The diabetes mellitus medication choice decision aid: a randomized trial.
BACKGROUND
Patient involvement in the choice of antihyperglycemic agents could improve adherence and optimize glycemic control in patients with type 2 diabetes mellitus.


METHODS
We conducted a pilot, cluster randomized trial of Diabetes Medication Choice, a decision aid that describes 5 antihyperglycemic drugs, their treatment burden (adverse effects, administration, and self-monitoring demands), and impact on hemoglobin A(1c) (HbA(1c)) levels. Twenty-one clinicians were randomized to use the decision aid during the clinical encounter and 19 to dispense usual care and an educational pamphlet. We used surveys and video analysis to assess postvisit decisional outcomes, and medical and pharmacy records to assess 6-month medication adherence and HbA(1c) levels.


RESULTS
Compared with usual care patients (n = 37), patients receiving the decision aid (n = 48) found the tool more helpful (clustered-adjusted mean difference [AMD] in a 7-point scale, 0.38; 95% confidence interval [CI], 0.04-0.72); had improved knowledge (AMD, 1.10 of 10 questions; 95% CI, 0.11-2.09); and had more involvement in making decisions about diabetes medications (AMD, 21.8 of 100; 95% CI, 13.0-30.5). At 6-month follow-up, both groups had nearly perfect medication use (median, 100% of days covered), with better adherence (AMD, 9% more days covered; 95% CI, 4%-14%) and persistence (AMD, 12 more days covered; 95% CI, 3-21 days) in the usual care group, and no significant impact on HbA(1c) levels (AMD, 0.01; 95% CI, -0.49 to 0.50).


CONCLUSIONS
An innovative decision aid effectively involved patients with type 2 diabetes mellitus in decisions about their medications but did not improve adherence or HbA(1c) levels. Trial Registration clinicaltrials.gov Identifier: NCT00388050.
Mullan
Rebecca J
RJ
Knowledge and Encounter Research Unit, Mayo Center for Translational Science Activities, Mayo Clinic, Rochester, MN 55905, USA.
Montori
Victor M
VM
Shah
Nilay D
ND
Christianson
Teresa J H
TJ
Bryant
Sandra C
SC
Guyatt
Gordon H
GH
Perestelo-Perez
Lilisbeth I
LI
Stroebel
Robert J
RJ
Yawn
Barbara P
BP
Yapuncich
Victor
V
Breslin
Maggie A
MA
Pencille
Laurie
L
Smith
Steven A
SA
D000368:Aged; D002755:Choice Behavior; D016000:Cluster Analysis; D003661:Decision Support Techniques; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000187:drug effects; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010353:Patient Education as Topic; D010358:Patient Participation; D017060:Patient Satisfaction; D010817:Physician-Patient Relations; D010865:Pilot Projects
D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents