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Intensive care
Protocol
IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers
  1. Natasha Arianne Jawa1,2,
  2. David M Maslove3,4,
  3. Stephanie Sibley4,5,
  4. John Muscedere3,4,
  5. Miranda Hunt4,
  6. Michaela Hanley4,
  7. Tracy Boyd4,
  8. Robin Westphal4,
  9. Sunita Mathur6,
  10. Afolasade Fakolade6,
  11. Michelle Tryon4,
  12. John Gordon Boyd1,3,4
  1. 1 Centre for Neuroscience Studies, Queen's University, Kingston, Ontario, Canada
  2. 2 Queen's University School of Medicine, Kingston, Ontario, Canada
  3. 3 Medicine, Queen's University, Kingston, Ontario, Canada
  4. 4 Critical Care Medicine, Queen's University, Kingston, Ontario, Canada
  5. 5 Emergency Medicine, Queen's University, Kingston, Ontario, Canada
  6. 6 School of Rehabilitation Therapy, Queen's University, Kingston, Ontario, Canada
  1. Correspondence to Natasha Arianne Jawa; tasha.jawa{at}queensu.ca

Abstract

Introduction Survivors of critical illness and their caregivers are at risk for long-term cognitive, physical and psychiatric impairments known as post-intensive care syndrome (PICS) and PICS-family, respectively. This study will assess the feasibility of a randomised controlled trial (RCT) evaluating an intensive care unit (ICU) follow-up care bundle versus standard-of-care for ICU patients and their caregivers.

Methods and analysis This is a single-centre feasibility study. Survivors of critical illness will be eligible if: age ≥18 years, life expectancy ≥6 months and high risk for PICS. We define high risk as ICU stay ≥4 days or involving 1+ of mechanical ventilation, tracheostomy, delirium or lack of access to a primary care physician (PCP). 20 ICU survivor-primary caregiver dyads will be enrolled (n=10 dyads per group) and randomised 1:1 to the intervention versus control group. The intervention will be: (1) diaries to journal patient experiences, (2) information packages on expectations post-discharge and (3) specialised follow-up care at 1 and 3 months post-discharge. The control group will receive standard of care in the ICU and follow-up with their PCP. The primary outcome is feasibility, defined as: (1) consent rate >80%, (2) enrolment rate of 4 participants/month, (3) follow-up rate>70% and (4) data capture rate >80%. Our secondary objective is to explore the perspectives of survivors of critical illness and their families about the intervention and their participation in the study. Tertiary outcomes will be a battery of cognitive, physical functioning and psychiatric outcomes.

Implications Survivorship from critical illness extends beyond surviving an ICU stay. This project will lay the foundation for performing a large, multicentre pragmatic RCT with survivors of critical illness and their caregivers, paving the way for improved long-term healthcare.

Ethics and dissemination This study has received approval (6039808) from the Queen’s University Health Sciences/Affiliated Teaching Hospitals Research Ethics Board. Results will be presented at critical care conferences. A lay summary co-designed with ICU survivor participants will be provided to patients.

Trial registration number NCT06681649.

  • Adult intensive & critical care
  • Cognition
  • Caregiver Burden
  • Feasibility Studies
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This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2024-086799

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    Strengths and limitations of this study

    • The mixed-methods approach integrates qualitative and quantitative data, enhancing the robustness of the findings and ensuring a comprehensive understanding of patient and caregiver outcomes.

    • The inclusion of intensive care unit survivor and caregiver representatives in study design ensures relevance and alignment with real-world needs, promoting patient-centred research.

    • The single-centre design restricts the generalisability of findings to diverse healthcare settings and populations.

    • The relatively short follow-up duration of 6 months may limit the detection of significant differences in secondary and tertiary outcomes.

