Developing a web-based patient decision aid for gastrostomy in motor neuron disease: a study protocol.
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ABSTRACT: Introduction
Motor neuron disease (MND) is a progressive, incurable disease, characterised by degeneration of the nerves in the brain and spinal cord. Due to the multisystem effects of the disease, patients are faced with many complex, time-sensitive decisions, one of which is the decision on gastrostomy feeding. There are currently no published decision aids (DAs) to support patients making this decision in the UK. This study will develop and pilot a patient DA to provide evidence-based information on gastrostomy placement and feeding that is relevant to people with MND; communicate the risks and benefits associated with each option; check understanding and clarify personal values and preferences, enabling patients to make a decision congruent with their values and appropriate for them.Methods and analysis
A two-phase process, observing the International Patient Decision Aid Standards, will be used to develop the DA, over 24 months starting January 2019. Phase 1 will use literature reviews and stakeholder interviews and surveys to identify essential content for the DA, and explore the best way to present this. In the second phase, a prototype DA will be developed and revised using stakeholder feedback in an iterative process. Stakeholders will include individuals with MND, their carers and the healthcare professionals working with them.Ethics and dissemination
Ethical approval for the study has been granted by West of Scotland Research Ethics Service, reference 19/WS/0078. Study findings will be disseminated through academic and non-academic publications, conference presentations, stakeholder websites and social media. A feasibility study will follow to explore the acceptability and practicality of the DA for patients, carers and HCPs in practice and to assess whether the DA shows promise of being beneficial for the intended population.
SUBMITTER: Maunsell R
PROVIDER: S-EPMC6937039 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
Publications
Developing a web-based patient decision aid for gastrostomy in motor neuron disease: a study protocol.
Maunsell Rose R Bloomfield Suzanne S Erridge Clare C Foster Claire C Hardcastle Maggi M Hogden Anne A Kidd Alison A Lisiecka Dominika D McDermott Christopher J CJ Morrison Karen K Recio-Saucedo Alejandra A Rickenbach Louise L White Sean S Williams Peter P Wheelwright Sally J SJ
BMJ open 20191218 12
<h4>Introduction</h4>Motor neuron disease (MND) is a progressive, incurable disease, characterised by degeneration of the nerves in the brain and spinal cord. Due to the multisystem effects of the disease, patients are faced with many complex, time-sensitive decisions, one of which is the decision on gastrostomy feeding. There are currently no published decision aids (DAs) to support patients making this decision in the UK. This study will develop and pilot a patient DA to provide evidence-based ...[more]
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Project description:OBJECTIVES:Gastrostomy decision making is a complicated, multifaceted process for people with motor neuron disease (MND). This study explored demographic and disease-related factors that may impact on gastrostomy uptake; and reasons why people with MND accepted or declined gastrostomy, with a focus on how perceptions of swallowing and nutrition may influence decision making. DESIGN:Prospective, cross sectional, mixed methods. SETTING:An Australian multidisciplinary, specialty MND Service. PARTICIPANTS:33 patients were recommended gastrostomy by the treating medical specialist. 16 of 33 were invited to participate in the prospective decision making study; of whom 10 provided informed consent. PRIMARY AND SECONDARY OUTCOME MEASURES:Demographic and disease-related factors contributing to uptake are described. A stepped approach was applied to gain a comprehensive understanding of why people with MND accept or decline gastrostomy. Instruments included standardised assessments, nutrition survey and semistructured interview. Data were collected at three separate appointments, spanning a 3-week period. RESULTS:Gastrostomy uptake was 73% following medical specialist recommendation. Participants took days, weeks or months to consider their preferences, with lengthy hospital waiting times for the procedure. Gender, site of onset and rate of disease progression were observed to contribute to uptake. Age and symptom duration did not. Integration of quantitative and qualitative data suggests that patient perceptions of swallowing and nutrition contribute to gastrostomy acceptance; however, the decision making process is heterogeneous and these factors may not be the sole or primary reasons for acceptance. Other reported factors included: reducing carer burden, improving quality of life, increasing independence, continuing participation in social outings and gaining control. CONCLUSIONS:Future research may give greater insight into how healthcare organisations can better facilitate gastrostomy decision making, to meet the needs of people living with MND. Larger, prospective, multisite studies may build on these findings to better inform clinical guidelines and minimise the impacts of delayed gastrostomy insertion.
