Exploring differences in the use of the statin choice decision aid and diabetes medication choice decision aid in primary care.
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SUBMITTER: Ballard AY
PROVIDER: S-EPMC5553736 | biostudies-other | 2017 Aug
REPOSITORIES: biostudies-other
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Project description:OBJECTIVE:To assess the efficacy of the Diabetes Medication Choice Decision Aid among patients with type 2 diabetes in Greece. DESIGN:Open-label cluster randomised controlled trial. SETTING:Primary and secondary care practices across Greece. PARTICIPANTS:5 sites allocated to the decision aid (n=101 patients) and 4 sites to control (n=103 patients). INTERVENTION:Clinicians and patients in the intervention arm used a decision aid, based on outcomes that both consider important when choosing among antihyperglycaemic medications. Patients in the control arm received usual care. OUTCOME MEASURES:The primary outcome was patient's level of decisional comfort after the initial clinical encounter. Secondary outcomes included patient's knowledge about type 2 diabetes and medications, and patient's and clinician's satisfaction. Adherence to prescribed antihyperglycaemic medication and change in glycated haemoglobin were assessed at 24?weeks. RESULTS:Patients in both arms had similar scores in overall decisional comfort (mean difference between the usual care and decision aid arms -6.9, 95% CI -21.5 to 7.7) and its subscales. Patients' knowledge was high in both arms (mean difference 2.3%, 95% CI -15.7% to 20.4%). Patients and clinicians in both groups were equally satisfied with the decision-making. No significant difference in medication adherence and glycaemic control was found across arms. Clinicians found the decision aid useful and reported that its integration in their daily routine was easy. CONCLUSIONS:The decision aid was implemented and positively received in the clinical setting in Greece, in line with the patient-centred approach endorsed by current guidelines. However, this trial yielded imprecise results in terms of patient outcomes. Further research is needed to investigate the interaction between the patient and the clinician in order to clarify the association between the use of decision aids and implementation of shared decision-making. TRIAL REGISTRATION NUMBER:NCT01861756. Pre-results.
| S-EPMC5129072 | biostudies-literature
Project description:Bisphosphonates 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.This 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.This 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.Clinical Trials.gov Identifier: NCT00578981.
| S-EPMC2796658 | biostudies-literature
Project description: Not available
| S-EPMC8115947 | biostudies-literature
Project description:Comparative effectiveness research (CER) documents important differences in antidepressants in terms of efficacy, safety, cost, and burden to the patient. Decision aids can adapt this evidence to help patients participate in making informed choices. In turn, antidepressant therapy will more likely reflect patients' values and context, leading to improved adherence and mood outcomes.The objective of this study is to develop the Depression Medication Choice decision aid for use during primary care encounters, and to test its efficacy by conducting a clustered practical randomized trial comparing the decision aid to usual depression care in primary care practices.We will use a novel practice-based, patient-centered approach based on participatory action research that involves a multidisciplinary team of designers, investigators, clinicians, patient representatives, and other stakeholders for the development of the decision aid. We will then conduct a clustered practical randomized trial enrolling clinicians and their patients (n = 300) with moderate to severe depression from rural, suburban and inner city primary care practices (n = 10). The intervention will consist of the use of the depression medication choice decision aid during the clinical encounter. This trial will generate preliminary evidence of the relative impact of the decision aid on patient involvement in decision making, decision making quality, patient knowledge, and 6-month measures of medication adherence and mental health compared to usual depression care.Upon completion of the proposed research, we will have developed and evaluated the efficacy of the decision aid depression medication choice as a novel translational tool for CER in depression treatment, engaged patients with depression in their care, and refined the process by which we conduct practice-based trials with limited research footprint.Clinical Trials.gov: NCT01502891.
