Systematic geriatric assessment for older patients with frailty in the emergency department: a randomised controlled trial

This trial complied with the ethical rules stated in the Declaration of Helsinki. The study protocol, informed consent forms, and data protection plan were approved by the Ethics Committee II of the Helsinki University Hospital (reference number HUS/1711/2018), and the research permit was issued by the Helsinki University Hospital (reference number HUS/278/2018).

The trial was registered in the ClinicalTrials.gov (registration number and date: NCT03751319, 23/11/2018).

This was a single centre, randomised controlled trial with parallel group, two-arm, superiority design. Recruited patients were randomised to the intervention and the control groups with a 1:1 allocation ratio.

The trial was conducted in an academic ED with 60 000 annual adult patient visits. The ED is adjoined both Helsinki University Hospital and Espoo Community Hospital wards located on the same hospital campus. Older frail patients follow general adult patient pathways in the ED. The ED has a geriatric nurse and physical therapist from adjoining community hospital available on demand, to help with mobilisation and rehabilitative measures and to organise home-care. At the time of trial, the ED had no systematic protocol for geriatric assessment, and no specific geriatric care outside the study protocol was in practice in the ED.

The eligibility criteria for participants were the following: an ED-visit during the recruitment period; age ≥ 75 years; frail, or at risk of frailty, defined by the CFS level of four to nine; and residency in the hospital service area.

A random sequence for two-group allocation was computer-generated using the online service provided by GraphPad Software. No blocking or any restrictions was applied for sequence generation.

Numbered sealed envelopes with corresponding codes inside (“I” for the intervention group and “C” for the control group) were sealed by an assisting person outside the study group.

Screening for eligibility was done at all hours throughout the study period. The ED secretary assigned an individual code for all patients who met the age and residency criteria, and coded research forms were delivered to patients’ nurses in the ED. Nurses were asked to assess the CFS-grade of the patient, and to obtain background and National Early Warning Score 2 (NEWS2) data if the assessed CFS of the patient was from four to nine. NEWS2 is a structured acute care risk assessment tool based on measured vital signs [26]. Patient enrolment was active during office hours. For eligible patients, written and verbal information about the study was given and consent requested. Consent was obtained from the patient’s relative or caregiver in the ED or through a phone call for those who were not capable of consenting. Eligible consented patients were then enrolled and registered in the study. A health-related quality of life (HRQoL) assessment (the EQ-5D-5 L-questionnaire) was filled in with each patient or with a caregiver, as appropriate. After enrolment, a study physician opened the envelope concordant with the patient’s registration number and filled in the study group in the registration sheet. If a major concern or life-threatening condition was recognised during trial enrolment, it was communicated to the ED team providers.

ED team (ED physician of any speciality and ED nurses) treated both intervention and control group patients according to standard principles for chief complaint and acute condition. No systematic assessment or screening for geriatric conditions or further assessment or care were included in standard care, but if ED team recognised a need for geriatric nurse and physical therapist consultations, it was available.

For the intervention group, systematic geriatric assessment was added to their standard care. Assessment was provided separate from ED team care. While the ED team physician was in charge of the acute care for all enrolled patients, the geriatric assessment was led by second physician assigned for the assessment protocol. Two geriatricians and two emergency physicians with consultation support from a geriatrician were allocated for providing the assessment for the six-month study enrolment period. Assessment was performed in structured form, but with consideration of patient co-operation and abilities for each test.

The study physicians based the evaluation of functioning on activities of daily living and observed the patients’ ability to walk. An orthostatic test was performed when possible. The Abbreviated Mental Test 4 (AMT4) and Six-Item-Screener were used for assessment of cognitive status [27, 28]. The study physicians screened the patients for delirium with the 4 ‘A’s Test (4AT) [29], and for depression with the Patient Health Questionnaire 2 (PHQ-2) [30]. Risk of falls and sarcopenia were evaluated using clinical judgment. Medication reviews were performed with special attention to potential adverse effects, interactions, or undertreatment. Any need for further assessment, testing, or rehabilitation was evaluated. The study physicians interviewed the relatives or caregivers for those patients who could not provide a patient history, with the patient’s consent as appropriate. If the patient could not co-operate, assessments were performed as feasible, and further information was sought from the electronic medical records (EMR).

