Heart-assist Devices, Heart Failure
Conditions
Keywords
heart failure, heart-assist devices, decision making, decision support techniques, hospice care, palliative care, caregivers
Brief summary
The left ventricular assist device (LVAD) is growing rapidly among people dying from end-stage heart failure who are unable to get a heart transplant. These patients elect to live out the remainder of their lives dependent on a partial artificial heart-so-called destination therapy (DT). Although patients may live longer with a DT LVAD, it poses many risks, including stroke, serious infection, and bleeding. Most of these patients have other medical problems that are not fixed by the DT LVAD. Patients must be connected to electricity at all times. A caregiver is required, which often places stress on loved ones. Therefore, the decision whether or not to get a DT LVAD is often an extremely difficult one. Unfortunately, our research shows problems with the way this medical decision is currently being made in hospitals across the United States. Hospitals that offer DT LVAD treatment do not follow a standard process. The forms, pamphlets, websites, and videos used to help patients and families are biased and too difficult for most people to understand. Lastly, this is an emotional and even scary decision for most patients and their families, but the process does not help them deal with these feelings. Using feedback from patients, caregivers, clinicians, the study team made a paper and video decision aid to help people who are offered DT LVAD make this most difficult of decisions. Unlike the information that is now available, our decision aid focuses on options, fears, and the needs of caregivers, is balanced, and is paired with training for doctors and nurses on how to best talk about DT LVAD. The investigators now propose to test the effectiveness and implementation of this intervention. The investigators will apply the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework to a stepped-wedge, cluster-randomized, controlled trial across 6 medical centers. Aim 1. Evaluate the Reach and Effectiveness of the DT LVAD shared decision support intervention to improve patient and caregiver experiences. Hypothesis 1a: The intervention will reach 90% of eligible patients. Hypothesis 1b: Post-implementation, patients and caregivers will have improved decision quality (greater knowledge and higher value-treatment concordance). Aim 2. Assess the Adoption, Implementation, and Maintenance of the DT LVAD shared decision support intervention across multiple providers and settings. Hypothesis 2: The intervention will be: adopted by key personnel; implemented consistently; and maintained after trial completion.
Detailed description
The investigators plan to test the effectiveness and implementation of a shared decision support intervention for DT LVAD. Six DT LVAD programs from across the U.S. will participate in a stepped-wedge randomized study design. In this design, each site participates in both the control and intervention phase with the timing of the transition randomly assigned. Sites all begin in the control phase, where usual care consists of the current education, decision making, and informed consent process. When sites reach their randomly assigned time to transition to the intervention, their coordinators and key staff will participate in communication training and decision coaching. The pamphlet and video decision aid will be formally integrated into the existing education, decision making, and informed consent process. In both pre- and post-phases, the investigators will enroll patients and caregivers and survey them prior to their DT LVAD decision (baseline) and then at 1 month and 6 months after to determine the interventions effect on decision quality and a host of secondary outcomes. These patient- and caregiver-centered outcomes will be compared within each hospital before and after implementation to determine the effectiveness of the intervention. The investigators will also survey clinicians before, during, and after implementation of the shared decision support intervention. The implementation will be guided using the well-known RE-AIM evaluative framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). Formal study of the implementation will promote widespread dissemination of this DT LVAD shared decision support.
Interventions
BEHAVIORALDT LVAD Decision Support Intervention
Decision coaching and training of staff prior to intervention, to allow for additional decision support to patients and caregivers considering DT LVAD. Decision aid materials will be used with patients and caregivers.
