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Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease.

ABSTRACT: Erythropoiesis-stimulating agents (ESAs) are commonly used for the treatment of anemia due to chronic kidney disease (CKD) and end stage renal disease (ESRD). Patients often lack an understanding of the potential risks and benefits of ESAs, despite government mandated education on this topic. Decision aids are tools commonly used to discuss important information in health care settings. To address this knowledge gap, we designed this study to evaluate the effectiveness of a novel ESA decision aid at promoting informed shared decision making (ISDM) between patients and providers related to ESA use for CKD- and ESRD-related anemia.Using the principles of informed shared decision making theory, we designed and piloted an ESA decision aid intended to increase CKD and ESRD patient understanding of the potential risks and benefits of ESAs. Informed by the findings during development, the ESA decision aid was modified and finalized for testing. We will perform a randomized clinical trial to assess if administration of the ESA decision aid improves patient understanding of the risks and benefits of ESA use compared to control patients receiving standard care. Participants with either CKD or ESRD and who are receiving ESAs will be eligible for participation. The primary outcome is patients' score on the Patient Anemia Knowledge in Kidney Disease (PAKKD) survey assessed at enrollment and 3 months after. Secondary outcomes include decisional conflict related to ESAs, and patient satisfaction with provider communication.The Anemia Risk Communication for patients with Kidney Disease (ARC-KD) study will assess the effectiveness of a novel ESA decision aid to improve patient understanding of ESA use to manage CKD- and ESRD-related anemia. This decision aid is the first resource targeted to improve patient understanding of anemia management in the kidney health context. With the increasing options available for anemia management, this will serve as an important foundation to evolve in the future to optimize anemia-related shared decision making.ClinicalTrials.gov, number NCT01992926 . Registered 11/14/2013.

SUBMITTER: Beach LB

PROVIDER: S-EPMC4949884 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease.

Beach Lauren B LB Wild Marcus M Ramachandran Gowri G Ikizler H Omer HO Cavanaugh Kerri L KL

BMC nephrology 20160718 1

<h4>Background</h4>Erythropoiesis-stimulating agents (ESAs) are commonly used for the treatment of anemia due to chronic kidney disease (CKD) and end stage renal disease (ESRD). Patients often lack an understanding of the potential risks and benefits of ESAs, despite government mandated education on this topic. Decision aids are tools commonly used to discuss important information in health care settings. To address this knowledge gap, we designed this study to evaluate the effectiveness of a no ...[more]

PMID: 27430294

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Project description:Clinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient's risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence.This is a two-armed single-blinded randomized controlled trial with the target of 300 patients per arm. The setting is eleven community and three academic primary care practices in Metro Detroit. Patients are men and women aged between 50 and 75 years who are not up to date on colorectal cancer screening. ColoDATES Web (intervention arm), a decision aid that incorporates interactive personal risk assessment and preference clarification tools, is compared to a non-interactive website that matches ColoDATES Web in content but does not contain interactive tools (control arm). Primary outcomes are patient uptake of colorectal cancer screening; patient decision quality (knowledge, preference clarification, intent); clinician's degree of shared decision making; and patient-clinician concordance in the screening test chosen. Secondary outcome incorporates a Structural Equation Modeling approach to understand the mechanism of the causal pathway and test the validity of the proposed conceptual model based on Theory of Planned Behavior. Clinicians and those performing the analysis are blinded to arms.The central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient's and clinician's preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making 'black box' that currently exists between the delivery of decision aids to patients and subsequent patient behavior.ClinicalTrials.gov ID NCT01514786.