| S-EPMC7045239 | biostudies-literature
Project description:BACKGROUND:Hydroxyurea, chronic blood transfusions, and bone marrow transplantation are efficacious, disease-modifying therapies for sickle cell disease but involve complex risk-benefit trade-offs and decisional dilemma compounded by the lack of comparative studies. A patient decision aid can inform patients about their treatment options, the associated risks and benefits, help them clarify their values, and allow them to participate in medical decision making. OBJECTIVE:The objective of this study was to develop a literacy-sensitive Web-based patient decision aid based on the Ottawa decision support framework, and through a randomized clinical trial estimate the effectiveness of the patient decision aid in improving patient knowledge and their involvement in decision making. METHODS:We conducted population decisional needs assessments in a nationwide sample of patients, caregivers, community advocates, policy makers, and health care providers using qualitative interviews to identify decisional conflict, knowledge and expectations, values, support and resources, decision types, timing, stages and learning, and personal clinical characteristics. Interview transcripts were coded using QSR NVivo 10. Alpha testing of the patient decision aid prototype was done to establish usability and the accuracy of the information it conveyed, and then was followed by iterative cycles of beta testing. We conducted a randomized clinical trial of adults and of caregivers of pediatric patients to evaluate the efficacy of the patient decision aid. RESULTS:In a decisional needs assessment, 223 stakeholders described their preferences, helping to guide the development of the patient decision aid, which then underwent alpha testing by 30 patients and 38 health care providers and iterative cycles of beta testing by 87 stakeholders. In a randomized clinical trial, 120 participants were assigned to either the patient decision aid or standard care (SC) arm. Qualitative interviews revealed high levels of usability, acceptability, and utility of the patient decision aid in education, values clarification, and preparation for decision making. On the acceptability survey, 72% (86/120) of participants rated the patient decision aid as good or excellent. Participants on the patient decision aid arm compared to the SC arm demonstrated a statistically significant improvement in decisional self-efficacy (P=.05) and a reduction in the informed sub-score of decisional conflict (P=.003) at 3 months, with an improvement in preparation for decision making (P<.001) at 6 months. However, there was no improvement in terms of the change in knowledge, the total or other domain scores of decisional conflicts, or decisional self-efficacies at 6 months. The large amount of missing data from survey completion limited our ability to draw conclusions about the effectiveness of the patient decision aid. The patient decision aid met 61 of 62 benchmarks of the international patient decision aid collaboration standards for content, development process, and efficacy. CONCLUSIONS:We have developed a patient decision aid for sickle cell disease with extensive input from stakeholders and in a randomized clinical trial demonstrated its acceptability and utility in education and decision making. We were unable to demonstrate its effectiveness in improving patient knowledge and involvement in decision making. TRIAL REGISTRATION:ClinicalTrials.gov NCT03224429; https://clinicaltrials.gov/ct2/show/NCT03224429 and ClinicalTrials.gov NCT02326597; https://clinicaltrials.gov/ct2/show/NCT02326597.
| S-EPMC6934048 | biostudies-literature
Project description:BackgroundIn cancers with a chronic phase, patients and family caregivers face difficult decisions such as whether to start a novel therapy, whether to enroll in a clinical trial, and when to stop treatment. These decisions are complex, require an understanding of uncertainty, and necessitate the consideration of patients' informed preferences. For some cancers, such as medullary thyroid carcinoma, these decisions may also involve significant out-of-pocket costs and effects on family members. Providers have expressed a need for web-based interventions that can be delivered between consultations to provide education and prepare patients and families to discuss these decisions. To ensure that these tools are effective, usable, and understandable, studies are needed to identify patients', families', and providers' decision-making needs and optimal design strategies for a web-based patient decision aid.ObjectiveFollowing the international guidelines for the development of a web-based patient decision aid, the objectives of this study are to engage potential users to guide development; review the existing literature and available tools; assess users' decision-making experiences, needs, and design recommendations; and identify shared decision-making approaches to address each need.MethodsThis study used the decisional needs assessment approach, which included creating a stakeholder advisory panel, mapping decision pathways, conducting an environmental scan of existing materials, and administering a decisional needs assessment questionnaire. Thematic analyses identified current decision-making pathways, unmet decision-making needs, and decision support strategies for meeting each need.ResultsThe stakeholders reported wide heterogeneity in decision timing and pathways. Relevant existing materials included 2 systematic reviews, 9 additional papers, and multiple educational websites, but none of these met the criteria for a patient decision aid. Patients and family members (n=54) emphasized the need for plain language (46/54, 85%), shared decision making (45/54, 83%), and help with family discussions (39/54, 72%). Additional needs included information about uncertainty, lived experience, and costs. Providers (n=10) reported needing interventions that address misinformation (9/10, 90%), foster realistic expectations (9/10, 90%), and address mistrust in clinical trials (5/10, 50%). Additional needs included provider tools that support shared decision making. Both groups recommended designing a web-based patient decision aid that can be tailored to (64/64, 100%) and delivered on a hospital website (53/64, 83%), focuses on quality of life (45/64, 70%), and provides step-by-step guidance (43/64, 67%). The study team identified best practices to meet each need, which are presented in the proposed decision support design guide.ConclusionsPatients, families, and providers report multifaceted decision support needs during the chronic phase of cancer. Web-based patient decision aids that provide tailored support over time and explicitly address uncertainty, quality of life, realistic expectations, and effects on families are needed.
