Co-development of a transitions in care bundle for patient transitions from the intensive care unit: a mixed-methods analysis of a stakeholder consensus meeting.

BACKGROUND: Intensive care unit (ICU) patients undergoing transitions in care are at increased risk of adverse events and gaps in medical care. We evaluated existing patient- and family-centered transitions in care tools and identified facilitators, barriers, and implementation considerations for the application of a transitions in care bundle in critically ill adults (i.e., a collection of evidence-based patient- and family-centred tools to improve outcomes during and after transitions from the intensive care unit [ICU] to hospital ward or community). METHODS: We conducted a concurrent mixed methods (quan + QUAL) study, including stakeholders with experience in ICU transitions in care (i.e., patient/family partners, researchers, decision-makers, providers, and other knowledge-users). First, participants scored existing transitions in care tools using the modified Appraisal of Guidelines, Research and Evaluation (AGREE-II) framework. Transitions in care tools were discussed by stakeholders and either accepted, accepted with modifications, or rejected if consensus was achieved (≥70% agreement). We summarized quantitative results using frequencies and medians. Second, we conducted a qualitative analysis of participant discussions using grounded theory principles to elicit factors influencing AGREE-II scores, and to identify barriers, facilitators, and implementation considerations for the application of a transitions in care bundle. RESULTS: Twenty-nine stakeholders attended. Of 18 transitions in care tools evaluated, seven (39%) tools were accepted with modifications, one (6%) tool was rejected, and consensus was not reached for ten (55%) tools. Qualitative analysis found that participants' AGREE-II rankings were influenced by: 1) language (e.g., inclusive, balance of jargon and lay language); 2) if the tool was comprehensive (i.e., could stand alone); 3) if the tool could be individualized for each patient; 4) impact to clinical workflow; and 5) how the tool was presented (e.g., brochure, video). Participants discussed implementation considerations for a patient- and family-centered transitions in care bundle: 1) delivery (e.g., tool format and timing); 2) continuity (e.g., follow-up after ICU discharge); and 3) continuous evaluation and improvement (e.g., frequency of tool use). Participants discussed existing facilitators (e.g., collaboration and co-design) and barriers (e.g., health system capacity) that would impact application of a transitions in care bundle. CONCLUSIONS: Findings will inform future research to develop a transitions in care bundle for transitions from the ICU, co-designed with patients, families, providers, researchers, decision-makers, and knowledge-users.

Restricted visitation policies in acute care settings during the COVID-19 pandemic: a scoping review.

BACKGROUND: Restricted visitation policies in acute care settings because of the COVID-19 pandemic have negative consequences. The objective of this scoping review is to identify impacts of restricted visitation policies in acute care settings, and describe perspectives and mitigation approaches among patients, families, and healthcare professionals. METHODS: We searched Medline, Embase, PsycINFO, Healthstar, CINAHL, Cochrane Central Register of Controlled Trials on January 01/2021, unrestricted, for published primary research records reporting any study design. We included secondary (e.g., reviews) and non-research records (e.g., commentaries), and performed manual searches in web-based resources. We excluded records that did not report primary data. Two reviewers independently abstracted data in duplicate. RESULTS: Of 7810 citations, we included 155 records. Sixty-six records (43%) were primary research; 29 (44%) case reports or case series, and 26 (39%) cohort studies; 21 (14%) were literature reviews and 8 (5%) were expert recommendations; 54 (35%) were commentary, editorial, or opinion pieces. Restricted visitation policies impacted coping and daily function (n = 31, 20%) and mental health outcomes (n = 29, 19%) of patients, families, and healthcare professionals. Participants described a need for coping and support (n = 107, 69%), connection and communication (n = 107, 69%), and awareness of state of well-being (n = 101, 65%). Eighty-seven approaches to mitigate impact of restricted visitation were identified, targeting families (n = 61, 70%), patients (n = 51, 59%), and healthcare professionals (n = 40, 46%). CONCLUSIONS: Patients, families, and healthcare professionals were impacted by restricted visitation polices in acute care settings during COVID-19. The consequences of this approach on patients and families are understudied and warrant evaluation of approaches to mitigate their impact. Future pandemic policy development should include the perspectives of patients, families, and healthcare professionals. TRIAL REGISTRATION: The review was registered on PROSPERO (CRD42020221662) and a protocol peer-reviewed prior to data extraction.

Partnering With Family Members to Detect Delirium in Critically Ill Patients.

