Dataset Information

Development and evaluation of a decision aid for family surrogate decision-makers for patients with acute kidney injury requiring renal replacement therapy (RRT) in ICUs: a study protocol.

ABSTRACT:

Introduction

Shared decision making is endorsed by guidelines for both acute kidney injury and critical care medicine. However, there is still a huge need for effective interventions, especially those focusing on decisions about renal replacement therapy for intensive care unit (ICU) patients with acute kidney injury. The decision aids provide evidence-based support for shared decision making, to achieve better decisions through enhanced knowledge of treatment options and treatment aligns with patients' preferences and values. Therefore, our objectives are to develop and evaluate a decision aid systematically and rigorously for family surrogate decision makers of ICU patients with acute kidney injury who need renal replacement therapy.

Methods and analysis

We will use a systematic development process that focuses on user-centred design to develop and evaluate the decision aid in three phases: (1) development of a draft prototype for the decision aid based on extensive literature reviews, interviews with key stakeholders and evidence synthesis; (2) alpha testing ('near live' usability) the decision aid during simulated clinical encounters to test its comprehensibility, acceptability and usability and (3) beta testing ('live' usability) to examine the aid's clinical feasibility. User testing will be conducted using mixed-methods approach to support iterative revision of the decision aid. The IPDASi (V.4.0) will be used for following qualitative assessment. All interviews will be analysed by Colaizzi's seven-step approach to qualitative analysis. The coding scheme will use to analyse user interactions. Questionnaire surveys will be analysed using paired sample t-tests when related to the before-and-after survey, otherwise using one-sample t-test.

Ethics and dissemination

Ethical approval for this research was obtained from the Ethics Committee of the First Affiliated Hospital of Army Medical University, PLA (Ref: KY2020104). All participants will sign a formal informed consent form. The findings will be published in peer-reviewed journals and reported in appropriate meetings.

Trial registration number

ChiCTR2000031613.

SUBMITTER: Zheng M

PROVIDER: S-EPMC7883861 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Development and evaluation of a decision aid for family surrogate decision-makers for patients with acute kidney injury requiring renal replacement therapy (RRT) in ICUs: a study protocol.

Zheng Miao M Yin Changlin C Cao Ying Y Zhang Yonghui Y Zhang Kuoliang K Zhang Xiaoqin X Bian Wei W Wang Lihua L

BMJ open 20210212 2

<h4>Introduction</h4>Shared decision making is endorsed by guidelines for both acute kidney injury and critical care medicine. However, there is still a huge need for effective interventions, especially those focusing on decisions about renal replacement therapy for intensive care unit (ICU) patients with acute kidney injury. The decision aids provide evidence-based support for shared decision making, to achieve better decisions through enhanced knowledge of treatment options and treatment align ...[more]

PMID: 33579767

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Project description:In advanced dementia, feeding problems are nearly universal, and families face difficult decisions about feeding options. Initial interviews for a randomized trial were used to describe surrogates' perceptions of feeding options, and to determine whether a decision aid on feeding options in advanced dementia would improve knowledge, reduce expectation of benefit from tube feeding, and reduce conflict over treatment choices for persons with advanced dementia.Semistructured interview with prestudy and poststudy design for surrogates in the intervention group.Twenty-four skilled nursing facilities across North Carolina participating in a cluster randomized trial.Two hundred and fifty-five surrogate decision makers for nursing home residents with advanced dementia and feeding problems, in control (n = 129) and intervention (n = 126) groups.For intervention surrogates only, an audiovisual-print decision aid provided information on dementia, feeding problems in dementia, advantages and disadvantages of feeding tubes or assisted oral feeding options, and the role of surrogates in making these decisions.The interview included open-ended items asking surrogates to report advantages and disadvantages of tube feeding and assisted oral feeding. Knowledge of feeding options was measured with 19 true/false items and items measuring expectation of benefit from tube feeding. Surrogates reported which of these two feeding options they preferred for the person with dementia, and how confident they were in this choice; their level of conflict about the choice was measured using the decisional conflict scale.Before the decision aid, surrogates described advantages and disadvantages of assisted oral feeding and tube feeding in practical, ethical, and medical terms. After review of the decision aid, intervention surrogates had improved knowledge scores (15.5 vs 16.8; P < .001), decreased expectation of benefits from tube feeding (2.73 vs 2.32; P = .001), and reduced decisional conflict (2.24 vs 1.91; P < .001). Surrogates preferred assisted oral feeding initially and reported more certainty about this choice after the decision aid.A structured decision aid can be used to improve decision making about feeding options in dementia care.

