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| ID | Type | Description | Link |
|---|---|---|---|
| CDR-1310-06998 | Other Grant/Funding Number | Patient Centered Outcomes Research Institute |
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| Name | Class |
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| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Usual Care | No Intervention | Patients and caregivers will receive the current usual education and consent process for DT LVAD at each hospital. This often means viewing consent forms and industry materials. | |
| DT LVAD Decision Support Intervention | Experimental | In the intervention phase of the study, patients and caregivers will receive the new decision support intervention, which consists primarily of decision aid materials about DT LVAD. The standard consent process will also still take place, but will be supplemented with additional decision support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DT LVAD Decision Support Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline 2 (post-education: average 3 days after enrollment) |
| 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%). | Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment) |
| 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. | At time of intervention phase start |
| 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. | Baseline 2 (post-education: average 3 days after enrollment) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Decision Conflict (Decision Conflict Scale) | Decision Conflict Scale: 16-items, scoring 0-100 with higher score indicating greater decisional conflict. | Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up |
| Changes in Decision Regret (Decision Regret Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Allen, MD, MHS | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States | ||
| St. Vincent Indianapolis Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24352519 | Background | Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available. | |
| 23616602 |
| Label | URL |
|---|---|
| Decision Aids for Patients Considering Destination Therapy Left Ventricular Assist Device | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 11, 2016 | Aug 23, 2018 |
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| 6 months after study enrollment end date |
| 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). | Baseline 1 (enrollment) and 1 Month Follow-Up |
Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret. |
| 1 Month Follow-Up, and 6 Month Follow-Up |
| 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. | Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up |
| 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". | Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up |
| 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. | Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up |
| 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. | 6 Month Follow-Up |
| 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. | Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up |
| 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. | Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up |
| 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). | 1 Month Follow-Up, and 6 Month Follow-Up |
| 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. | 6 Month Follow-Up |
| Indianapolis |
| Indiana |
| 46260 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine in St.Louis | St Louis | Missouri | 63110 | United States |
| Duke University Medicine | Durham | North Carolina | 27710 | United States |
| Background |
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| 35569806 | Derived | Raymer DS, Allen LA, Chaussee EL, McIlvennan CK, Thompson JS, Fairclough DL, Dunlay SM, Matlock DD, Larue SJ. Health Literacy in Patients Considering a Left Ventricular Assist Device: Findings From the DECIDE-LVAD Trial. J Card Fail. 2022 Aug;28(8):1318-1325. doi: 10.1016/j.cardfail.2022.04.009. Epub 2022 May 13. |
| 34465131 | Derived | McIlvennan CK, Jones J, Makic M, Meek PM, Chaussee E, Thompson JS, Matlock DD, Allen LA. Stress and Coping Among Family Caregivers of Patients With a Destination Therapy Left Ventricular Assist Device: A Multicenter Mixed Methods Study. Circ Heart Fail. 2021 Oct;14(10):e008243. doi: 10.1161/CIRCHEARTFAILURE.120.008243. Epub 2021 Sep 1. |
| 34296623 | Derived | Knoepke CE, Chaussee EL, Matlock DD, Thompson JS, McIlvennan CK, Ambardekar AV, Schaffer EM, Khazanie P, Scherer L, Arnold RM, Allen LA. Changes over Time in Patient Stated Values and Treatment Preferences Regarding Aggressive Therapies: Insights from the DECIDE-LVAD Trial. Med Decis Making. 2022 Apr;42(3):404-414. doi: 10.1177/0272989X211028234. Epub 2021 Jul 23. |
| 32428430 | Derived | Matlock DD, McIlvennan CK, Thompson JS, Morris MA, Venechuk G, Dunlay SM, LaRue SJ, Lewis EF, Patel CB, Blue L, Chaussee EL, Glasgow RE, Walsh MN, Allen LA. Decision Aid Implementation among Left Ventricular Assist Device Programs Participating in the DECIDE-LVAD Stepped-Wedge Trial. Med Decis Making. 2020 Apr;40(3):289-301. doi: 10.1177/0272989X20915227. |
| 32148099 | Derived | McIlvennan CK, Matlock DD, Allen LA, Thompson JS, Ranby KW, Sannes TS. Perceived Stress and Depressive Symptoms as Predictors of Decisional Conflict in Dyads Considering a Left Ventricular Assist Device. Circ Cardiovasc Qual Outcomes. 2020 Mar;13(3):e006155. doi: 10.1161/CIRCOUTCOMES.119.006155. Epub 2020 Mar 9. |