    Introduction

    Recovery from critical illness and intensive care unit (ICU) admission extends far beyond ICU survival and is limited by post-intensive care syndrome (PICS). PICS is a condition characterised by long-term cognitive, psychological and functional impairments, and is associated with reduced quality of life.1 Up to 80% of survivors of critical illness will experience cognitive impairment, physical impairment and/or psychiatric illness.1 2

    Cognitive impairment

    The neurological consequences of critical illness can be divided into three overarching categories: (1) delirium, (2) cognitive impairment and (3) psychiatric disorders3 (figure 1). Delirium is an acute neurological state characterised by impaired attention, altered level of consciousness and disorganised thinking,4 affecting up to 84% of patients during their ICU admission.5–7 Among survivors of critical illness, delirium is an independent risk factor for decreased global cognitive function and executive function.8

    Figure 1
    Figure 1

    Relationship between critical illness and neurological sequelae.

    Neurocognitive impairment affects 25–80% of patients following critical illness,7 9 and persists up to 6 years following discharge from ICU.10 The impact of cognitive dysfunction among survivors of critical illness is not limited to the patient themselves; the patient’s family, caregivers and society may also be affected. One-third of previously employed patients never return to work following critical illness, in large part due to protracted cognitive impairment.11 This causes families and caregivers to incur substantial financial costs to care for patients even years following their critical illness.

    Psychological impairment

    The ICU is an inherently difficult environment for patients, with there being little differentiation between day and night, sleep interruptions for clinical assessments and bloodwork, a plethora of unfamiliar sights and sounds, and patients commonly undergoing a range of anxiety-inducing medical procedures. Anxiety, depression and post-traumatic stress disorder (PTSD) are consequently prevalent among survivors of critical illness; up to 18% of survivors of critical illness experience anxiety 1 year following discharge, while up to 11% experience depression12 and up to 63% experience PTSD following their ICU admission.13

    Physical functioning impairment

    Survivors of critical illness often additionally face functional and physical impairments as part of PICS, including muscle weakness, reduced mobility and chronic pain.14 15 Up to 50% develop ICU-acquired weakness, which can persist for months or years, limiting daily activities, contributing to long-term disability and hindering return to work.13 16 Chronic fatigue and reduced endurance further exacerbate these limitations.14

    Risk factors for PICS

    Factors predisposing an individual towards the development of PICS include prolonged ICU stays, mechanical ventilation, sepsis, ICU delirium, deep sedation, immobility, pre-existing comorbidities (such as diabetes or cardiovascular disease), female sex and older age.14 17–21 Delirium during the ICU stay is a particularly strong predictor of long-term cognitive dysfunction.8

    Prognosis of PICS

    The long-term prognosis for PICS is highly variable, with physical impairments often improving through therapy between 3 and 12 months post-discharge, while cognitive and mental health issues persist.2 22

    Caregiver outcomes

    Caregivers of survivors of critical illness similarly experience reduced health-related quality of life and poor psychosocial outcomes. Caregivers are known to experience substantial strain, even months after ICU discharge.23 Six months following ICU discharge, up to 24% of caregivers of survivors of critical illness were found to have anxiety, up to 36% had depression and up to 57% demonstrated evidence of PTSD.24 Caregivers also reported significant financial burden, often due to loss of employment as a result of their need to be a caregiver.24 Greater symptom burden among survivors of critical illness has also been associated with reduced sleep quality and increased health risk behaviours among caregivers,25 with caregivers of survivors of critical illness with adverse physical and psychological outcomes experiencing the highest burden and poorer mental health-related quality of life.26 The psychological impacts of PICS-family tend to wane over time, particularly with therapy.27

    Lack of standardised post-ICU follow-up care

    The importance of post-discharge follow-up of survivors of critical illness and their caregivers has only recently begun to be appreciated. Over the past two decades, advancements in clinical care and healthcare technology have led to an increase in ICU survivorship.28 29 As a result, exploring the long-term outcomes of critical illnesses has become more feasible and even a priority.2 30 While mortality is an important indicator of outcomes following ICU discharge, the patient’s health-related quality of life following discharge may be more important to their well-being.31 32 Patients experience a variety of other issues following their ICU stay that impact their overall functioning physically, mentally and in terms of their ability to lead a fulfilling daily life (figure 2). Therefore, longitudinal follow-up and care for this vulnerable population is imperative to their long-term well-being.

