Maggie Breslin

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). CONCLUSION 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.

The Chest Pain Choice Decision Aid A Randomized Trial

Background— Cardiac stress testing in patients at low risk for acute coronary syndrome is associated with increased false-positive test results, unnecessary downstream procedures, and increased cost. We judged it unlikely that patient preferences were driving the decision to obtain stress testing. Methods and Results— The Chest Pain Choice trial was a prospective randomized evaluation involving 204 patients who were randomized to a decision aid or usual care and were followed for 30 days. The decision aid included a 100-person pictograph depicting the pretest probability of acute coronary syndrome and available management options (observation unit admission and stress testing or 24–72 hours outpatient follow-up). The primary outcome was patient knowledge measured by an immediate postvisit survey. Additional outcomes included patient engagement in decision making and the proportion of patients who decided to undergo observation unit admission and cardiac stress testing. Compared with usual care patients (n=103), decision aid patients (n=101) had significantly greater knowledge (3.6 versus 3.0 questions correct; mean difference, 0.67; 95% CI, 0.34–1.0), were more engaged in decision making as indicated by higher OPTION (observing patient involvement) scores (26.6 versus 7.0; mean difference, 19.6; 95% CI, 1.6–21.6), and decided less frequently to be admitted to the observation unit for stress testing (58% versus 77%; absolute difference, 19%; 95% CI, 6%–31%). There were no major adverse cardiac events after discharge in either group. Conclusions— Use of a decision aid in patients with chest pain increased knowledge and engagement in decision making and decreased the rate of observation unit admission for stress testing. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01077037.

Creating a Conversation: Insights from the Development of a Decision Aid

The authors share lessons learned from their development ofStatin Choice, a decision aid for patients with diabetes who are considering using statins to reduce their cardiovascular risk.

The design of a decision aid about diabetes medications for use during the consultation with patients with type 2 diabetes

OBJECTIVE To describe the process used to develop a medication choice decision aid (DA) for patients with type 2 diabetes. METHODS We developed the DA through active collaboration with patients, clinicians, and designers, direct observations of clinical encounters, literature review, and collaborative development of design criteria. Insights from these processes informed the iterative creation of prototypes that were reviewed and field tested in actual consultations. RESULTS The goal of the DA was to facilitate a conversation between the clinician and the patient about diabetes medication options. Four iterations of the DA were developed and field-tested before arriving at issue cards that organized the data for five medications around glucose control, hypoglycemia, weight changes, daily routine, self-monitoring and side effects. These cards successfully generated conversations during consultations. An ongoing clinical trial will determine if this DA affects patient adherence and outcomes. CONCLUSIONS A collaboratively developed DA designed to create a conversation about diabetes medications may lead to more patient-centered treatment choices. PRACTICE IMPLICATIONS If effective, this DA could replace disease-centered treatment algorithms for patient-centered conversations that enhance the management of patients with type 2 diabetes.

Translating comparative effectiveness into practice: The case of diabetes medications

Background:In recent years, there has been significant interest and investment in conducting comparative effectiveness research (CER) of medical treatments to improve the quality of care and reduce costs. The Agency for Healthcare Research and Quality (AHRQ) has been leading this effort and has invested a significant amount of resources to advance CER. However, little is known about translating the findings from CER into routine practice such that it provides value to the patients, clinicians, and the healthcare system. Methods:We present the role of shared decision making for patient-centered CER translation and its application to diabetes medications. CER of oral diabetes medications suggests that all medications are similar in their effects on glycemic control, but there is variability in side-effects, which may affect medication adherence and treatment intensification. Shared decision making, facilitated by tools such as decision aids, may enhance the quality of diabetes care by activating patients, enhancing the patient-clinician communication, and improving uptake and adherence to the medication that is determined to be consistent with patients’ goals, values, and preferences. We describe the iterative, multidisciplinary process for developing and testing a diabetes medication decision aid, and examine the implications for CER translation. Results:In our pilot study we found the decision aid to be acceptable to patients and providers and effective for knowledge translation; however, it did not impact short-term outcomes. Discussion:Our pilot trial found that decision aids enhanced the discussion about diabetes medications without any adverse effects on the outcomes. Further issues related to the use of decision aids to translate CER need to be addressed in larger trials to understand the effectiveness and efficiency of translating evidence into routine practice in unique contexts of patients, providers, and healthcare systems.

Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

BackgroundBisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE) for postmenopausal women at risk for osteoporotic fractures; and (2) assess the feasibility and validity (i.e., absence of contamination) of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.Methods/DesignThis is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of <-1.0, not receiving bisphosphonate therapy, and receiving care at participating primary care practices in and around Rochester, Minnesota, USA will be eligible to participate in the trial. We will measure the effect of OSTEOPOROSIS CHOICE on five outcomes: (a) patient knowledge regarding osteoporosis risk factors and treatment; (b) quality of the decision-making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of bisphosphonate use and adherence, and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination). Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months.DiscussionThis pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform the design of a larger trial that could provide more precise estimates of the efficacy of the decision aid.Trial registrationClinical Trials.gov Identifier: NCT00578981

The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department

BackgroundChest pain is a common presenting complaint in the emergency department (ED). Despite the frequency with which clinicians evaluate patients with chest pain, accurately determining the risk of acute coronary syndrome (ACS) and sharing risk information with patients is challenging. The aims of this study are (1) to develop a decision aid (CHEST PAIN CHOICE) that communicates the short-term risk of ACS and (2) to evaluate the impact of the decision aid on patient participation in decision-making and resource use.Methods/DesignThis is a protocol for a parallel, 2-arm randomized trial to compare an intervention group receiving CHEST PAIN CHOICE to a control group receiving usual ED care. Adults presenting to the Saint Marys Hospital ED in Rochester, MN USA with a primary complaint of chest pain who are being considered for admission for prolonged ED observation in a specialized unit and urgent cardiac stress testing will be eligible for enrollment. We will measure the effect of CHEST PAIN CHOICE on six outcomes: (1) patient knowledge regarding their short-term risk for ACS and the risks of radiation exposure; (2) quality of the decision making process; (3) patient and clinician acceptability and satisfaction with the decision aid; (4) the proportion of patients who decided to undergo observation unit admission and urgent cardiac stress testing; (5) economic costs and healthcare utilization; and (6) the rate of delayed or missed ACS. To capture these outcomes, we will administer patient and clinician surveys after each visit, obtain video recordings of the clinical encounters, and conduct 30-day phone follow-up.DiscussionThis pilot randomized trial will develop and evaluate a decision aid for use in ED chest pain patients at low risk for ACS and provide a preliminary estimate of its effect on patient participation in decision-making and resource use.Trial registrationClinical Trials.gov Identifier: NCT01077037

The design of a low literacy decision aid about rheumatoid arthritis medications developed in three languages for use during the clinical encounter

BackgroundShared decision-making in rheumatoid arthritis (RA) care is a priority among policy makers, clinicians and patients both nationally and internationally. Demands on patients to have basic knowledge of RA, treatment options, and details of risk and benefit when making medication decisions with clinicians can be overwhelming, especially for those with limited literacy or limited English language proficiency. The objective of this study is to describe the development of a medication choice decision aid for patients with rheumatoid arthritis (RA) in three languages using low literacy principles.MethodsBased on the development of a diabetes decision aid, the RA decision aid (RA Choice) was developed through a collaborative process involving patients, clinicians, designers, decision-aid and health literacy experts. A combination of evidence synthesis and direct observation of clinician-patient interactions generated content and guided an iterative process of prototype development.ResultsThree iterations of RA Choice were developed and field-tested before completion. The final tool organized data using icons and plain language for 12 RA medications across 5 issues: frequency of administration, time to onset, cost, side effects, and special considerations. The tool successfully created a conversation between clinician and patient, and garnered high acceptability from clinicians.ConclusionsThe process of collaboratively developing an RA decision aid designed to promote shared decision making resulted in a graphically-enhanced, low literacy tool. The use of RA Choice in the clinical encounter has the potential to enhance communication for RA patients, including those with limited health literacy and limited English language proficiency.

State of the Science: Tools and Measurement for Shared Decision Making

Shared decision making (SDM) has been advocated as an approach to selecting medical tests and treatments for many situations. The goal of SDM is to ensure that patients are well informed, are meaningfully involved in decisions, and receive treatments that meet their goals and preferences. There is considerable evidence about the tools used to promote SDM, called patient decision aids, and many different measures have been developed to assess the impact of SDM. However, fairly little is known about the applicability of the tools and measures in the emergency department (ED) setting. This article builds on insights from two keynote lectures presented at the 2016 Academic Emergency Medicine Consensus Conference discussing the state of the science for measurement of SDM and the design of patient decision aids to promote SDM conversations and highlights some key areas for further research to advance SDM in the ED.