| S-EPMC8325074 | biostudies-literature
Project description:BackgroundA main element of patient-centred care, Patient Decision Aids (PtDAs) facilitate shared decision-making (SDM). A recent update of the International Patient Decision Aids Standards (IPDAS) emphasised patient involvement during PtDA development, but omitted a methodology for doing so. This article reports on the value of user-centred design (UCD) methods for the development of a PtDA that aims to support inflammatory arthritis patients in their choice between disease modifying anti-rheumatic drugs (DMARDs).MethodsThe IPDAS development process model in combination with UCD methods were applied. The process was overseen by an eight-member multidisciplinary steering group. Patients and health professionals were iteratively consulted. Qualitative in-depth interviews combined with rapid prototyping were conducted with patients to assess their needs for specific functionality, content and design of the PtDA. Group meetings with health professionals were organized to assess patients' needs and to determine how the PtDA should be integrated into patient pathways. The current literature was reviewed to determine the clinical evidence to include in the PtDA. To evaluate usability among patients, they were observed using the PtDA while thinking aloud and then interviewed.ResultsThe combination of patient interviews with rapid prototyping revealed that patients wanted to compare multiple DMARDs both for their clinical aspects and implications for daily life. Health professionals mainly wanted to refer patients to a reliable, easily adjustable source of information about DMARDs. A web-based PtDA was constructed consisting of four parts: 1) general information about SDM, inflammatory arthritis and DMARDs; 2) an application to compare particular DMARDs; 3) value clarification exercises; and 4) a printed summary of patients' notes, preferences, worries and questions that they could bring to discuss with their rheumatologist.ConclusionsThe study demonstrated that UCD methods can be of great value for the development of PtDAs. The early, iterative involvement of patients and health professionals was helpful in developing a novel user-friendly PtDA that allowed patients to choose between DMARDs. The PtDA fits the values of all stakeholders and easily integrates with the patient pathway and daily workflow of health professionals. This collaborative designed PtDA may improve SDM and patient participation in arthritis care.
| S-EPMC5405550 | biostudies-literature
Project description:BackgroundAn individualized approach using shared decision-making (SDM) and goal setting is a person-centred strategy that may facilitate prioritization of treatment options. SDM has not been adopted extensively in clinical practice. An interprofessional approach to SDM with tools to facilitate patient participation may overcome barriers to SDM use. The aim was to explore decision-making experiences of health professionals and people with diabetes (PwD), then develop an intervention to facilitate interprofessional shared decision-making (IP-SDM) and goal-setting.MethodsThis was a multi-phased study. 1) Feasibility: Using a descriptive qualitative study, individual interviews with primary care physicians, nurses, dietitians, pharmacists, and PwD were conducted. The interviews explored their experiences with SDM and priority-setting, including facilitators and barriers, relevance of a decision aid for priority-setting, and integration of SDM and a decision aid into practice. 2) Development: An evidence-based SDM toolkit was developed, consisting of an online decision aid, MyDiabetesPlan, and implementation tools. MyDiabetesPlan was reviewed by content experts for accuracy and comprehensiveness. Usability assessment was done with 3) heuristic evaluation and 4) user testing, followed by 5) refinement.ResultsSeven PwD and 10 clinicians participated in the interviews. From interviews with PwD, we identified that: (1) approaches to decision-making were diverse and dynamic; (2) a trusting relationship with the clinician and dialog were critical precursors to SDM; and, (3) goal-setting was a dynamic process. From clinicians, we found: (1) complementary (holistic and disease specific) approaches to the complex patient were used; (2) patient-provider agendas for goal-setting were often conflicting; (3) a flexible approach to decision-making was needed; and, (4) conflict could be resolved through SDM. Following usability assessment, we redesigned MyDiabetesPlan to consist of data collection and recommendation stages. Findings were used to finalize a multi-component toolkit and implementation strategy, consisting of MyDiabetesPlan, instructional card and videos, and orientation meetings with participating patients and clinicians.ConclusionsA decision aid can provide information, facilitate clinician-patient dialog and strengthen the therapeutic relationship. Implementation of the decision aid can fit into a model of team care that respects and exemplifies professional identity, and can facilitate intra-team communication.Trial registrationClinicaltrials.gov Identifier: NCT02379078. Date of Registration: 11 February 2015.