    Figure 2
    Figure 2

    Problems affecting survivors of critical illness following discharge.65

    ICU follow-up clinics have recently begun to be introduced across Canada as a first step towards improving health-related quality of life among survivors of critical illness. These clinics provide an opportunity for clinicians to contextualise the ICU experience for survivors and may allow patients and caregivers to set more realistic goals and expectations of their path to recovery.33 However, many of these clinics have been created by clinicians without formalised processes for their implementation or examination of their effectiveness at improving patient and family caregiver outcomes. Furthermore, there are currently no specific criteria for referral to the ICU follow-up clinic in most centres, with referral being highly provider-dependent.

    While literature on existing ICU follow-up clinics is scarce, published studies have generally employed the following interventions in ICU clinics: diaries including narratives, events and observations by survivors of critical illness; assessment of physical and cognitive function and medication review; counselling for psychological stress related to the ICU experience or referrals for physical therapy or neuropsychological counselling.34 These interventions have not been formally studied for their efficacy or effectiveness among ICU survivor populations to date.

    Those that have examined the utility of post-ICU follow-up clinics have yielded mixed results, with one recent study reporting no significant improvement in the quality of life for survivors of acute respiratory failure following a 1 year nurse-led collaborative care programme aimed at ICU recovery.35 One small pilot study evaluating the effectiveness of a dyadic (ie, patient and caregiver) resiliency intervention (involving psychosocial resiliency skills training in the areas of acceptance, self-efficacy, coping strategies, and enhancing the bond between caregivers and survivors) found no difference in quality of life among caregivers of survivors of critical illness, despite showing improvements in survivor quality of life.36 It is presently unknown whether an ICU follow-up clinic focused on a variety of elements of both patient and caregiver well-being would yield different results. Despite this lack of efficacy data, questionnaires administered to patients following participation in ICU follow-up programmes have demonstrated great satisfaction with the services provided.37 38 It is therefore critically important to delineate the aspects of past interventions that have been helpful for patients and caregivers, and whether the interventions employed in these studies were adequately implemented, to improve the quality of the follow-up care intervention designed.

    Patient and caregiver feedback is critical to: (a) understand the specific needs of survivors of critical illness and their caregivers following hospital discharge, (b) ascertain the degree of existing issues with access to follow-up care, (c) determine perspectives on the utility of a post-ICU follow-up bundle of care and (d) understand how to successfully implement and sustain a post-ICU follow-up bundle of care for this vulnerable cohort of survivors of critical illness. By understanding patient and caregiver perspectives, the existing ICU follow-up clinic can be tailored to suit the needs of our survivors of critical illness.

    As a first step towards standardising ICU follow-up care and understanding the effectiveness of a bundled intervention, this study will evaluate the feasibility of performing an open-label pragmatic randomised controlled trial (RCT) among survivors of critical illness and their caregivers.

    Study objectives

    Primary

    The feasibility of conducting a pragmatic, RCT of the effectiveness of an ICU follow-up bundle of care versus standard care with survivors of critical illness and caregivers was determined by measuring:

    1. Consent rate, measured as the proportion of eligible population who consent to participate.

    2. Enrolment rate, measured as the proportion of consented participants who are randomised.

    3. Follow-up rate, measured as the proportion of enrolled participants who complete follow-up visits at 1, 3, and 6 months.

    4. Data capture rate, measured as the percentage of data elements acquired at each study time point.

    5. Rate of adverse events,39 40 assessed using the number of hospital and ICU readmissions, as well as the number of visits to the emergency department at 6 months.