OBJECTIVES: To evaluate the diagnostic accuracy of family-administered tools to detect delirium in critically ill patients. DESIGN: Diagnostic accuracy study. SETTING: Large, tertiary care academic hospital in a single-payer health system. PATIENTS: Consecutive, eligible patients with at least one family member present (dyads) and a Richmond Agitation-Sedation Scale greater than or equal to -3, no primary direct brain injury, the ability to provide informed consent (both patient and family member), the ability to communicate with research staff, and anticipated to remain admitted in the ICU for at least a further 24 hours to complete all assessments at least once. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Family-administered delirium assessments (Family Confusion Assessment Method and Sour Seven) were completed once daily. A board-certified neuropsychiatrist and team of ICU research nurses conducted the reference standard assessments of delirium (based on Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition, criteria) once daily for a maximum of 5 days. The mean age of the 147 included patients was 56.1 years (SD, 16.2 yr), 61% of whom were male. Family members (n = 147) were most commonly spouses (n = 71, 48.3%) of patients. The area under the receiver operating characteristic curve on the Family Confusion Assessment Method was 65.0% (95% CI, 60.0-70.0%), 71.0% (95% CI, 66.0-76.0%) for possible delirium (cutpoint of 4) on the Sour Seven and 67.0% (95% CI, 62.0-72.0%) for delirium (cutpoint of 9) on the Sour Seven. These area under the receiver operating characteristic curves were lower than the Intensive Care Delirium Screening Checklist (standard of care) and Confusion Assessment Method for ICU. Combining the Family Confusion Assessment Method or Sour Seven with the Intensive Care Delirium Screening Checklist or Confusion Assessment Method for ICU resulted in area under the receiver operating characteristic curves that were not significantly better, or worse for some combinations, than the Intensive Care Delirium Screening Checklist or Confusion Assessment Method for ICU alone. Adding the Family Confusion Assessment Method and Sour Seven to the Intensive Care Delirium Screening Checklist and Confusion Assessment Method for ICU improved sensitivity at the expense of specificity. CONCLUSIONS: Family-administered delirium detection is feasible and has fair, but lower diagnostic accuracy than clinical assessments using the Intensive Care Delirium Screening Checklist and Confusion Assessment Method for ICU. Family proxy assessments are essential for determining baseline cognitive function. Engaging and empowering families of critically ill patients warrant further study.

A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study.

BACKGROUND: Delirium is very common in critically ill patients admitted to the intensive care unit (ICU) and results in negative long-term outcomes. Family members are also at risk of long-term complications, including depression and anxiety. Family members are frequently at the bedside and want to be engaged; they know the patient best and may notice subtle changes prior to the care team. By engaging family members in delirium care, we may be able to improve both patient and family outcomes by identifying delirium sooner and capacitating family members in care. METHODS: The primary aim of this study is to determine the effect of family-administered delirium prevention, detection, and management in critically ill patients on family member symptoms of depression and anxiety, compared to usual care. One-hundred and ninety-eight patient-family dyads will be recruited from four medical-surgical ICUs in Calgary, Canada. Dyads will be randomized 1:1 to the intervention or control group. The intervention consists of family-partnered delirium prevention, detection, and management, while the control group will receive usual care. Delirium, depression, and anxiety will be measured using validated tools, and participants will be followed for 1- and 3-months post-ICU discharge. All analyses will be intention-to-treat and adjusted for pre-identified covariates. Ethical approval has been granted by the University of Calgary Conjoint Health Research Ethics Board (REB19-1000) and the trial registered. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. DISCUSSION: Critically ill patients are frequently unable to participate in their own care, and partnering with their family members is particularly important for improving experiences and outcomes of care for both patients and families. TRIAL REGISTRATION: Registered September 23, 2019 on Clinicaltrials.gov NCT04099472.

Factors affecting hesitancy toward COVID-19 vaccine booster doses in Canada: a cross-national survey.

OBJECTIVE: COVID-19 transmission, emergence of variants of concern, and weakened immunity have led to recommended vaccine booster doses for COVID-19. Vaccine hesitancy challenges broad immunization coverage. We deployed a cross-national survey to investigate knowledge, beliefs, and behaviours toward continued COVID-19 vaccination. METHODS: We administered a national, cross-sectional online survey among adults in Canada between March 16 and March 26, 2022. We utilized descriptive statistics to summarize our sample, and tested for demographic differences, perceptions of vaccine effectiveness, recommended doses, and trust in decisions, using the Rao-Scott correction for weighted chi-squared tests. Multivariable logistic regression was adjusted for relevant covariates to identify sociodemographic factors and beliefs associated with vaccine hesitancy. RESULTS: We collected 2202 completed questionnaires. Lower education status (high school: odds ratio (OR) 1.90, 95% confidence interval (CI) 1.29, 2.81) and having children (OR 1.89, CI 1.39, 2.57) were associated with increased odds of experiencing hesitancy toward a booster dose, while higher income ($100,000-$149,999: OR 0.60, CI 0.39, 0.91; $150,000 or more: OR 0.49, CI 0.29, 0.82) was associated with decreased odds. Disbelief in vaccine effectiveness (against infection: OR 3.69, CI 1.98, 6.90; serious illness: OR 3.15, CI 1.69, 5.86), disagreeing with government decision-making (somewhat disagree: OR 2.70, CI 1.38, 5.29; strongly disagree: OR 4.62, CI 2.20, 9.7), and beliefs in over-vaccinating (OR 2.07, CI 1.53, 2.80) were found associated with booster dose hesitancy. CONCLUSION: COVID-19 vaccine hesitancy may develop or increase regarding subsequent vaccines. Our findings indicate factors to consider when targeting vaccine-hesitant populations.

