scholarly journals Development of a decision support intervention for family members of adults who lack capacity to consent to trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Victoria Shepherd ◽  
Fiona Wood ◽  
Richard Griffith ◽  
Mark Sheehan ◽  
Kerenza Hood
Keyword(s):  
Clinical Trial ◽  
Decision Support ◽  
Informed Consent ◽  
Decision Aid ◽  
Decision Aids ◽  
Family Members ◽  
Complex Interventions ◽  
Information Provision ◽  
Theoretical Frameworks ◽  
Capacity To Consent

Abstract Background Informed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient’s ‘presumed will’, but these decisions can be challenging and families may experience an emotional and decisional burden. Decisions made on behalf of others are conceptually different from those made for ourselves. Innovations have been developed to improve informed consent processes for research, including a number of decision aids, however there are no interventions for proxies who are faced with more complex decisions. This article outlines the development of a novel decision aid to support families making decisions about research participation on behalf of an adult who lacks capacity to consent. Methods Decision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed with the involvement of lay advisors and relevant stakeholders. Results Previous research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy’s role and utilises a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid to ensure that it would be acceptable for use. Conclusions Frameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users. Feasibility testing and outcome measure development is required prior to any evaluation of its effectiveness.

scholarly journals Development of a decision support intervention for family members of adults who lack capacity to consent to trials

2019 ◽  
Author(s):  
Victoria Shepherd ◽  
Fiona Wood ◽  
Richard Griffith ◽  
Mark Sheehan ◽  
Kerenza Hood
Keyword(s):  
Clinical Trial ◽  
Decision Support ◽  
Informed Consent ◽  
Decision Aid ◽  
Decision Aids ◽  
Family Members ◽  
Complex Interventions ◽  
Information Provision ◽  
Theoretical Frameworks ◽  
Capacity To Consent

Abstract Background Informed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient’s ‘presumed will’, but they can experience an emotional and decisional burden as a result. Decisions made on behalf of others are conceptually different from those we make for ourselves. Despite innovations to improve informed consent processes for research, including the development of decision aids, there are no interventions for proxies who arguably are faced with more complex decisions. This article outlines the development of a novel decision aid aimed at supporting families making decisions about research participation on behalf of an adult who lacks capacity to consent. Methods Decision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using the MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who had acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed in conjunction with lay advisors and relevant stakeholders. Results Previous research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy’s role and uses a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid and helped to ensure that it would be acceptable for use. Conclusions Frameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users but requires feasibility testing and outcome measure development prior to any evaluation of its effectiveness.

scholarly journals Development of a decision support intervention for family members of adults who lack capacity to consent to trials

2020 ◽  
Author(s):  
Victoria Shepherd ◽  
Fiona Wood ◽  
Richard Griffith ◽  
Mark Sheehan ◽  
Kerenza Hood
Keyword(s):  
Clinical Trial ◽  
Decision Support ◽  
Informed Consent ◽  
Decision Aid ◽  
Decision Aids ◽  
Family Members ◽  
Complex Interventions ◽  
Information Provision ◽  
Theoretical Frameworks ◽  
Capacity To Consent

Abstract Background Informed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient’s ‘presumed will’, but they can experience an emotional and decisional burden as a result. Decisions made on behalf of others are conceptually different from those we make for ourselves. Despite innovations to improve informed consent processes for research, including the development of decision aid, there are no interventions for proxies who arguably are faced with more complex decisions. This article outlines the development of a novel decision aid aimed at supporting families making decisions about research participation on behalf of an adult who lacks capacity to consent. Methods Decision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using the MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who had acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed in conjunction with lay advisors and relevant stakeholders. Results Previous research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy’s role and uses a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid and helped to ensure that it would be acceptable for use.Conclusions Frameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users but requires feasibility testing and outcome measure development prior to any evaluation of its effectiveness.

scholarly journals Development of a decision support intervention for family members of adults who lack capacity to consent to trials

2021 ◽  
Author(s):  
Victoria Shepherd ◽  
Fiona Wood ◽  
Richard Griffith ◽  
Mark Sheehan ◽  
Kerenza Hood
Keyword(s):  
Clinical Trial ◽  
Decision Support ◽  
Decision Aid ◽  
Decision Aids ◽  
Family Members ◽  
Complex Interventions ◽  
Information Provision ◽  
Theoretical Frameworks ◽  
Support Tool ◽  
Capacity To Consent

Abstract BackgroundInformed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient’s ‘presumed will’, but these decisions can be challenging and families may experience an emotional and decisional burden. Decisions made on behalf of others are conceptually different from those made for ourselves. Innovations have been developed to improve informed consent processes for research, including a number of decision aids, however there are no interventions for proxies who are faced with more complex decisions. This article outlines the development of a novel decision aid to support families making decisions about research participation on behalf of an adult who lacks capacity to consent. MethodsDecision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed with the involvement of lay advisors and relevant stakeholders. ResultsPrevious research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy’s role and utilises a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid to ensure that it would be acceptable for use.ConclusionsFrameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users. Feasibility testing and outcome measure development is required prior to any evaluation of its effectiveness.

