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IntroductionClinically important upper gastrointestinal bleeding is conventionally defined as bleeding accompanied by haemodynamic changes, requiring red blood cell transfusions or other invasive interventions. However, it is unclear if this clinical definition reflects patient values and preferences. This protocol describes a study to elicit views from patients and families regarding features, tests, and treatments for upper gastrointestinal bleeding that are important to them.Methods and analysisThis is a sequential mixed-methods qualitative-dominant multi-centre study with an instrument-building aim. We developed orientation tools and educational materials in partnership with patients and family members, including a slide deck and executive summary. We will invite intensive care unit (ICU) survivors and family members of former ICU patients to participate. Following a virtual interactive presentation, participants will share their perspectives in an interview or focus group. Qualitative data will be analysed using inductive qualitative content analysis, wherein codes will be derived directly from the data rather than using preconceived categories. Concurrent data collection and analysis will occur. Quantitative data will include self-reported demographic characteristics. This study will synthesise the values and perspectives of patients and family members to create a new trial outcome for a randomised trial of stress ulcer prophylaxis. This study is planned for May 2022 to August 2023. The pilot work was completed in Spring 2021.Ethics and disseminationThis study has ethics approval from McMaster University and the University of Calgary. Findings will be disseminated via manuscript and through incorporation as a secondary trial outcome on stress ulcer prophylaxis.Trial registration numberNCT05506150.

Oral anticoagulants (OACs) are very commonly prescribed for prevention of serious vascular events, but are also associated with serious medication-related bleeding. Mitigation of harm is believed to require high-quality OAC management. This study aimed to identify barriers and facilitators for optimal OAC management from the perspective of patients, caregivers and healthcare providers. Using a qualitative descriptive study design, we conducted five focus groups, three with patients and caregivers and two with health care providers, in two health regions in Southwestern Ontario. An expert facilitator led the discussions using a semi-structured interview guide. Each session was digitally recorded, transcribed verbatim and anonymized. Transcripts were analyzed in duplicate using conventional content analysis. Forty-two (19 patients, 7 caregivers, and 16 providers including physicians, nurses and pharmacists) participated. More than half of the patients received OAC for the treatment of venous thromboembolism (57.9%) and the majority (94.7%) were on chronic therapy (defined as >3 years). Data analysis organized codes describing barriers and facilitators into 4 main themes-medication-related, patient-related, provider-related, and system-related. Barriers highlighted were problems with medication access due to cost, patient difficulties with adherence, knowledge and adjusting their lifestyles to OAC therapy, provider expertise, time for adequate communication amongst providers and their patients, and health care system inadequacies in supporting communications and monitoring. Facilitators identified generally addressed these barriers. Many barriers to optimal OAC management exist even in the era of DOACs, many of which are amenable to facilitators of improved care coordination, patient education, and adherence monitoring.

The current COVID-19 vaccines are suboptimal against the evolving SARS-CoV-2 variants, particularly in high-risk populations. A next-generation vaccine strategy capable of effective induction of respiratory mucosal immunity remains to be clinically developed. Here, we report an open-label, multi-arm phase 1 study (NCT05094609) to evaluate a multi-antigenic COVID-19 vaccine delivered once via inhaled aerosol to the lung of intramuscular mRNA-vaccinated humans without or with prior SARS-CoV-2 infection (uninfected vs infected). Escalating doses of a human adenoviral (HuAd)-vectored or chimpanzee Ad (ChAd)-vectored vaccine are evaluated in the uninfected cohort. A selected Ad vaccine is further evaluated in the infected cohort. The safety is assessed as a primary outcome. Ag-specific immune responses (secondary outcome) are assessed in peripheral blood and in respiratory tract via bronchoscopy at baseline and at timepoint(s) post-vaccination. Eighteen-65-year-old, healthy participants who have received at least 3 doses of mRNA COVID-19 vaccine are enrolled with those vaccinated with any Ad-vectored COVID-19 vaccine excluded. At baseline, there is minimally detectable mucosal immunity in the lung of uninfected or infected humans. While all tested doses (1 × 10 5 to 1 × 10 8 TCID 50 ) of HuAd and ChAd vaccines are safe, ChAd vaccine markedly outperforms the HuAd counterpart in immunogenicity. Thus, an optimal aerosol dose of ChAd vaccine induces the tripartite respiratory mucosal immunity consisting of T cell, trained innate and antibody immunity. Our study thus presents a promising next-generation aerosol COVID-19 vaccine strategy for further clinical development. Vaccination provides protection from COVID-19, but optimization in design and route is an ever-ongoing process. Here the authors pursue an open-label, multi-arm phase I clinical trial to report the safety of a multi-valent, aerosol vaccine administered via inhalation, as well as superior mucosal immunity induced by ChAd over HuAd vectors.

