Study protocols for the development and randomized controlled pilot trial of a patient decision aid to facilitate women's choice between oral and LAI ART for HIV (Preprint)

2021 ◽  
Author(s):  
Morgan M. Philbin ◽  
Tara McCrimmon ◽  
Victoria Shaffer ◽  
Deanna Kerrigan ◽  
Margaret Pereyra ◽  
...  
Keyword(s):  
Decision Making ◽  
Mixed Methods ◽  
Decision Aid ◽  
Phase 1 ◽  
Shared Decision ◽  
Patient Decision Aid ◽  
Phase 3 ◽  
Web Based ◽  
Randomized Controlled ◽  
Patient Decision

BACKGROUND Many women with HIV (WWH) have suboptimal adherence to oral antiretroviral therapy (ART) due to multilevel barriers to HIV care access and retention. A long-acting injectable (LAI) version of ART was approved by the Food and Drug Administration in January 2021 and has the potential to overcome many of these barriers by eliminating the need for daily pill-taking. However, it may not be optimal for all WWH. It is critical to develop tools that facilitate patient-provider shared decision making about oral versus LAI ART modalities to promote women’s adherence and long-term HIV outcomes. OBJECTIVE This study will develop and pilot test a web-based patient decision aid, called i.ART+support (iARTs). This decision aid aims to support shared decision-making between WWH and their providers, and help women choose between oral and LAI HIV treatment. METHODS The study will occur in three phases. In Phase 1, we will utilize a mixed-methods approach to collect data from WWH and medical and social service providers to inform i.ARTs content. During Phase 2, we will conduct focus groups with WWH and providers to refine i.ARTs content and develop the web-based decision aid. In Phase 3, i.ARTs will be tested in a randomized controlled trial (RCT) with n=180 women in Miami, FL and assessed for feasibility, usability and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART refills, and clinic attendance. RESULTS Phase 1 participant recruitment began in September 2021. CONCLUSIONS This study is the first to develop a web-based patient decision aid to support WWH choices between oral and LAI ART. Its strengths include the incorporation of both patient and provider perspectives, a mixed-methods design, and implementation in a real-world clinical setting. CLINICALTRIAL We will apply for Clinicaltrials.gov registration prior to Phase 3 when we enroll our first participant in the RCT. This is anticipated to occur in April 2023.

scholarly journals Decision Making when Cancer Becomes Chronic: A Decisional Needs Assessment of Medullary Thyroid Cancer Patients’, Families’, and Providers’ Needs for a Web-based Patient Decision Aid (Preprint)

2021 ◽  
Author(s):  
Danielle Shojaie ◽  
Aubri S Hoffman ◽  
Ruth Amaku ◽  
Maria E Cabanillas ◽  
Julie Ann Sosa ◽  
...  
Keyword(s):  
Decision Making ◽  
Decision Support ◽  
Needs Assessment ◽  
Shared Decision Making ◽  
Decision Aid ◽  
Chronic Phase ◽  
Shared Decision ◽  
Patient Decision Aid ◽  
Web Based ◽  
Patient Decision

BACKGROUND In cancers with a chronic phase, patients and family caregivers may 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 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 expressed a need for web-based interventions that can be delivered between consultations to provide education and prepare patients and families for discussing these decisions. To ensure these tools are effective, usable, and understandable, studies are needed to identify patients’, families’, and providers’ primary decision-making needs and optimal design strategies for a web-based patient decision aid. OBJECTIVE Following international guidelines for development of a web-based patient decision aid, the objectives of this study were to: 1) engage potential users to guide development; 2) review the existing literature and available tools; 3) assess users’ decision-making experiences, needs, and design recommendations; and 4) identify shared decision-making approaches to address each need. METHODS This study used the Decisional Needs Assessment approach, including 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 the current decision-making pathways, unmet decision-making needs, and decision support strategies to meet each need. RESULTS Stakeholders reported wide heterogeneity in decision timing and pathways. Relevant existing materials included two systematic reviews, 9 additional papers, and multiple educational websites, but nothing that met the criteria of a patient decision aid. Patients and family members emphasized needing plain language (46 of 54, 85%), shared decision making (45 of 54, 83%), and help with family discussions (39 of 54, 72%). Additional needs included information about uncertainty, lived experience, and costs. Providers (n = 10) reported needing interventions that address misinformation (9 of 10, 90%), foster realistic expectations (9 of 10, 90%), and address mistrust in clinical trials (5 of 10, 50%). Additional needs included provider tools to support shared decision making. Both groups recommended designing a web-based patient decision aid that can be tailored (64 of 64, 100%) and delivered on a hospital website (53 of 64, 83%), and that focuses on quality of life (45 of 64, 70%) and provides step-by-step guidance (43 of 64, 67%). The study team identified best practices to meet each need, which are presented in the proposed Decision Support Design Guide. CONCLUSIONS Patients, families, and providers report multifaceted decision support needs during the chronic phase of cancer. Web-based patient decision aids are needed that provide tailored support over time, and explicitly address uncertainty, quality of life, realistic expectations, and effects on families.