Development and pilot testing of a decision support intervention for men with prostate cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 132-132
Author(s):  
June M. Chan ◽  
Matthew R. Cooperberg ◽  
John Neuhaus ◽  
Mark Bridge ◽  
Lauren Stupar ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Decision Support ◽  
Decision Aid ◽  
Decision Quality ◽  
Support Intervention ◽  
Decision Support Intervention ◽  
Before And After ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer

132 Background: We evaluated the feasibility and efficacy of a decision support intervention designed to help men with low-risk prostate cancer consider active surveillance and standard treatments. The intervention incorporated a decision aid with coaching and question-listing. Our decision aid is the first to include data on long-term survival and side effects from men with prostate cancer undergoing active surveillance, surgery, and radiation. Methods: To develop the intervention, we conducted focus groups using the Nominal Group Technique. We used a survey instrument from the International Patient Decision Aids Standards to measure the stakeholder endorsement of our intervention. To test the intervention, we administered it to newly diagnosed men with low-risk prostate cancer (Gleason sum < = 3+4, stage < = T2N0M0, PSA < = 10 ng/ml) seen at UCSF. Before and after the intervention, we administered a survey with questions from the Decision Quality Instrument for Prostate Cancer. Our primary outcome was change in knowledge as assessed by two multiple-choice items: How many men diagnosed with early stage prostate cancer will eventually die of prostate cancer? How much would waiting 3 months to make a treatment decision affect chances of survival? Correct answers were: “Most will die of something else” and “A little or not at all.” Results: The development phase involved 6 patients, 1 family member, 2 physicians, and 5 other health care providers and four iterations of the intervention until consensus endorsement was reached. In the pilot test, 57 men consented, and 44 received the decision support intervention and completed surveys at both timepoints. Before the intervention, 30/44 (68%) got both questions right, compared to 36/44 (82%) after the intervention. 82% maintained or achieved perfect scores; 16% answered 1 or more incorrectly both before and after the intervention; and 2% answered both items correctly before, but 1 wrong after. Conclusions: This novel decision support intervention was feasible, and appeared to improve knowledge and informed decision-making. Data will guide the development of a larger scale randomized clinical trial to improve decision quality in men with prostate cancer, in the community. Clinical trial information: NCT02451345.

scholarly journals Making their decisions for prostate cancer treatment: Patients’ experiences and preferences related to process

2018 ◽  
Vol 12 (10) ◽  
Author(s):  
Deb Feldman-Stewart ◽  
Christine Tong ◽  
Michael Brundage ◽  
Jackie Bender ◽  
John Robinson
Keyword(s):  
Prostate Cancer ◽  
Decision Support ◽  
Cancer Patients ◽  
Decision Aid ◽  
Decision Aids ◽  
Treatment Decisions ◽  
Prostate Cancer Treatment ◽  
Total N ◽  
Canadian Provinces ◽  
Recruiting Strategy

Introduction: We sought to determine the experiences and preferences of prostate cancer patients related to the process of making their treatment decisions, and to the use of decision support.Methods: Population surveys were conducted in four Canadian provinces in 2014–2015. Each provincial cancer registry mailed surveys to a random sample of their prostate cancer patients diagnosed in late 2012. Three registries’ response rates were 46–55%; the fourth used a different recruiting strategy, producing a response rate of 13% (total n=1366).Results: Overall, 90% (n=1113) of respondents reported that they were involved in their treatment decisions. Twenty-three percent (n=247) of respondents wanted more help with the decision than they received and 52% of them (n=128) reported feeling wellinformed. Only 51% (n=653) of all respondents reported receiving any decision support, but an additional 34% (n=437) would want to if they were aware of its existence. A quarter (25%, n=316) of respondents found it helpful to use a decision aid, a type of decision support that provides assistance to decision processes and provides information, but 64% (n=828) reported never having heard of decision aids; 26% (n=176) of those who had never heard of decision aids wanted more help with the decision than they received compared to 13% (n=36) of those who had used a decision aid.Conclusions: The majority of respondents wanted to participate in their treatment decisions, but a portion wanted more help than they received. Half of those who wanted more help felt well-informed, thus, needed support beyond information. Decision aids have potential to provide information and support to the decision process.