RéSUMé: OBJECTIF: La transmission de la COVID-19, l'émergence de variants préoccupants et l'affaiblissement de l'immunité ont conduit à recommander des doses de rappel de vaccin contre la COVID-19. L'hésitation à la vaccination remet en question une large couverture vaccinale. Nous avons déployé une enquête transnationale pour étudier les connaissances, les croyances et les comportements en faveur de la poursuite de la vaccination contre la COVID-19. MéTHODES: Nous avons mené une enquête nationale transversale en ligne auprès d'adultes au Canada, entre le 16 et le 26 mars 2022. Nous avons utilisé des statistiques descriptives pour résumer notre échantillon et testé les différences démographiques, les perceptions de l'efficacité des vaccins, les doses recommandées et la confiance dans les décisions, en utilisant la correction de Rao-Scott pour les tests du chi carré pondérés. La régression logistique multivariée a été ajustée pour les covariables pertinentes afin d'identifier les facteurs sociodémographiques et les croyances associés à l'hésitation à la vaccination. RéSULTATS: Nous avons collecté 2 202 questionnaires remplis. Un faible niveau d'éducation (lycée : rapport de cotes (OR) 1,90, intervalle de confiance (IC) à 95% 1,29, 2,81) et le fait d'avoir des enfants (OR 1,89, IC 1,39, 2,57) étaient associés à une probabilité accrue d'éprouver une hésitation à l'égard d'une dose de rappel, tandis qu'un revenu plus élevé (100 000 $­149 999 $ : OR 0,60, IC 0,39, 0,91; 150 000 $ ou plus : OR 0,49, IC 0,29, 0,82) était associé à une diminution des probabilités. Incrédulité dans l'efficacité du vaccin (contre l'infection : OR 3,69, IC 1,98, 6,90; maladie grave : OR 3,15, IC 1,69, 5,86), en désaccord avec la prise de décision du gouvernement (plutôt en désaccord : OR 2,70, IC 1,38, 5,29; fortement en désaccord : OR 4,62, IC 2,20, 9,7) et la croyance dans le sur-vaccination (OR 2,07, IC 1,53, 2,80) ont été associées à une hésitation à recevoir une dose de rappel. CONCLUSION: Une hésitation à l'égard du vaccin contre la COVID-19 peut se développer ou augmenter à l'égard des vaccins ultérieurs. Nos résultats indiquent des facteurs à prendre en compte lors du ciblage des populations hésitantes à la vaccination.

The evolution of vaccine hesitancy through the COVID-19 pandemic: A semi-structured interview study on booster and bivalent doses.

We sought in-depth understanding on the evolution of factors influencing COVID-19 booster dose and bivalent vaccine hesitancy in a longitudinal semi-structured interview-based qualitative study. Serial interviews were conducted between July 25th and September 1st, 2022 (Phase I: univalent booster dose availability), and between November 21st, 2022 and January 11th, 2023 (Phase II: bivalent vaccine availability). Adults (≥18 years) in Canada who had received an initial primary series and had not received a COVID-19 booster dose were eligible for Phase I, and subsequently invited to participate in Phase II. Twenty-two of twenty-three (96%) participants completed interviews for both phases (45 interviews). Nearly half of participants identified as a woman (n = 11), the median age was 37 years (interquartile range: 32-48), and most participants were employed full-time (n = 12); no participant reported needing to vaccinate (with a primary series) for their workplace. No participant reported having received a COVID-19 booster dose at the time of their interview in Phase II. Three themes relating to the development of hesitancy toward continued vaccination against COVID-19 were identified: 1) effectiveness (frequency concerns; infection despite vaccination); 2) necessity (less threatening, low urgency, alternate protective measures); and 3) information (need for data, contradiction and confusion, lack of trust, decreased motivation). The data from interviews with individuals who had not received a COVID-19 booster dose or bivalent vaccine despite having received a primary series of COVID-19 vaccines highlights actionable targets to address vaccine hesitancy and improve public health literacy.