Project description:BACKGROUND:Many women with depression experience significant difficulty making a decision about whether or not to use antidepressant medication in pregnancy. Patient decision aids (PDAs) are tools that assist patients in making complex health decisions. PDAs can reduce decision-making difficulty and lead to better treatment outcomes. We describe the methods for a pilot randomized controlled trial of an interactive web-based PDA for women who are having difficulty deciding about antidepressant drug use in pregnancy. METHODS/DESIGN:This is a pilot randomized controlled trial that aims to assess the feasibility of a larger, multi-center efficacy study. The PDA aims to help a woman: (1) understand why an antidepressant is being recommended, (2) be knowledgeable about potential benefits and risks of treatment and non-treatment with antidepressants, and (3) be clear about which benefits and risks are most important to her, with the goal of improving confidence in her decision-making. We include women aged 18 years or older who are: (1) planning a pregnancy or are pregnant (gestational age less than 30 weeks), (2) diagnosed with major depressive disorder, (3) deciding whether or not to use a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) antidepressant in pregnancy, and (4) having at least moderate decision-making difficulty as per a Decisional Conflict Scale (DCS) Score ?25. Participants are randomized to receive the PDA or an informational resource sheet via a secure website, and have access to the stated allocation until their final study follow-up. The primary outcomes of the pilot study are feasibility of recruitment and retention, acceptability of the intervention, and adherence to the trial protocol. The primary efficacy outcome is DCS score at 4 weeks post randomization, with secondary outcomes including depressive and anxiety symptoms. DISCUSSION:Our PDA represents a key opportunity to optimize the decision-making process for women around antidepressants in pregnancy, leading to effective decision-making and optimizing improved maternal and child outcomes related to depression in pregnancy. The electronic nature of the PDA will facilitate keeping it up-to-date, and allow for widespread dissemination after efficacy is demonstrated. TRIAL REGISTRATION:This trial is registered on ClinicalTrials.Gov under the identifier NCT02308592 (first registered: 2 December 2014).

Project description:ObjectiveTo evaluate the effectiveness of a contraceptive decision aid in reducing decisional conflict among women seeking reversible contraception.Study designWe conducted a randomized trial of a computer-based decision aid compared to a control group for women presenting for reversible contraception at two clinics affiliated with an academic medical center. The primary outcome was change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale. We hypothesized the decision aid would reduce the decisional conflict score by 10 points on a 100-point scale (0 = no conflict, 100 = high conflict) compared to the control group. Secondary outcomes included contraceptive method chosen and satisfaction with the healthcare visit.ResultsWe enrolled and randomized 253 women, and 241 had complete data for our primary outcome. Overall, pre-visit decisional conflict scores were low, reflecting low levels of decisional conflict in our sample; median score 15 (range 0-80) in the decision aid and 10 (0-85) in the control group (p = 0.45). Both groups had a similar reduction in median decisional conflict after the healthcare visit: -10 (-80 to 25) and -10 (-60 to 5) in the decision aid and control groups respectively (p = 0.99). Choice of contraception (p = 0.23) and satisfaction with healthcare provider (p = 0.79) also did not differ by study group.ConclusionsDecisional conflict around contraception was low in both groups at baseline. Use of a computerized contraceptive decision aid did not reduce decisional conflict, alter method choice, or impact satisfaction compared to the control group among women choosing reversible contraception.ImplicationsUse of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception. Future studies could focus on testing the decision aid in different clinical settings, especially where barriers to providing comprehensive contraceptive counseling exist.

Project description:Systemic Lupus erythematosus (SLE), also commonly referred to as lupus, is a rare, but sometimes, fatal disease, that primarily affects young women. Lupus nephritis, a common manifestation of lupus, is more common and more devastating in patients of minority race/ethnicity. Patients have negative views of immunosuppressive drugs for lupus nephritis due to a concern about side effects and under-appreciation of its benefit. We designed a study to assess the effectiveness of individualized, computerized patient decision-aid for immunosuppressive drugs for lupus nephritis compared to a standard pamphlet for patient decision-making.Adult women with lupus nephritis, with a current lupus nephritis flare or at risk of a future lupus nephritis flare will be randomized to individualized, computerized patient decision-aid for immunosuppressive drugs vs. standard pamphlet with information about lupus and its treatment including immunosuppressive drugs and outcomes. Patients will complete outcome assessments immediately after the intervention has been administered. Patients will be followed at 3-months with a brief survey, either in person or on the phone, and at 6-months with medical record review for exploratory outcomes. Co-primary outcomes are decisional conflict and informed choice regarding immunosuppressive drugs (combines values, knowledge and choice). Secondary outcomes include: (1) assessment of patient-physician communication by assessing audio-taped physician-patient communication after intervention administration; (2) concordance between patient's desired and actual role in immunosuppressive drugs decision-making using the control preference scale (CPS); and (3) patient perception of physician interaction using the interpersonal process of care- short form (IPC-SF).This is one of the first studies to evaluate the effectiveness of an educational intervention targeting minorities with lupus nephritis. This patient-centered lupus nephritis decision-aid will be available in the public domain in English and Spanish.ClinicalTrials.gov Identifier: NCT02319525 ; registered on November 5, 2014.

