ABSTRACT
BACKGROUND: Peer support is a promising intervention to mitigate post-ICU disability, however there is a paucity of rigorously designed studies. OBJECTIVES: The objective of this study was to establish feasibility of an in-person, co-designed, peer-support model. METHODS: Prospective, randomised, adaptive, single-centre pilot trial with blinded outcome assessment, conducted at a university-affiliated hospital in Melbourne, Australia. Intensive care unit survivors (and their nominated caregiver, where survivor and caregiver are referred to as a dyad), >18 years of age, able to speak and understand English and participate in phone surveys, were eligible. Participants were randomised to the peer-support model (six sessions, fortnightly) or usual care (no follow-up or targeted information). Two sequential models were piloted: 1. Early (2-3 weeks post hospital discharge) 2. Later (4-6 weeks post hospital discharge). Primary outcome was feasibility of implementation measured by recruitment, intervention attendance, and outcome completion. Secondary outcomes included post-traumatic stress and social support. RESULTS: Of the 231 eligible patients, 80 participants were recruited. In the early model we recruited 38 participants (28 patients, 10 carers; 18 singles, 10 dyads), with an average (standard deviation) age of 60 (18) years; 55 % were female. Twenty-two participants (58 %) were randomised to intervention. Participants in the early intervention model attended a median (interquartile range) of 0 (0-1) sessions (total 24 sessions), with 53% (n = 20) completing the main secondary outcome of interest (Impact of Event Scale) at the baseline and 37 % (n = 14) at the follow-up. For the later model we recruited 42 participants (32 patients, 10 carers; 22 singles, 10 dyads), with an average (standard deviation) age of 60.4 (15.4) years; 50 % were female. Twenty-one participants (50 %) were randomised to intervention. The later intervention model attended a median (interquartile range) of 1 (0-5) sessions (total: 44 sessions), with the main secondary outcome impact of events scale (IES-R) completed by 41 (98 %) participants at baseline and 29 (69 %) at follow-up. CONCLUSIONS: In this pilot trial, a peer-support model that required in-person attendance delivered in a later posthospital phase of recovery appeared more feasible than an early model. Further research should investigate alternative modes of intervention delivery to improve feasibility (ACTRN12621000737831).
ABSTRACT
BACKGROUND: Process evaluation within clinical trials provides an assessment of the study implementation's accuracy and quality to explain causal mechanisms and highlight contextual factors associated with variation in outcomes. OBJECTIVES: This study aimed to identify the barriers and facilitators of implementing early mobilisation (EM) within a trial. METHODS: This is a qualitative process evaluation study within the Trial of Early Activity and Mobilisation (TEAM) phase 3 randomised controlled trial. Semistructured interviews were conducted remotely with multiprofessional clinicians (physiotherapists, medical staff, and nursing staff) involved in the delivery of the TEAM intervention at Australian hospitals participating in the TEAM study. Inductive coding was used to establish themes which were categorised into the Behaviour system involving domains of Capability, Opportunity, and Motivation (COM-B), which allowed barriers and enablers affecting EM to be identified. FINDINGS: Semistructured interviews were conducted in three different states of Australia. There were 16 participants, including 10 physiotherapists, five physicians, and one nurse. The key themes that facilitated EM were mentoring, champions, additional staff, organisation of the environment, cultural changes, communication, and documented safety criteria. In contrast, the main factors that hindered EM were lack of expertise and confidence in delivering EM, heavy sedation, interdisciplinary conflicts, and perceived risks related to EM. CONCLUSION: A wide range of barriers and facilitators that influenced EM within the TEAM study were identified using the COM-B framework. Many of these have been previously identified in the literature; however, participation in the study was viewed positively by multidisciplinary team members.
Subject(s)
Communication , Early Ambulation , Australia , Humans , Qualitative ResearchABSTRACT
OBJECTIVES: To evaluate the methodological quality and thematic completeness of existing clinical practice guidelines, addressing early mobilization of adults in the ICU. DATA SOURCES: Systematic review of Medline, Embase, CINAHL, Cochrane, and grey literature from January 2008 to February 2020. STUDY SELECTION: Two reviewers independently screened titles and abstracts and then full texts for eligibility. Ten publications were included. DATA EXTRACTION: A single reviewer extracted data from the included publications and a second reviewer completed cross-checking. Qualitative data were extracted in five categories relating to the key factors influencing delivery of early mobilization to critically ill patients. DATA SYNTHESIS: Methodological quality was appraised using the Appraisal of Guidelines for Research and Evaluation II tool. Appraisal of Guidelines for Research and Evaluation II scores for applicability were low. Median quality scores for editorial independence, rigor of development, and stakeholder engagement were also poor. Narrative synthesis of publication content was undertaken. All publications supported implementation of early mobilization. Most documents agreed upon seven topics: 1) early mobilization is safe and may reduce healthcare costs, 2) safety criteria should be provided, 3) a protocolized or structured approach should be used, 4) collaborative teamwork is required, 5) staff require specific skills or experience, 6) patient and family engagement is important, and 7) program evaluation and outcome measurement are a key component of implementation. There was no consensus on dosage and patient selection. The areas of team culture and leadership were poorly addressed. CONCLUSIONS: Despite significant variation in the methodological quality of clinical practice guidelines for early mobilization, there were important consistencies in recommendations internationally. Future research should address gaps related to patient selection, dosage, team culture, and expertise. Future clinical practice guidelines in this area should focus on engagement of patients and families in the development process and provision of resources to support implementation based on the consideration of known barriers and facilitators.