Family coaching during Spontaneous Awakening Trials and Spontaneous Breathing Trials (FamCAB): pilot study protocol.

INTRODUCTION: Many patients in the intensive care unit (ICU) require weaning from deep sedation (Spontaneous Awakening Trials, SATs) and mechanical ventilation (Spontaneous Breathing Trials, SBTs) in their journey to recovery. These procedures can be distressing for patients and their families. The presence of family members as 'coaches' during SATs/SBTs could provide patients with reassurance, reduce stress for patients and families and potentially improve procedural success rates. METHODS AND ANALYSIS: This study will be executed in two phases:Development of a coaching module: a working group including patient partners (i.e., former ICU patients or family members of former ICU patients), researchers, and ICU clinicians will develop an educational module on family coaching during SATs/SBTs (FamCAB). This module will provide families of critically ill patients basic information about SATs/SBTs as well as coaching guidance.Pilot testing: family members of ICU patients will complete the FamCAB module and provide information on: (1) demographics, (2) anxiety and (3) satisfaction with care in the ICU. Family members will then coach the patient through the next clinically indicated SATs and/or SBTs. Information around duration of time and success rates of SATs and/or SBTs (ability to conduct a complete assessment) alongside feedback will be collected. ICU clinical staff (including physicians and nurses) will be asked for feedback on practicality and perceived benefits or drawbacks of family coaching during these procedures. Feasibility and acceptability of family coaching in SATs/SBTs will be determined. DISCUSSION: The results of this work will inform whether a larger study to explore family coaching during SATs/SBTs is warranted. ETHICS AND DISSEMINATION: This study has received ethical approval from the University of Calgary Conjoint Health Research Ethics Board. Results from this pilot study will be made available via peer-reviewed journals and presented at critical care conferences on completion.

Development and preclinical testing of the critical care pain observation tool for family caregiver use (CPOT-Fam).

Background and Aims: Pain assessment in noncommunicative intensive care unit (ICU) patients is challenging. For these patients, family caregivers (i.e., family members, friends) may be able to assist in pain assessment by identifying individualistic signs of pain due to their intimate patient knowledge. This study adapted the critical care pain observation tool (CPOT) to facilitate pain assessment in adult ICU patients by family caregivers. Methods: This study was conducted through three distinct phases: (1)CPOT adaptation for family caregiver use (to create the CPOT-Fam): A working group met monthly to adapt the CPOT and develop educational material and sample cases for practice scoring until consensus was reached.(2)CPOT-Fam preclinical testing: Family caregiver study participants viewed educational materials and scored four randomly selected sample cases using the CPOT-Fam. Scores were compared to reference scores to assess agreement and identify CPOT-Fam sections requiring revision. Open-ended feedback on the CPOT-Fam was collected.(3)CPOT-Fam revision: the CPOT-Fam was revised by the working group considering score agreement and feedback received from study participants. Results: Of the n = 30 participants, n = 14 (47.0%) had experience with an ICU patient. Agreement between CPOT-Fam participant scores and reference scores were highest for the vocalization dimension (Is the patient making any sounds?; Intraclass correlation coefficient; ICC = 1.0) and lowest for the body movements dimension (What are the patient's body movements like?; ICC = 0.85. Participants indicated they found the CPOT-Fam to be "informative" and "easy-to-use" but "not graphic enough"; participants also indicated that descriptors like "lack of breath" and "struggling to move" are helpful with identifying individualistic behaviors of pain exhibited by their loved ones. Conclusion: The CPOT-Fam shows ease of use and may be of value in involving family caregivers in ICU care. Clinical pilot testing is needed to determine feasibility and acceptability and identify further areas for refinement.

Preliminary clinical testing to inform development of the Critical Care Pain Observation Tool for Families (CPOT-Fam).

