An interventional study of Arm A: Online, patient-facing decision-making aid (app) with personalized risk information. and Arm B - Online, patient-facing decision-making app without personalized risk information. in Shared Decision-making, sponsored by Stanford University. Recruiting at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Stanford University · Not applicable, Interventional, and Health services research
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. The study design is best described as a mixed methods evaluation and refinement of a digital app to improve ICD decision-making. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.
Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.
Participants with heart failure who agree to participate will be recorded in a REDCap system database. The investigators will document in a recruitment tracking log all potentially eligible participants found to be ineligible or who decline participation. The reason for ineligibility or reason for decline will be captured along with age, gender, and race/ethnicity. At the time of their enrollment, the investigators will collect additional information from each participant about their employment status (full-time or part-time employment, no employment, retired), education (no postsecondary education, some postsecondary education), household size (living alone, living with at least one other person).
Participants with heart failure will be asked if they are willing to be interviewed, participate in focus groups, or complete surveys to determine their views on 1) which elements of patient outcome questionnaires are important to them; 2) which decision aid components or educational tools they like or find valuable. Interactions with participants will include open-ended interviews, focus groups, and surveys. These interviews, focus groups, and surveys will be conducted by study staff to help develop a patient-centric shared decision making software tool. Development will occur iteratively with new testing after any modifications. The same individuals may be asked to re-test the app following alterations.
Collaborating teams from UC San Francisco (Site PI: Daniel Morin, MD, MPH) and East Carolina University (Site PI: Samuel Sears, PhD) will join the study before the third month of operation. The participation of these clinical sites is not needed in the first steps on digital tool development. By successfully initiating the project at Stanford, the process of initiation at the clinical sites will be facilitated and is consistent with the mandated use of a single IRB for the three sites.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 600 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Past ICD implantation (not including pacemakers).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm Description: The participant will use the pre-visit, participant-facing app with personal risk information derived from participant characteristics. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool that displays the same personalized information.
Device: Arm A: Online, patient-facing decision-making aid (app) with personalized risk information.
Arm Description: The participant will use the pre-visit, participant-facing app without personal risk information. During a clinical encounter, the clinician will have access to an abbreviated clinician-facing digital tool.
Device: Arm B - Online, patient-facing decision-making app without personalized risk information.
Arm Description: Participant will receive usual clinical care without use of the digital decision-making app.
Other: Arm C - Usual Care/No Device
The online, patient-facing decision-making aid will have the following features: 1) Clinical Data Input, 2) Introduction via Animated Video, 3) Common Questions, 4) Check-In Quiz, 5) Risk and Values Exploration based on patient specific information, 6) Wrap-Up, 7) Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue.
The online, patient-facing decision-making aid will have the following features: 1) Clinical Data Input, 2) Introduction via Animated Video, 3) Common Questions, 4) Check-In Quiz, 5) Generic Risk and Values Exploration without patient specific information, 6) Wrap-Up, 7) Patient-Physician Worksheet, These steps will be completed by the patient in advance of a provider visit where a shared-decision making process will decide whether an ICD is an appropriate sudden cardiac death-prevention strategy to pursue.
Usual Care/No Device
Decisional Conflict Scale (DCS)
The Decisional Conflict Scale is a validated, 16-item questionnaire scale assessing whether a participant feels conflicted regarding a past medical decision. The range is 0 to 100 with higher scores indicating more conflict, a negative outcome.
Time frame: Immediately after decision-making visit as well as at 3 months.
Patient Knowledge of Heart Failure and Implantable Cardioverter-Defibrillators (ICDs)
Scale Title: PKKT-13 (13-Item Patient Knowledge Assessment) Outcome Measure: Patient Knowledge of Heart Failure and Implantable Cardioverter-Defibrillators (ICDs) Description: The PKKT-13 assesses participants' knowledge of heart failure, sudden cardiac death, ICD benefits and risks, and shared decision-making. The questionnaire consists of 13 true/false/don't know questions. Scoring: Each correct response receives 1 point; incorrect and "Don't Know" responses receive 0 points. Total scores range from 0 (minimum) to 13 (maximum). Score Interpretation: Higher scores indicate greater patient knowledge and therefore a better outcome.
Time frame: Baseline , Day 0, week 8, week 16
Decision Regret Scale
Outcome Measure Title: Decision Regret Scale (DRS) Outcome Measure Description: The Decision Regret Scale (DRS) is a 5-item questionnaire that measures participants' regret regarding their decision to receive or decline an implantable cardioverter-defibrillator (ICD). Each item is rated on a 5-point Likert scale, ranging from strongly agree to strongly disagree. Responses are scored and transformed to a total score ranging from 0 (minimum) to 100 (maximum). Higher scores indicate greater decision regret and therefore a worse outcome. A score of 0 indicates no regret, while a score of 100 indicates the highest level of regret.