Background The 3 Wishes Project (3WP) is an end-of-life program that honors the dignity of dying patients by fostering meaningful connections among patients, families, and clinicians. Since 2013, it has become embedded in the culture of end-of-life care in over 20 ICUs across North America. The purpose of the current study is to describe the variation in implementation of 3WP across sites, in order to ascertain which factors facilitated multicenter implementation, which factors remain consistent across sites, and which may be adapted to suit local needs. Methods Using the methodology of qualitative description, we collected interview and focus group data from 85 clinicians who participated in the successful initiation and sustainment of 3WP in 9 ICUs. We describe the transition between different models of 3WP implementation, from core clinical program to the incorporation of various research activities. We describe various sources of financial and in-kind resources accessed to support the program. Results Beyond sharing a common goal of improving end-of-life care, sites varied considerably in organizational context, staff complement, and resources. Despite these differences, the program was successfully implemented at each site and eventually evolved from a clinical or research intervention to a general approach to end-of-life care. Key to this success was flexibility and the empowerment of frontline staff to tailor the program to address identified needs with available resources. This adaptability was fueled by cross-pollination of ideas within and outside of each site, resulting in the establishment of a network of like-minded individuals with a shared purpose. Conclusions The successful initiation and sustainment of 3WP relied on local adaptations to suit organizational needs and resources. The semi-structured nature of the program facilitated these adaptations, encouraged creative and important ways of relating within local clinical cultures, and reinforced the main tenet of the program: meaningful human connection at the end of life. Local adaptations also encouraged a team approach to care, supplementing the typical patient-clinician dyad by explicitly empowering the healthcare team to collectively recognize and respond to the needs of dying patients, families, and each other. Trial registration NCT04147169 , retrospectively registered with clinicaltrials.gov on October 31, 2019.

Abstract Rationale The austere setting of the intensive care unit (ICU) can suppress expressions of spirituality. Objectives To describe how family members and clinicians experience and express spirituality during the dying process in a 21-bed medical–surgical ICU. Methods Reflecting the care of 70 dying patients, we conducted 208 semistructured qualitative interviews with 76 family members and 150 clinicians participating in the Three Wishes Project. Interviews were recorded and transcribed verbatim. Data were analyzed by three investigators using qualitative interpretive description. Measurements and Main Results Participants characterize dying as a spiritual event. Spirituality is an integral part of the life narrative of the patient before, during, and after death. Experiences and expressions of spirituality for patients, families, and clinicians during end-of-life care in the ICU are supported by eliciting and implementing wishes in several ways. Eliciting wishes stimulates conversations for people of diverse spiritual orientations to respond to death in personally meaningful ways that facilitate continuity and closure, and ease emotional trauma. Soliciting wishes identifies positive aspirations, which provide comfort in the face of death. The act of soliciting wishes brings clinician humanity to the fore. Wishing makes individual spiritual preferences and practices more accessible. Wishes may be grounded in spiritual goals, such as peace, comfort, connections, and tributes; they may seek a spiritually enhanced environment or represent specific spiritual interventions. Conclusions Family members and clinicians consider spirituality an important dimension of end-of-life care. The Three Wishes Project invites and supports the expression of myriad forms of spirituality during the dying process in the ICU.