    Secondary

    1. To determine the qualitative impact of a post-ICU follow-up clinic intervention on patients and caregivers, assessed via qualitative analysis of focus group discussions.

    2. To perform a process evaluation of the multimodal ICU follow-up bundle of care intervention to understand the implementation, acceptability, content, barriers and facilitators to use of diaries, informational materials and the follow-up clinic.

    Tertiary

    1. To determine the effectiveness of a post-ICU follow-up clinic intervention in improving the following clinical patient outcomes: (a) neurocognitive outcomes, measured using the MoCA41; (b) frailty, measured using the CFS42; (c) quality of life outcomes, measured using the 36-item Short Form Health Survey for quality-of-life assessment (SF-36)43; (d) health-related quality of life and utility weights, measured using the Health Utilities Index Mark 3 (HUI3)44; (e) anxiety and depression, measured using the Hospital Anxiety and Depression Scale to evaluate anxiety and depression (HADS)45; (f) PTSD, measured using the post-traumatic stress symptoms-14 to evaluate for post-traumatic stress disorder symptoms (PTSS-14)46; (g) chronic pain, measured using the Chronic Pain Grade Scale47; (h) chronic fatigue, measured using the Fatigue Severity Scale48; (i) activities of daily living (ADLs) and instrumental ADLs (IADLs), measured using the Katz Index of ADLs49 and the Lawton IADL scale,50 respectively; (j) lower extremity strength, measured using the 30 s Sit-to-Stand Test51 and 60 s Sit-to-Stand Test52; (k) dyadic resiliency among survivors of critical illness and caregivers, measured using the dyadic Connor-Davidson 10-item Resiliency Scale (CD-RISC-10)53 and (l) polypharmacy evaluated via medication reconciliation to determine the number of concurrent medications in use.

    2. To determine the effectiveness of a post-ICU follow-up clinic intervention in improving the following caregiver outcomes: (a) caregiver burden, measured using the Caregiver Burden Scale54; (b) sleep quality, measured using the Pittsburgh Sleep Quality Index55; (c) quality of life outcomes, measured using the SF-36; (d) health-related quality of life and utility weights, measured using the HUI3; (e) anxiety and depression, measured using the HADS; (f) PTSD, measured using the PTSS-14; (g) dyadic resiliency among survivors of critical illness and caregivers, measured using the dyadic CD-RISC-10.

    Exploratory

    The exploratory objectives of this study are to determine the effect of a post-ICU follow-up clinic intervention on: (1) changes in weight and body-mass index following ICU discharge; (2) return to work by survivors of critical illness; (3) employment status relative to previous among caregivers and (4) mortality.

    Methods and analysis

    Patient and public involvement

    ICU survivor and caregiver representatives will inform knowledge acquisition, translation and dissemination efforts throughout this study as active participants in the research process. Specifically, survivors of critical illness and caregivers in earlier focus groups will participate in the co-design of the study questions used in subsequent focus groups, and all participants will co-design the final resources and tools used to ensure they reflect real-life experiences and concerns of the target population. At the conclusion of the study, all participants will be offered the opportunity to participate in a community outreach event to share the overall findings and final resources developed through the study, helping to translate findings into usable resources for the community.

    Study design and setting

    This feasibility study will take place in the 34-bed medical-surgical ICU at a tertiary academic hospital in Ontario. 20 survivors of critical illness and 20 associated informal caregivers (one caregiver per patient) will be enrolled as dyads to participate in this study. Survivors of critical illness and their associated caregiver will be randomised 1:1 to receive either the post-ICU follow-up clinic intervention or standard of care (10 survivors of critical illness and 10 caregivers per group).

    Eligibility criteria

    The inclusion criteria for the ICU survivor group are:

    1. Age greater than or equal to 18 years.

    2. Life expectancy greater than or equal to 6 months as determined by the attending physician.

    3. High risk for long-term functional sequelae following ICU discharge, defined as ICU stay greater than or equal to 4 days, or involving at least one of: mechanical ventilation, tracheostomy, delirium (defined as Confusion Assessment Method positive or documented history of delirium in the patient’s medical record by the clinical care team at some point during their ICU admission) or lack of access to a primary care physician for clinical follow-up.

