This study evaluated the impact of an integrated health and social care intervention aimed at improving outcomes for ICU survivors and their caregivers in the year following hospital discharge. We compared caregivers who attended this intervention with a contemporary, usual care cohort (caregivers who had been exposed to critical care and were currently caring for a critical care survivor) who did not attend the programme. A caregiver was defined as the individual who provided most of the financial, emotional, and physical support for the patient, or the individual primarily responsible for caring for the patient on an unpaid basis . Previous work has described the outcomes of patients who participated in this intervention, alongside a detailed process evaluation .
The study involved the expansion of the Intensive care Syndrome: Promoting Independence and Return to Employment (InS:PIRE) programme from a single general Intensive Care Unit (ICU), to four further ICUs throughout Scotland between 2016 and 2020. We recruited a contemporary usual care cohort from sites who had no active follow-up or rehabilitation for ICU survivors.
Using a multicentre cohort design we compared caregivers who attended the InS:PIRE intervention with a contemporary usual care cohort from sites who had no active follow-up for ICU survivors or caregivers. We report a cohort study, as per the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines .
Ethical approval was granted by the Northwest (Liverpool Central) Research Ethics Committee (reference number: 17/NM/0199). All participants provided written consent.
The InS:PIRE programme is a complex intervention and has been described previously [16-17]. Briefly, all patients receive individual reviews with 1) an ICU doctor and nurse; 2) pharmacist; and 3) physiotherapist. These reviews offer a debrief of the ICU stay, an assessment of ongoing problems, goal setting, and patient directed management plans. Clinical Psychology services, alongside occupational therapy is available. Peer support was embedded in the programme using shared waiting areas, group sessions, and the presence of patient and caregiver volunteers who were further along the recovery trajectory . Of note several group sessions were set up for caregivers exclusively, including the clinical psychological support. Every site involved local community organisations who provided welfare advice including information on relevant government benefits and housing. This support was delivered through a combination of individual appointments, drop-in sessions, or group discussions. Support for caregivers from local agencies was also integrated at every site. In contrast to other ICU recovery services which often include a single clinical appointment, InS:PIRE was designed as a recovery programme; patients and caregivers attend each week for five weeks and are followed up for one year after initial attendance.
InS:PIRE was co-designed with local patients and caregivers. During this process, patients and caregivers both described the necessity for a specific and deliberate focus on caregivers within any rehabilitation service. This is also consistent with previous evidence is this field . Initial single centre work showed that supporting caregivers was feasible, safe and acceptable, thus, this support was included in this multi-centre scale up [20, 21]. Caregivers could attend all sessions and were eligible to receive the same support as patients. This only differed with the physiotherapy and pharmacy sessions which were aimed specifically at patient recovery.
Participants were invited to the programme between 4 and 12 weeks after hospital discharge. Patient inclusion criteria were any patient receiving level three care (multiple organ support and / or invasive respiratory support) or more than seven days of level two care (single organ support or postoperative care). There was no upper age limit for inclusion. Exclusion criteria were any patient who was terminally ill, had suffered a traumatic brain injury, or was an in-patient under psychiatric services. Caregiver inclusion criteria were: paired consented patient data had to be available and caregiving responsibilities occurred in an informal, non-paid basis. We limited inclusion in the research to one caregiver per patient, however, multiple caregivers could attend InS:PIRE.
Five sites piloted the InS:PIRE programme as part of a quality improvement collaborative (intervention cohort) over two years. Caregivers in the intervention cohort were consecutively recruited to this study between May 2016 to October 2018 (follow-up completed December 2019). Caregiver outcome measures were completed via a pre-planned 12-month follow-up appointment. Participants were given the opportunity to complete questionnaires at InS:PIRE attendance or via telephone.
Usual care cohort
Patients in the usual care cohort were recruited from eight hospitals in Scotland between 10-16 months post hospital discharge. Patients were identified by searching the local electronic records system and were recruited by postal survey. Questionnaire packs were sent to eligible patients with pre-paid return envelopes. Alongside these patient packs, we asked the patient’s primary caregiver (or closest family member) to complete a separate pack. Reminder questionnaire packs were sent if the pack was not returned after one month. Participants were also given opportunity to call to discuss issues or recruitment with researchers. The usual care cohort were recruited between July 2017 and March 2020. Ethical approval was in place to continue beyond March 2020, however, the impact of the coronavirus disease 2019 pandemic was unknown, thus recruitment to this study was closed in an attempt to reduce any confounding effect.
We created a short questionnaire in order to collect family member demographics. Data collected included age, relationship to patient, and gender.
In-hospital patient demographic and clinical data was obtained from clinical notes and discharge summaries. Patient comorbidity data (including mental health data) were obtained from medical notes and critical care admission records. Critical care length of stay was taken for the highest level of care and during the first critical care admission only.
The Scottish Index of Multiple Deprivation (SIMD) is produced by the Scottish Government as a measure of deprivation, with postcode areas defining data on socio-economic status. This research split the SIMD into five categories to define socio-economic status; quintile one represented the most deprived and quintile five the least .
Hospital Anxiety and Depression Scale
The primary outcome measure in this study was caregiver anxiety. Anxiety and depression were measured using the Hospital Anxiety and Depression Score (HADS) . The HADS questionnaire contains 14 statements relating to mood, with seven statements relating to depression and seven to anxiety. Each statement has four potential options (scored 0-3). The cut-off points widely adopted for HADS are described in S1. In this analysis we classified anxiety and depression as a score of 8 or above utilising the score subscales . Appropriate licensing requirements were in place for the use of the HADS.
Carer Strain Index
Alongside the HADS, the Carer Strain Index (CSI) was utilised . The CSI measures strain, including social strain, related to care provision from the caregiver’s perspective. There are elements related to emotional adjustment, social issues, physical and financial strain. Each question is given one point; a score of seven or greater is the generally accepted cut off point for a high level of strain.
The Insomnia Severity Index
The Insomnia Severity Index (ISI) is a seven-item questionnaire which has been validated as a screening tool for clinical insomnia. Participants are asked to rank the severity of their sleep problems on a scale of zero to four and answer four other questions regarding satisfaction with their sleeping patterns . We defined insomnia as a score of 8 and greater from a maximum score of 28 (range 0 to 28).
Analyses was undertaken using R (Version 4.0.3). All missing covariates were imputed using categorical and regression trees analysis with the Multivariate Imputation by Chained Equations (MICE) software package. We used 5 imputations and 10 iterations. Information on missing data is presented in S2.
Continuous variables were expressed as medians and interquartile range (IQR). The Kruskall-Wallis test was used to compare different sub-groups and the chi-squared test to analyse categorical variables. Logistic regression was used to understand the impact of the intervention on the main outcomes of this study.
Models were created using domain knowledge and previous evidence in the field. All models were adjusted for: relationship with the patient; caregiver age; caregiver gender; time to follow up and socio-economic status (SIMD quintiles). We also adjusted patient level demographics which are known to influence recovery including: hospital length of stay; patient age and the presence of a mental health comorbidity (pre-existing).