| S-EPMC3663744 | biostudies-literature
Project description:BACKGROUND:Care of patients with diabetes often occurs in the context of other chronic illness. Competing disease priorities and competing patient-physician priorities present challenges in the provision of care for the complex patient. Guideline implementation interventions to date do not acknowledge these intricacies of clinical practice. As a result, patients and providers are left overwhelmed and paralyzed by the sheer volume of recommendations and tasks. An individualized approach to the patient with diabetes and multiple comorbid conditions using shared decision-making (SDM) and goal setting has been advocated as a patient-centred approach that may facilitate prioritization of treatment options. Furthermore, incorporating interprofessional integration into practice may overcome barriers to implementation. However, these strategies have not been taken up extensively in clinical practice. OBJECTIVES:To systematically develop and test an interprofessional SDM and goal-setting toolkit for patients with diabetes and other chronic diseases, following the Knowledge to Action framework. METHODS:1. Feasibility study: Individual interviews with primary care physicians, nurses, dietitians, pharmacists, and patients with diabetes will be conducted, exploring their experiences with shared decision-making and priority-setting, including facilitators and barriers, the relevance of a decision aid and toolkit for priority-setting, and how best to integrate it into practice.2. Toolkit development: Based on this data, an evidence-based multi-component SDM toolkit will be developed. The toolkit will be reviewed by content experts (primary care, endocrinology, geriatricians, nurses, dietitians, pharmacists, patients) for accuracy and comprehensiveness.3. Heuristic evaluation: A human factors engineer will review the toolkit and identify, list and categorize usability issues by severity.4. Usability testing: This will be done using cognitive task analysis.5. Iterative refinement: Throughout the development process, the toolkit will be refined through several iterative cycles of feedback and redesign. DISCUSSION:Interprofessional shared decision-making regarding priority-setting with the use of a decision aid toolkit may help prioritize care of individuals with multiple comorbid conditions. Adhering to principles of user-centered design, we will develop and refine a toolkit to assess the feasibility of this approach.
| S-EPMC3937124 | biostudies-literature
Project description:BackgroundThe United States Preventive Services Task Force (USPSTF) issued recommendations for older, heavy lifetime smokers to complete annual low-dose computed tomography (LDCT) scans of the chest as screening for lung cancer. The USPSTF recommends and the Centers for Medicare and Medicaid Services require shared decision making using a decision aid for lung cancer screening with annual LDCT. Little is known about how decision aids affect screening knowledge, preferences, and behavior. Thus, we tested a lung cancer screening decision aid video in screening-eligible primary care patients.MethodsWe conducted a single-group study with surveys before and after decision aid viewing and medical record review at 3 months. Participants were active patients of a large US academic primary care practice who were current or former smokers, ages 55-80 years, and eligible for screening based on current screening guidelines. Outcomes assessed pre-post decision aid viewing were screening-related knowledge score (9 items about screening-related harms of false positives and overdiagnosis, likelihood of benefit; score range = 0-9) and preference (preferred screening vs. not). Screening behavior measures, assessed via chart review, included provider visits, screening discussion, LDCT ordering, and LDCT completion within 3 months.ResultsAmong 50 participants, knowledge increased from pre- to post-decision aid viewing (mean = 2.6 vs. 5.5, difference = 2.8; 95% CI 2.1, 3.6, p < 0.001). Preferences across the overall sample remained similar such that 54% preferred screening at baseline and 50% after viewing; however, 28% of participants changed their preference (to or away from screening) from baseline to after viewing. We assessed screening behavior for 36 participants who had a primary care visit during the 3-month period following enrollment. Eighteen of 36 preferred screening after decision aid viewing. Of these 18, 10 discussed screening, 8 had a test ordered, and 6 completed LDCT. Among the 18 who preferred no screening, 7 discussed screening, 5 had a test ordered, and 4 completed LDCT.ConclusionsIn primary care patients, a lung cancer screening decision aid improved knowledge regarding screening-related benefits and harms. Screening preferences and behavior were heterogeneous.Trial registrationThis study is registered at www.clinicaltrials.gov . NCT03077230 (registered retrospectively,November 22, 2016).
