12):2159–71. doi: 10.1016/j.pec.2017.06.030.
    1. O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995;15(1):25–30. doi: 10.1177/0272989X9501500105.
    1. Becerra-Perez M, Menear M, Turcotte S, Labrecque M, Légaré F. More primary care patients regret health decisions if they experienced decisional conflict in the consultation: a secondary analysis of a multicenter descriptive study. BMC Fam Pract. 2016 Nov 10;17(1):156. doi: 10.1186/s12875-016-0558-0.
    1. Kaplan AL, Crespi CM, Saucedo JD, Connor SE, Litwin MS, Saigal CS. Decisional conflict in economically disadvantaged men with newly diagnosed prostate cancer: baseline results from a shared decision-making trial. Cancer. 2014 Sep 1;120(17):2721–7. doi: 10.1002/cncr.28755. doi: 10.1002/cncr.28755.
    1. Solli O, Stavem K, Kristiansen IS. Health-related quality of life in diabetes: the associations of complications with EQ-5D scores. Health Qual Life Outcomes. 2010 Feb 4;8:18. doi: 10.1186/1477-7525-8-18.
    1. Wong EM, Afshar R, Qian H, Zhang M, Elliott TG, Tang TS. Diabetes distress, depression and glycemic control in a Canadian-based specialty care setting. Can J Diabetes. 2017 Aug;41(4):362–5. doi: 10.1016/j.jcjd.2016.11.006.
    1. Liu L, Li Y, Sha K, Wang Y, He X. Patient assessment of chronic illness care, glycemic control and the utilization of community health care among the patients with type 2 diabetes in Shanghai, China. PLoS One. 2013;8(9):e73010. doi: 10.1371/journal.pone.0073010.
    1. Shim YT, Lee J, Toh MP, Tang WE, Ko Y. Health-related quality of life and glycaemic control in patients with type 2 diabetes mellitus in Singapore. Diabet Med. 2012 Aug;29(8):e241–8. doi: 10.1111/j.1464-5491.2012.03689.x.
    1. Fisher L, Polonsky WH, Hessler DM, Masharani U, Blumer I, Peters AL, Strycker LA, Bowyer V. Understanding the sources of diabetes distress in adults with type 1 diabetes. J Diabetes Complications. 2015;29(4):572–7. doi: 10.1016/j.jdiacomp.2015.01.012.
    1. Légaré F, Stacey D, Turcotte S, Cossi M, Kryworuchko J, Graham ID, Lyddiatt A, Politi MC, Thomson R, Elwyn G, Donner-Banzhoff N. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2014 Sep 15;(9):CD006732. doi: 10.1002/14651858.CD006732.pub3.
    1. Kim J, Whitney A, Hayter S, Lewis C, Campbell M, Sutherland L, Fowler B, Googe S, McCoy R, Pignone M. Development and initial testing of a computer-based patient decision aid to promote colorectal cancer screening for primary care practice. BMC Med Inform Decis Mak. 2005 Nov 28;5:36. doi: 10.1186/1472-6947-5-36.
    1. Bailey RA, Pfeifer M, Shillington AC, Harshaw Q, Funnell MM, VanWingen J, Col N. Effect of a patient decision aid (PDA) for type 2 diabetes on knowledge, decisional self-efficacy, and decisional conflict. BMC Health Serv Res. 2016 Jan 14;16:10. doi: 10.1186/s12913-016-1262-4.
    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. Br Med J. 2014 Sep 25;349:g5651. doi: 10.1136/bmj.g5651.
    1. Yu CH, Stacey D, Sale J, Hall S, Kaplan DM, Ivers N, Rezmovitz J, Leung F, Shah BR, Straus SE. 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 Jan 22;9:16. doi: 10.1186/1748-5908-9-16.
