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.

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

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

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.

User-testing of a decision-support tool for parents facing threatened periviable delivery: The Periviable GOALS decision aid

2020 ◽  
Author(s):  
Brownsyne Tucker Edmonds ◽  
Shelley M Hoffman ◽  
Tatiana Laitano ◽  
Kimberly Coleman-Phox ◽  
Esperanza Castillo ◽  
...  
Keyword(s):  
Decision Support ◽  
Decision Aid ◽  
Decision Support Tool ◽  
User Testing ◽  
Support Tool

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.

Randomized trial of a hospice video decision aid for patients with advanced cancer and their caregivers.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11513-11513
Author(s):  
Areej El-Jawahri ◽  
Olivia Vanbenschoten ◽  
Alyssa L. Fenech ◽  
Amanda L. Jankowski ◽  
Netana Markovitz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Advanced Cancer ◽  
Decision Aid ◽  
Hospice Care ◽  
Decision Support Tool ◽  
Verbal Description ◽  
Post Intervention ◽  
Support Tool ◽  
Video Group ◽  
The Impact

11513 Background: Although hospice provides high-quality end-of-life (EOL) care for patients with advanced cancer and their family caregivers, the service remains underutilized in part due to lack of adequate information provided to patients and families about hospice care. Methods: We conducted a single-site randomized clinical trial of a hospice video decision aid versus a verbal description in 150 hospitalized patients with advanced cancer and their caregivers. Patients without an available caregiver were still eligible to participate. Intervention participants (75 patients; 18 caregivers) received a verbal description about hospice plus a six-minute video depicting hospice care. Control participants (75 patients; 26 caregivers) received only the verbal description. The primary endpoint was patient preference for hospice care immediately after the intervention, adjusting for baseline preferences. Secondary outcomes included patient and caregiver knowledge and perceptions of hospice (Hospice Perception and Knowledge Questionnaire). Results: Between 2/2017 and 1/2019, we enrolled 55.7% (150/269) of potentially eligible patients and 44 caregivers. Post-intervention, patients assigned to the video group were more likely to prefer hospice care at the EOL (86.7% vs. 82.7%, OR = 2.85, P = 0.08), but this was not statistically significant. Patients in the video group reported greater knowledge about hospice (B = 0.50, P = 0.024) and were less likely to endorse that hospice care is only about death (6.7% vs. 21.6%, OR = 0.28, P = 0.035). Post-intervention, caregivers assigned to the video were more likely to prefer hospice care for their loved ones (94.4% vs. 65.4%, P = 0.031), reported greater knowledge about hospice (B = 1.94, P < 0.001), and were less likely to endorse that hospice care is only about death (0.0% vs. 23.1%, P = 0.066). Conclusions: Patients with advanced cancer and their caregivers who viewed a hospice video decision support tool were more informed about hospice care and reported more favorable perceptions of hospice. Future work should examine the impact of the video on hospice utilization and length-of-stay among patients with advanced cancer. Clinical trial information: NCT03040102.

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.

scholarly journals Family Caregivers’ Decision-Support Needs Beyond the Decision Aid

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 67-67
Author(s):  
Katherine Britt ◽  
Karen Schlag
Keyword(s):  
Decision Support ◽  
Family Caregivers ◽  
Decision Aids ◽  
Decision Quality ◽  
Support Needs ◽  
Support Tool ◽  
Situational Contexts ◽  
Surrogate Decision ◽  
Eol Care ◽  
The Impact

Abstract Of the estimated 16 million U.S. family members currently providing essential yet unpaid caregiving for persons with dementia (PWD), many will also make end-of-life (EOL) care decisions as surrogates, a process that can be fraught with uncertainty. Even with dementia death rates rising, many families delay advanced care planning (ACP) discussions, and surrogate decision makers often lack crucial information and support, implicating the need to further study this topic in aging. While decision aids (DA) serve as a support tool for caregivers, they can be less effective when failing to address unresolved decisional needs. Utilizing the Ottawa Decision Support Framework (ODSF), which asserts caregiver decision needs affect decision quality, this study sought to identify surrogate decision-support needs extending beyond general ACP. This mixed study used cognitive interviews and focus groups with family caregivers (N=13) and healthcare professionals (n=14) to assess their knowledge and understanding of hospice and artificial hydration and nutrition. Data were audio-recorded, transcribed verbatim, and analyzed with thematic content analysis. Three main themes were identified: DAs alone aren’t enough to foster quality decision making for surrogates; individualized communication is necessary to clarify PWD and caregiver value priorities and disease trajectories; and clarification of the impact of care choices within situational contexts is quintessential. Further development is needed to create a practice protocol from these themes to inform professionals assisting surrogates in ACP at EOL. Practical implications from this study include highlighting the importance of individualized communication between PWD, providers, and caregivers in addressing EOL care decisional needs.

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