scholarly journals Patient decision aid based on multi-criteria decision analysis for disease-modifying drugs for multiple sclerosis: prototype development

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
I. E. H. Kremer ◽  
P. J. Jongen ◽  
S. M. A. A. Evers ◽  
E. L. J. Hoogervorst ◽  
W. I. M. Verhagen ◽  
...  
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Decision Aid ◽  
Healthcare Professionals ◽  
Treatment Options ◽  
Shared Decision ◽  
Patient Decision Aid ◽  
Disease Modifying Drugs ◽  
Patient Decision ◽  
Further Development

Abstract Background Since decision making about treatment with disease-modifying drugs (DMDs) for multiple sclerosis (MS) is preference sensitive, shared decision making between patient and healthcare professional should take place. Patient decision aids could support this shared decision making process by providing information about the disease and the treatment options, to elicit the patient’s preference and to support patients and healthcare professionals in discussing these preferences and matching them with a treatment. Therefore, a prototype of a patient decision aid for MS patients in the Netherlands—based on the principles of multi-criteria decision analysis (MCDA) —was developed, following the recommendations of the International Patient Decision Aid Standards. MCDA was chosen as it might reduce cognitive burden of considering treatment options and matching patient preferences with the treatment options. Results After determining the scope to include DMDs labelled for relapsing-remitting MS and clinically isolated syndrome, users’ informational needs were assessed using focus groups (N = 19 patients) and best-worst scaling surveys with patients (N = 185), neurologists and nurses (N = 60) to determine which information about DMDs should be included in the patient decision aid. Next, an online format and computer-based delivery of the patient decision aid was chosen to enable embedding of MCDA. A literature review was conducting to collect evidence on the effectiveness and burden of use of the DMDs. A prototype was developed next, and alpha testing to evaluate its comprehensibility and usability with in total thirteen patients and four healthcare professionals identified several issues regarding content and framing, methods for weighting importance of criteria in the MCDA structure, and the presentation of the conclusions of the patient decision aid ranking the treatment options according to the patient’s preferences. Adaptations were made accordingly, but verification of the rankings provided, validation of the patient decision aid, evaluation of the feasibility of implementation and assessing its value for supporting shared decision making should be addressed in further development of the patient decision aid. Conclusion This paper aimed to provide more transparency regarding the developmental process of an MCDA-based patient decision aid for treatment decisions for MS and the challenges faced during this process. Issues identified in the prototype were resolved as much as possible, though some issues remain. Further development is needed to overcome these issues before beta pilot testing with patients and healthcare professionals at the point of clinical decision-making can take place to ultimately enable making conclusions about the value of the MCDA-based patient decision aid for MS patients, healthcare professionals and the quality of care.

scholarly journals Construction of a patient decision aid for the treatment of uncomplicated urinary tract infection in primary care

2020 ◽  
Author(s):  
Yves-Marie VINCENT ◽  
Adèle FRACHON ◽  
Clotilde BUFFETEAU ◽  
Guillaume CONORT
Keyword(s):  
Primary Care ◽  
Decision Making ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Decision Aid ◽  
Uncomplicated Urinary Tract Infection ◽  
Shared Decision ◽  
Patient Decision Aid ◽  
Patient Decision

Abstract Background: Uncomplicated urinary tract infection (uUTI) is a frequent disorder in general practice. The risk of developing pyelonephritis remains low after uUTI, nonetheless, empiric antibiotic therapy is frequently prescribed for symptomatic purposes. This can lead to adverse effects and antibiotic resistance. Furthermore, patients sometimes wish to avoid taking antibiotics. Some European countries recommend discussing a delayed prescription with the patient and developing a shared decision. The aim of our study is to develop a patient decision aid (PtDA) that can be used in primary care to make a shared decision about whether to treat uUTI with antibiotics or not.Methods: We followed the steps recommended by the International Patient Decision Aids Standards, with a scoping phase, a design phase (including focus groups and literature review),and an alpha-testing phase. A steering group, made up of patients and physicians, met throughout the study to develop a draft and then a final version of a prototype PtDA.Results: The information included in the PtDA is the definition of uUTI, information on the options, their benefits, risks, and consequences, based on a review of the literature. The results of the focus group made it possible to determine the patient's values and preferences to be considered in decision-making, namely: the discomfort felt, the impact on daily life, the representations of antibiotics, and the position relative to the risk of adverse effect. The choices of presentation, organisation and design are the result of the work of the steering group, improved by feedback from alpha testing.Conclusions: Our results confirm a need for shared decision-making and the equipoise in this situation. More advice from outside physicians is still lacking. This PtDA needs to be validated in a beta-testing phase, and then tested in a clinical study comparing its use with the systematic prescription approach.