Sponsors
Patient-Centered Outcomes Research Institute
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients who have advanced heart failure and are being evaluated for DT LVAD * Caregivers of patients who are being evaluated for DT LVAD
Exclusion criteria
* Under 18 years of age * Non-English Speaking * Unable to consent * Prisoner * Already implanted with DT LVAD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach of Intervention | Baseline 2 (post-education: average 3 days after enrollment) | Reach: The proportion of the target population who participate in the intervention. We will assess the percentage of patients and caregivers that receive the pamphlet and video decision aids. |
| Effectiveness of Intervention: Knowledge | Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment) | Effectiveness: Assessed based on if the decision support intervention led to a quality decision. Decision quality is defined as the extent to which the implemented decision reflects the considered preferences of a well-informed patient. By this definition, a decision is a quality decision if the treatment chosen is concordant with a knowledgeable patient's values. Decision quality measures consist of 2 domains: knowledge and values. This is part one of the decision quality measure: -Knowledge: DT LVAD knowledge score improvement from Baseline 1 (enrollment) to Baseline 2 (post-education), measured by percentage of score improvement (scale of 0-100%). |
| Adoption of Intervention | At time of intervention phase start | Adoption: The absolute number of settings who are willing to initiate a program. We will assess the number of sites who agreed to be part of the study and who initiate intervention at intervention period. |
| Implementation of Intervention | Baseline 2 (post-education: average 3 days after enrollment) | Implementation: The extent to which the intervention is implemented as intended. We will assess implementation by surveying the consistency of decision aid delivery by the sites to the enrolled patients. |
| Maintenance of Intervention | 6 months after study enrollment end date | Maintenance: Assessing whether sites decide at the conclusion of the study to maintain, modify, or discontinue a program. We will assess maintenance by counting the number of sites who continue the intervention after the study enrollment period has ended. |
| Effectiveness of Intervention: Values-Choice Concordance | Baseline 1 (enrollment) and 1 Month Follow-Up | Effectiveness: Assessed based on if the decision support intervention led to a quality decision (see Knowledge outcome measure for full description). This is part two of the decision quality measure: -Values: Concordance between patients' and caregivers' stated values and their treatment choice at 1-Month. Values measured on a Likert scale of 1-10, with 1 being Do everything I can to live longer, even if that means having major surgery and being dependent on a machine and 10 being Live with whatever time I have left, without going through major surgery or being dependent on a machine; correlated with patient-reported treatment decision of accepted or declined DT LVAD. Measured by kendall's tau correlation coefficient, which ranges 1 to -1, score closer to 1 or -1 shows greater values-choice concordance (a correlation coefficient of 0 means no concordance). Confidence intervals obtained from the distribution after 500 bootstrap samples (2.5, 97.5 percentiles). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up | Control Preferences Scale (patients only) includes 2 parts: Preferred and Actual (Actual at 1-Month and 6-Month only). Each is a 1-item question with 5-answer options, assessing preferred or actual control in decision making. Active role indicated if 1 of first 3 answer options were selected: for Preferred, those 3 answer options were I prefer to make the final selection about which treatment I will receive, I prefer to make the final selection of my treatment after seriously considering my doctor's opinion, or I prefer that my doctor and I share responsibility for deciding which treatment is best; for Actual, answer options were I made the final selection about which treatment I would receive, I made the final selection of my treatment after seriously considering my doctor's opinion, or My doctor and I shared responsibility for deciding which was treatment best for me. The percentage of patients who selected an active response option was calculated. |
| Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up | PEACE Illness Acceptance Measure (patients only): 2 part measure: part 1 measures illness acceptances (questions 1-5 of 12-items), scoring 5-20 with higher score indicating greater acceptance of illness; part 2 measures struggle with illness (questions 6-12 of 12-items), scoring 7-28 with higher score indicating greater struggle with illness. |
| Changes in Decision Conflict (Decision Conflict Scale) | Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up | Decision Conflict Scale: 16-items, scoring 0-100 with higher score indicating greater decisional conflict. |
| Changes in Patient Treatment Status (Medical Record Review (Patients Only) | 6 Month Follow-Up | Medical record review (patients only): Treatment received by 6 months, below numbers reported as number of participants who received an LVAD. |
| Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only]) | 1 Month Follow-Up, and 6 Month Follow-Up | Family Satisfaction with Care (caregivers only): The 10-item Family Satisfaction with Decision-Making around Care of Critically Ill Patients subscale of the Family Satisfaction with Care in the Intensive Care Unit-24. Scoring for each question was on a scale of 0-100, with 0 indicating low satisfaction and 100 indicating high satisfaction; combined total of all 10 questions was taken for final mean score of 0-100 (higher score indicating higher satisfaction). |
| Changes in Decision Regret (Decision Regret Scale) | 1 Month Follow-Up, and 6 Month Follow-Up | Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret. |
| Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up | Perceived Stress Scale (collected at Baseline 1 and 6-month follow-up only):10-items, scoring 0-40 with higher score indicating greater stress.; Patient Health Questionnaire-2: 2-items, score of 0-6 with higher score indicating greater depression. |
| Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only]) | Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up | EuroQol Visual Analogue Scale (patients only): 1-item scale, score of 0-100 with 0 being worst imaginable health state and 100 being best imaginable health state. |
| Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only]) | Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up | Preparedness for Caregiving Scale (caregivers only): 8-items, scoring 0-4 with higher score indicating more preparedness. |
| Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only]) | 6 Month Follow-Up | Canadian Health Care Evaluation Project - Bereavement Questionnaire (bereaved caregivers only): Score of 0-100 with higher score indicating greater satisfaction. |
Countries
United States
Participant flow
Recruitment details
Occurred from June 2015-Jan 2017 in both the inpatient and outpatient setting. Patients were identified by the study team when a destination therapy left ventricular assist device evaluation was initiated; caregivers were identified by the medical team or patient. Recruitment and data collection were identical across control and intervention arms.