Time frame: Day 0, week 8, week 16
Preparation for Decision-Making Scale
Outcome Measure Title: Preparation for Decision Making Scale (PDMS) Outcome Measure Description: The Preparation for Decision Making Scale (PDMS) is a 10-item questionnaire that measures how well educational materials and the decision-making process prepare participants to make an informed decision about receiving an implantable cardioverter-defibrillator (ICD). Each item is rated on a 5-point scale ranging from "Not at all" to "A great deal." The total score is calculated as the mean of the item scores, rescaled to a range of 0 (minimum) to 100 (maximum). Higher scores indicate greater preparation for decision-making and therefore a better outcome.
Time frame: Day 0, Week 8, week 16
Weekly Physical Activity Assessed Using the International Physical Activity Questionnaire for the Elderly (IPAQ-E) Short Form
Weekly physical activity is assessed using the International Physical Activity Questionnaire for the Elderly (IPAQ-E) Short Form. Participants report the frequency (days per week) and duration (hours and minutes per day) of walking, moderate-intensity physical activity, and vigorous-intensity physical activity during the previous 7 days. Daily sitting time is also recorded. Physical activity is measured in minutes per week, calculated by multiplying the number of days by the average duration of each activity. For each activity category, the minimum is 0 minutes per week. The questionnaire does not specify a maximum duration or total activity score. Higher values indicate greater physical activity, generally representing a better outcome, while higher sitting time indicates greater sedentary behavior, generally representing a worse outcome.
Time frame: day 0, week 8, week 16
Clinician Satisfaction with the Decision-Making Visit (CSDA)
Clinician satisfaction with the implantable cardioverter-defibrillator (ICD) decision-making visit is assessed using a clinician-completed questionnaire. Satisfaction with the patient discussion is measured using a 5-point Likert scale ranging from 1 (Very dissatisfied) to 5 (Very satisfied). The minimum score is 1 and the maximum score is 5. Higher scores indicate greater clinician satisfaction and therefore a better outcome.
Time frame: day 0
Patient Satisfaction with the Decision-Making Visit (PSDA)
Patient satisfaction with the implantable cardioverter-defibrillator (ICD) decision-making process is assessed using a patient-reported questionnaire. The questionnaire evaluates satisfaction with the decision-making tool, worksheet, physician discussion, quality of information received, and preparation for the visit. Satisfaction items are measured using a 5-point Likert scale ranging from 1 (Very dissatisfied) to 5 (Very satisfied). The minimum score is 1 and the maximum score is 5 for each item. Higher scores indicate greater patient satisfaction and therefore a better outcome.
Time frame: day 0
Health-Related Quality of Life Assessed Using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) is a 36-item patient-reported questionnaire that assesses health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each of the eight domains is scored on a scale ranging from 0 (minimum) to 100 (maximum). Higher scores indicate better health-related quality of life and therefore a better outcome, while lower scores indicate poorer health-related quality of life and therefore a worse outcome.
Time frame: Baseline, Week 8, week 16
Heart Failure-Related Health Status Assessed Using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12)
The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a 12-item patient-reported questionnaire that assesses heart failure-related health status and quality of life. It evaluates four domains: physical limitations, symptom frequency, quality of life, and social limitations over the previous two weeks. Responses are scored and transformed to a scale ranging from 0 (minimum) to 100 (maximum). Higher scores indicate better heart failure-related health status, fewer symptoms, fewer physical and social limitations, and better quality of life, representing a better outcome. Lower scores indicate worse heart failure-related health status and greater limitations, representing a worse outcome.
Time frame: Baseline, Week 8, week 16
Illness Intrusiveness Assessed Using the Illness Intrusiveness Ratings Scale (IIRS)
The Illness Intrusiveness Ratings Scale (IIRS) is a 13-item patient-reported questionnaire that assesses the extent to which illness and its treatment interfere with daily life and activities. The instrument evaluates three domains: Relationships and Personal Development, Intimacy, and Instrumental Activities. Each item is rated on a 7-point scale ranging from 1 (Not very much) to 7 (Very much). The total score ranges from 13 (minimum) to 91 (maximum). Higher scores indicate greater illness-related interference with daily life and therefore a worse outcome, while lower scores indicate less interference and a better outcome. Responses marked "Not applicable" are treated as missing, and total and subscale scores are prorated based on answered items.
Time frame: Baseline, Week 8, week 16
System Usability Scale (SUS)
System Usability Scale (SAS) Standard Version is a metric for determining the ease of use of an online app. The app development process will focus on optimizing the user experience in each module of the proposed application. With a range of 0 to 100, a higher score is better. A score above 70 is considered acceptable.
Time frame: Day 1 (SUS will be assessed immediately following testing of the app, or a specific module of the app)
Plan to share: Yes — Upon reasonable request after January 1, 2027, IPD will be provided without cost.
Supporting information: Study protocol
Time frame: IPD from this developmental stage will be available after January 1, 2027 for a period of at least 5 years.
Access criteria: Electronic access will be provided to IPD upon approval of reasonable requests.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 14 months is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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