A Study Evaluating a Decision Support Tool for Patients and Caregivers Offered a Heart Assist Device for End Stage Heart Failure

Overview

About this study

The purpose of this study is to evaluate the effectiveness and implementation of a new shared decision support tool. Using feedback from patients, caregivers, and clinicians, a paper and video decision aid has been made to help people who are offered DT LVAD (a partial artificial heart—so-called destination therapy left ventricular assist device) make this most difficult of decisions. Although patients may live longer with a DT LVAD, it poses many risks, including stroke, serious infection, and bleeding.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.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Shannon Dunlay, M.D., M.S.

Closed for enrollment

More information

Publications

  • Conveying the complex trade-offs of continuous-flow left ventricular assist devices is challenging and made more difficult by absence of an evidence summary for the full range of possible outcomes. We aimed to summarize the current evidence on outcomes of continuous-flow left ventricular assist devices. Read More on PubMed
  • Left ventricular assist devices (LVADs) are being used with increasing frequency to treat severe heart failure. Patients seek out informational resources when considering implantation. The primary study objective was to characterize the scope and quality of available LVAD educational materials. Read More on PubMed
  • Destination therapy left ventricular assist devices (DT LVADs) are one of the most invasive medical interventions for end-stage illness. How patients decide whether or not to proceed with device implantation is unknown. We aimed to understand the decision-making processes of patients who either accept or decline DT LVADs. Read More on PubMed
  • Decision aids are intended to help people participate in decisions that involve weighing the benefits and harms of treatment options often with scientific uncertainty. Read More on PubMed
  • Heart failure (HF) is an important contributor to both the burden and cost of national healthcare expenditures, with more older Americans hospitalized for HF than for any other medical condition. With the aging of the population, the impact of HF is expected to increase substantially. Read More on PubMed
  • The number of patients with advanced heart failure that has become unresponsive to conventional medical therapy is increasing rapidly. One of the most promising new alternatives to heart transplantation is use of ventricular assist devices (VADs). To date, there are no guidelines for appropriate selection for use of these devices that are approved by national societies in the field. This review addresses all of the general criteria for clinicians to keep in mind regarding when to refer a patient for evaluation and the specific issues addressed in patient selection. The field of mechanical circulatory support has advanced significantly over the past 10 years, resulting in rapid expansion of patients with advanced heart failure who can benefit from implantable devices. With progress of technology, limitations associated with age, body size, and comorbidities gradually become less prohibitive. The continuing simplification of design along with continued reduction in size of the devices, plus eventual elimination of the external drive line will make the use of VADs a superior option to heart transplant and even to medical management in many patients. We anticipate that the patient selection process outlined in the present review will continue to shift toward less advanced cases of heart failure. Read More on PubMed
  • The 5th annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes and analyzes the first 6 years of patient and data collection. The current analysis includes more than 6000 patients and updated risk factors for continuous flow pumps. Among continuous flow pumps, actuarial survival is 80% at 1 year and 70% at 2 years. Quality of life indicators are generally favorable and adverse event burden will likely influence patient selections of advanced heart failure therapies. Read More on PubMed
  • The original version of the International Patient Decision Aid Standards (IPDAS) recommended that patient decision aids (PtDAs) should be carefully developed, user-tested and open to scrutiny, with a well-documented and systematically applied development process. We carried out a review to check the relevance and scope of this quality dimension and, if necessary, to update it. Read More on PubMed
  • To describe the application of the stepped wedge cluster randomized controlled trial (CRCT) design. Read More on PubMed
  • Good-quality care requires that procedures, treatments, and tests be not only medically appropriate, but also desired by informed patients. Current evidence shows that most medical decisions are made by physicians with little input from patients. This article describes issues surrounding informed patient decision making and the steps necessary to improve the way decisions are made. Creating incentives for providers and health care organizations to inform patients and incorporate patients' goals into decisions is critical. Patient surveys are needed to monitor the quality of decision making. Health information technology can help by collecting information from patients about their symptoms, how well they understand their options, and what is important to them, and sharing that information with providers. We review public and private developments that could facilitate the development of tools and methods to improve patient-centered care. Read More on PubMed