Pre-assignment details
This study had a stepped-wedge design. All 6 sites started in the control phase, and then were transitioned to the intervention phase over pre-determined and randomly assigned time points (all sites ended in intervention). Participant assignment to control or intervention was determined by phase the site was in at time of participant enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Patient Control Patients being considered for destination therapy (DT) LVAD therapy enrolled during the control phase. These patients receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials. | 135 |
| Patient Intervention Patients being considered for DT LVAD therapy enrolled during the intervention phase. These patients receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education. | 113 |
| Caregiver Control Caregivers of patients being considered for DT LVAD therapy enrolled during the control phase. These caregivers receive the usual care education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials. | 111 |
| Caregiver Intervention Caregivers of patients being considered for DT LVAD enrolled during the intervention phase. These caregivers receive the intervention, consisting of staff trained in decision making and use of a decision aid pamphlet and video during education. | 71 |
| Total | 430 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 1-Month Follow-Up | Death | 13 | 8 | 0 | 0 |
| 1-Month Follow-Up | Lost to Follow-up | 2 | 5 | 11 | 3 |
| 1-Month Follow-Up | Withdrawal by Subject | 3 | 14 | 8 | 10 |
| 6-Month Follow-Up | Death | 14 | 14 | 0 | 0 |
| 6-Month Follow-Up | Lost to Follow-up | 4 | 5 | 13 | 6 |
| 6-Month Follow-Up | Withdrawal by Subject | 1 | 0 | 1 | 2 |
| Enrollment | Agreed to Medical Record Review Only | 7 | 8 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Patient Control | Patient Intervention | Caregiver Control | Caregiver Intervention |
|---|---|---|---|---|---|
| Age, Continuous | 62.2 years STANDARD_DEVIATION 10.6 | 63.5 years STANDARD_DEVIATION 9.7 | 63.2 years STANDARD_DEVIATION 10.2 | 60.2 years STANDARD_DEVIATION 11.2 | 62.2 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 2 Participants | 3 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 396 Participants | 124 Participants | 100 Participants | 108 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants | 9 Participants | 10 Participants | 1 Participants | 5 Participants |
| Mean Cognitive Function Score | 0.61 scores on a scale STANDARD_DEVIATION 1.49 | 0.7 scores on a scale STANDARD_DEVIATION 1.55 | 0.66 scores on a scale STANDARD_DEVIATION 1.25 | 0.60 scores on a scale STANDARD_DEVIATION 1.69 | 0.39 scores on a scale STANDARD_DEVIATION 1.29 |
| Mean Literacy Score, as measured by Revised (REALM-R) measure | 7.24 scores on a scale STANDARD_DEVIATION 1.61 | 6.93 scores on a scale STANDARD_DEVIATION 1.9 | 6.95 scores on a scale STANDARD_DEVIATION 2 | 7.46 scores on a scale STANDARD_DEVIATION 1.5 | 7.70 scores on a scale STANDARD_DEVIATION 0.98 |
| Numeracy Score | 4.13 units on a scale STANDARD_DEVIATION 1.18 | 4.03 units on a scale STANDARD_DEVIATION 1.1 | 4.21 units on a scale STANDARD_DEVIATION 1.13 | 4.04 units on a scale STANDARD_DEVIATION 1.28 | 4.31 units on a scale STANDARD_DEVIATION 1.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 19 Participants | 12 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 4 Participants | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 4 Participants | 9 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 342 Participants | 104 Participants | 88 Participants | 91 Participants | 59 Participants |
| Region of Enrollment United States | 430 participants | 135 participants | 113 participants | 111 participants | 71 participants |
| Sex: Female, Male Female | 193 Participants | 24 Participants | 15 Participants | 92 Participants | 62 Participants |
| Sex: Female, Male Male | 237 Participants | 111 Participants | 98 Participants | 19 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 31 / 135 | 39 / 113 |
| other Total, other adverse events | 117 / 135 | 78 / 113 |
| serious Total, serious adverse events | 87 / 135 | 57 / 113 |
Outcome results
Primary
Adoption of Intervention
Adoption: The absolute number of settings who are willing to initiate a program. We will assess the number of sites who agreed to be part of the study and who initiate intervention at intervention period.
