Effect of the statin choice encounter decision aid in Spanish patients with type 2 diabetes: A randomized trial.
OBJECTIVE
Statin choice, an encounter decision aid (DA), was developed in the USA to facilitate shared decision making between patients and clinicians about the use of statins to reduce cardiovascular risk. We aimed to assess the efficacy of this DA, compared to usual primary care, in Spanish patients with type 2 diabetes.


METHODS
Cluster randomized trial with 29 clinicians and 168 patients. Knowledge of statins, cardiovascular risk perception, decisional conflict, anxiety and satisfaction with the decision making process were assessed immediately after intervention, and self-reported adherence at three months.


RESULTS
Intervention significantly improved knowledge (p=0.01), perception of the 10-year risk of myocardial infarction without (p=0.01) and with statins (p=0.08), and satisfaction (p=0.01). There were no significant differences in decisional conflict, anxiety, consultation time or adherence, although more intervention patients reported taking all pills during the last week (92.7% vs. 81%; p=0.19).


CONCLUSIONS
The statin choice DA improved the quality of decision making about statins.


CONCLUSIONS
This trial contributes to the body of evidence substantiating the efficacy of statin choice and extending it to Spanish clinicians and their patients with type 2 diabetes.


BACKGROUND
This trial is registered with the European Union Clinical Trials Register (EudraCT: 2010-023912-14).
Evaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain; Health Services Research on Chronic Patients Network (REDISSEC), Spain; Center for Biomedical Research of the Canary Islands (CIBICAN), Tenerife, Spain. Electronic address: lperperr@gobiernodecanarias.org.
Lilisbeth
L
Perestelo-Pérez
Health Services Research on Chronic Patients Network (REDISSEC), Spain; Center for Biomedical Research of the Canary Islands (CIBICAN), Tenerife, Spain; Canarian Islands Foundation of Health Research (FUNCANIS), Tenerife, Spain.
Amado
A
Rivero-Santana
Division of Endocrinology and Nutrition, Insular University Hospital, Las Palmas de Gran Canaria, Spain.
Mauro
M
Boronat
Canarian Islands Foundation of Health Research (FUNCANIS), Tenerife, Spain.
Juan A
JA
Sánchez-Afonso
Canarian Islands Foundation of Health Research (FUNCANIS), Tenerife, Spain.
Jeanette
J
Pérez-Ramos
Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN, USA; Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA.
Victor M
VM
Montori
Evaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain; Health Services Research on Chronic Patients Network (REDISSEC), Spain; Center for Biomedical Research of the Canary Islands (CIBICAN), Tenerife, Spain.
Pedro
P
Serrano-Aguilar
D000328:Adult; D002318:Cardiovascular Diseases / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control*; D002755:Choice Behavior; D016000:Cluster Analysis; D003657:Decision Making; D003661:Decision Support Techniques; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy / Q000523:psychology*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence; D017063:Outcome Assessment, Health Care; D010358:Patient Participation / Q000523:psychology*; D018802:Patient-Centered Care / Q000379:methods; D011320:Primary Health Care; D011369:Professional-Patient Relations; D013030:Spain; D016896:Treatment Outcome
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cardiovascular risk; Communication; Decision aid; Patient involvement (empowerment; Randomized controlled trial; Shared decision making; Spain; Statin choice; Type 2 diabetes; self-management)