Skip to main content
Top
Published in: BMC Health Services Research 1/2012

Open Access 01-12-2012 | Study protocol

The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial

Authors: Annie LeBlanc, Kari L Ruud, Megan E Branda, Kristina Tiedje, Kasey R Boehmer, Laurie J Pencille, Holly Van Houten, Marc Matthews, Nilay D Shah, Carl R May, Barbara P Yawn, Victor M Montori

Published in: BMC Health Services Research | Issue 1/2012

Login to get access

Abstract

Background

Shared decision making contributes to high quality healthcare by promoting a patient-centered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient’s values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice.

Methods/Design

We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms.

Discussion

Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices.

Trial registration

NCT00388050
Appendix
Available only for authorised users
Literature
1.
go back to reference Centers for Disease Control and Prevention: National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2007. In Book National Diabetes Fact Sheet: General Information and National Estimates on Diabetes in the United States, 2007. 2008 Centers for Disease Control and Prevention: National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2007. In Book National Diabetes Fact Sheet: General Information and National Estimates on Diabetes in the United States, 2007. 2008
2.
go back to reference Huang ES, Brown SE, Ewigman BG, Foley EC, Meltzer DO: Patient perceptions of quality of life with diabetes-related complications and treatments. Diabetes Care. 2007, 30: 2478-2483. 10.2337/dc07-0499.CrossRefPubMedPubMedCentral Huang ES, Brown SE, Ewigman BG, Foley EC, Meltzer DO: Patient perceptions of quality of life with diabetes-related complications and treatments. Diabetes Care. 2007, 30: 2478-2483. 10.2337/dc07-0499.CrossRefPubMedPubMedCentral
3.
go back to reference Bolen S, Feldman L, Vassy J, Wilson L, Yeh HC, Marinopoulos S, Wiley C, Selvin E, Wilson R, Bass EB, Brancati FL: Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med. 2007, 147: 386-399.CrossRefPubMed Bolen S, Feldman L, Vassy J, Wilson L, Yeh HC, Marinopoulos S, Wiley C, Selvin E, Wilson R, Bass EB, Brancati FL: Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med. 2007, 147: 386-399.CrossRefPubMed
4.
go back to reference Heisler M, Vijan S, Anderson RM, Ubel PA, Bernstein SJ, Hofer TP: When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make?. J Gen Intern Med. 2003, 18: 893-902. 10.1046/j.1525-1497.2003.21132.x.CrossRefPubMedPubMedCentral Heisler M, Vijan S, Anderson RM, Ubel PA, Bernstein SJ, Hofer TP: When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make?. J Gen Intern Med. 2003, 18: 893-902. 10.1046/j.1525-1497.2003.21132.x.CrossRefPubMedPubMedCentral
5.
go back to reference Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Legare F, Thomson R: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011, CD001431-Art. No., 10 Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Legare F, Thomson R: Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011, CD001431-Art. No., 10
6.
go back to reference Weymiller AJ, Montori VM, Jones LA, Gafni A, Guyatt GH, Bryant SC, Christianson TJ, Mullan RJ, Smith SA: Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Intern Med. 2007, 167: 1076-1082. 10.1001/archinte.167.10.1076.CrossRefPubMed Weymiller AJ, Montori VM, Jones LA, Gafni A, Guyatt GH, Bryant SC, Christianson TJ, Mullan RJ, Smith SA: Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Intern Med. 2007, 167: 1076-1082. 10.1001/archinte.167.10.1076.CrossRefPubMed
7.