    1. Yu CH, Ke C, Jovicic A, Hall S, Straus SE, IP-SDM Team Beyond pros and cons - developing a patient decision aid to cultivate dialog to build relationships: insights from a qualitative study and decision aid development. BMC Med Inform Decis Mak. 2019 Sep 18;19(1):186. doi: 10.1186/s12911-019-0898-5.
    1. Eysenbach G. CONSORT-EHEALTH: implementation of a checklist for authors and editors to improve reporting of web-based and mobile randomized controlled trials. Stud Health Technol Inform. 2013;192:657–61.
    1. Campbell MK, Piaggio G, Elbourne DR, Altman DG, CONSORT Group Consort 2010 statement: extension to cluster randomised trials. Br Med J. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661.
    1. Yu CH, Ivers NM, Stacey D, Rezmovitz J, Telner D, Thorpe K, Hall S, Settino M, Kaplan DM, Coons M, Sodhi S, Sale J, Straus SE. 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. Trials. 2015 Jun 27;16:286. doi: 10.1186/s13063-015-0797-8.
    1. Cheng AY, Barnes T. Executive summary: Canadian diabetes association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes. 2013;37(Suppl 3):S291–360.
    1. Staying Healthy With Diabetes. Diabetes Canada | Clinical Practice Guidelines. 2012. [2020-09-14]. .
    1. User Manual - Decision Conflict Scale. Patient Decision Aids - Ottawa Hospital Research Institute. 1993. [2020-09-04]. .
    1. Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626–31. doi: 10.2337/diacare.28.3.626.
    1. Ware J. SF-36 Physical & Mental Health Summary Scales: A Manual for Users of Version 1. Boston, MA: Health Assessment Lab; 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 Nov;28(11):2655–61. doi: 10.2337/diacare.28.11.2655.
    1. Francis J, Eccles M, Johnston M, Walker A, Grimshaw J, Foy R, Kaner E, Smith L, Bonetti D. Constructing Questionnaires Based on the Theory of Planned Behavior? A Manual for Health Services Researchers. Newcastle upon Tyne, UK: Centre for Health Services Research; 2004.
    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 Mar;34(3):220–33. doi: 10.1097/00005650-199603000-00003.
    1. Bohannon RW, Maljanian R, Landes M. Test-retest reliability of short form (SF)-12 component scores of patients with stroke. Int J Rehabil Res. 2004 Jun;27(2):149–50. doi: 10.1097/01.mrr.0000127350.25287.08.
    1. Cheak-Zamora NC, Wyrwich KW, McBride TD. Reliability and validity of the SF-12v2 in the medical expenditure panel survey. Qual Life Res. 2009 Aug;18(6):727–35. doi: 10.1007/s11136-009-9483-1.
    1. Schmittdiel J, Mosen DM, Glasgow RE, Hibbard J, Remmers C, Bellows J. Patient assessment of chronic illness care (PACIC) and improved patient-centered outcomes for chronic conditions. J Gen Intern Med. 2008 Jan;23(1):77–80. doi: 10.1007/s11606-007-0452-5.
    1. Szecsenyi J, Rosemann T, Joos S, Peters-Klimm F, Miksch A. German diabetes disease management programs are appropriate for restructuring care according to the chronic care model: an evaluation with the patient assessment of chronic illness care instrument. Diabetes Care. 2008 Jun;31(6):1150–4. doi: 10.2337/dc07-2104.
    1. Légaré F, Borduas F, Freitas A, Jacques A, Godin G, Luconi F, Grimshaw J, CPD-KT team Development of a simple 12-item theory-based instrument to assess the impact of continuing professional development on clinical behavioral intentions. PLoS One. 2014;9(3):e91013. doi: 10.1371/journal.pone.0091013.
    1. Légaré F, Guerrier M, Nadeau C, Rhéaume C, Turcotte S, Labrecque M. Impact of DECISION + 2 on patient and physician assessment of shared decision making implementation in the context of antibiotics use for acute respiratory infections. Implement Sci. 2013 Dec 26;8:144. doi: 10.1186/1748-5908-8-144.