After completing the assessments, the study physicians provided individual, multi-dimensional recommendations and advice regarding medical care, medications, rehabilitation, nutrition, and evaluation of the need for home-care to the patient, the ED-physician and nurses providing acute care, hospital wards, and home-care. This was done verbally both in the ED and through phone calls, and with structured documentation in the EMR. A Geriatric nurse and physical therapist from community hospital helped to organise support, care, and at-home rehabilitation for discharged patients. Detailed recommendations of mobilisation, nutrition, further assessments, and medical treatment were forwarded to the hospital wards if the patient was admitted. The protocol for trial participants is summarised in Fig. 1.

Due to the active intervention provided in the ED, blinding of patients or personnel was not possible. However, the study physicians did not actively inform the ED personnel providing care for control patients about the patients’ enrolment in the trial. Geriatric assessment and recommendations were documented in the EMR for patient’s future care, so outcome-assessment was not blinded.

The pre-specified primary outcome measure was the cumulative LOS, as given by the total number of overnight stays in hospital wards (both at the tertiary hospital and the community hospital ward) during 365-day follow-up from the date of the enrolment. All hospital admissions, from the index ED-visit or later, during the follow up period were included. Primary outcome data were retrieved from the tertiary hospital EMR with portal to the community hospital records after follow-up.

The pre-specified secondary outcomes were cumulative number of admissions to hospital wards during the 365-day follow-up time, admission rate from the index visit, readmissions to the ED within 72 h, 30 days, and 365 days after the index visit, proportion of patients alive and home-dwellingat 365 days after the enrolment, and HRQoL-measurement using the EuroQol EQ-5D-5 L instrument [31, 32]. Secondary outcome data were acquired by reviewing the EMR, and by phone interview (with patients, or their caregiver as surrogate) for EQ-5D-5 L with standardised forms designed for phone interview, after the 365-day follow-up time. The EuroQol Crosswalk Index Value Calculator v2 with the Denmark value set was used for EQ-5D-5 L index-value calculations.

The pre-specified outcome measures for assessing the safety and feasibility of the intervention were LOS in the ED on the index-visit, hospital-LOS from the index-visit, 365-day mortality, and number of ED visits related to falls during the follow-up period. Data for these outcomes were obtained by reviewing the EMR. Other prespecified adverse events were not defined.

We based the sample size calculation on an assumed total hospital stay of 25 ± 15 days during the 365-day follow-up time. The assumed hospital stay was an estimation based on previous five-year ED patient data and national reports on inpatient care. A reduction of 10 % in hospital stay was assumed for the intervention group. We calculated a minimum sample size of 392 patients in each group to reach a power of 80 % with 5 % alpha level. A goal was set to recruit a total of 900 patients in order to exceed minimum sample size requirements.

For the outcomes depending on 365-day follow-up time, to account for patients who died during the follow-up, total follow-up time contributed by patients in each group were calculated. Rate per 100 person-years and rate ratio estimate with 95 % confidence interval (CI) applying the Byar method were calculated. For the binary outcomes, risk ratios (RR) with 95 % CI were calculated, and the significance of differences were tested with \({\chi }^{2}\)tests. For the other outcomes, means with standard deviations (SD) and differences of means with 95 % CI, or medians with inter-quartile range (IQR) and difference of medians were calculated. Significance of mean differences were tested with t test and median difference with Mann Whitney U test. A P value < 0.05 was considered statistically significant for all outcomes. Intention-to-treat analyses were performed, except for the EQ-5D-5 L-outcome, where only patients with data available were included.

We used the IBM SPSS Statistics for Windows software version 25.0 (Armonk, NY: IBM Corp) for statistical analyses. OpenEpi, Version 3 calculator was used for rate ratio calculations.