| 31129442 | Derived | Warraich HJ, Allen LA, Blue LJ, Chaussee EL, Thompson JS, McIlvennan CK, Flint KM, Matlock DD, Patel CB. Comorbidities and the decision to undergo or forego destination therapy left ventricular assist device implantation: An analysis from the Trial of a Shared Decision Support Intervention for Patients and their Caregivers Offered Destination Therapy for End-Stage Heart Failure (DECIDE-LVAD) study. Am Heart J. 2019 Jul;213:91-96. doi: 10.1016/j.ahj.2019.04.008. Epub 2019 Apr 25. |
| 30316931 | Derived | McIlvennan CK, Matlock DD, Thompson JS, Dunlay SM, Blue L, LaRue SJ, Lewis EF, Patel CB, Fairclough DL, Leister EC, Swetz KM, Baldridge V, Walsh MN, Allen LA. Caregivers of Patients Considering a Destination Therapy Left Ventricular Assist Device and a Shared Decision-Making Intervention: The DECIDE-LVAD Trial. JACC Heart Fail. 2018 Nov;6(11):904-913. doi: 10.1016/j.jchf.2018.06.019. Epub 2018 Oct 10. |
| 29482225 | Derived | Allen LA, McIlvennan CK, Thompson JS, Dunlay SM, LaRue SJ, Lewis EF, Patel CB, Blue L, Fairclough DL, Leister EC, Glasgow RE, Cleveland JC Jr, Phillips C, Baldridge V, Walsh MN, Matlock DD. Effectiveness of an Intervention Supporting Shared Decision Making for Destination Therapy Left Ventricular Assist Device: The DECIDE-LVAD Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):520-529. doi: 10.1001/jamainternmed.2017.8713. |
| 27203272 | Derived | McIlvennan CK, Thompson JS, Matlock DD, Cleveland JC Jr, Dunlay SM, LaRue SJ, Lewis EF, Patel CB, Walsh MN, Allen LA. A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: DECIDE-LVAD: Rationale, Design, and Pilot Data. J Cardiovasc Nurs. 2016 Nov/Dec;31(6):E8-E20. doi: 10.1097/JCN.0000000000000343. |
| 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. |
| FG002 | 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. |
| FG003 | 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. |
| Agreed to Survey Data Collection |
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| COMPLETED |
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| NOT COMPLETED |
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| 1-Month Follow-Up |
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| 6-Month Follow-Up |
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| 12-Month Medical Record Follow-Up |
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Baseline characteristics collected for patient and caregiver participants only; does not apply to the "Sites" arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in baseline characteristics analysis, as this data was primarily collected in surveys.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mean Cognitive Function Score | Measured with the Short Portable Mental Status Questionnaire. Number of incorrect answers out of 10 questions, scale range of 0 to 10, with lower number indicating better cognitive function. | Mean | Standard Deviation | scores on a scale |
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| Mean Literacy Score, as measured by Revised (REALM-R) measure | Measured with the Rapid Estimate of Adult Literacy in Medicine, Revised (REALM-R) measure. Number of correctly read words out of 8 listed, scale range of 0-8, with higher number indicating higher literacy. | Mean | Standard Deviation | scores on a scale |
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| Numeracy Score | Measured with the Subjective Numeracy Score measure. Range of 1-6, higher numeracy toward 6. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| 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. | Reach pertains to only those participants in the intervention phase, and therefore the control arms are not included here. | Posted | Count of Participants | Participants | Baseline 2 (post-education: average 3 days after enrollment) |
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| 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%). | 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. | Posted | Mean | Standard Error | percentage of score improvement | Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment) |
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| 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. | 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. | Posted | Count of Units | Sites | At time of intervention phase start | Sites | Sites |
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| 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. | 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. | Posted | Number | percentage of eligible participants | Baseline 2 (post-education: average 3 days after enrollment) |
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| 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. | 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. | Posted | Count of Units | Sites | 6 months after study enrollment end date | Sites | Sites |
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| Secondary | Changes in Decision Conflict (Decision Conflict Scale) | Decision Conflict Scale: 16-items, scoring 0-100 with higher score indicating greater decisional conflict. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up |
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| Secondary | Changes in Decision Regret (Decision Regret Scale) | Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret. | 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. | Posted | Mean | Standard Error | units on a scale | 1 Month Follow-Up, and 6 Month Follow-Up |
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| 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up |
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| 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". | 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. | Posted | Mean | Standard Error | units on a scale | Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up |