go back to reference Breslin M, Mullan RJ, Montori VM: The design of a decision aid about diabetes medications for use during the consultation with patients with type 2 diabetes. Patient Educ Couns. 2008, 73 (3): 465-472. 10.1016/j.pec.2008.07.024.CrossRefPubMed Breslin M, Mullan RJ, Montori VM: The design of a decision aid about diabetes medications for use during the consultation with patients with type 2 diabetes. Patient Educ Couns. 2008, 73 (3): 465-472. 10.1016/j.pec.2008.07.024.CrossRefPubMed
8.
go back to reference Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, et al: The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009, 169: 1560-1568.CrossRefPubMed Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, et al: The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009, 169: 1560-1568.CrossRefPubMed
9.
go back to reference Gravel K, Legare F, Graham I: Barriers and facilitators to implementing shared decision-making in clinical practice: a systematic review of health professionals’ perceptions. Implement Sci. 2006, 1: 16-10.1186/1748-5908-1-16.CrossRefPubMedPubMedCentral Gravel K, Legare F, Graham I: Barriers and facilitators to implementing shared decision-making in clinical practice: a systematic review of health professionals’ perceptions. Implement Sci. 2006, 1: 16-10.1186/1748-5908-1-16.CrossRefPubMedPubMedCentral
10.
go back to reference Michie S: Talking to primary care patients about weight: a study of GPs and practice nurses in the UK. Psychol Health Med. 2007, 12: 521-525. 10.1080/13548500701203441.CrossRefPubMed Michie S: Talking to primary care patients about weight: a study of GPs and practice nurses in the UK. Psychol Health Med. 2007, 12: 521-525. 10.1080/13548500701203441.CrossRefPubMed
11.
go back to reference Montori VM, Breslin M, Maleska M, Weymiller AJ: Creating a conversation: insights from the development of a decision aid. PLoS Med. 2007, 4: e233-10.1371/journal.pmed.0040233.CrossRefPubMedPubMedCentral Montori VM, Breslin M, Maleska M, Weymiller AJ: Creating a conversation: insights from the development of a decision aid. PLoS Med. 2007, 4: e233-10.1371/journal.pmed.0040233.CrossRefPubMedPubMedCentral
12.
go back to reference Glasgow RE, McKay HG, Piette JD, Reynolds KD: The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management?. Patient Educ Couns. 2001, 44: 119-127. 10.1016/S0738-3991(00)00186-5.CrossRefPubMed Glasgow RE, McKay HG, Piette JD, Reynolds KD: The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management?. Patient Educ Couns. 2001, 44: 119-127. 10.1016/S0738-3991(00)00186-5.CrossRefPubMed
13.
go back to reference Glasgow RE: RE-AIMing research for application: ways to improve evidence for family medicine. J Am Board Fam Med. 2006, 19: 11-19. 10.3122/jabfm.19.1.11.CrossRefPubMed Glasgow RE: RE-AIMing research for application: ways to improve evidence for family medicine. J Am Board Fam Med. 2006, 19: 11-19. 10.3122/jabfm.19.1.11.CrossRefPubMed
14.
go back to reference May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, Rapley T, Ballini L, Ong BN, Rogers A, et al: Development of a theory of implementation and integration: normalization process theory. Implement Sci. 2009, 4: 29-10.1186/1748-5908-4-29.CrossRefPubMedPubMedCentral May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, Rapley T, Ballini L, Ong BN, Rogers A, et al: Development of a theory of implementation and integration: normalization process theory. Implement Sci. 2009, 4: 29-10.1186/1748-5908-4-29.CrossRefPubMedPubMedCentral
15.
go back to reference O’Connor AM: Validation of a decisional conflict scale. Med Decis Making. 1995, 15: 25-30. 10.1177/0272989X9501500105.CrossRefPubMed O’Connor AM: Validation of a decisional conflict scale. Med Decis Making. 1995, 15: 25-30. 10.1177/0272989X9501500105.CrossRefPubMed
17.