Time frame: At time of intervention phase start
Population: Adoption is measured by sites only; does not apply to the Patient and Caregiver arms. Adoption pertains to only the intervention phase; thus, for overall number of participants analyzed, includes patients and caregivers in intervention phase only.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Patient Intervention | Adoption of Intervention | 6 Sites |
Primary
Effectiveness of Intervention: Knowledge
Effectiveness: Assessed based on if the decision support intervention led to a quality decision. Decision quality is defined as the extent to which the implemented decision reflects the considered preferences of a well-informed patient. By this definition, a decision is a quality decision if the treatment chosen is concordant with a knowledgeable patient's values. Decision quality measures consist of 2 domains: knowledge and values. This is part one of the decision quality measure: -Knowledge: DT LVAD knowledge score improvement from Baseline 1 (enrollment) to Baseline 2 (post-education), measured by percentage of score improvement (scale of 0-100%).
Time frame: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)
Population: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Effectiveness analysis, as this data was collected in surveys.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Intervention | Effectiveness of Intervention: Knowledge | 5.4 percentage of score improvement | Standard Error 1.6 |
| Caregiver Intervention | Effectiveness of Intervention: Knowledge | 10.9 percentage of score improvement | Standard Error 1.9 |
| Caregiver Control | Effectiveness of Intervention: Knowledge | 9.1 percentage of score improvement | Standard Error 1.7 |
| Caregiver Intervention | Effectiveness of Intervention: Knowledge | 13.9 percentage of score improvement | Standard Error 2.2 |
Primary
Effectiveness of Intervention: Values-Choice Concordance
Effectiveness: Assessed based on if the decision support intervention led to a quality decision (see Knowledge outcome measure for full description). This is part two of the decision quality measure: -Values: Concordance between patients' and caregivers' stated values and their treatment choice at 1-Month. Values measured on a Likert scale of 1-10, with 1 being Do everything I can to live longer, even if that means having major surgery and being dependent on a machine and 10 being Live with whatever time I have left, without going through major surgery or being dependent on a machine; correlated with patient-reported treatment decision of accepted or declined DT LVAD. Measured by kendall's tau correlation coefficient, which ranges 1 to -1, score closer to 1 or -1 shows greater values-choice concordance (a correlation coefficient of 0 means no concordance). Confidence intervals obtained from the distribution after 500 bootstrap samples (2.5, 97.5 percentiles).
Time frame: Baseline 1 (enrollment) and 1 Month Follow-Up
Population: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Effectiveness analysis, as this data was collected in surveys.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patient Intervention | Effectiveness of Intervention: Values-Choice Concordance | 0.17 kendall's tau correlation coefficient |
| Caregiver Intervention | Effectiveness of Intervention: Values-Choice Concordance | 0.48 kendall's tau correlation coefficient |
| Caregiver Control | Effectiveness of Intervention: Values-Choice Concordance | 0.12 kendall's tau correlation coefficient |
| Caregiver Intervention | Effectiveness of Intervention: Values-Choice Concordance | 0.49 kendall's tau correlation coefficient |
Primary
Implementation of Intervention
Implementation: The extent to which the intervention is implemented as intended. We will assess implementation by surveying the consistency of decision aid delivery by the sites to the enrolled patients.