| S-EPMC5765651 | biostudies-literature
Project description:We evaluated how computerized clinical decision support (CDS) affects the counseling women receive when primary care physicians (PCPs) prescribe potential teratogens and how this counseling affects women's behavior.Between October 2008 and April 2010, all women aged 18-50 years visiting one of three community-based family practice clinics or an academic general internal medicine clinic were invited to complete a survey 5-30 days after their clinic visit. Women who received prescriptions were asked if they were counseled about teratogenic risks or contraception and if they used contraception at last intercourse.Eight hundred one women completed surveys; 27% received a prescription for a potential teratogen. With or without CDS, women prescribed potential teratogens were more likely than women prescribed safer medications to report counseling about teratogenic risks. However, even with CDS 43% of women prescribed potential teratogens reported no counseling. In multivariable models, women were more likely to report counseling if they saw a female PCP (odds ratio: 1.97; 95% confidence interval: 1.26-3.09). Women were least likely to report counseling if they received angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Women who were pregnant or trying to conceive were not more likely to report counseling. Nonetheless, women who received counseling about contraception or teratogenic risks were more likely to use contraception after being prescribed potential teratogens than women who received no counseling.Physician counseling can reduce risk of medication-induced birth defects. However, efforts are needed to ensure that PCPs consistently inform women of teratogenic risks and provide access to highly effective contraception.
| S-EPMC3837561 | biostudies-literature
Project description:ImportanceGuidelines recommend shared decision-making prior to initiating lung cancer screening (LCS). However, evidence is lacking on how to best implement shared decision-making in clinical practice.ObjectiveTo evaluate the impact of an LCS Decision Tool (LCSDecTool) on the quality of decision-making and LCS uptake.Design, setting, and participantsThis randomized clinical trial enrolled participants at Veteran Affairs Medical Centers in Philadelphia, Pennsylvania; Milwaukee, Wisconsin; and West Haven, Connecticut, from March 18, 2019, to September 29, 2021, with follow-up through July 18, 2022. Individuals aged 55 to 80 years with a smoking history of at least 30 pack-years who were current smokers or had quit within the past 15 years were eligible to participate. Individuals with LCS within 15 months were excluded. Of 1047 individuals who were sent a recruitment letter or had referred themselves, 140 were enrolled.InterventionA web-based patient- and clinician-facing LCS decision support tool vs an attention control intervention.Main outcome and measuresThe primary outcome was decisional conflict at 1 month. Secondary outcomes included decisional conflict immediately after intervention and 3 months after intervention, knowledge, decisional regret, and anxiety immediately after intervention and 1 and 3 months after intervention and LCS by 6 months.ResultsOf 140 enrolled participants (median age, 64.0 [IQR, 61.0-69.0] years), 129 (92.1%) were men and 11 (7.9%) were women. Of 137 participants with data available, 75 (53.6%) were African American or Black and 62 (44.3%) were White; 4 participants (2.9%) also reported Hispanic or Latino ethnicity. Mean decisional conflict score at 1 month did not differ between the LCSDecTool and control groups (25.7 [95% CI, 21.4-30.1] vs 29.9 [95% CI, 25.6-34.2], respectively; P = .18). Mean LCS knowledge score was greater in the LCSDecTool group immediately after intervention (7.0 [95% CI, 6.3-7.7] vs 4.9 [95% CI, 4.3-5.5]; P < .001) and remained higher at 1 month (6.3 [95% CI, 5.7-6.8] vs 5.2 [95% CI, 4.5-5.8]; P = .03) and 3 months (6.2 [95% CI, 5.6-6.8] vs 5.1 [95% CI, 4.4-5.8]; P = .01). Uptake of LCS was greater in the LCSDecTool group at 6 months (26 of 69 [37.7%] vs 15 of 71 [21.1%]; P = .04).Conclusions and relevanceIn this randomized clinical trial of an LCSDecTool compared with attention control, no effect on decisional conflict occurred at 1 month. The LCSDecTool used in the primary care setting did not yield a significant difference in decisional conflict. The intervention led to greater knowledge and LCS uptake. These findings can inform future implementation strategies and research in LCS shared decision-making.Trial registrationClinicalTrials.gov Identifier: NCT02899754.
