scholarly journals A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Robert D Furberg ◽  
Melissa Raspa ◽  
Anne C Wheeler ◽  
Lauren A McCormack ◽  
Donald B Bailey
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Decision Aid ◽  
Digital Health ◽  
Controlled Trial ◽  
The United States ◽  
Informed Decision ◽  
Consent Process ◽  
Decisional Capacity ◽  
Randomized Controlled

BACKGROUND Any study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants’ decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial. OBJECTIVE The objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection. METHODS A two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States. RESULTS Data analysis will be completed by late 2018. CONCLUSIONS By developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process. CLINICALTRIAL ClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/10360

A randomized controlled trial of a self-administered, online decision-aid (“Navya Patient Preference Tool”) to reduce decisional conflict in women with early breast cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7033-7033
Author(s):  
Shalaka P Joshi ◽  
Lakshmi Ramarajan ◽  
Ojas Deshpande ◽  
Elizabeth Fernandes ◽  
Vaibhav Vanmali ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Randomized Controlled Trial ◽  
Decision Aid ◽  
Controlled Trial ◽  
Decisional Conflict ◽  
Shared Decision ◽  
Breast Cancer Patients ◽  
Medical Encounter ◽  
Randomized Controlled

7033 Background: Shared decision making to confront choices with clinical equipoise, has been the privilege of those patients with access to time intensive consults with oncologists. We conducted a randomized controlled trial for breast cancer patients to use an online, self-administered, out-of-the-medical-encounter decision aid (DA) to choose between breast conserving surgery (BCS) and mastectomy. Methods: Navya Patient Preference Tool (Navya PPT) is a multilingual DA based on adaptive conjoint analysis of tradeoffs between cost, adverse effects of radiation, and breast conservation. Prior analysis established high internal reliability and external validity of the Navya PPT. Eligible cT1/2, cN0 breast cancer patients planned for surgery were block randomized, in 1:1:1 ratio, to receive the research questionnaire (RQ) to measure decisional conflict on choice of surgery (control, arm 1), Navya PPT followed by RQ (experimental, arm 2) or Navya PPT followed by RQ administered with key male family member (experimental, arm 3). Groups were stratified with respect to age, socio-economic status (SES) and educational level. The study was powered to detect a decrease in Decisional Conflict Index (DCI) by 0.25 (β-0.8, two sided α- 0.01). Results: Between June 2017 and December 2019, 247/255 patients were randomized to arm 1 (83), arm 2 (84), and arm 3 (80). Median age was 48 years (IQR 23-76), and median pT size was .5 cm (0.5-6 cm). 59% of patients were middle or lower SES and 46.2% had ≤ 12th grade education. DCI was significantly reduced in arm 2 as compared with arm 1 (1.34 vs. 1.65, Cohen’s d 0.49 (± 0.31) p<0.05) as well as in arm 3 as compared with arm 1 (1.30 vs. 1.65, Cohen’s d 0.54 (± 0.31) p<0.05). 80% (± 6%) of patients underwent surgery of choice as determined by Navya PPT. BCS rate was similar in all three arms (85.2, 88.9 and 86.5% respectively (p=0.779). Conclusions: Online, self-administered, adaptive DAs used out of the medical encounter can reduce decisional conflict and increase access to shared decision making for every patient; especially in practices with low doctor to patient ratios. Clinical trial information: IEC/0116/1619/001 .

scholarly journals A Digital Health App to Assess Decisional Capacity to Provide Informed Consent: Protocol for a Randomized Controlled Trial

10.2196/10360 ◽  
2018 ◽  
Vol 7 (11) ◽  
pp. e10360 ◽  
Author(s):  
Robert D Furberg ◽  
Melissa Raspa ◽  
Anne C Wheeler ◽  
Lauren A McCormack ◽  
Donald B Bailey
Keyword(s):  
Randomized Controlled Trial ◽  
Informed Consent ◽  
Digital Health ◽  
Controlled Trial ◽  
Decisional Capacity ◽  
Randomized Controlled

scholarly journals Integrating shared decision-making into primary care: lessons learned from a multi-centre feasibility randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Catherine H. Yu ◽  
Farid Medleg ◽  
Dorothy Choi ◽  
Catherine M. Spagnuolo ◽  
Lakmini Pinnaduwage ◽  
...  
Keyword(s):  
Primary Care ◽  
Decision Making ◽  
Randomized Controlled Trial ◽  
Shared Decision Making ◽  
Decision Aid ◽  
Controlled Trial ◽  
Clinical Care ◽  
Shared Decision ◽  
Primary Care Clinics ◽  
Randomized Controlled

Abstract Background MyDiabetesPlan is a web-based, interactive patient decision aid that facilitates patient-centred, diabetes-specific, goal-setting and shared decision-making (SDM) with interprofessional health care teams. Objective Assess the feasibility of (1) conducting a cluster randomized controlled trial (RCT) and (2) integrating MyDiabetesPlan into interprofessional primary care clinics. Methods We conducted a cluster RCT in 10 interprofessional primary care clinics with patients living with diabetes and at least two other comorbidities; half of the clinics were assigned to MyDiabetesPlan and half were assigned to usual care. To assess recruitment, retention, and resource use, we used RCT conduct logs and financial account summaries. To assess intervention fidelity, we used RCT conduct logs and website usage logs. To identify barriers and facilitators to integration of MyDiabetesPlan into clinical care across the IP team, we used audiotapes of clinical encounters in the intervention groups. Results One thousand five hundred and ninety-seven potentially eligible patients were identified through searches of electronic medical records, of which 1113 patients met the eligibility criteria upon detailed chart review. A total of 425 patients were randomly selected; of these, 213 were able to participate and were allocated (intervention: n = 102; control: n = 111), for a recruitment rate of 50.1%. One hundred and fifty-one patients completed the study, for a retention rate of 70.9%. A total of 5745 personnel-hours and $6104 CAD were attributed to recruitment and retention activities. A total of 179 appointments occurred (out of 204 expected appointments—two per participant over the 12-month study period; 87.7%). Forty (36%), 25 (23%), and 32 (29%) patients completed MyDiabetesPlan at least twice, once, and zero times, respectively. Mean time for completion of MyDiabetesPlan by the clinician and the patient during initial appointments was 37 min. From the clinical encounter transcripts, we identified diverse strategies used by clinicians and patients to integrate MyDiabetesPlan into the appointment, characterized by rapport building and individualization. Barriers to use included clinician-related, patient-related, and technical factors. Conclusion An interprofessional approach to SDM using a decision aid was feasible. Lower than expected numbers of diabetes-specific appointments and use of MyDiabetesPlan were observed. Addressing facilitators and barriers identified in this study will promote more seamless integration into clinical care. Trial registration Clinicaltrials.gov Identifier: NCT02379078. Date of Registration: February 11, 2015. Protocol version: Version 1; February 26, 2015.

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