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


CONCLUSIONS
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.


BACKGROUND
NCT00388050.
Department of Health Sciences Research, Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN 55905, USA.
Annie
A
LeBlanc
Kari L
KL
Ruud
Megan E
ME
Branda
Kristina
K
Tiedje
Kasey R
KR
Boehmer
Laurie J
LJ
Pencille
Holly
H
Van Houten
Marc
M
Matthews
Nilay D
ND
Shah
Carl R
CR
May
Barbara P
BP
Yawn
Victor M
VM
Montori
D001241:Aspirin / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D002755:Choice Behavior; D016000:Cluster Analysis; D057186:Comparative Effectiveness Research; D003661:Decision Support Techniques; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy / Q000523:psychology*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D008297:Male; D008910:Minnesota; D010353:Patient Education as Topic; D010358:Patient Participation; D018802:Patient-Centered Care / Q000379:methods; D011369:Professional-Patient Relations; D036301:Qualitative Research; D012017:Referral and Consultation; D012307:Risk Factors; D019035:Rural Health Services / Q000592:standards; D019037:Urban Health Services / Q000592:standards; D000078329:Workforce
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D001241:Aspirin