Introduction: Many patients in the intensive care unit (ICU) cannot communicate. For these patients, family caregivers (family members/close friends) could assist in pain assessment. We previously adapted the Critical Care Pain Observation Tool (CPOT) for family caregiver use (CPOT-Fam). In this study, we conducted preliminary clinical evaluation of the CPOT-Fam to inform further tool development. Methods: For preliminary testing, we collected (1) pain assessments of patients in the ICU from family caregivers (CPOT-Fam) and nurses (CPOT) and determined the degree of agreement (kappa coefficient, κ) and (2) collected openended feedback on the CPOT-Fam from family caregivers. For refinement, we used preliminary testing data to refine the CPOT-Fam with a multidisciplinary working group. Results: We assessed agreement between family caregiver and nurse pain scores for 29 patients. Binary agreement (κ) between CPOT-Fam and CPOT item scores (scores ≥2 considered indicative of significant pain) was fair, κ = 0.43 (95% confidence interval [CI] 0.18-0.69). Agreement was highest for the CPOT-Fam items ventilator compliance/vocalization (weighted κ = 0.48, 95% CI 0.15-0.80) and lowest for muscle tension (weighted κ = 0.10, 95% [CI] -0.17 to 0.20). Most participants (n = 19; 69.0%) reported a very positive experience using the CPOT-Fam, describing it as "good" and "easy-to-use/clear/straightforward." We iteratively refined the CPOT-Fam over five cycles using the data collected until no further revisions were suggested. Conclusion: Our preliminary clinical testing suggests that family involvement in pain assessment in the ICU is well perceived. The CPOT-Fam has been further refined and is now ready for clinical pilot testing to determine its feasibility and acceptability.

Introduction: De nombreux patients de l'unité de soins intensifs (USI) ne peuvent pas communiquer. Pour cespatients, les aidants familiaux (membres de la famille/amis proches) pourraient aider à l'évaluation de la douleur. Nous avons précédemment adapté l'outil d'observation de la douleur en soins intensifs (CPOT) pour qu'il puisse être utilisé par des aidants familiaux (CPOTFam). Dans cette étude, nous avons mené une évaluation clinique préliminaire du CPOT-Fam afin d'éclairer davantage le développement de l'outil.Méthodes: Pour les tests préliminaires, nous avons recueilli (1) des évaluations de la douleur des patients en unité de soins intensifs auprès d'aidants familiaux (CPOT-Fam) et d'infirmières (CPOT) et déterminé le degré de concordance (coefficient de Kappa, κ) et (2) des commentaires ouverts sur le CPOT-Fam auprès d'aidants familiaux. Nous avons ensuite utilisé les données des tests préliminaires pour affiner le CPOT-Fam avec un groupe de travail multidisciplinaire.Résultats: Nous avons évalué la concordance entre les scores obtenus par des aidants familiaux et des infirmières pour les énoncés portant sur la douleur pour 29 patients. La concordance binaire (κ) entre les scores obtenus pour les énoncés du CPOT-Fam et du CPOT (un score ≥ 2 était considéré comme un indicateur de douleur importante) était passable, κ = 0,43 (intervalle de confiance à 95 % [IC] 0,18-0,69). La concordance était la plus élevée pour les énoncés du CPOT-Fam portant sur l'observance de la ventilation/vocalisation (κ pondéré = 0,48, IC à 95 % 0,15-0,80) et la plus faible pour la tension musculaire (κ pondéré = 0,10, 95% [IC] − 0,17 à 0,20). La plupart des participants (n = 19; 69,0 %) ont fait état d'une expérience très positive de l'utilisation du CPOT-Fam, le décrivant comme « bon ¼ et « facile à utiliser/clair/simple. ¼ Nous avons affiné le CPOT-Fam de manière itérative sur cinq cycles en utilisant les données recueillies jusqu'à ce qu'aucune autre révision ne soit suggérée.Conclusion: Nos tests cliniques préliminaires indiquent que la participation de la famille à l'évaluation de la douleur dans l'unité de soins intensifs est bien perçue. Le CPOT-Fam a été affiné et est maintenant prêt pour le test clinique pilote afin de déterminer sa faisabilité et son acceptabilité.

A scoping review of methods to measure and evaluate citizen engagement in health research.

BACKGROUND: Citizen engagement, or partnering with interested members of the public in health research, is becoming more common. While ongoing assessment of citizen engagement practices is considered important to its success, there is little clarity around aspects of citizen engagement that are important to assess (i.e., what to look for) and methods to assess (i.e., how to measure and/ or evaluate) citizen engagement in health research. METHODS: In this scoping review, we included peer-reviewed literature that focused primarily on method(s) to measure and/or evaluate citizen engagement in health research. Independently and in duplicate, we completed title and abstract screening and full-text screening and extracted data including document characteristics, citizen engagement definitions and goals, and methods to measure or evaluate citizen engagement (including characteristics of these methods). RESULTS: Our search yielded 16,762 records of which 33 records (31 peer-reviewed articles, one government report, one conference proceeding) met our inclusion criteria. Studies discussed engaging citizens (i.e., patients [n = 16], members of the public [n = 7], service users/consumers [n = 4], individuals from specific disease groups [n = 3]) in research processes. Reported methods of citizen engagement measurement and evaluation included frameworks, discussion-based methods (i.e., focus groups, interviews), survey-based methods (e.g., audits, questionnaires), and other methods (e.g., observation, prioritization tasks). Methods to measure and evaluate citizen engagement commonly focused on collecting perceptions of citizens and researchers on aspects of citizen engagement including empowerment, impact, respect, support, and value. DISCUSSION AND CONCLUSION: We found that methods to measure and/or evaluate citizen engagement in health research vary widely but share some similarities in aspect of citizen engagement considered important to measure or evaluate. These aspects could be used to devise a more standardized, modifiable, and widely applicable framework for measuring and evaluating citizen engagement in research. PATIENT OR PUBLIC CONTRIBUTION: Two citizen team members were involved as equal partners in study design and interpretation of its findings. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework (10.17605/OSF.IO/HZCBR).

