Review question/objective

This qualitative systematic review aims to synthesize evidence on the experiences of informal caregivers in the provision of care to adult individuals living with a left ventricular assist device (LVAD).

Specifically, the review questions are:

* What roles and responsibilities do informal caregivers/support persons assume in caring for adult persons living with a LVAD in a home setting?

* What are the perceived physical, psychosocial or social consequences of caregiving on informal caregivers/support persons caring for an adult individual with a LVAD?

* What are the variables that contribute to the aforementioned consequences on informal caregivers/support persons caring for an adult individual with a LVAD? Certain known variables such as bridge-to transplant (BTT) and destination therapy (DT) may warrant further investigation if the evidence supports further analyses.

* What do informal caregivers/support persons identify as important resources and/or coping strategies in caring for an adult individual with a LVAD?

Background

Heart failure (HF) is characterized as a clinical syndrome that results from a wide range of clinical disorders that impede ventricular filling and the ability of the ventricles to pump blood effectively.1 The global burden of HF is significant. It is estimated that 5.7 million adult Americans have HF and that number is expected to increase by 46% by 2030.2 Approximately 500,000 Canadians have HF with an incidence of 50,000 new cases each year.3,4 Heart failure is the largest contributor to age-standardized years of living, resulting in disability among men in high-income regions of North America, Oceania, Eastern and Western Europe, southern Latin America and Central Asia.2

Although both ventricles may be affected, HF typically involves the left ventricle and may progress to right sided or biventricular failure. The development and progression of HF is depicted by four stages (A to D). Stage D represents the end stage of HF, where specialized mechanical support therapies may be warranted.1 Mechanical circulatory support (MCS) therapies, such as ventricular assist devices, are either short or long term surgical interventions used to assist the right, left or both ventricles, depending on the clinical presentation.5 Left Ventricular Assist Device (LVAD) implants are the most commonly implanted MCS device with the goal of supporting advanced heart failure patients with long term circulatory support.6

As a long term MCS device, an LVAD is designed to augment or replace the function of a failing left ventricle and deliver blood from the left ventricle to the body. LVAD therapy was first shown to be superior to medical management in its "clinically meaningful" survival benefits and in ensuring a better quality of life in the landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial.7 Although the primary goal of ventricular assist devices is to improve survival, ameliorating quality of life is also critically important to patients and their caregivers.8

The number of individuals living with HF and end-stage HF, in particular, is increasing due, in part, to an aging population and advances in medical and surgical therapies. An anticipated 3-fold increase in the number of incident HF hospitalizations over the upcoming years without a concurrent increase in available donor hearts may result in a consequent increase in the use of MCS therapies, such as LVADs to sustain life.8 The decision to proceed with an LVAD impacts both patients and their informal caregivers. Informal caregivers are primarily spouses but also include siblings, parents, offspring, or close friends and others. In most centers, the standard of care is for LVAD patients to have designated informal caregivers/support persons to assist them in living with an LVAD when they return to the community.

The role of the caregiver is a significant commitment as the duration of LVAD therapy varies from days to weeks, and even years. The LVAD may be indicated as a bridge to transplant (BTT) where the goal is to optimize the patient's physical wellbeing prior to transplantation, or as destination therapy (DT) when heart transplantation is not an option.1,8,9 The approval of LVADs for DT varies among countries. A LVAD may be an option as a DT for advanced-stage HF patients who do not respond to optimal medical therapy and are not suitable candidates for heart transplantation (direct DT) or where there have been unsuccessful attempts to bridge to heart transplant candidacy.

The perceived burden of care by informal caregivers/support persons may be affected by the urgency and indications of device implantation as well as the LVAD type. For example, the perception of burden may be greater in an unplanned and/or emergency implantation situation.10 Regardless of the implantation circumstances; the expectations on caregivers are significant. Prior to patient discharge, informal caregiver/support persons must receive training by healthcare providers in maintaining and troubleshooting the LVAD. Upon discharge, the informal caregiver is partially or completely responsible for helping the patient perform the prescribed self-care regimen. This regimen includes monitoring of vital signs, assessing clinical symptoms, monitoring LVAD function, troubleshooting LVAD alarms, and obtaining emergency services when needed.8,11

Informal LVAD caregivers must make significant lifestyle adjustments and incorporate the complex caregiving demands into their own often very busy lives. This accommodation frequently takes a personal toll on caregivers: research literature suggests that this caregiving role is characterized by stress, financial strain, grief and clinical depression.3,10,12-18 In addition, the life adjustments made by the requirements of caregiving can give rise to the loss of jobs, financial issues, and compromising hobbies, social activities and attention to the caregivers' own health.12

Informal LVAD caregivers adapt over time to the necessary adjustments that they have to make. These adaptations are both physical and emotional/spiritual. The role of the healthcare team is to assist the caregiver in coping with these adaptations. To support the physical demands, the healthcare team provides education and training related to the LVAD, and treatment of health related issues of the patient. They also provide psychological support by instilling confidence and offering emotional reassurance to the caregiver.14 Marcuccilli and Casida identified seven coping strategies of caregivers: positive thinking, good family support, developing a routine, acceptance, prayer, faith and hope, religiosity and fatalism.8 Baker et al. identifies methods of caregiver coping as "problem-focused strategies".12 Caregivers adopt situation-specific strategies, including hiring help, downsizing their home, purchasing mechanical aids, and developing effective and efficient routines.9 Underlying these strategies are factors that contribute to the informal LVAD caregivers/support persons' ability to adapt. Baker et al. suggests that resilience "may be an attribute of or a process used by caregivers that serves as the antecedent of the adaptive state".(12(p199) In the process of resilience, protective factors including self-efficacy, hope and competency compensate for or reduce the risk of adversity of situations.12