BackgroundPandemic-related restrictions are expected to continue to shape end-of-life care and impact the experiences of dying hospitalised patients and their families.ObjectiveTo understand families’ experiences of loss and bereavement during and after the death of their loved one amidst the SARS-CoV-2 (COVID-19) pandemic.DesignQualitative descriptive study.SettingThree acute care units in a Canadian tertiary care hospital.ParticipantsFamily members of 28 hospitalised patients who died from March–July 2020.Main outcome measuresQualitative semistructured interviews conducted 6–16 months after patient death inquired about family experiences before and beyond the death of their loved one and garnered suggestions to improve end-of-life care.ResultsPandemic restrictions had consequences for families of dying hospitalised patients. Most family members described an attitude of acquiescence, some framing their experience as a sacrifice made for the public good. Families appreciated how clinicians engendered trust in the name of social solidarity while trying to mitigate the negative impact of family separation. However, fears about the patient’s experience of isolation and changes to postmortem rituals also created despair and contributed to long-lasting grief.ConclusionProfound loss and enduring grief were described by family members whose final connections to their loved one were constrained by pandemic circumstances. Families observed solidarity among clinical staff and experienced a sense of unity with staff, which alleviated some distress. Their suggestions to improve end-of-life care given pandemic restrictions included frequent, flexible communication, exceptions for family presence when safe, and targeted efforts to connect patients whose isolation is intensified by functional impairment or limited technological access.Trial registration numberNCT04602520; Results.

ObjectiveThe Word Cloud is a frequent wish in the 3 Wishes Project developed to nurture peace and ease the grieving process for dying critically ill patients. The objective was to examine whether Word Clouds can act as a heuristic approach to encourage a narrative orientation to medicine. Narrative medicine is an approach which can strengthen relationships, compassion and resilience.DesignWord Clouds were created for 42 dying patients, and we interviewed 37 family members and 73 clinicians about their impact. We conducted a directed qualitative content analysis, using the 3 stages of narrative medicine (attention, representation, affiliation) to examine the narrative medicine potential of Word Clouds.ResultsThe elicitation of stories for the Word Cloud promotes narrative attention to the patient as a whole person. The distillation of these stories into a list of words and the prioritisation of those words for arrangement in the collage encourages a representation that did not enforce a beginning, middle or end to the story of the patient's life. Strong affiliative connections were achieved through the honouring of patients, caring for families and sharing of memories encouraged through the creation, sharing and discussion of Word Clouds.ConclusionsIn the 3 Wishes Project, Word Clouds are 1 way that families and clinicians honour a dying patient. Engaging in the process of making a Word Cloud can promote a narrative orientation to medicine, forging connections, making meaning through reminiscence and leaving a legacy of a loved one. Documenting and displaying words to remember someone in death reaffirms their life.

ObjectivesThe Short-Form HIV Disability Questionnaire (SF-HDQ) was developed to measure the presence, severity and episodic nature of health challenges across six domains. Our aim was to assess the sensibility, utility and implementation of the SF-HDQ in clinical practice.DesignMixed methods study design involving semistructured interviews and questionnaire administration.ParticipantsWe recruited adults living with HIV and HIV clinicians in Canada, Ireland and the USA.MethodsWe electronically administered the SF-HDQ followed by a Sensibility Questionnaire (face and content validity, ease of usage, format) and conducted semistructured interviews to explore the utility and implementation of the SF-HDQ in clinical practice. The threshold for sensibility was a median score of >5/7 (adults living with HIV) and>4/7 (HIV clinicians) for ≥80% of items. Qualitative interview data were analysed using directed content analysis.ResultsMedian sensibility scores were >5 (adults living with HIV; n=29) and >4 (HIV clinicians; n=16) for 18/19 (95%) items. Interview data indicated that the SF-HDQ represents the health-related challenges of living with HIV and other concurrent health conditions; captures the daily episodic nature of HIV; and is easy to use. Clinical utility included measuring health challenges and change over time, guiding referral to specialists and services, setting goals, facilitating communication and fostering a multidisciplinary approach to care. Considerations for implementation included flexible, person-centred approaches to administration, and communicating scores based on personal preferences.ConclusionsThe SF-HDQ possesses sensibility and utility for use in clinical settings with adults living with HIV and HIV clinicians in three countries.