Project description:BackgroundShared decision making (SDM) is a widely recommended yet unproven strategy for increasing colorectal cancer (CRC) screening uptake. Previous trials of decision aids to increase SDM and CRC screening uptake have yielded mixed results.PurposeTo assess the impact of decision aid-assisted SDM on CRC screening uptake.DesignRCT.Setting/participantsThe study was conducted at an urban, academic safety-net hospital and community health center between 2005 and 2010. Participants were asymptomatic, average-risk patients aged 50-75 years due for CRC screening.InterventionStudy participants (n=825) were randomized to one of two intervention arms (decision aid plus personalized risk assessment or decision aid alone) or control arm. The interventions took place just prior to a routine office visit with their primary care providers.Main outcome measuresThe primary outcome was completion of a CRC screening test within 12 months of the study visit. Logistic regression was used to identify predictors of test completion and mediators of the intervention effect. Analysis was completed in 2011.ResultsPatients in the decision-aid group were more likely to complete a screening test than control patients (43.1% vs 34.8%, p=0.046) within 12 months of the study visit; conversely, test uptake for the decision aid and decision aid plus personalized risk assessment arms was similar (43.1% vs 37.1%, p=0.15). Assignment to the decision-aid arm (AOR=1.48, 95% CI=1.04, 2.10), black race (AOR=1.52, 95% CI=1.12, 2.06) and a preference for a patient-dominant decision-making approach (AOR=1.55, 95% CI=1.02, 2.35) were independent determinants of test completion. Activation of the screening discussion and enhanced screening intentions mediated the intervention effect.ConclusionsDecision aid-assisted SDM has a modest impact on CRC screening uptake. A decision aid plus personalized risk assessment tool is no more effective than a decision aid alone.Trial registrationThis study is registered at www.clinicaltrials.govNCT00251862.

Project description:BACKGROUND:Shared decision making is particularly important in situations with different treatment alternatives. For the treatment of idiopathic Parkinson disease, both pharmacological and surgical approaches can be applied. OBJECTIVE:In this research project, a series of studies will be conducted to investigate how decision aids for patients with idiopathic Parkinson disease should be designed in order to support the decision-making process. METHODS:In Study 1a, qualitative interviews will be conducted to determine which needs frequently occur for patients with idiopathic Parkinson disease. In Study 1b, the identified needs will then be rated for personal relevance by an independent group of patients in an online survey. In Study 2, a randomized controlled trial will be used to pretest different decision aids in a sample group of people who do not have a medical background and who do not have Parkinson disease. In Study 3, a randomized controlled trial will be used to investigate the effect of the decision aids that had been evaluated as positive in Study 2 with patients who have idiopathic Parkinson disease. RESULTS:This series of studies received ethical approval in January 2020. As of June 2020, data collection for Study 1a has started, and it is estimated that Studies 1a, 1b, 2, and 3 will take approximately 4, 4, 6, and 6 months to complete, respectively. It is planned to present the results and analyses at international conferences and to submit the results to peer-reviewed journals for publication, once the studies have been completed. The findings will also be shared with clinicians and patients through presentations at information events. CONCLUSIONS:This series of studies is intended to result in an evidence-based decision aid for patients with idiopathic Parkinson disease in order to support the informed and reflected shared decision-making process. We further intend to contribute to a deeper understanding of the individual preferences of patients with idiopathic Parkinson disease and the impact of those preferences on treatment decisions.

Dataset Information

Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease.

Publications

Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease.

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