| S-EPMC10469267 | biostudies-literature
Project description:BackgroundType 2 diabetes is 2-3 times more prevalent in people of South Asian and African/African Caribbean ethnicity than people of European ethnicity living in the UK. The former 2 groups also experience excess atherosclerotic cardiovascular disease (ASCVD) complications of diabetes. We aimed to study ethnic differences in statin initiation, a cornerstone of ASCVD primary prevention, for people with type 2 diabetes.Methods and findingsObservational cohort study of UK primary care records, from 1 January 2006 to 30 June 2019. Data were studied from 27,511 (88%) people of European ethnicity, 2,386 (8%) people of South Asian ethnicity, and 1,142 (4%) people of African/African Caribbean ethnicity with incident type 2 diabetes, no previous ASCVD, and statin use indicated by guidelines. Statin initiation rates were contrasted by ethnicity, and the number of ASCVD events that could be prevented by equalising prescribing rates across ethnic groups was estimated. Median time to statin initiation was 79, 109, and 84 days for people of European, South Asian, and African/African Caribbean ethnicity, respectively. People of African/African Caribbean ethnicity were a third less likely to receive guideline-indicated statins than European people (n/N [%]: 605/1,142 [53%] and 18,803/27,511 [68%], respectively; age- and gender-adjusted HR 0.67 [95% CI 0.60 to 0.76], p < 0.001). The HR attenuated marginally in a model adjusting for total cholesterol/high-density lipoprotein cholesterol ratio (0.77 [95% CI 0.69 to 0.85], p < 0.001), with no further diminution when deprivation, ASCVD risk factors, comorbidity, polypharmacy, and healthcare usage were accounted for (fully adjusted HR 0.76 [95% CI 0.68, 0.85], p < 0.001). People of South Asian ethnicity were 10% less likely to receive a statin than European people (1,489/2,386 [62%] and 18,803/27,511 [68%], respectively; fully adjusted HR 0.91 [95% CI 0.85 to 0.98], p = 0.008, adjusting for all covariates). We estimated that up to 12,600 ASCVD events could be prevented over the lifetimes of people currently affected by type 2 diabetes in the UK by equalising statin prescribing across ethnic groups. Limitations included incompleteness of recording of routinely collected data.ConclusionsIn this study we observed that people of African/African Caribbean ethnicity with type 2 diabetes were substantially less likely, and people of South Asian ethnicity marginally less likely, to receive guideline-indicated statins than people of European ethnicity, even after accounting for sociodemographics, healthcare usage, ASCVD risk factors, and comorbidity. Underuse of statins in people of African/African Caribbean or South Asian ethnicity with type 2 diabetes is a missed opportunity to prevent cardiovascular events.
| S-EPMC8241069 | biostudies-literature
Project description:PurposeOsteoporosis Choice, an encounter decision aid, can engage patients and clinicians in shared decision making about osteoporosis treatment. Its effectiveness compared to the routine provision to clinicians of the patient's estimated risk of fracture using the FRAX calculator is unknown.MethodsPatient-level, randomized, three-arm trial enrolling women over 50 with osteopenia or osteoporosis eligible for treatment with bisphosphonates, where the use of Osteoporosis Choice was compared to FRAX only and to usual care to determine impact on patient knowledge, decisional conflict, involvement in the decision-making process, decision to start and adherence to bisphosphonates.ResultsWe enrolled 79 women in the three arms. Because FRAX estimation alone and usual care produced similar results, we grouped them for analysis. Compared to these, use of Osteoporosis Choice increased patient knowledge (median score 6 vs. 4, p = .01), improved understanding of fracture risk and risk reduction with bisphosphonates (p = .01 and p<.0001, respectively), had no effect on decision conflict, and increased patient engagement in the decision making process (OPTION scores 57% vs. 43%, p = .001). Encounters with the decision aid were 0.8 minutes longer (range: 33 minutes shorter to 3.0 minutes longer). There were twice as many patients receiving and filling prescriptions in the decision aid arm (83% vs. 40%, p = .07); medication adherence at 6 months was no different across arms.ConclusionSupporting both patients and clinicians during the clinical encounter with the Osteoporosis Choice decision aid efficiently improves treatment decision making when compared to usual care with or without clinical decision support with FRAX results.Trial registrationclinical trials.gov NCT00949611.
| S-EPMC4444262 | biostudies-literature