go back to reference Elwyn G, Hutchings H, Edwards A, Rapport F, Wensing M, Cheung WY, Grol R: The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect. 2005, 8: 34-42. 10.1111/j.1369-7625.2004.00311.x.CrossRefPubMed Elwyn G, Hutchings H, Edwards A, Rapport F, Wensing M, Cheung WY, Grol R: The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect. 2005, 8: 34-42. 10.1111/j.1369-7625.2004.00311.x.CrossRefPubMed
18.
go back to reference Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R: Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care. 2003, 12: 93-99. 10.1136/qhc.12.2.93.CrossRefPubMedPubMedCentral Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R: Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care. 2003, 12: 93-99. 10.1136/qhc.12.2.93.CrossRefPubMedPubMedCentral
19.
go back to reference Abadie R, Weymiller AJ, Tilburt J, Shah N, Charles C, Gafni A, Montori V: Clinician’s use of the Statin Choice decision aid in patients with diabetes: a videographic study nested in a randomized trial. J Eval Clin Pract. 2009, 15 (3): 492-497. 10.1111/j.1365-2753.2008.01048.x.CrossRefPubMed Abadie R, Weymiller AJ, Tilburt J, Shah N, Charles C, Gafni A, Montori V: Clinician’s use of the Statin Choice decision aid in patients with diabetes: a videographic study nested in a randomized trial. J Eval Clin Pract. 2009, 15 (3): 492-497. 10.1111/j.1365-2753.2008.01048.x.CrossRefPubMed
20.
go back to reference Montori VM, Shah ND, Pencille LJ, Branda ME, Van Houten HK, Swiglo BA, Kesman RL, Tulledge-Scheitel SM, Jaeger TM, Johnson RE, et al: Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial. Am J Med. 2011, 124: 549-556. 10.1016/j.amjmed.2011.01.013.CrossRefPubMed Montori VM, Shah ND, Pencille LJ, Branda ME, Van Houten HK, Swiglo BA, Kesman RL, Tulledge-Scheitel SM, Jaeger TM, Johnson RE, et al: Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial. Am J Med. 2011, 124: 549-556. 10.1016/j.amjmed.2011.01.013.CrossRefPubMed
21.
22.
go back to reference Gudex C, Dolan P, Kind P, Williams A: Health state valuations from the general public using the visual analogue scale. Qual Life Res. 1996, 5: 521-531. 10.1007/BF00439226.CrossRefPubMed Gudex C, Dolan P, Kind P, Williams A: Health state valuations from the general public using the visual analogue scale. Qual Life Res. 1996, 5: 521-531. 10.1007/BF00439226.CrossRefPubMed
23.
go back to reference Sapin C, Fantino B, Nowicki ML, Kind P: Usefulness of EQ-5D in assessing health status in primary care patients with major depressive disorder. Health Qual Life Outcomes. 2004, 2: 20-10.1186/1477-7525-2-20.CrossRefPubMedPubMedCentral Sapin C, Fantino B, Nowicki ML, Kind P: Usefulness of EQ-5D in assessing health status in primary care patients with major depressive disorder. Health Qual Life Outcomes. 2004, 2: 20-10.1186/1477-7525-2-20.CrossRefPubMedPubMedCentral
24.
go back to reference Hayes AJ, Clarke PM, Glasziou PG, Simes RJ, Drury PL, Keech AC: Can self-rated health scores be used for risk prediction in patients with type 2 diabetes?. Diabetes Care. 2008, 31: 795-797. 10.2337/dc07-1391.CrossRefPubMed Hayes AJ, Clarke PM, Glasziou PG, Simes RJ, Drury PL, Keech AC: Can self-rated health scores be used for risk prediction in patients with type 2 diabetes?. Diabetes Care. 2008, 31: 795-797. 10.2337/dc07-1391.CrossRefPubMed
25.
go back to reference Sullivan MD, Anderson RT, Aron D, Atkinson HH, Bastien A, Chen GJ, Feeney P, Gafni A, Hwang W, Katz LA, et al: Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design. Am J Cardiol. 2007, 99: 90i-102i. 10.1016/j.amjcard.2007.03.027.CrossRefPubMed Sullivan MD, Anderson RT, Aron D, Atkinson HH, Bastien A, Chen GJ, Feeney P, Gafni A, Hwang W, Katz LA, et al: Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design. Am J Cardiol. 2007, 99: 90i-102i. 10.1016/j.amjcard.2007.03.027.CrossRefPubMed
26.