scholarly journals Construction of a patient decision aid for the treatment of uncomplicated urinary tract infection in primary care

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yves-Marie Vincent ◽  
Adèle Frachon ◽  
Clotilde Buffeteau ◽  
Guillaume Conort
Keyword(s):  
Primary Care ◽  
Decision Making ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Decision Aid ◽  
Uncomplicated Urinary Tract Infection ◽  
Shared Decision ◽  
Patient Decision Aid ◽  
Patient Decision

Abstract Background Uncomplicated urinary tract infection (uUTI) is very common among women in primary care. The risk of developing pyelonephritis remains low after uUTI, nonetheless, empiric antibiotic therapy is frequently prescribed for symptomatic purposes. This may lead to adverse effects and antibiotic resistance. Furthermore, patients may express the will to limit the use of antibiotics. Some European countries recommend discussing a delayed prescription with the patient and developing a shared decision. The aim of this study is to create a patient decision aid (PtDA) used in primary care settings to make a shared decision between practitioners and women about whether or not to treat uUTI with antibiotics. Methods We followed the steps recommended by the International Patient Decision Aids Standards, with a scoping phase, a design phase (including focus groups and literature review), and an alpha-testing phase. A steering group, made of patients and physicians, met throughout the study to develop a prototype PtDA. Results The information included in the PtDA is the definition of uUTI, information on the options, their benefits, risks, and consequences, based on a review of the literature. The results of the focus group made possible to determine the patient’s values and preferences to consider in decision-making, including: the discomfort felt, the impact on daily life, patients’ perceptions of antibiotics, and the position relative to the risk of adverse effect. The choices in presentation, organisation and design are the result of the work of the steering group, improved by feedback from alpha testing. We confirmed the need for shared decision-making and the equipoise in this situation. Conclusions We developed a PtDA to be used in primary care for sharing decision on the use of antibiotic in uUTI. It needs to be validated in a beta-testing phase, with complementary advice from peers, and then tested in a clinical study comparing its use with the systematic prescription approach.

scholarly journals Protecting Fertility During Cancer Treatment: Assessing Patients’ and Providers’ Decision-making Needs and Preferences for a Web-based Patient Decision Aid (Preprint)

2020 ◽  
Author(s):  
Aubri Hoffman ◽  
Laura Crocker ◽  
Aakrati Mathur ◽  
Deborah Holman ◽  
June Weston ◽  
...  
Keyword(s):  
Decision Making ◽  
Focus Group ◽  
Fertility Preservation ◽  
Young Women ◽  
Decision Aid ◽  
Ad Hoc ◽  
Unmet Needs ◽  
Patient Decision Aid ◽  
Web Based ◽  
Patient Decision

BACKGROUND As cancer treatments continue to improve, it is increasingly important that reproductive-aged young women have an opportunity to decide whether they want to undergo fertility preservation treatments to try to protect their ability to have a child after cancer. Clinical practice guidelines recommend that providers offer fertility counseling to all young women with cancer, but as few as 12% of women recall discussing fertility preservation. Patients report limited awareness, opportunity, and time to make this complex personal decision. The long-term goal of this program of research is to develop an interactive webbased patient decision aid to improve awareness, access, knowledge, and decision making for all young women with cancer. The International Patient Decision Aid Standards collaboration recommends a formal decisional needs assessment to inform and guide the design of understandable, meaningful, and usable patient decision aid interventions. OBJECTIVE This study assessed providers’ and survivors’ fertility preservation decision-making experiences, unmet needs, and design preferences to inform the development of a web-based patient decision aid. METHODS Semi-structured interviews and an ad hoc focus group assessed current decision-making experiences, unmet needs, and recommendations for a patient decision aid. Two researchers coded and analyzed transcripts using NVIVO. A stakeholder advisory panel guided the study and interpretation of results. RESULTS A total of 51 participants participated in 46 interviews (n=18 providers and 28 survivors) and 1 ad hoc focus group (n=7 survivors). Primary themes included (1) the importance of fertility decisions for survivorship, (2) significant but potentially modifiable barriers to optimal decision making exist, and (3) there is strong support for developing a patient decision aid website. Providers reported needing an intervention that could quickly raise awareness and facilitate timely referrals. Survivors reported needing understandable information and help with managing uncertainty, costs, and pressures. Design recommendations included: providing tailored information (eg, by age and cancer type), optional interactive features, and multimedia delivery at multiple time points, preferably outside the consultation. CONCLUSIONS Decision making about fertility preservation is an important step in providing high-quality comprehensive cancer care, and a priority for many survivors’ optimal quality of life. Decision support interventions are needed to address gaps in care and help women quickly navigate towards an informed, values-congruent decision. Survivors and providers support developing a patient decision aid website to make information directly available to women outside of the consultation and to provide self-tailored content according to women’s clinical characteristics and their information-seeking and deliberative styles. CLINICALTRIAL Not applicable

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