Involving members of the public (citizens) in health research is important. It helps make sure that research focuses on issues that are most important to citizens. It also helps ensure that the research done is respectful of citizen participation and most likely to provide benefit. However, the best way to engage citizens in research is unclear. In this scoping review, we examined existing studies that assessed citizen engagement in health research. We found that citizen engagement was often assessed by asking for feedback from both citizens and researchers. Feedback was collected in person (one on one interviews or group discussions) or in writing (using surveys or audits). Frameworks (organized ways of thinking about an issue) were also sometimes used to measure empowerment, impact, respect, support, and value of engaging citizens. It was clear from the frameworks that there is a need to develop clearer roles for citizens in research. The two citizen members of our research team who helped interpret our study findings felt that a set of guidelines for citizens to help them best participate in health research needs to be developed. We believe these observations could be used to create a more standard method for assessing citizen engagement in research.

Development and pilot implementation of a patient-oriented discharge summary for critically Ill patients.

BACKGROUND: Patients leaving the intensive care unit (ICU) often experience gaps in care due to deficiencies in discharge communication, leaving them vulnerable to increased stress, adverse events, readmission to ICU, and death. To facilitate discharge communication, written summaries have been implemented to provide patients and their families with information on medications, activity and diet restrictions, follow-up appointments, symptoms to expect, and who to call if there are questions. While written discharge summaries for patients and their families are utilized frequently in surgical, rehabilitation, and pediatric settings, few have been utilized in ICU settings. AIM: To develop an ICU specific patient-oriented discharge summary tool (PODS-ICU), and pilot test the tool to determine acceptability and feasibility. METHODS: Patient-partners (i.e., individuals with lived experience as an ICU patient or family member of an ICU patient), ICU clinicians (i.e., physicians, nurses), and researchers met to discuss ICU patients' specific informational needs and design the PODS-ICU through several cycles of discussion and iterative revisions. Research team nurses piloted the PODS-ICU with patient and family participants in two ICUs in Calgary, Canada. Follow-up surveys on the PODS-ICU and its impact on discharge were administered to patients, family participants, and ICU nurses. RESULTS: Most participants felt that their discharge from the ICU was good or better (n = 13; 87.0%), and some (n = 9; 60.0%) participants reported a good understanding of why the patient was in ICU. Most participants (n = 12; 80.0%) reported that they understood ICU events and impacts on the patient's health. While many patients and family participants indicated the PODS-ICU was informative and useful, ICU nurses reported that the PODS-ICU was "not reasonable" in their daily clinical workflow due to "time constraint". CONCLUSION: The PODS-ICU tool provides patients and their families with essential information as they discharge from the ICU. This tool has the potential to engage and empower patients and their families in ensuring continuity of care beyond ICU discharge. However, the PODS-ICU requires pairing with earlier discharge practices and integration with electronic clinical information systems to fit better into the clinical workflow for ICU nurses. Further refinement and testing of the PODS-ICU tool in diverse critical care settings is needed to better assess its feasibility and its effects on patient health outcomes.

Study protocol: development and pilot testing of the Critical Care Pain Observation Tool for families (CPOT-Fam).