    4. Access to email or mail (to complete follow-up questionnaires).

    5. Presence of an informal caregiver.

    The inclusion criteria for the caregiver group are: informal caregiver (eg, spouse, offspring) for ICU survivor as defined above and age greater than or equal to 18 years.

    Survivors of critical illness and caregivers will be excluded if they have neurological or communication difficulties which would preclude completion of follow-up assessments or participation in focus groups; inability to speak or read English (required for completion of standardised questionnaires, clinical assessments and for participation in focus groups); or failure to provide consent/failure to have consent provided by a substitute decision maker.

    As the purpose of this study is primarily to evaluate feasibility, we are targeting high-risk participants only as this subset of survivors of critical illness is expected to experience the most pronounced benefit from the intervention.

    Recruitment and consent

    Patients will be screened for eligibility and recruited by the research team from the Kingston Health Sciences Centre (KHSC) ICU. Participants will be evaluated for capacity to consent. If capable, participants will be asked to sign the informed consent form. If participants do not have capacity to consent for themselves, consent will be obtained from the participant’s substitute decision maker. If consent was obtained via the substitute decision maker, the participant’s capacity for consent will be evaluated on an ongoing basis prior to discharge from hospital. If the participant gains capacity to consent, consent will be sought from the participant. If the participant does not regain capacity to consent prior to hospital discharge, an assessment will be made by the study principal investigator to ascertain whether the participant is likely to be able to complete the required study visits. If the participant is deemed unlikely to be able to participate in future visits, then the participant will be withdrawn and an additional patient will be enrolled in their place.

    Participants will be informed of their right to withdraw from the study at any time. If the study has not yet been completed and closed, that individual’s clinical outcome data will be removed from the study and deleted. However, because this study includes a focus group component, it will not be possible for participants to withdraw their consent to have their qualitative data included in the study after having participated in the focus group.

    To facilitate recruitment and retention, follow-up visits will be scheduled when patients are already returning to KHSC for clinical care and will be offered at flexible times, whenever possible. Participants will receive ethical compensation ($25 gift card per visit) for travel and time required for their participation.

    Study intervention

    Participants will be randomised 1:1 into two groups.

    Group 1: intervention group

    The intervention group will receive follow-up care through the specialised post-ICU follow-up clinic at KHSC at approximately 1 and 3 months following ICU discharge. These time points were selected to maximise the potential benefit of the post-ICU care bundle for participants, as prior to 1 month we expect that many survivors of critical illness will still be admitted to hospital or undergoing rehabilitation services and would therefore be unable to attend, or benefit from, follow-up visits. Caregivers will also be invited to participate in the follow-up clinic along with the ICU survivor participant.

    During the follow-up clinic visit, survivors of critical illness and caregivers will meet with three healthcare providers: (1) ICU physician, (2) social worker and (3) pharmacist. The appointment will cover the patient and caregiver’s progress through their recovery, discuss and develop mitigation strategies for barriers to recovery, contextualise the patient’s ICU stay, provide therapeutic support and resources for physical and psychological impairments, arrange necessary referrals for specialist care, provide return-to-work guidance and review medications. Patients and caregivers will also have the opportunity to revisit the ICU and their specific room to further contextualise their ICU admission. The specific elements of these visits will be evaluated throughout this study and ultimately refined as part of the development of the final standardised clinic protocol.

    In addition to receiving specialised follow-up clinical care, ICU survivor participants and their caregivers will also receive the following additional items as part of a bundled care intervention programme: informational pamphlet on critical illness and expectations following ICU discharge; flyer on critical illness and expectations following ICU discharge (brief version, which may be placed in a frequently visited location in the participant’s home as a consistent reminder) and diaries in which the healthcare team, family members and the patient themselves are able to journal their experiences, updates, progress and barriers in the ICU and following discharge (online supplemental appendix).