Time frame: Baseline 2 (post-education: average 3 days after enrollment)
Population: Implementation was collected for patient participants only; does not apply to the Caregiver arm. Implementation pertains to only patients in the intervention phase; control arms are not included here.Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Intervention | Implementation of Intervention | Provided by Clinician (Non-Study Personnel) | 98.3 percentage of eligible participants |
| Patient Intervention | Implementation of Intervention | Patient Kept Decision Aids | 90.9 percentage of eligible participants |
| Patient Intervention | Implementation of Intervention | Clinician Went through Pamphlet with Patient | 26.4 percentage of eligible participants |
| Patient Intervention | Implementation of Intervention | Patient Viewed Video in Clinical Setting | 46.8 percentage of eligible participants |
Primary
Maintenance of Intervention
Maintenance: Assessing whether sites decide at the conclusion of the study to maintain, modify, or discontinue a program. We will assess maintenance by counting the number of sites who continue the intervention after the study enrollment period has ended.
Time frame: 6 months after study enrollment end date
Population: Maintenance is measured by sites only; does not apply to the Patient and Caregiver arms. Maintenance pertains to only the intervention phase; thus, for overall number of participants analyzed, includes patients and caregivers in intervention phase only.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Patient Intervention | Maintenance of Intervention | 5 Sites |
Primary
Reach of Intervention
Reach: The proportion of the target population who participate in the intervention. We will assess the percentage of patients and caregivers that receive the pamphlet and video decision aids.
Time frame: Baseline 2 (post-education: average 3 days after enrollment)
Population: Reach pertains to only those participants in the intervention phase, and therefore the control arms are not included here.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Intervention | Reach of Intervention | 107 Participants |
| Caregiver Intervention | Reach of Intervention | 64 Participants |
Secondary
Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only])
Canadian Health Care Evaluation Project - Bereavement Questionnaire (bereaved caregivers only): Score of 0-100 with higher score indicating greater satisfaction.
Time frame: 6 Month Follow-Up
Population: Bereaved Caregiver Satisfaction was collected for caregiver participants only; does not apply to the Patient arm. This measure was also collected among bereaved caregivers only; 11 bereaved caregivers responded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Intervention | Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only]) | 73.0 units on a scale | Standard Error 6 |
| Caregiver Intervention | Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only]) | 62.0 units on a scale | Standard Error 10.2 |
Secondary
Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only])
Preparedness for Caregiving Scale (caregivers only): 8-items, scoring 0-4 with higher score indicating more preparedness.
Time frame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Population: Preparedness for Caregiving Scale was collected for caregiver participants only; does not apply to the Patient arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Intervention | Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only]) | Baseline 1 Survey Score | 3.05 units on a scale | Standard Error 0.1 |
| Patient Intervention | Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only]) | 1-Month Follow-Up Survey Score | 3.17 units on a scale | Standard Error 0.1 |
| Patient Intervention | Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only]) | 6-Month Follow-Up Survey Score | 3.24 units on a scale | Standard Error 0.11 |
| Caregiver Intervention | Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only]) | Baseline 1 Survey Score | 2.81 units on a scale | Standard Error 0.13 |
| Caregiver Intervention | Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only]) | 1-Month Follow-Up Survey Score | 3.02 units on a scale | Standard Error 0.13 |
| Caregiver Intervention | Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only]) | 6-Month Follow-Up Survey Score | 2.99 units on a scale | Standard Error 0.13 |
Secondary
Changes in Decision Conflict (Decision Conflict Scale)
Decision Conflict Scale: 16-items, scoring 0-100 with higher score indicating greater decisional conflict.