  • The purpose of this study was to further validate a novel instrument to measure satisfaction with end-of-life care, called the Canadian Health Care Evaluation Project (CANHELP) questionnaire. Data were collected by a cross-sectional survey of patients who had advanced, life-limiting illnesses and their family caregivers, and who completed CANHELP, a global rating of satisfaction, and a quality of life questionnaire. We conducted factor analysis, assessed internal consistency using Cronbach's alpha, and evaluated construct validity by describing the correlation amongst CANHELP, global rating of satisfaction and the quality of life questionnaire scores. There were 361 patient and 193 family questionnaires available for analysis. In the factor analysis, we identified six easily interpretable factors which explained 55.4% and 60.2% of the variance for the patient and caregiver questionnaire, respectively. For the patient version, the subscales derived from these factors were Relationship with Doctors, Illness Management, Communication, Decision-Making, Role of the Family, and Your Well-being. For the family questionnaire, the factors were Relationship with Doctors, Characteristics of Doctors and Nurses, Illness Management, Communication and Decision-Making, Your Involvement, and Your Well-being. Each subscale for each questionnaire had acceptable to excellent internal consistency (Cronbach's alpha ranged from 0.69-0.94). We observed good correlations between the CANHELP overall satisfaction score and global rating of satisfaction (correlation coefficient 0.49 and 0.63 for patient and family, respectively) which was greater than the correlations between CANHELP and the quality of life instruments. We conclude that the CANHELP Questionnaire is a valid and internally consistent instrument to measure satisfaction with end-of-life care. Read More on PubMed
  • Patients with advanced heart failure have improved survival rates and quality of life when treated with implanted pulsatile-flow left ventricular assist devices as compared with medical therapy. New continuous-flow devices are smaller and may be more durable than the pulsatile-flow devices. Read More on PubMed
  • The Promoting Action on Research Implementation in Health Services, or PARIHS, framework is a theoretical framework widely promoted as a guide to implement evidence-based clinical practices. However, it has as yet no pool of validated measurement instruments that operationalize the constructs defined in the framework. The present article introduces an Organizational Readiness to Change Assessment instrument (ORCA), organized according to the core elements and sub-elements of the PARIHS framework, and reports on initial validation. Read More on PubMed
  • To identify a set of critical facts and key goals and concerns for five common medical conditions, benign prostate disease, hip and knee osteoarthritis, herniated disc and spinal stenosis and examine the validity of the method for identifying these items. Read More on PubMed
  • Studies of end-of-life care have shown that Latino patients want more aggressive care compared to white patients. While this has been attributed to aspects of ethnicity, national origin, and religion, it is possible that limited education might obscure the true relationship between Latino patients and their end-of-life care preferences. Read More on PubMed
  • This study evaluated the impact of left ventricular assist device (LVAD) support on survival and quality of life in inotrope-dependent heart failure patients ineligible for cardiac transplantation. Read More on PubMed
  • Current public health and medical evidence rely heavily on efficacy information to make decisions regarding intervention impact. This evidence base could be enhanced by research studies that evaluate and report multiple indicators of internal and external validity such as Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) as well as their combined impact. However, indices that summarize the combined impact of, and complex interactions among, intervention outcome dimensions are not currently available. We propose and discuss a series of composite metrics that combine two or more RE-AIM dimensions, and can be used to estimate overall intervention impact. Although speculative and, at this point, there have been limited empirical data on these metrics, they extend current methods and are offered to yield more integrated composite outcomes relevant to public health. Such approaches offer potential to help identify interventions most likely to meaningfully impact population health. Read More on PubMed
  • To develop a set of quality criteria for patient decision support technologies (decision aids). Read More on PubMed