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| 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. | Preparedness for Caregiving Scale was collected for caregiver participants only; does not apply to the "Patient" arm. | Posted | Mean | Standard Error | units on a scale | Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up |
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| 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. | 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. | Posted | Mean | Standard Error | units on a scale | 6 Month Follow-Up |
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| 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. | 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. | Posted | Number | percentage of patients in active role | Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up |
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| 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up |
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| 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). | Family Satisfaction with Care was collected for caregiver participants only; does not apply to the "Patient" arm. | Posted | Mean | Standard Error | units on a scale | 1 Month Follow-Up, and 6 Month Follow-Up |
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| 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. | 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. | Posted | Count of Participants | Participants | 6 Month Follow-Up |
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| 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). | 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. | Posted | Number | 95% Confidence Interval | kendall's tau correlation coefficient | Baseline 1 (enrollment) and 1 Month Follow-Up |
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Adverse events were collected at 1-Month, 6-Month and 12-Month follow-up, reported here cumulatively.
Medical adverse events reported for patient participants only, therefore the caregiver arms are not included. This study's aims focus on patients' medical history/treatment/outcomes only. Thus, caregiver medical record data was not collected (caregiver medical data is not relevant for outcomes). Survey outcomes data solely were collected for caregivers. Medical data were collected for patients only; thus, adverse events include the patient arms only.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 31 | 135 | 87 | 135 | 117 | 135 |
| EG001 | 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. | 39 | 113 | 57 | 113 | 78 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurological Event | Cardiac disorders | Systematic Assessment |
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| Major Bleeding Event | Blood and lymphatic system disorders | Systematic Assessment |
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| Right Ventricular Assist Device Implant | Cardiac disorders | Systematic Assessment |
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| Major Infection | Infections and infestations | Systematic Assessment |
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| Endotrachael Mechanical Ventilation | Cardiac disorders | Systematic Assessment | Need for endotrachael mechanical ventilation other than for the 72 hours around LVAD implant surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Inotrope Support | Cardiac disorders | Systematic Assessment |
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| Renal Replacement Therapy/Dialysis | Renal and urinary disorders | Systematic Assessment |
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| Implantable Cardioverter Defibrillator Shocks | Cardiac disorders | Systematic Assessment |
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| Psychiatric Episode | Psychiatric disorders | Systematic Assessment |
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Limitations include: 1) Missing data were somewhat frequent and concentrated among the group of patients who did not undergo implantation of DT LVAD. Our models adjusted for missing data as possible. 2) The population was mostly white males.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Larry Allen, Principal Investigator | University of Colorado School of Medicine | 303-724-4713 | larry.allen@ucdenver.edu |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2016 | Aug 23, 2018 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2016 | Jan 22, 2020 | SAP_002.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | 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. |
| OG003 | 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. |
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| Sites |
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| Sites |
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| OG003 | 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. |
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| OG003 | 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. |
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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.
| OG003 | 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. |
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| OG001 | 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. |
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| Participants |
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| Participants |
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| OG001 |
| 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. |
| OG002 | 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. |
| OG003 | 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. |
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