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

ABSTRACT: Chest 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.This 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 Mary's 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.This 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.Clinical Trials.gov Identifier: NCT01077037.

SUBMITTER: Pierce MA

PROVIDER: S-EPMC2881067 | biostudies-literature | 2010 May

REPOSITORIES: biostudies-literature

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

Pierce Meghan A MA Hess Erik P EP Kline Jeffrey A JA Shah Nilay D ND Breslin Maggie M Branda Megan E ME Pencille Laurie J LJ Asplin Brent R BR Nestler David M DM Sadosty Annie T AT Stiell Ian G IG Ting Henry H HH Montori Victor M VM

Trials 20100517

<h4>Background</h4>Chest 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 ...[more]

PMID: 20478056

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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.

Project description:BackgroundApproximately 2 million patients present to emergency departments in the USA annually with signs and symptoms of ureterolithiasis (or renal colic, the pain from an obstructing kidney stone). Both ultrasound and CT scan can be used for diagnosis, but the vast majority of patients receive a CT scan. Diagnostic pathways utilizing ultrasound have been shown to decrease radiation exposure to patients but are potentially less accurate. Because of these and other trade-offs, this decision has been proposed as appropriate for Shared Decision-Making (SDM), where clinicians and patients discuss clinical options and their consequences and arrive at a decision together. We developed a decision aid to facilitate SDM in this scenario. The objective of this study is to determine the effects of this decision aid, as compared to usual care, on patient knowledge, radiation exposure, engagement, safety, and healthcare utilization.MethodsThis is the protocol for an adaptive randomized controlled trial to determine the effects of the intervention-a decision aid ("Kidney Stone Choice")-on patient-centered outcomes, compared with usual care. Patients age 18-55 presenting to the emergency department with signs and symptoms consistent with acute uncomplicated ureterolithiasis will be consecutively enrolled and randomized. Participants will be blinded to group allocation. We will collect outcomes related to patient knowledge, radiation exposure, trust in physician, safety, and downstream healthcare utilization.DiscussionWe hypothesize that this study will demonstrate that "Kidney Stone Choice," the decision aid created for this scenario, improves patient knowledge and decreases exposure to ionizing radiation. The adaptive design of this study will allow us to identify issues with fidelity and feasibility and subsequently evaluate the intervention for efficacy.Trial registrationClinicalTrials.gov NCT04234035 . Registered on 21 January 2020 - Retrospectively Registered.

Project description:Tamoxifen and raloxifene are chemopreventive drugs that can reduce women’s relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women’s knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer.We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women’s intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable ‘informed choice’ (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman’s decision and relevant attitudes.Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067.The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision makers must retain over time. Examining informed decisions increases understanding of the impact of DAs. A standard for defining and measuring sufficient knowledge for informed decisions is needed.ClinicalTrials.gov: NCT00967824

Project description:ImportanceNoninvasive testing and coronary angiography are used to evaluate patients who present to the emergency department (ED) with chest pain, but their effects on outcomes are uncertain.ObjectiveTo determine whether cardiovascular testing-noninvasive imaging or coronary angiography-is associated with changes in the rates of coronary revascularization or acute myocardial infarction (AMI) admission in patients who present to the ED with chest pain without initial findings of ischemia.Design, setting, and participantsThis retrospective cohort analysis used weekday (Monday-Thursday) vs weekend (Friday-Sunday) presentation as an instrument to adjust for unobserved case-mix variation (selection bias) between 2011 and 2012. National claims data (Truven MarketScan) was used. The data included a total of 926 633 privately insured patients ages 18 to 64 years who presented to the ED with chest pain without initial diagnosis consistent with acute ischemia.ExposuresNoninvasive testing or coronary angiography within 2 days or 30 days of presentation.Main outcomes and measuresThe primary end points were coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery) and AMI admission at 7, 30, 180, and 365 days. The secondary end points were coronary angiography and coronary artery bypass grafting in those who underwent angiography.ResultsThe patients were ages 18 to 64 years with an average age of 44.4 years. A total of 536 197 patients (57.9%) were women. Patients who received testing (224 973) had increased risk at baseline and had greater risk of AMI admission than those who did not receive testing (701 660) (0.35% vs 0.14% at 30 days). Weekday patients (571 988) had similar baseline comorbidities to weekend patients (354 645) but were more likely to receive testing. After risk factor adjustment, testing within 30 days was associated with a significant increase in coronary angiography (36.5 per 1000 patients tested; 95% CI, 21.0-52.0) and revascularization (22.8 per 1000 patients tested; 95% CI, 10.6-35.0) at 1 year but no significant change in AMI admissions (7.8 per 1000 patients tested; 95% CI, -1.4 to 17.0). Testing within 2 days was also associated with a significant increase in coronary revascularization but no difference in AMI admissions.Conclusions and relevanceCardiac testing in patients with chest pain was associated with increased downstream testing and treatment without a reduction in AMI admissions, suggesting that routine testing may not be warranted. Further research into whether specific high-risk subgroups benefit from testing is needed.

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

Publications

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

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