Decision Support to Masters, Mates on Watch, and Pilots: The Piloting Expert System

1990 ◽  
Vol 43 (03) ◽  
pp. 364-384 ◽  
Author(s):  
Martha Grabowski
Keyword(s):  
Decision Making ◽  
New York ◽  
Decision Support ◽  
Expert System ◽  
Decision Aid ◽  
Decision Aids ◽  
Gulf Of Alaska ◽  
Lessons Learned ◽  
Simple Task ◽  
Cognitive Decision

Piloting large vessels in increasingly congested waterways is no simple task. As in many ‘decision-making under uncertainty’ scenarios, masters, mates and pilots engaged in piloting are inundated with much information and required to make crucial decisions in real time. Piloting is also an inherently judgmental activity. Pilots and ships' captains invariably develop heuristics for transiting particular waterways. As vessels become larger, cargoes more hazardous, and the waterways more congested, decision aid technology is being considered to improve piloting decision-making. This paper describes one approach to providing improved on-board decision support to masters, mates on watch, and pilots navigating in restricted waters. We discuss (1) the use of cognitive decision aids in piloting, (2) the design of such a decision aid developed for New York harbour, (3) simulator experiments evaluating the expert system, and (4) plans to apply the approach and ‘lessons learned’ to the development of an expert system for tankers transiting the Gulf of Alaska.

scholarly journals Go to the Hospital or Stay Here?: A Randomized Clinical Trial

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 760-760
Author(s):  
Sarah Worch ◽  
Ruth Tappen
Keyword(s):  
Clinical Trial ◽  
Decision Aid ◽  
Long Term Care ◽  
Decision Aids ◽  
Decisional Conflict ◽  
Term Care ◽  
Patient Decision Aids ◽  
Patient Decision ◽  
Initial Clinical Trial

Abstract With the exception of guides for making end of life choices, there are very few if any patient decision aids created for residents of long-term care facilities. Further, only half of patient decision aids produced for any purpose have actually been field tested with patients and even fewer have been evaluated by providers other than the developers of the decision aid. Development of Go to the Hospital or Stay Here? was based on expert experience combined with extensive input from over 270 long-term care residents, their families and their caregivers. The initial clinical trial of this decision aid is reported in this presentation. Increased knowledge, reduced decisional conflict, increased preference for care in the nursing home when possible and a high rating of the helpfulness of the Guide were found in those who received the Guide (n=97) compared to those who did not (n=95).

The Effects of Pedigree and Source Type on Trust in a Dual Adviser Context

2017 ◽  
Vol 61 (1) ◽  
pp. 319-323 ◽  
Author(s):  
Carl J. Pearson ◽  
Christopher B. Mayhorn
Keyword(s):  
Decision Making ◽  
Decision Support ◽  
Decision Aid ◽  
Decision Aids ◽  
Decision Makers ◽  
Influential Factor ◽  
Trust Development ◽  
Conflicting Information ◽  
Source Type ◽  
Human Decision

In a world with increasing ubiquity of automated decision aids, human decision makers often find themselves receiving input from automation and another human simultaneously. Previous research has shown how certain characteristics of a human or automated decision aid affect the development of trust. Little research has investigated how these factors of trust development are involved when more than one adviser is present. This study explored how pedigree (perceived expertise) and source type (human or automated) was related to trust and reliance in a decision-making task with conflicting information from two advisers. Results from this study indicate the pedigree is an influential factor across both human and automated decision aids. This study also found a relationship between trust attitudes and behavioral reliance. These findings are relevant for designing decision support systems that involve multiple advisers or for informing the effects of introducing decision aids in a manner with respect to decision aid pedigree.

scholarly journals A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development (Preprint)

2018 ◽  
Author(s):  
Robert D Furberg ◽  
Alexa M Ortiz ◽  
Rebecca R Moultrie ◽  
Melissa Raspa ◽  
Anne C Wheeler ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Support ◽  
Informed Consent ◽  
Fragile X Syndrome ◽  
Fragile X ◽  
Decision Support Tool ◽  
Consent Process ◽  
Decisional Capacity ◽  
Design And Development ◽  
Support Tool

BACKGROUND Challenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial. OBJECTIVE We describe the design and development process of a tablet-based decision support tool. METHODS Our development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles. RESULTS We used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice. CONCLUSIONS The informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources. CLINICALTRIAL ClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW)

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