    Supplemental material

    Group 2: control group

    The control group will receive generalised standard of care during their ICU stay and follow-up through their primary care provider. This nature of this follow-up is not specified by the study protocol. At the end of the study (ie, after 6 months following ICU discharge), all participants randomised to the control group will be provided with access to the post-ICU follow-up clinic and informational materials designed as part of this study.

    Study assessments

    The schedule of assessments is outlined in the study schema in figure 3, and described in detail in table 1 (survivors of critical illness) and table 2 (caregivers).

    Figure 3
    Figure 3

    Study schema.

    View this table:
    Table 1

    Schedule of assessments—survivors of critical illness

    View this table:
    Table 2

    Schedule of assessments—caregivers

    Clinical assessments

    Clinical assessments are outlined in online supplemental table 1. MoCA and 30/60 s Sit-to-Stand tests will be performed by a trained evaluator for all participants (JGB or NAJ).

    Supplemental material

    Qualitative assessments

    Focus groups will be used for qualitative assessment of the post-ICU follow-up clinic versus standard of care. Focus groups were chosen as the qualitative method for this study, as they leverage the interaction among participants to generate rich discussions and insights and allow participants to build on each other’s responses, challenge viewpoints or provide additional perspectives, lending to a deeper understanding of the topic. Focus groups will also allow us to gather insights from a diverse set of participants within the same session, providing a range of perspectives and experiences that cognitive interviewing with selected participants only would not permit. Focus groups with control participants are being employed to gain an unbiased perspective on tools and resources that survivors of critical illness and caregivers would desire as part of their follow-up care.

    All focus groups will be conducted in a secure, confidential meeting space or virtually, based on participant preference. Only the focus group participants and research study team will be present in the room during the conduct of the focus groups. Focus groups will be recorded using an audio recording device. Data in the audio recording will be transcribed via a secure artificial intelligence platform (eg, Google, Otter, Sonix) after the focus group has been completed. Transcripts will be verified against the original audio recording by a member of the research team to ensure accuracy and will be edited as needed.

    Focus groups will seek to ascertain the following details: whether the patient has an identified primary care provider; identification of other specialty services following the patient; perceived availability of outpatient/local healthcare and other resources; knowledge regarding their reasons for being in the post-ICU follow-up clinic; quality of service, staff compassion/kindness, perceived appropriateness of visit duration; comprehensiveness/clarity of care/recommendations provided; clinic structure and access to clinic services; feasibility/convenience, coordination with other appointments; potential utility of resources/support material; basic knowledge on recommendations after critical illness and perceived benefit of the clinic.

    Sample size considerations

    The ICU is a 34-bed unit. We estimate that approximately four patients per week will be eligible for participation in this study. Based on enrolment rates for our other studies in our single-centre ICU, we aim to enrol 2–4 participants per week over a 12-month enrolment period (beginning at the time of Queen’s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB) study approval) or until our total enrolment target of 20 participants per group (10 survivors of critical illness+10 caregivers) is reached. This sample size was chosen as it is in line with prior literature in a similar population suggesting that 10–20 participants per group is sufficient to evaluate feasibility outcomes56–58 and also provides the necessary number of participants to adequately assess our secondary outcomes for this study.

    Sample size in qualitative research is determined to be the point at which data saturation is reached. Saturation is defined as the point at which new information yields little to no change in the overall findings (ie, the point at which the same perspectives from different people are being elicited, with no additional information presented). Recent literature suggests that two-to-three focus groups identify upwards of 80% of themes on a topic.59 Therefore, we aim to conduct two focus groups throughout this study. Our target of eight participants per focus group was selected based on the topic of the focus groups, the amount of detail required from participants for the purpose of this research study and the involvement of the participants in the topic. Since participants are heavily invested in the topic of discussion and have ample experience in the area (they have all gone through—or are going through—the ICU survivorship process), fewer participants are required to reach saturation. Balancing this with the need for a lot of detailed information from participants, we have chosen the middle of the suggested range of 6–10 for focus group participants, at eight per group.60

    Because of the need to evaluate data saturation on an ongoing basis throughout this study, qualitative data will be analysed concurrently with data collection (ie, we will perform a coding analysis after each focus group to ascertain the point at which saturation is reached).

