Piloting a parent and patient decision aid to support clinical trial decision making in childhood cancer

2019 ◽  
Vol 28 (7) ◽  
pp. 1520-1529 ◽  
Author(s):  
Eden G. Robertson ◽  
Claire E. Wakefield ◽  
Richard J. Cohn ◽  
Robert A. Battisti ◽  
Mark W. Donoghoe ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Childhood Cancer ◽  
Decision Aid ◽  
Patient Decision Aid ◽  
Patient Decision

scholarly journals Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease: Randomized Controlled Trial

10.2196/14462 ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. e14462
Author(s):  
Lakshmanan Krishnamurti ◽  
Diana Ross ◽  
Cynthia Sinha ◽  
Traci Leong ◽  
Namita Bakshi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Sickle Cell Disease ◽  
Randomized Clinical Trial ◽  
Sickle Cell ◽  
Decision Aid ◽  
Care Providers ◽  
Patient Decision Aid ◽  
Cell Disease ◽  
Patient Decision

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

scholarly journals Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Lakshmanan Krishnamurti ◽  
Diana Ross ◽  
Cynthia Sinha ◽  
Traci Leong ◽  
Namita Bakshi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Sickle Cell Disease ◽  
Randomized Clinical Trial ◽  
Sickle Cell ◽  
Decision Aid ◽  
Care Providers ◽  
Patient Decision Aid ◽  
Cell Disease ◽  
Patient Decision

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 (<italic>P</italic>=.05) and a reduction in the informed sub-score of decisional conflict (<italic>P</italic>=.003) at 3 months, with an improvement in preparation for decision making (<italic>P</italic>&lt;.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. CLINICALTRIAL ClinicalTrials.gov NCT03224429; https://clinicaltrials.gov/ct2/show/NCT03224429 and ClinicalTrials.gov NCT02326597; https://clinicaltrials.gov/ct2/show/NCT02326597

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.

Using a patient decision aid about insulin treatment in type 2 diabetes clinics

2021 ◽  
Vol 16 (1) ◽  
pp. 76-108
Author(s):  
Ayeshah Syed
Keyword(s):  
Type 2 Diabetes ◽  
Decision Making ◽  
Decision Aid ◽  
Insulin Treatment ◽  
Treatment Phase ◽  
Activity Analysis ◽  
Patient Decision Aid ◽  
Healthcare Settings ◽  
Patient Decision

The Candlin Researcher AwardThe low uptake of insulin leaves many Malaysians with type 2 diabetes at risk of developing complications. To improve decision making about insulin treatment, a patient decision aid (PDA) was developed for use with patients. However, although it is generally accepted that PDAs can support informed and shared decision making, there is limited discursive data showing how they are used in doctor–patient consultations. This paper reports on activity analysis of clinic consultations in which a PDA about insulin treatment was used. Eleven consultations with diverse participants conducted in three healthcare settings in Malaysia were systematically mapped to identify structural, interactional and thematic patterns. Two main phases of Assessment and Treatment were identified, with doctors generally participating more than patients. Mapping of the Treatment phase showed that structural patterns depended on two main factors: whether patients had read the PDA and whether they responded negatively or positively towards insulin. While mapping is only a preliminary stage of activity analysis, the findings offer insights into structural, interactional and thematic patterns in PDA use at the level of the whole consultation. They also point towards key areas for closer analysis of discursive practices.

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