go back to reference Eddy DM, Pawlson LG, Schaaf D, Peskin B, Shcheprov A, Dziuba J, Bowman J, Eng B: The potential effects of HEDIS performance measures on the quality of care. Health Aff (Millwood). 2008, 27: 1429-1441. 10.1377/hlthaff.27.5.1429.CrossRef Eddy DM, Pawlson LG, Schaaf D, Peskin B, Shcheprov A, Dziuba J, Bowman J, Eng B: The potential effects of HEDIS performance measures on the quality of care. Health Aff (Millwood). 2008, 27: 1429-1441. 10.1377/hlthaff.27.5.1429.CrossRef
27.
go back to reference Sawin CT, Walder DJ, Bross DS, Pogach LM: Diabetes process and outcome measures in the Department of Veterans Affairs. Diabetes Care. 2004, 27 (Suppl 2): B90-B94.CrossRefPubMed Sawin CT, Walder DJ, Bross DS, Pogach LM: Diabetes process and outcome measures in the Department of Veterans Affairs. Diabetes Care. 2004, 27 (Suppl 2): B90-B94.CrossRefPubMed
28.
go back to reference Hearnshaw H, Lindenmeyer A: What do we mean by adherence to treatment and advice for living with diabetes? A review of the literature on definitions and measurements. Diabet Med. 2006, 23: 720-728.CrossRefPubMed Hearnshaw H, Lindenmeyer A: What do we mean by adherence to treatment and advice for living with diabetes? A review of the literature on definitions and measurements. Diabet Med. 2006, 23: 720-728.CrossRefPubMed
29.
go back to reference Vermeire E, Wens J, Van Royen P, Biot Y, Hearnshaw H, Lindenmeyer A: Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus. Cochrane Datab Syst Rev. 2005, CD003638-Art. No, 2 Vermeire E, Wens J, Van Royen P, Biot Y, Hearnshaw H, Lindenmeyer A: Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus. Cochrane Datab Syst Rev. 2005, CD003638-Art. No, 2
30.
go back to reference Glick H, Doshi J, Sonnad S, Polsky D: Economic Evaluation in Clinical Trials. 2007, New Yok: Oxford United Press Glick H, Doshi J, Sonnad S, Polsky D: Economic Evaluation in Clinical Trials. 2007, New Yok: Oxford United Press
31.
go back to reference Donner A, LKlar N: Design and Analysis of Cluster Randomisation Trials in Health Research. 2000, London: Arnold Donner A, LKlar N: Design and Analysis of Cluster Randomisation Trials in Health Research. 2000, London: Arnold
32.
go back to reference Yudkin PL, Moher M: Putting theory into practice: a cluster randomized trial with a small number of clusters. Stat Med. 2001, 20: 341-349. 10.1002/1097-0258(20010215)20:3<341::AID-SIM796>3.0.CO;2-G.CrossRefPubMed Yudkin PL, Moher M: Putting theory into practice: a cluster randomized trial with a small number of clusters. Stat Med. 2001, 20: 341-349. 10.1002/1097-0258(20010215)20:3<341::AID-SIM796>3.0.CO;2-G.CrossRefPubMed
33.
go back to reference Denzin N: The Sage Handbook of Qualitative Research. 2005, Thousand Oaks: Sage Publications, 3 Denzin N: The Sage Handbook of Qualitative Research. 2005, Thousand Oaks: Sage Publications, 3
34.
go back to reference Miles M, Huberman A: Qualitative Data Analysis: An Expanded Sourcebook. 1994, Thousand Oaks: Sage Publications, 2 Miles M, Huberman A: Qualitative Data Analysis: An Expanded Sourcebook. 1994, Thousand Oaks: Sage Publications, 2
35.
go back to reference Strauss A: Qualitative Analysis for Social Scientists. 1987, New York: Cambridge University PressCrossRef Strauss A: Qualitative Analysis for Social Scientists. 1987, New York: Cambridge University PressCrossRef
Metadata
Title
The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial
Authors
Annie LeBlanc
Kari L Ruud
Megan E Branda
Kristina Tiedje
Kasey R Boehmer
Laurie J Pencille
Holly Van Houten
Marc Matthews
Nilay D Shah
Carl R May
Barbara P Yawn
Victor M Montori
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2012
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/1472-6963-12-130

Other articles of this Issue 1/2012

BMC Health Services Research 1/2012 Go to the issue