Project description:IntroductionAlthough shortcomings in clinician-family communication and decision making for incapacitated, critically ill patients are common, there are few rigorously tested interventions to improve outcomes. In this manuscript, we present our methodology for the Pairing Re-engineered Intensive Care Unit Teams with Nurse-Driven Emotional support and Relationship Building (PARTNER 2) trial, and discuss design challenges and their resolution.Methods and analysisThis is a pragmatic, stepped-wedge, cluster randomised controlled trial comparing the PARTNER 2 intervention to usual care among 690 incapacitated, critically ill patients and their surrogates in five ICUs in Pennsylvania. Eligible subjects will include critically ill patients at high risk of death and/or severe long-term functional impairment, their main surrogate decision-maker and their clinicians. The PARTNER intervention is delivered by the interprofessional ICU team and overseen by 4-6 nurses from each ICU. It involves: (1) advanced communication skills training for nurses to deliver support to surrogates throughout the ICU stay; (2) deploying a structured family support pathway; (3) enacting strategies to foster collaboration between ICU and palliative care services and (4) providing intensive implementation support to each ICU to incorporate the family support pathway into clinicians' workflow. The primary outcome is surrogates' ratings of the quality of communication during the ICU stay as assessed by telephone at 6-month follow-up. Prespecified secondary outcomes include surrogates' scores on the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the modified Patient Perception of Patient Centredness scale, the Decision Regret Scale, nurses' scores on the Maslach Burnout Inventory, and length of stay during and costs of the index hospitalisation.We also discuss key methodological challenges, including determining the optimal level of randomisation, using existing staff to deploy the intervention and maximising long-term follow-up of participants.Ethics and disseminationWe obtained ethics approval through the University of Pittsburgh, Human Research Protection Office. The findings will be published in peer-reviewed journals.Trial registration numberNCT02445937.

Project description:ObjectivesOptimistic expectations about prognosis by surrogate decision-makers in ICUs are common, but there are few data about the causes and clinical consequences. Our objective was to determine the causes of optimistic expectations about prognosis among surrogates and whether it is associated with more use of life support at the end of life.DesignProspective, multicenter cohort study from 2009 to 2012.SettingTwelve ICUs from multiple regions of the United States.SubjectsThe surrogates and physicians of 275 incapacitated ICU patients at high risk of death.InterventionsNone.Measurements and main resultsSurrogates and physicians completed a validated instrument assessing their prognostic expectations for hospital survival. We determined the proportion of surrogates with optimistic expectations, defined as a prognostic estimate that was at least 20% more optimistic than the physician's, then determined how frequently this arose from surrogates miscomprehending the physicians' prognosis versus holding more hopeful beliefs compared with the physician. We used multivariable regression to examine whether optimistic expectations were associated with length of stay, stratified by survival status, and time to withdrawal of life support among nonsurvivors. Overall, 45% of surrogates (95% CI, 38-51%) held optimistic expectations about prognosis, which arose from a combination of misunderstanding the physician's prognostic expectations and from holding more hopeful beliefs compared with the physician. Optimistic expectations by surrogates were associated with significantly longer duration of ICU treatment among nonsurvivors before death (β coefficient = 0.44; 95% CI, 0.05-0.83; p = 0.027), corresponding to a 56% longer ICU stay. This difference was associated with a significantly longer time to withdrawal of life support among dying patients whose surrogates had optimistic prognostic expectations compared with those who did not (β coefficient = 0.61; 95% CI, 0.16-1.07; p = 0.009).ConclusionsThe prevalent optimism about prognosis among surrogates in ICUs arises both from surrogates' miscomprehension of physicians' prognostications and from surrogates holding more hopeful beliefs. This optimism is associated with longer duration of life support at the end of life.

Project description:Background:Treatment decisions commonly have to be made in intensive care units (ICUs). These decisions are difficult for surrogate decision makers and often lead to decisional conflict, psychological distress, and treatments misaligned with patient preferences. Objective:To determine whether a decision aid about prolonged mechanical ventilation improved prognostic concordance between surrogate decision makers and clinicians compared with a usual care control. Design:Multicenter, parallel, randomized, clinical trial. (ClinicalTrials.gov: NCT01751061). Setting:13 medical and surgical ICUs at 5 hospitals. Participants:Adult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses. Intervention:A Web-based decision aid provided personalized prognostic estimates, explained treatment options, and interactively clarified patient values to inform a family meeting. The control group received information according to usual care practices followed by a family meeting. Measurements:The primary outcome was improved concordance on 1-year survival estimates, measured with the clinician-surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality). Outcomes assessors were blinded to group allocation. Results:The study enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups (mean difference in score change from baseline, -1.7 percentage points [95% CI, -8.3 to 4.8 percentage points]; P = 0.60). Surrogates' postintervention estimates of patients' 1-year prognoses did not differ between intervention and control groups (median, 86.0% [interquartile range {IQR}, 50.0%] vs. 92.5% [IQR, 47.0%]; P = 0.23) and were substantially more optimistic than results of a validated prediction model (median, 56.0% [IQR, 43.0%]) and physician estimates (median, 50.0% [IQR, 55.5%]). Eighty-two intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences. Although intervention surrogates had greater reduction in decisional conflict than control surrogates (mean difference in change from baseline, 0.4 points [CI, 0.0 to 0.7 points]; P = 0.041), other surrogate and patient outcomes did not differ. Limitation:Contamination among clinicians could have biased results toward the null hypothesis. Conclusion:A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes. Decision support in acute care settings may require greater individualized attention for both the cognitive and affective challenges of decision making. Primary Funding Source:National Institutes of Health.

Project description:BackgroundFew educational resources have been developed to inform patients' renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients' treatment and support patients' decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function.MethodsWe designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in "stages." For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families.ResultsThe video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals' testimonials regarding various considerations that might influence patients' and families' treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably.ConclusionsThis rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values.

Dataset Information

Development and evaluation of a decision aid for family surrogate decision-makers for patients with acute kidney injury requiring renal replacement therapy (RRT) in ICUs: a study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Development and evaluation of a decision aid for family surrogate decision-makers for patients with acute kidney injury requiring renal replacement therapy (RRT) in ICUs: a study protocol.

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