    1. Heneghan C, Perera R, Ward A, Fitzmaurice D, Meats E, Glasziou P. Assessing differential attrition in clinical trials: self-monitoring of oral anticoagulation and type II diabetes. BMC Med Res Methodol. 2007 May 2;7:18. doi: 10.1186/1471-2288-7-18.
    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 Decis Making. 2006;26(4):373–90. doi: 10.1177/0272989X06290492.
    1. Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017 Dec 6;17(1):162. doi: 10.1186/s12874-017-0442-1.
    1. Twisk J, de Boer M, de Vente W, Heymans M. Multiple imputation of missing values was not necessary before performing a longitudinal mixed-model analysis. J Clin Epidemiol. 2013 Sep;66(9):1022–8. doi: 10.1016/j.jclinepi.2013.03.017.
    1. Collins LM, Schafer JL, Kam CM. A comparison of inclusive and restrictive strategies in modern missing data procedures. Psychol Methods. 2001 Dec;6(4):330–51.
    1. Kuznetsova A, Brockhoff PB, Christensen RH. Package: tests in linear mixed effects models. J Stat Soft. 2017;82(13):-. doi: 10.18637/jss.v082.i13.
    1. The R Project for Statistical Computing. 2018. [2019-05-03].
    1. Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4:CD001431. doi: 10.1002/14651858.CD001431.pub5.
    1. Rutherford C, King MT, Butow P, Legare F, Lyddiatt A, Souli I, Rincones O, Stacey D. Is quality of life a suitable measure of patient decision aid effectiveness? Sub-analysis of a Cochrane systematic review. Qual Life Res. 2019 Mar;28(3):593–607. doi: 10.1007/s11136-018-2045-7.
    1. van Weert JC, van Munster BC, Sanders R, Spijker R, Hooft L, Jansen J. Decision aids to help older people make health decisions: a systematic review and meta-analysis. BMC Med Inform Decis Mak. 2016 Apr 21;16:45. doi: 10.1186/s12911-016-0281-8.
    1. Hall AK, Bernhardt JM, Dodd V, Vollrath MW. The digital health divide: evaluating online health information access and use among older adults. Health Educ Behav. 2015 Apr;42(2):202–9. doi: 10.1177/1090198114547815.
    1. Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. Br Med J. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147.
    1. Horevoorts NJ, Vissers PA, Mols F, Thong MS, van de Poll-Franse LV. Response rates for patient-reported outcomes using web-based versus paper questionnaires: comparison of two invitational methods in older colorectal cancer patients. J Med Internet Res. 2015 May 7;17(5):e111. doi: 10.2196/jmir.3741.
    1. Ebert JF, Huibers L, Christensen B, Christensen MB. Paper- or web-based questionnaire invitations as a method for data collection: cross-sectional comparative study of differences in response rate, completeness of data, and financial cost. J Med Internet Res. 2018 Jan 23;20(1):e24. doi: 10.2196/jmir.8353.
    1. Knechel NA. The challenges of enrolling older adults into intervention studies. Yale J Biol Med. 2013 Mar;86(1):41–7.
    1. Rahimi K, Malhotra A, Banning AP, Jenkinson C. Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review. Br Med J. 2010 Nov 1;341:c5707. doi: 10.1136/bmj.c5707.
    1. Costlow MR, Landsittel DP, James AE, Kahn JM, Morton SC. Model for a patient-centered comparative effectiveness research center. Clin Transl Sci. 2015 Apr;8(2):155–9. doi: 10.1111/cts.12257.
    1. Stolee P, Rockwood K, Fox RA, Streiner DL. The use of goal attainment scaling in a geriatric care setting. J Am Geriatr Soc. 1992 Jun;40(6):574–8. doi: 10.1111/j.1532-5415.1992.tb02105.x.
    1. Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? J Am Med Assoc. 2003 May 21;289(19):2554–9. doi: 10.1001/jama.289.19.2554.

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