BACKGROUND: Patients in the intensive care unit (ICU) often have limited ability to communicate making it more difficult to identify and effectively treat their pain. Family caregivers or close friends of critically ill patients may be able to identify signs of pain before the clinical care team and could potentially assist in routine pain assessments. This study will adapt the Critical Care Pain Observation Tool (CPOT) for use by family members to create the CPOT-Fam and compare family CPOT-Fam assessments with nurse-provided CPOT assessments for a given patient. METHODS: This study will be executed in two phases: 1) Development of the CPOT-Fam - A working group of patient partners, ICU clinicians, and researchers will adapt the CPOT for use by family caregivers (creating the CPOT-Fam) and produce an accompanying educational module to deliver information on pain and how to use the tool. The CPOT-Fam will undergo preclinical testing with participants (i.e., members of the public and family caregivers of critically ill adults), who will complete the educational module and provide CPOT-Fam scores on sample cases. Feedback on the CPOT-Fam will be collected. 2) Pilot testing the CPOT - Fam family caregivers of critically ill adults will complete the educational module and provide information on the following: (1) demographics, (2) anxiety, (3) caregiving self-efficacy, and (4) satisfaction with care in the ICU. Family caregivers will then provide a proxy assessment of their critically ill loved one's pain through the CPOT-Fam and also provide a subjective (i.e., questionnaire-based including open-ended responses) account of their loved one's pain status. A comparison (i.e., agreement) will be made between family caregiver provided CPOT-Fam scores and ICU nurse-provided CPOT scores (collected from the provincial health information system), calculated independently and blinded to one another. Feasibility and acceptability of the CPOT-Fam will be determined. DISCUSSION: The results of this work will produce a family caregiver CPOT (i.e., CPOT-Fam), determine feasibility and acceptability of the CPOT-Fam, and compare pain assessments conducted by family caregivers and ICU nurses. The results will inform whether a larger study to determine a role for family caregivers in ICU pain assessment using the CPOT-Fam is warranted.

Incorporating and evaluating citizen engagement in health research: a scoping review protocol.

BACKGROUND: Citizen engagement in research is an emerging practice that involves members of the general public in research processes such as priority setting, planning, decision-making, research conduct, implementation, evaluation, and dissemination. Engaging citizens in research, particularly health research, increases the relevance of study findings, minimizes waste by facilitating stewardship over resources, and builds public trust in the research. While several existing frameworks guide the application of citizen engagement principles to health research, it is unclear how citizen engagement can be utilized to maximize benefits and minimize risks and challenges in health research. To address the gaps in knowledge around citizen engagement in health research, we propose a scoping review to synthesize the state of knowledge on methods to incorporate and evaluate citizen engagement in research. A protocol is presented in this manuscript. METHODS: The methodology for our scoping review is guided by Arksey and O' Malley's framework for scoping reviews, and additional recommendations by Levac and colleagues. We will include peer-reviewed and gray literature that report on citizen engagement in health research (including biomedical, clinical, health systems and services, and social, cultural, environmental and population health) and report method(s) to conduct, measure, or evaluate citizen engagement. We will systematically search electronic databases (MEDLINE, EMBASE, CINAHL, JSTOR, PsycINFO, Scopus, and Science Direct) from inception onwards and search relevant organizations' websites for additional studies, frameworks, and reports on citizen engagement. Title and abstract and full-text citations will be screened independently and in duplicate. Data will be extracted independently and in duplicate, including document characteristics, citizen engagement definitions and goals, and outcomes of citizen engagement (e.g., barriers, facilitators). DISCUSSION: This review will synthesize the definitions, goals, methods, outcomes, and significance of citizen engagement in health research, as well as any potential barriers, facilitators, and challenges outlined in existing literature. The findings will provide an evidence-based foundation for developing new or improved guidance for citizen engagement in health research. Overall, we anticipate that our scoping review will be a preliminary step to meaningful engagement of citizens in research and strengthen the relationship between the scientific community and the public through transparency and collaboration. SYSTEMATIC REVIEW REGISTRATION: Open Science Framework  https://osf.io/hzcbr .

A Modified Delphi Process to Prioritize Experiences and Guidance Related to ICU Restricted Visitation Policies During the Coronavirus Disease 2019 Pandemic.

To create evidence-based consensus statements for restricted ICU visitation policies to support critically ill patients, families, and healthcare professionals during current and future pandemics. DESIGN: Three rounds of a remote modified Delphi consensus process. SETTING: Online survey and virtual polling from February 2, 2021, to April 8, 2021. SUBJECTS: Stakeholders (patients, families, clinicians, researchers, allied health professionals, decision-makers) admitted to or working in Canadian ICUs during the coronavirus disease 2019 pandemic. MEASUREMENTS AND MAIN RESULTS: During Round 1, key stakeholders used a 9-point Likert scale to rate experiences (1-not significant, 9-significant impact on patients, families, healthcare professionals, or patient- and family-centered care) and strategies (1-not essential, 9-essential recommendation for inclusion in the development of restricted visitation policies) and used a free-text box to capture experiences/strategies we may have missed. Consensus was achieved if the median score was 7-9 or 1-3. During Round 2, participants used a 9-point Likert scale to re-rate experiences/strategies that did not meet consensus during Round 1 (median score of 4-6) and rate new items identified in Round 1. During Rounds 2 and 3, participants ranked items that reached consensus by order of importance (relative to other related items and experiences) using a weighted ranking system (0-100 points). Participants prioritized 11 experiences (e.g., variability of family's comfort with technology, healthcare professional moral distress) and developed 21 consensus statements (e.g., communicate policy changes to the hospital staff before the public, permit visitors at end-of-life regardless of coronavirus disease 2019 status, creating a clear definition for end-of-life) regarding restricted visitation policies. CONCLUSIONS: We have formulated evidence-informed consensus statements regarding restricted visitation policies informed by diverse stakeholders, which could enhance patient- and family-centered care during a pandemic.