    Randomisation

    Randomisation will be used to reduce selection bias and balance baseline characteristics of each group based on underlying characteristics of the population that could potentially confound results.61 Randomisation will occur at the time of study enrolment (day 1 of study participation).

    Concealment of allocation

    The randomisation scheme will be concealed from the research study team, participants and providers, however, using a randomisation generator in the Research Electronic Data Capture (REDCap) system at the time of participant enrolment.

    Blinding

    Blinding is not possible due to the nature of the intervention being a follow-up clinical care visit, which will inherently be known to participants, providers and research team members.

    Statistical methods

    Any patient who is registered on to this trial but never received the study intervention will be described, including the reason(s) for non-participation. Details of the reasons for non-consent, enrolment, follow-up or evaluation will also be described. Characteristics of the study population will be summarised using measures of central tendency for continuous data and frequencies/proportions for categorical values.

    Primary objectives

    Feasibility will be assessed through (1) consent rate, (2) enrolment rate, (3) follow-up rate at 1, 3 and 6 months after ICU discharge and (4) data capture rate. Based on our eligibility criteria and our existing ICU population, feasibility of consent will be defined as a rate of 4 patients per month. Feasibility of enrolment will be defined as a rate of 80%, based on similar studies in our ICU. Feasibility of data capture will be defined as a data capture rate of 80%. Feasibility for long-term follow-up data collection will be defined as a rate of 70% based on prior work by our group and others.

    Secondary objectives

    Braun and Clarke’s six-step thematic analysis will be employed to analyse data for this study, beginning with data familiarisation wherein open-ended questions will be analysed for common themes from which initial codes will be generated. We will search for themes based on patterns in the data through reflexive thematic analysis, whereby findings are categorised inductively with an openness towards unexpected findings. Themes will then be reviewed, defined and named. Subsequently, themes will be further organised into a structured matrix in accordance with the framework method, allowing for systematic comparison and analysis across cases.62 This integration enhances the rigour and comprehensiveness of qualitative analysis by combining the inductive approach of thematic analysis with the deductive organisation of data in the framework method.

    Focus groups will also be coded based on the theoretical domains framework and focused into three specific aspects of behaviour change based on the capabilities, opportunities and motivations behaviour change theory framework. Potential changes to the intervention to mitigate any barriers discovered will then be mapped to inform behaviour change onto the barriers/facilitators identified using the behavioural change wheel.

    Analysis will be conducted after each focus group to determine when saturation is reached. Qualitative analyses will be conducted using NVivo software.

    Tertiary objectives

    The following study populations are defined and will be analysed as specified below:

    1. Intent to treat population: the total population of patients registered in the study and analysed in accordance with the group to which they were initially randomised.

    2. Per protocol population: the total population of patients who completed the study and analysed in accordance with the intervention they followed during the study.

    Changes in clinical outcome measures between follow-up time points and between intervention versus control groups will be examined using either McNemar’s test, Kruskal-Wallis test or paired/unpaired t-tests, as appropriate. Statistical analyses will be performed using R statistical software. Dyadic analysis will also be explored to evaluate changes in outcomes across patient-caregiver dyads.

    Integration of quantitative and qualitative data

    The triangulation method will be used to integrate both qualitative and quantitative components of this study, where possible.63 64 Using this method, a convergence coding matrix will be created to depict the findings from each study component and whether they are in agreement with each other, in partial agreement, silence or dissonance.