| S-EPMC6749701 | biostudies-literature
Project description:The aim of this study was to develop and evaluate a proof-of-concept open-source individualized Patient Decision Aid (iPDA) with a group of patients, physicians, and computer scientists. The iPDA was developed based on the International Patient Decision Aid Standards (IPDAS). A previously published questionnaire was adapted and used to test the user-friendliness and content of the iPDA. The questionnaire contained 40 multiple-choice questions, and answers were given on a 5-point Likert Scale (1-5) ranging from "strongly disagree" to "strongly agree." In addition to the questionnaire, semi-structured interviews were conducted with patients. We performed a descriptive analysis of the responses. The iPDA was evaluated by 28 computer scientists, 21 physicians, and 13 patients. The results demonstrate that the iPDA was found valuable by 92% (patients), 96% (computer scientists), and 86% (physicians), while the treatment information was judged useful by 92%, 96%, and 95%, respectively. Additionally, the tool was thought to be motivating for patients to actively engage in their treatment by 92%, 93%, and 91% of the above respondents groups. More multimedia components and less text were suggested by the respondents as ways to improve the tool and user interface. In conclusion, we successfully developed and tested an iPDA for patients with stage I-II Non-Small Cell Lung Cancer (NSCLC).
| S-EPMC10995236 | biostudies-literature
Project description:BackgroundPatients with metastatic melanoma and their physicians are confronted with a complex decision regarding first-line therapy. Risks and benefits vary considerably between various treatment options. With this in mind, we aim to develop and evaluate a patient decision aid (PtDA) to inform patients about the risks and benefits of treatment options, namely, immunotherapy as monotherapy, immunotherapy as combination therapy, and treatment with BRAF/MEK inhibitors. We aim to test whether the use of this PtDA before medical consultation will increase patients' knowledge of treatment options and thus promote shared decision-making (SDM) and patient decision satisfaction.MethodsIn total, 128 patients with metastatic melanoma from two German cancer centers will be randomized to the intervention group (IG), receiving access to the PtDA before medical consultation, or the control group (CG), receiving treatment as usual (TAU), i.e., medical consultation alone. There will be three major assessment points (before intervention, T0; after intervention, T1; and 3 months after intervention, T2). The main outcome is the patient's knowledge of their treatment options, measured by a self-developed, piloted multiple-choice test at T1. Secondary outcome measures will include the extent of SDM during medical consultation, assessed by Observer OPTION 5, and patient decision satisfaction, assessed by the Satisfaction with Decision Scale (SwD), at T1 and T2.DiscussionThis trial will assess the effectiveness of a developed PtDA to enhance patient knowledge of treatment options for metastatic melanoma, SDM, and patient decision satisfaction. If the efficacy can be proven, the PtDA will be implemented nationwide in Germany to close a relevant gap in the education and care of patients with metastatic melanoma.Trial registrationClinicalTrials.gov NCT04240717 . Registered on 27 January 2020.
| S-EPMC8056554 | biostudies-literature
Project description:BackgroundTaiwan has a high national caesarean rate coupled with a low vaginal birth after caesarean (VBAC) rate. This study aims to develop and evaluate a web-based decision-aid with communication support tools, to increase shared decision making (SDM) about birth after caesarean.MethodsA quantitative approach will be adopted using a randomized pre-test and post-test experimental design in a medical centre in northern Taiwan. The web-based decision aid consists of five sections. Section 1 provides a two-part video to introduce SDM and how to participate in SDM. Section 2 presents an overview of functions and features of the birth decision-aid. Section 3 presents relevant VBAC information, including definitions, benefits and risks, and an artificial intelligence (AI) calculator for rate and likelihood of VBAC success. Section 4 presents the information regarding elective repeat caesarean delivery (ERCD), involving definitions, benefits, and risks. Section 5 comprises four steps of decision making to meet women's values and preferences. Pregnant women who have had one previous caesarean and are eligible for VBAC, will be recruited at 14-16 weeks. Participants will complete a baseline survey prior to random allocation to either the control group (usual care) or intervention group (usual care plus an AI-decision aid). A follow up survey at 35-38 weeks will measure change in decisional conflict, knowledge, birth mode preference, and decision-aid acceptability. Actual birth outcomes and satisfaction will be assessed one month after birth.DiscussionThe innovative web-based decision-aid with support tools will help to promote pregnant women's decision-making engagement and communication with their providers and improve opportunities for supportive communication about VBAC SDM in Taiwan. Linking web-based AI data analysis into the medical record will also be assessed for feasibility during implementation in clinical practice.Trial registrationClinicalTrials.gov identifier (NCT05091944), Registered on October 24, 2021.
| S-EPMC9910264 | biostudies-literature
Project description:BACKGROUND:Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice. OBJECTIVE:This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management. METHODS:The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only). RESULTS:Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021. CONCLUSIONS:myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia. TRIAL REGISTRATION:Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15994.
| S-EPMC7382012 | biostudies-literature
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).
| S-EPMC4770694 | biostudies-literature