Time frame: Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Population: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Decision Conflict analysis, as this data was collected in surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Intervention | Changes in Decision Conflict (Decision Conflict Scale) | Baseline 1 Survey Score | 20.2 units on a scale | Standard Error 1.99 |
| Patient Intervention | Changes in Decision Conflict (Decision Conflict Scale) | Baseline 2 Survey Score | 16.5 units on a scale | Standard Error 1.95 |
| Patient Intervention | Changes in Decision Conflict (Decision Conflict Scale) | 1-Month Follow-Up Survey Score | 15.5 units on a scale | Standard Error 1.89 |
| Patient Intervention | Changes in Decision Conflict (Decision Conflict Scale) | 6-Month Follow-Up Survey Score | 15.4 units on a scale | Standard Error 1.89 |
| Caregiver Intervention | Changes in Decision Conflict (Decision Conflict Scale) | Baseline 2 Survey Score | 18.4 units on a scale | Standard Error 2.23 |
| Caregiver Intervention | Changes in Decision Conflict (Decision Conflict Scale) | 1-Month Follow-Up Survey Score | 17.9 units on a scale | Standard Error 2.17 |
| Caregiver Intervention | Changes in Decision Conflict (Decision Conflict Scale) | 6-Month Follow-Up Survey Score | 14.2 units on a scale | Standard Error 2.21 |
| Caregiver Intervention | Changes in Decision Conflict (Decision Conflict Scale) | Baseline 1 Survey Score | 23.4 units on a scale | Standard Error 2.24 |
| Caregiver Control | Changes in Decision Conflict (Decision Conflict Scale) | 1-Month Follow-Up Survey Score | 13.1 units on a scale | Standard Error 2.09 |
| Caregiver Control | Changes in Decision Conflict (Decision Conflict Scale) | Baseline 2 Survey Score | 9.70 units on a scale | Standard Error 1.9 |
| Caregiver Control | Changes in Decision Conflict (Decision Conflict Scale) | 6-Month Follow-Up Survey Score | 11.9 units on a scale | Standard Error 1.98 |
| Caregiver Control | Changes in Decision Conflict (Decision Conflict Scale) | Baseline 1 Survey Score | 19.0 units on a scale | Standard Error 2.06 |
| Caregiver Intervention | Changes in Decision Conflict (Decision Conflict Scale) | 6-Month Follow-Up Survey Score | 17.4 units on a scale | Standard Error 2.52 |
| Caregiver Intervention | Changes in Decision Conflict (Decision Conflict Scale) | Baseline 2 Survey Score | 18.8 units on a scale | Standard Error 2.4 |
| Caregiver Intervention | Changes in Decision Conflict (Decision Conflict Scale) | Baseline 1 Survey Score | 21.4 units on a scale | Standard Error 2.59 |
| Caregiver Intervention | Changes in Decision Conflict (Decision Conflict Scale) | 1-Month Follow-Up Survey Score | 19.5 units on a scale | Standard Error 2.62 |
Secondary
Changes in Decision Regret (Decision Regret Scale)
Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret.
Time frame: 1 Month Follow-Up, and 6 Month Follow-Up
Population: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Decision Regret analysis, as this data was collected in surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Intervention | Changes in Decision Regret (Decision Regret Scale) | 6-Month Follow-Up Survey | 12.1 units on a scale | Standard Error 2.28 |
| Patient Intervention | Changes in Decision Regret (Decision Regret Scale) | 1-Month Follow-Up Survey | 14.3 units on a scale | Standard Error 2.15 |
| Caregiver Intervention | Changes in Decision Regret (Decision Regret Scale) | 1-Month Follow-Up Survey | 17.9 units on a scale | Standard Error 2.84 |
| Caregiver Intervention | Changes in Decision Regret (Decision Regret Scale) | 6-Month Follow-Up Survey | 19.1 units on a scale | Standard Error 2.96 |
| Caregiver Control | Changes in Decision Regret (Decision Regret Scale) | 1-Month Follow-Up Survey | 11.2 units on a scale | Standard Error 2.37 |
| Caregiver Control | Changes in Decision Regret (Decision Regret Scale) | 6-Month Follow-Up Survey | 10.4 units on a scale | Standard Error 2.46 |
| Caregiver Intervention | Changes in Decision Regret (Decision Regret Scale) | 6-Month Follow-Up Survey | 17.1 units on a scale | Standard Error 3.38 |
| Caregiver Intervention | Changes in Decision Regret (Decision Regret Scale) | 1-Month Follow-Up Survey | 17.5 units on a scale | Standard Error 3.32 |
Secondary
Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only])
Family Satisfaction with Care (caregivers only): The 10-item Family Satisfaction with Decision-Making around Care of Critically Ill Patients subscale of the Family Satisfaction with Care in the Intensive Care Unit-24. Scoring for each question was on a scale of 0-100, with 0 indicating low satisfaction and 100 indicating high satisfaction; combined total of all 10 questions was taken for final mean score of 0-100 (higher score indicating higher satisfaction).