  • The HeartMate vented electric left ventricular assist device has been approved for use as destination therapy. Thus, the study of quality-of-life outcomes, as well as morbidity and mortality, is imperative. The purpose of our study was to describe change with time (from 1 month to 1 year) in patients who received a HeartMate vented electric left ventricular assist device as a bridge to heart transplantation and to identify quality-of-life predictors of survival after left ventricular assist device implantation. Read More on PubMed
  • This study describes the process and outcomes of continuous outpatient support with inotropes (COSI) in patients with Stage D heart failure (HF). Although Stage D HF has recently been defined as end-stage disease requiring special interventions for survival such as COSI or ventricular assist devices, concern has been raised regarding the safety, efficacy, mortality outcomes, and ethics of COSI. Read More on PubMed
  • Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated. Read More on PubMed
  • In the course of developing a standardised, non-disease-specific instrument for describing and valuing health states (based on the items in Table 1), the EuroQol Group (whose members are listed in the Appendix) conducted postal surveys in England, The Netherlands and Sweden which indicate a striking similarity in the relative valuations attached to 14 different health states. The data were collected using a visual analogue scale similar to a thermometer. The EuroQol instrument is intended to complement other quality-of-life measures and to facilitate the collection of a common data set for reference purposes. Others interested in participating in the extension of this work are invited to contact the EuroQol Group. Read More on PubMed
  • A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The anxiety and depressive subscales are also valid measures of severity of the emotional disorder. It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments. Read More on PubMed
  • Preference-sensitive treatment decisions involve making value trade-offs between benefits and harms that should depend on informed patient choice. There is strong evidence that patient decision aids not only improve decision quality but also prevent the overuse of options that informed patients do not value. This paper discusses progress in implementing decision aids and the policy prospects for reaching a "tipping point" in the adoption of "informed patient choice" as a standard of practice. Read More on PubMed
  • The study objective was to evaluate the psychometric properties of a decisional conflict scale (DCS) that elicits: 1) health-care consumers' uncertainty in making a health-related decision; 2) the factors contributing to the uncertainty; and 3) health-care consumers' perceived effective decision making. The DCS was developed in response to the lack of instruments available to evaluate health-care-consumer decision aids and to tailor decision-supporting interventions to particular consumer needs. The scale was evaluated with 909 individuals deciding about influenza immunization or breast cancer screening. A subsample of respondents was retested two weeks later. The test-retest reliability coefficient was 0.81. Internal consistency coefficients ranged from 0.78 to 0.92. The DCS discriminated significantly (p < 0.0002) between those who had strong intentions either to accept or to decline invitations to receive influenza vaccine or breast cancer screening and those whose intentions were uncertain. The scale also discriminated significantly (p < 0.0002) between those who accepted or rejected immunization and those who delayed their decisions to be immunized. There was a weak inverse correlation (r = -0.16, p < 0.05) between the DCS and knowledge test scores. The psychometric properties of the scale are acceptable. It is feasible and easy to administer. Evaluations of responsiveness to change and validation with more difficult decisions are warranted. Read More on PubMed
  • As patients become more involved in health care decisions, there may be greater opportunity for decision regret. The authors could not find a validated, reliable tool for measuring regret after health care decisions. Read More on PubMed
  • The responsibility of caregiving for patients requiring left ventricular assistance device (LVAD) support may be significant. However, little is known about their experience. Data from the Interagency Registry for Mechanically Assisted Circulatory Support (2006-2009) reported that 1722 patients had received LVADs as a bridge to transplantation, recovery, or destination therapy. The use of this advanced technology in the management of endstage heart failure is expected to continue, suggesting increased involvement of family members and significant others. The purpose of this qualitative study was to describe the experiences of caregivers of patients who received LVAD therapy as a bridge to transplantation. Read More on PubMed

Study Results Summary

Not yet available

Supplemental Study Information

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CLS-20266927

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