    Limitations

    The primary limitations of this study include its single-centre design, which may limit the generalisability of the findings to other healthcare settings. Additionally, the small sample size and relatively short follow-up duration may not capture longer-term outcomes or provide statistically significant results for secondary and tertiary outcomes. The study focuses on survivors of critical illness at high risk for long-term sequelae, which may reduce the applicability of the findings to a broader ICU population. Furthermore, blinding was not possible due to the nature of the intervention, which could introduce bias in the responses of participants during follow-up assessments.

    Ethics and dissemination

    This study is approved by the Queen’s University HSREB, REB approval number: 6039808.

    Risks of participation

    There is a risk associated with the possibility of a privacy breach. To combat this, all information collected from patients will be recorded either directly into a REDCap database on the internal Queen’s University network or recorded on paper stored behind two locks at KHSC and then entered into the REDCap database, which can only be accessed by study team members. All patient identifiers will be coded and anonymised. Audio recordings and transcripts will be kept securely on an access-restricted, password-protected folder.

    While the nature of the questions asked in the focus groups are not expected to reveal underlying psychological issues, there is a possibility that interview participants may reveal information regarding significant depression including risk for self-harm. In rare instances in which this information arises, the research team member conducting the interviews will relay this information to the study principal investigator following conclusion of the focus group, who will arrange for appropriate follow-up with a clinical care provider.

    Knowledge translation

    The driving force behind this feasibility study is to determine barriers to success in implementing a multicentre pragmatic RCT to evaluate the effectiveness of an ICU follow-up care bundle. The overarching goal of this programme of research is to assist in improving and understanding the outcomes of a post-ICU follow-up clinic which serves patients and caregivers in the best possible way, while being performed cost-effectively for families and the healthcare system. We plan to present our findings to the local Department of Critical Care Medicine, relevant subspecialties, hospital administration, other national ICU colleagues and at local, national and international scientific conferences and meetings. We will also submit a peer-reviewed manuscript to a relevant journal to disseminate findings to the scientific community. A lay summary will be provided to study participants following completion of the study.

    Implications

    ICU survivorship extends beyond surviving an ICU stay and is significantly limited by PICS. Caregivers are additionally burdened by the ICU admission of a loved one and experience long-term sequelae themselves (PICS-family). This programme of research is the first of its kind to evaluate the feasibility of a pragmatic, mixed-methods, multi-intervention, RCT among survivors of critical illness and their caregivers, with the aim of improving long-term outcomes for survivors of critical illness and their caregivers. The mixed-methods design employed through this project enables survivors of critical illness and their caregivers to be directly involved as integral members of the research team, placing patient and family centred care at the core of improved ICU survivorship. Together, a bundled intervention that incorporates multiple clinical care visits with specialised healthcare providers, written educational materials and narrative journal entries chronicling patient journeys through their ICU admission and barriers/successes to recovery after discharge will be developed. Once developed, this bundled intervention programme will optimise long-term follow-up care for patients with critical illness and their caregivers following discharge, delivering information and healthcare in the way that is of most benefit to patients from both a qualitative perspective and objective healthcare outcomes standpoint. This project is driving systemic change to improve utility and access to care for patients, through an innovative research intervention that embeds patient perspectives at its core. Ultimately, this study will lay the foundation for performing a large, multicentre pragmatic RCT with survivors of critical illness and their caregivers, paving the way for improving long-term healthcare for these particularly vulnerable populations.

    Ethics statements

    Patient consent for publication

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    Footnotes

    • X @JawaTasha, @A_Fakolade_PhD, @jgordonboyd

    • Contributors JGB and NAJ designed the study and wrote the study protocol. NAJ drafted and revised the manuscript. DMM, SS, JM, MH, MH, TB, RW, SM, AF, MT and JGB reviewed and revised the manuscript. JGB is responsible for the overall content as guarantor.

    • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. NA Jawa is supported by a Queen’s Public Scholars Fellowship to undertake this work.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.