Time frame: 1 Month Follow-Up, and 6 Month Follow-Up
Population: Family Satisfaction with Care was collected for caregiver participants only; does not apply to the Patient arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Intervention | Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only]) | 1-Month Follow-Up Survey | 76.2 units on a scale | Standard Error 1.93 |
| Patient Intervention | Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only]) | 6-Month Follow-Up Survey | 74.5 units on a scale | Standard Error 2.11 |
| Caregiver Intervention | Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only]) | 1-Month Follow-Up Survey | 74.8 units on a scale | Standard Error 2.63 |
| Caregiver Intervention | Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only]) | 6-Month Follow-Up Survey | 77.0 units on a scale | Standard Error 2.81 |
Secondary
Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)
PEACE Illness Acceptance Measure (patients only): 2 part measure: part 1 measures illness acceptances (questions 1-5 of 12-items), scoring 5-20 with higher score indicating greater acceptance of illness; part 2 measures struggle with illness (questions 6-12 of 12-items), scoring 7-28 with higher score indicating greater struggle with illness.
Time frame: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Population: PEACE Illness Acceptance Measure was collected for patient participants only; does not apply to the Caregiver arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in PEACE Measure analysis, as this data was collected in surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Acceptance of Illness: Baseline 1 Survey Score | 17.5 units on a scale | Standard Error 0.26 |
| Patient Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Acceptance of Illness: 1-Month Survey Score | 17.4 units on a scale | Standard Error 0.27 |
| Patient Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Acceptance of Illness: 6-Month Survey Score | 17.5 units on a scale | Standard Error 0.28 |
| Patient Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Struggle with Illness: Baseline 1 Survey Score | 14.0 units on a scale | Standard Error 0.42 |
| Patient Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Struggle with Illness: 1-Month Survey Score | 13.6 units on a scale | Standard Error 0.47 |
| Patient Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Struggle with Illness: 6-Month Survey Score | 12.9 units on a scale | Standard Error 0.5 |
| Caregiver Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Struggle with Illness: 1-Month Survey Score | 12.9 units on a scale | Standard Error 0.57 |
| Caregiver Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Acceptance of Illness: Baseline 1 Survey Score | 17.1 units on a scale | Standard Error 0.31 |
| Caregiver Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Struggle with Illness: Baseline 1 Survey Score | 13.1 units on a scale | Standard Error 0.5 |
| Caregiver Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Acceptance of Illness: 1-Month Survey Score | 17.4 units on a scale | Standard Error 0.32 |
| Caregiver Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Struggle with Illness: 6-Month Survey Score | 12.0 units on a scale | Standard Error 0.62 |
| Caregiver Intervention | Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only) | Acceptance of Illness: 6-Month Survey Score | 18.2 units on a scale | Standard Error 0.34 |
Secondary
Changes in Patient Treatment Status (Medical Record Review (Patients Only)
Medical record review (patients only): Treatment received by 6 months, below numbers reported as number of participants who received an LVAD.
Time frame: 6 Month Follow-Up
Population: Medical record data was collected for patient participants only; does not apply to the Caregiver arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in medical record data analysis, as this data was collected in surveys.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patient Intervention | Changes in Patient Treatment Status (Medical Record Review (Patients Only) | 110 Participants |
| Caregiver Intervention | Changes in Patient Treatment Status (Medical Record Review (Patients Only) | 54 Participants |
Secondary
Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])
Control Preferences Scale (patients only) includes 2 parts: Preferred and Actual (Actual at 1-Month and 6-Month only). Each is a 1-item question with 5-answer options, assessing preferred or actual control in decision making. Active role indicated if 1 of first 3 answer options were selected: for Preferred, those 3 answer options were I prefer to make the final selection about which treatment I will receive, I prefer to make the final selection of my treatment after seriously considering my doctor's opinion, or I prefer that my doctor and I share responsibility for deciding which treatment is best; for Actual, answer options were I made the final selection about which treatment I would receive, I made the final selection of my treatment after seriously considering my doctor's opinion, or My doctor and I shared responsibility for deciding which was treatment best for me. The percentage of patients who selected an active response option was calculated.