Background Scaling-up and sustaining healthcare interventions can be challenging. Our objective was to describe how the 3 Wishes Project (3WP), a personalized end-of-life intervention, was scaled-up and sustained in an intensive care unit (ICU). Methods In a longitudinal mixed-methods study from January 12,013 - December 31, 2018, dying patients and families were invited to participate if the probability of patient death was > 95% or after a decision to withdraw life support. A research team member or bedside clinician learned more about each of the patients and their family, then elicited and implemented at least 3 personalized wishes for patients and/or family members. We used a qualitative descriptive approach to analyze interviews and focus groups conducted with 25 clinicians who cared for the enrolled patients. We used descriptive statistics to summarize patient, wish, and clinician characteristics, and analyzed outcome data in quarters using Statistical Process Control charts. The primary outcome was enrollment of terminally ill patients and respective families; the secondary outcome was the number of wishes per patient; tertiary outcomes included wish features and stakeholder involvement. Results Both qualitative and quantitative analyses suggested a three-phase approach to the scale-up of this intervention during which 369 dying patients were enrolled, having 2039 terminal wishes implemented. From a research project to clinical program to an approach to practice, we documented a three-fold increase in enrolment with a five-fold increase in total wishes implemented, without a change in cost. Beginning as a study, the protocol provided structure; starting gradually enabled frontline staff to experience and recognize the value of acts of compassion for patients, families, and clinicians. The transition to a clinical program was marked by handover from the research staff to bedside staff, whereby project catalysts mentored project champions to create staff partnerships, and family engagement became more intentional. The final transition involved empowering staff to integrate the program as an approach to care, expanding it within and beyond the organization. Conclusions The 3WP is an end-of-life intervention which was implemented as a study, scaled-up into a clinical program, and sustained by becoming integrated into practice as an approach to care.

ObjectivesThe objectives of this mixed-methods study were to assess the uptake, sustainability and influence of the Footprints Project.SettingTwenty-two-bed university-affiliated ICU in Hamilton, Canada.ParticipantsICU patients admitted and their families, as well as clinicians.InterventionsWe developed a personalised patient Footprints Form and Whiteboard to facilitate holistic, patient-centred care, to inform clinical encounters, and to create deeper connections among patients, families and clinicians.Outcome measuresWe conducted 3 audits to examine uptake and sustainability. We conducted semi-structured interviews with 10 clinicians, and held 5 focus groups with 25 clinicians; and we interviewed 5 patients and 13 family representatives of 5 patients who survived and 5 who died in the ICU. Transcripts were analysed using qualitative content analysis.ResultsThe Footprints Project facilitated holistic, patient-centred care by setting the stage for patient and family experience, motivating the patient and humanising the patient for clinicians. Through informing clinical encounters, Footprints helped clinicians initiate more personal conversations, foster deeper connections and guide treatment. Professional practice influences included more focused attention on the patient, enhanced interdisciplinary communication and changes in community culture. Initially used in 15.8% of patients (audit A), uptake increased to 51.4% in audit B, and was sustained at 57.8% in audit C.ConclusionsBy sharing valuable personal information about patients before and beyond their illness on individualised whiteboards at each bedside, the Footprints Project fosters humanism in critical care practice.