Impact of restricted visitation policies in hospitals on patients, family members and healthcare providers during the COVID-19 pandemic: a scoping review protocol.

INTRODUCTION: Flexible visitation policies in hospitals are an important component of care that contributes to reduced stress and increased satisfaction among patients and their family members. Early evidence suggests restricted visitation policies enacted in hospitals during the COVID-19 pandemic are having unintended consequences on patients, family members and healthcare providers. There is a need for a comprehensive summary of the impacts of restricted visitation policies on key stakeholders and approaches to mitigate that impact. METHODS AND ANALYSIS: We will conduct a scoping review as per the Arksey-O'Malley 5-stage scoping review method and the Scoping Review Methods Manual by the Joanna Briggs Institute. We will search relevant electronic databases (eg, CINAHL, MEDLINE, PsycINFO), grey literature and preprint repositories. We will include all study designs including qualitative and quantitative methodologies (excluding protocols) as well as reports, opinions and editorials, to identify the broad impact of restricted hospital visitation policies due to the COVID-19 pandemic on patients, family members or healthcare providers of hospitalised patients, and approaches taken or proposed to mitigate this impact. Two reviewers will calibrate the screening criteria and data abstraction form and will independently screen studies and abstract the data. Narrative synthesis with thematic analysis will be performed. ETHICS AND DISSEMINATION: Ethical approval is not applicable as this review will be conducted on published literature only. This scoping review will identify, describe and categorise impacts of restricted hospital visitation policies due to the COVID-19 pandemic on patients, family members and healthcare providers of hospitalised patients, and approaches that have been taken to mitigate impact. We will provide a comprehensive synthesis by developing a framework of restricted visitation policies and associated impacts. Our results will inform the development of consensus statements on restricted visitation policies to be implemented in future pandemics. PROSPERO REGISTRATION NUMBER: CRD42020221662.

Feasibility and acceptability of family administration of delirium detection tools in the intensive care unit: a patient-oriented pilot study.

BACKGROUND: Family-administered delirium detection tools may serve as valuable diagnostic adjuncts because family caregivers may be better able than providers to detect changes in patient cognition and behaviour from pre-illness levels of functioning. The aim of this pilot study was to assess the feasibility and acceptability of family-administered tools to detect delirium in critically ill patients. METHODS: In this single-centre pilot tool validation study conducted in August and September 2017, eligible family caregivers used the Family Confusion Assessment Method (FAM-CAM) and the Sour Seven questionnaire to detect delirium during the patient's intensive care unit (ICU) stay. We calculated descriptive statistics for all study variables. Patients and family caregivers were involved as research partners throughout the study. A patient-orient research approach was taken, engaging patients and family caregivers as full partners. RESULTS: Of 141 patients admitted to the ICU, 75 were eligible, of whom 53 were approached; 21 patients (40%), 23/38 family caregivers (60%) and 17/38 dyads (i.e., patient and family caregiver enrolled together) (45%) consented to participate. The most common reason for nonenrolment was refusal by the family, who commonly reported feeling overwhelmed. The completion rate for the FAM-CAM and Sour Seven questionnaire was 74% (17/23). Among 13 dyads, family caregivers detected delirium in 5 patients (38%) using the FAM-CAM, and delirium or possible delirium in 8 patients (62%) using the Sour Seven questionnaire, whereas trained research assistants detected delirium in 8 patients (62%) using the Confusion Assessment Method for the Intensive Care Unit 7 and the Richmond Agitation-Sedation Scale (κ coefficient for agreement between the former and the FAM-CAM and Sour Seven questionnaire 0.62 and 0.85, respectively). INTERPRETATION: Administration of the FAM-CAM and Sour Seven questionnaire by family caregivers to detect delirium in the ICU is feasible and acceptable, although, as with most family engagement strategies, it was not desired by all. Results from this pilot study support a definitive study with a larger sample to enable calculation of inferential statistics, but additional recruitment strategies are necessary to improve the response rate. Trial registration: Clinicaltrials.gov, no. NCT03379129.