Time frame: Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up
Population: Control Preferences Scale was collected for patient participants only; does not apply to the Caregiver arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Control Preferences Scale analysis, as this data was collected in surveys.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patient Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Preferred: 1-Month Follow-Up Survey Score | 86.6 percentage of patients in active role |
| Patient Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Actual: 1-Month Follow-Up Survey Score | 87.5 percentage of patients in active role |
| Patient Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Preferred: 6-Month Follow-Up Survey Score | 86.7 percentage of patients in active role |
| Patient Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Actual: 6-Month Follow-Up Survey Score | 85.8 percentage of patients in active role |
| Patient Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Preferred: Baseline 1 Survey Score | 84.1 percentage of patients in active role |
| Caregiver Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Actual: 6-Month Follow-Up Survey Score | 89.4 percentage of patients in active role |
| Caregiver Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Preferred: Baseline 1 Survey Score | 83.6 percentage of patients in active role |
| Caregiver Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Preferred: 1-Month Follow-Up Survey Score | 89.8 percentage of patients in active role |
| Caregiver Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Preferred: 6-Month Follow-Up Survey Score | 92.4 percentage of patients in active role |
| Caregiver Intervention | Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only]) | Actual: 1-Month Follow-Up Survey Score | 83.6 percentage of patients in active role |
Secondary
Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])
EuroQol Visual Analogue Scale (patients only): 1-item scale, score of 0-100 with 0 being worst imaginable health state and 100 being best imaginable health state.
Time frame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up
Population: EuroQol Visual Analogue Scale was collected for patient participants only; does not apply to the Caregiver arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in EuroQol Visual Analogue Scale analysis, as this data was collected in surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Intervention | Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only]) | Baseline 1 Survey Score | 44.6 units on a scale | Standard Error 2.69 |
| Patient Intervention | Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only]) | 1-Month Follow-Up Survey Score | 64.3 units on a scale | Standard Error 2.67 |
| Patient Intervention | Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only]) | 6-Month Follow-Up Survey Score | 69.6 units on a scale | Standard Error 2.57 |
| Caregiver Intervention | Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only]) | Baseline 1 Survey Score | 48.6 units on a scale | Standard Error 3.07 |
| Caregiver Intervention | Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only]) | 1-Month Follow-Up Survey Score | 60.5 units on a scale | Standard Error 3.13 |
| Caregiver Intervention | Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only]) | 6-Month Follow-Up Survey Score | 68.8 units on a scale | Standard Error 3.07 |
Secondary
Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)
Perceived Stress Scale (collected at Baseline 1 and 6-month follow-up only):10-items, scoring 0-40 with higher score indicating greater stress.; Patient Health Questionnaire-2: 2-items, score of 0-6 with higher score indicating greater depression.
Time frame: Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up
Population: Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Stress and Depression analysis, as this data was collected in surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patient Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: 1-Month Follow-Up Survey Score | 1.64 units on a scale | Standard Error 0.23 |
| Patient Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Stress: 6-Month Follow-Up Survey Score | 12.6 units on a scale | Standard Error 0.82 |
| Patient Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: 6-Month Follow-Up Survey Score | 1.06 units on a scale | Standard Error 0.21 |
| Patient Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: Baseline 1 Survey Score | 1.80 units on a scale | Standard Error 0.21 |
| Patient Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Stress: Baseline 1 Survey Score | 16.1 units on a scale | Standard Error 0.68 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: Baseline 1 Survey Score | 1.56 units on a scale | Standard Error 0.24 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: 1-Month Follow-Up Survey Score | 1.39 units on a scale | Standard Error 0.26 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: 6-Month Follow-Up Survey Score | 0.97 units on a scale | Standard Error 0.25 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Stress: 6-Month Follow-Up Survey Score | 11.9 units on a scale | Standard Error 1.03 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Stress: Baseline 1 Survey Score | 14.1 units on a scale | Standard Error 0.81 |
| Caregiver Control | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: Baseline 1 Survey Score | 0.79 units on a scale | Standard Error 0.22 |
| Caregiver Control | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Stress: Baseline 1 Survey Score | 14.3 units on a scale | Standard Error 0.86 |
| Caregiver Control | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Stress: 6-Month Follow-Up Survey Score | 12.1 units on a scale | Standard Error 1 |
| Caregiver Control | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: 1-Month Follow-Up Survey Score | 0.80 units on a scale | Standard Error 0.24 |
| Caregiver Control | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: 6-Month Follow-Up Survey Score | 0.54 units on a scale | Standard Error 0.21 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: 1-Month Follow-Up Survey Score | 1.35 units on a scale | Standard Error 0.29 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Stress: 6-Month Follow-Up Survey Score | 12.7 units on a scale | Standard Error 1.24 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Stress: Baseline 1 Survey Score | 16.4 units on a scale | Standard Error 1.06 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: Baseline 1 Survey Score | 1.04 units on a scale | Standard Error 0.26 |
| Caregiver Intervention | Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2) | Depression: 6-Month Follow-Up Survey Score | 0.69 units on a scale | Standard Error 0.24 |