Title: The effectiveness of interventions to promote patients' and families' involvement in adult intensive care settings: a systematic review.
Funder: Department of Health and Social Care

Abstract: Background: Despite increasing concern from policymakers and the public over a number of years (IoM 2001, NHS FYFV 2015) for greater patient and family member involvement (PFMI) in healthcare, this aspiration has not yet been met. Intensive care units (ICU) are a case in point, where PFMI can have profound consequences for care decisions, delivery and outcomes. Family members/carers have a special role since ICU patients are rarely in a position to communicate directly with clinicians, recollect their ICU experience and engage fully with the complexity of their condition. Studies have confirmed that family members can have a positive influence on a patient s care and recovery from ICU (Bench et al. 2016, Liput et al. 2016); but also that family members themselves can be adversely affected by an ICU stay even after discharge (Azoulay et al. 2014). The past decade has witnessed different, mainly local attempts at promoting PFMI in ICU; however, these lack a standard approach, which contributes to great variation in family satisfaction across UK ICUs (Wright et al. 2015). As an initial stage in a longer-term programme of research that aims to improve healthcare outcomes for intensive care patients as well as experiences for their families, this project will complete a systematic review of interventions designed to promote PFMI in adult intensive care settings. Aim: We aim to answer the following question: What are the available interventions, and which are most effective, for including patients and family members in the care processes and decisions made in adult intensive care settings? In doing so, we will develop a classification matrix of interventions, known as a typology, that takes into account their effectiveness and quality of their evidence base. Plan of investigation: We will employ well-recognised methods for searching, screening, abstracting, quality assessing and synthesising the included literature. A review protocol will be registered with the PROSPERO database. We will search a series of sources selected with the purpose of ensuring comprehensive coverage of the literature on PFMI, including the MEDLINE, EMBASE and CINAHL databases; as well as the Cochrane Central Register of Controlled Trials, Joanna Briggs and Cochrane Library with no date restriction. Manual searches of recent back issues of leading ICU journals will also be undertaken, as will the reference lists of included studies. Unpublished literature will be sought through grey literature databases. All evaluation studies that consider interventions to promote PFMI in adult ICUs will be included. All research designs will be eligible. Abstracts and papers will be independently screened by at least two members of the team to determine their inclusion. Included papers will be assessed for methodological rigour using a standard rating approach, which assesses quality of study and quality of information . Quality assessment will be completed by at least two members of the team. Data on interventions, evaluation methods and outcomes will be collated using a predetermined extraction table. These are likely to be heterogeneous in nature, which will mean that the review will follow a narrative approach to synthesis. Potential benefits to patients and the NHS: We will develop a typology of interventions that promote PFMI in ICU that takes into account their effectiveness, quality of their evidence base and factors that support or impede involvement. This will be made available for use by ICU clinicians to inform their decision-making for adopting particular approaches to PFMI for their units; and considered by ICU patients and their relatives/carers who may wish to be more involved in their care. Our team will draw from this typology to inform the development of a follow-up study to empirically validate and contextualise this typology in NHS settings.

Lay abstract: Politicians, doctors, nurses and other health professionals have long called for greater patient and family member involvement in adult intensive care to contribute, in partnership with health professionals, to the delivery of quality care; this is a priority area for the National Health Service, identified through a priority-setting partnership involving patients and carers. This is in response to a shared understanding that such involvement improves the quality and safety of care through better communication between patients, families and health professionals. Effort has been dedicated to activities designed to improve the participation of patients and their family members; however, there continues to be uncertainty about how well these activities work, and which are most likely to be successful. In this project we will work closely with patients, carers and health professionals &ndash; following a comprehensive and detailed approach known as systematic review &ndash; to understand the effectiveness and quality of evidence of such activities. Specifically, we will search a range of research databases and journals to identify reports of activities to improve the participation of patients and family members in adult intensive care. Information on available involvement activities, evaluation methods and outcomes will be examined and considered together. The quality of included research will be assessed in a detailed way following standard guidance. Results from this work will generate a comprehensive picture about what activities are available, which have been shown to work so far and under what circumstances. This will be shared with different hospitals and patient groups across England, to help them make informed decisions about which activities might suit them best. Our results will also identify any gaps in existing research, which will help plan future work to address such gaps and support greater patient and family member involvement in intensive care.

Research activity codes: 8.3 POLICY, ETHICS AND RESEARCH GOVERNANCE
Health categories: GENERIC HEALTH RELEVANCE