Should clinicians deliver decision aids? Further exploration of the statin choice randomized trial results.

BACKGROUND: Statin Choice is a decision aid about taking statins. The optimal mode of delivering Statin Choice (or any other decision aid) in clinical practice is unknown. METHODS: To investigate the effect of mode of delivery on decision aid efficacy, the authors further explored the results of a concealed 2 x 2 factorial clustered randomized trial enrolling 21 endocrinologists and 98 diabetes patients and randomizing them to 1) receive either the decision aid or pamphlet about cholesterol, and 2) have these delivered either during the office visit (by the clinician) or before the visit (by a researcher). We estimated between-group differences and their 95% confidence intervals (CI) for acceptability of information delivery (1-7), knowledge about statins and coronary risk (0-9), and decisional conflict about statin use (0-100) assessed immediately after the visit. Follow-up was 99%. RESULTS: The relative efficacy of the decision aid v. pamphlet interacted with the mode of delivery. Compared with the pamphlet, patients whose clinicians delivered the decision aid during the office visit showed significant improvements in knowledge (difference of 1.6 of 9 questions, CI 0.3, 2.8) and nonsignificant trends toward finding the decision aid more acceptable (odds ratio 3.1, CI 0.9, 11.2) and having less decisional conflict (difference of 7 of 100 points, CI -4, 18) than when a researcher delivered the decision aid just before the office visit. CONCLUSIONS: Delivery of decision aids by clinicians during the visit improves knowledge and shows a trend toward better acceptability and less decisional conflict.

A treatment decision aid may increase patient trust in the diabetes specialist. The Statin Choice randomized trial.

AIMS: Decision aids in practice may affect patient trust in the clinician, a requirement for optimal diabetes care. We sought to determine the impact of a decision aid to help patients with diabetes decide about statins (Statin Choice) on patients' trust in the clinician. METHODS: We randomized 16 diabetologists and 98 patients with type 2 diabetes referred to a subspecialty diabetes clinic to use the Statin Choice decision aid or a patient pamphlet about dyslipidaemia, and then to receive these materials from either the clinician during the visit or a researcher prior to the visit. Providers and patients were blinded to the study hypothesis. Immediately after the clinical encounter, patients completed a survey including questions on trust (range 0 to total trust = 100), knowledge, and decisional conflict. Researchers reviewed videotaped encounters and assessed patient participation (using the OPTION scale) and visit length. RESULTS: Overall mean trust score was 91 (median 97.2, IQR 86, 100). After adjustment for patient characteristics, results suggested greater total trust (trust = 100) with the decision aid [odds ratio (OR) 1.77, 95% CI 0.94, 3.35]. Total trust was associated with knowledge (for each additional knowledge point, OR 1.3, 95% CI 1.1, 1.6), patient participation (for each additional point in the OPTION scale, OR 1.1, 95% CI 1.1, 1.2), and decisional conflict (for every 5-point decrease in conflict, OR 1.5, 95% CI 1.2, 1.9). Total trust was not associated with visit length, which the decision aid did not significantly affect. There was no significant effect interaction across the trial factors. CONCLUSIONS: Preliminary evidence suggests that decision aids do not have a large negative impact on trust in the physician and may increase trust through improvements in the decision-making process.

Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial.

BACKGROUND: Poor quality of information transfer about the benefits and risks of statin drug use may result in patients not making informed decisions that they can act on in a timely fashion. METHODS: The effect of a decision aid about statin drugs on treatment decision making in 98 patients with diabetes was determined in a cluster randomized trial of decision aid vs control pamphlet, with concealed allocation, blinding of participants to study goals, and adherence to the intention-to-treat principle. Twenty-one endocrinologists conducted specialty outpatient metabolic consultations. Patients in the intervention group received Statin Choice, a tailored decision aid that presents the estimated 10-year cardiovascular risk, the absolute risk reduction with use of statin drugs, and the disadvantages of using statin drugs. Patients in the control group received the institution's pamphlet about cholesterol management. We measured acceptability, knowledge about options and cardiovascular risk, and decisional conflict immediately after the visit, and adherence to pill taking was measured 3 months later. RESULTS: Patients favored using the decision aid (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.2-6.9); patients who received the decision aid (n = 52) knew more (difference, 2.4 of 9 points; 95% CI, 1.5-3.3), had better estimated cardiovascular risk (OR, 22.4; 95% CI, 5.9-85.6) and potential absolute risk reduction with statin drugs (OR, 6.7; 95% CI, 2.2-19.7), and had less decisional conflict (difference, -10.6; 95% CI, -15.4 to -5.9 on a 100-point scale) than did patients in the control group (n = 46). Of 33 patients in the intervention group taking statin drugs at 3 months, 2 reported missing 1 dose or more in the last week compared with 6 of 29 patients in the control group taking statin drugs (OR, 3.4; 95% CI, 1.5-7.5). CONCLUSIONS: A decision aid enhanced decision making about statin drugs and may have favorably affected drug adherence.

Modest improvement in risk factor control after admission for a stroke or transient ischemic attack.

BACKGROUND: Although guidelines recommend control of risk factors for secondary stroke prevention, few studies examine the level of risk factor control achieved in a poststroke population. METHODS: We examined medical records of 99 consecutive patients admitted for ischemic stroke or transient ischemic attack to the Department of Veterans Affairs (VA) West Los Angeles Healthcare Center who were still alive 1 year later. Values for blood pressure, low-density lipoprotein, hemoglobin A1c, and body mass index were collected from a time period of up to 6 months before admission and compared with a time period 6 to 13 months after admission. RESULTS: For the entire sample, improvements in risk factor control were detected only in diastolic blood pressure (5 mm Hg) and hemoglobin A1c (0.9%) (P < .05). When analyzing just the subset of patients with suboptimal control before hospitalization, improvements were detected for systolic blood pressure (12 mm Hg), diastolic blood pressure (12 mm Hg), low-density lipoprotein (29 mg/dL), and hemoglobin A1c (1.4%) (all P < .01). However, a majority of patients with suboptimal control of systolic blood pressure, low-density lipoprotein, and body mass index before admission failed to achieve optimal control of that risk factor in the year after admission. Only 23 patients had all relevant risk factors measured in the VA system during the period after admission and had the final measurements of those risk factors in the optimal range. CONCLUSIONS: Although modest improvements were detected, there remains room for improvement in optimizing control of risk factors after a stroke.