An examination of the Cochrane Library of Systematic Reviews, the Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, Epistemonikos.org database, and the PROSPERO database indicates that no systematic reviews have been completed or are currently being investigated on this topic. A synthesis would provide a comprehensive, understanding of the roles and responsibilities of informal LVAD caregivers and the perceived consequences, as well as the factors that support coping strategies in caring for individuals with LVADs. This understanding will facilitate the development of appropriate targeted nursing interventions to ensure optimal support for informal caregivers/support persons now and in the future.

This systematic review aims to present the best available qualitative research evidence in the last 15 years, describing the experiences, feelings and beliefs of informal caregivers/support persons of patients living with a LVAD. The philosophical approach informing this review is that of critical realism. In this approach, critical realists believe there is a real world that exists independently of human perceptions, beliefs and theories. One understands and interprets the real world through his or her perspectives and views.18 Insights gleaned from this review will be critical to the development and implementation of optimal strategies to reduce the caregiver burden and to ultimately have a positive impact on the overall wellbeing of the informal caregiver/support person.

Inclusion criteria

Types of participants

This systematic review will consider studies that include the following:

* Informal caregivers/support persons of any age providing care to an adult over the age of 18 years.

* Informal caregivers/support persons providing care for individuals with a LVAD irrespective of the relationship.

* LVAD support - including for any type of LVAD, and for any indication or urgency around the LVAD implant. This will cover the widest possible range of circumstances faced by informal caregivers/support persons.

* LVAD support - including for any intended purpose. This includes both LVAD as DT and BTT.

Phenomena of interest

This review will consider studies that investigate the informal caregiving experiences in caring for adult individuals with LVADs. Studies incorporating interviews in which caregivers express their perceptions, attitudes and beliefs together with variables/factors that may impact their caregiver role will be included.

Context

This review will consider studies that involve informal caregiver/support persons' experiences caring for individuals with a LVAD in a home setting. The home setting is anywhere the patient and the informal caregiver reside once discharged from an acute care facility. This home setting may be either a temporary or permanent residential dwelling of the informal caregiver/support person. No other cultural, racial or gender-based interests are considered in this review.

Types of studies

This qualitative review will consider studies that focus on qualitative data including, but not limited to, designs such as phenomenology, grounded theory, ethnography and action research. Surveys that have a qualitative component, i.e. open answer/essay questions, will also be considered as appropriate for inclusion.

In the absence of research studies, other texts such as opinion papers and reports will be considered.

Search strategy

The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of MEDLINE and CINAHL will be undertaken followed by an analysis of the text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. Studies published in English only will be considered for inclusion in this review. Studies published from 2000 to the present will be considered for inclusion in this review. The year 2000 start date was established because of the landmark 2001 publication of the REMATCH study.7 The landmark trial resulted in an increase in long term LVAD implants worldwide beginning in the new millennia. The databases to be searched include: CIRRIE (Center for International Rehabilitation Research Information and Exchange), CINAHL, Embase (Ovid), Health Systems Research, Trip database, Medline (Ovid), PsychINFO, Social Science Citation Index (Web of Science), and Sociological Abstracts.

The search for unpublished studies will include: OpenGrey, hand search proceedings from the International Society of Heart and Lung Transplant, Dissertations and Theses (ProQuest), Index to Theses (theses.com), Canadian Health Research Collection (health policy reports), and Google.

Authors of primary studies will be contacted for missing information or to clarify unclear data.

Initial keywords to be used will be: ventricular dysfunction, left; heart failure; heart transplantation; heart-assist devices; mechanical device^*; (heart or ventricular) and (device^* or implant); caregiver^*; care-giver^*; carer^*; family, families; relative^*; spouse^*; wife; husband; partner, partners; "informal caregiver"; friend, friends; Caregiver burden.

Assessment of methodological quality

Qualitative papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Qualitative Assessment and Review Instrument (QARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.

Data extraction

Qualitative data will be extracted from papers included in the review using the standardized data extraction tool from JBI-QARI (Appendix II). The data extracted will include specific details about the phenomena of interest, populations, study methods and outcomes of significance to the review question and specific objectives. The authors' conclusions and comments will also be recorded at the time of extraction.

Data synthesis

Qualitative research findings will, where possible be pooled using JBI-QARI. This will involve the aggregation or synthesis of findings to generate a set of statements that represent that aggregation, through assembling the findings rated according to their quality, and categorizing these findings on the basis of similarity in meaning. These categories will then be subjected to a meta-synthesis in order to produce a single comprehensive set of synthesized findings that can be used as a basis for evidence-based practice. Where textual pooling is not possible the findings will be presented in narrative form.

Conflicts of interest

The authors declare that there are no conflicts of interest.

Acknowledgements

Canadian Council of Cardiovascular Nurses (CCCN) Research Grant ($1250).

References