Post-COVID-19 conditions clinic model
In the usual model of care, patients with multiple health issues often book appointments for several exams and visits, most likely on different days. For the patients, this type of organization is time-consuming and expensive, and may frequently lead to neglect disorders that are perceived, rightly or wrongly, as less important, or that do not require immediate treatment.
In our model of care, survivors of hospitalization were contacted and invited to undergo an evaluation by our multidisciplinary team, composed of an infectious disease specialist, a pulmonologist, a geriatrician, an intensivist, a psychologist, a cardiologist, and a haematologist. The rationale of our approach is to optimize the management of both clinical and organizational aspects, investigating all potentially detrimental sequelae of COVID-19, using the design of a cohort study.
Since COVID-19 is a multisystemic disease, we hypothesized that a multidisciplinary approach was crucial to identifying all patient’s clinical problems and unmet needs. Initially, we included patients who had severe disease, defined as requiring mechanical ventilation (Intensive Care Unit [ICU] group). Afterward, we extended the enrolment also to those admitted to acute medical wards (Acute Medical Wards [AMW] group).
We excluded paediatric subjects (< 18 years old), pregnant patients and residents in long care facilities.
At least 3 months after hospitalization, all eligible patients were contacted by phone and invited to undergo a follow-up visit. Those who accepted were scheduled. A caregiver was allowed to accompany patients with cognitive or physical impairment.
Patients were enrolled from June 2020 to July 2021. Vaccination for SARS-Cov-2 was introduced in Italy in March 2021 and patients were usually vaccinated 6 months after infection. Because all the patients were observed at least after 3 months and within 5 months after the hospitalization no patient was vaccinated.
Procedures
The post-COVID-19 assessment is organized following an integrated care pathway (Fig. 1), as follows.
On the first day, all patients undergo the following assessments:
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blood exam (full blood count, liver function tests, coagulation tests with D-dimer, renal functions test, glycaemia, lactate dehydrogenase, C reactive protein, pro-brain natriuretic peptide), chest X-ray, electrocardiogram, transthoracic echocardiogram.
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measurement of Body Mass Index (BMI).
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self-administered psychological questionnaires, fulfilled by the patients or by caregivers including: Post-traumatic Symptom Scale (PTSS), Hospital Anxiety and Depression Scale (HADS), Generalized Anxiety Disorder Assessment (GAD), Clinical Outcomes in Routine Evaluation-Outcome Measures, Insomnia Severity Index, Depression Anxiety Stress Scale, Anxiety Scale Questionnaire, Five Facet Mindfulness Questionnaire, Coping Orientation to Problems Experienced-New Italian Version.
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infectious disease visit with physical examination. Past clinical history, symptoms present at the time of discharge and occurring during the months before the visit, demographical information, and ongoing symptoms are collected. The disease severity is defined as the highest grade of respiratory support received during hospitalization, on the following scale: level 1, not admitted to hospital with resumption of normal activities; level 2, not admitted to hospital, but unable to resume normal activities; level 3, admitted to hospital but not requiring supplemental oxygen; level 4, admitted to hospital but requiring supplemental oxygen; level 5, admitted to hospital requiring non-invasive mechanical ventilation; level 6, admitted to hospital requiring extracorporeal membrane oxygenation, invasive mechanical ventilation (IMV), or both; and level 7, death.
Symptoms or signs collected during the interviews are alopecia, arthromyalgia, asthenia, weight loss, headache, impaired mobility, diarrhoea, peripheral neuropathies, dyspnoea, sexual dysfunctions, behavioural disorders, smell and taste alterations, sleep disorders, mood disorders, fever, cough.
In order to define a clinical homogeneity, we have grouped these symptoms into five macro-categories, hereinafter referred to as "symptoms categories"(SC): respiratory SC (dyspnoea, cough), neurological SC (peripheral neuropathies, headache, impaired mobility, behavioural disorders, cognitive disorders), psychological SC (sleep disorders, mood disorders), muscular disorders (arthromyalgia, asthenia), “other” SC (fever, alopecia, diarrhoea, weight loss, smell and taste alterations, sexual dysfunctions).
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pulmonary evaluation with simple spirometry, 6 min walking test, and calculation of Modified British Medical Research Council (MMRC) dyspnoea scale.
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geriatric evaluation if the patient was previously admitted in AMW, or intensive care evaluation if he was hospitalised in ICU.
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During geriatric and intensive care visits, several questionnaires are administered. In detail, health quality status is evaluated with the EQ5D-5L questionnaire; motor performance with the Short Physical Performance Battery. Cognitive performance is tested with the Montreal Cognitive Assessment and nutritional status with the Mini Nutritional Assessment (MNA). Regarding psychological status, we use PTSS-10 and HADS for patients younger than 65 years while GAD and Geriatric Depression Scale for those older than 65 years. Moreover, we evaluate patients’ frailty with the nine-point-based CFS: a score of 1 indicates a very fit person, while a score of 9 indicates a terminally ill person.
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nursing evaluation to check cutaneous lesions, pressure ulcers, and scarring outcomes.
On the second day, all specialists involved in this project meet for a joint evaluation to identify the clinical problems and the therapeutic pathways for each patient. Teamwork is coordinated by the infectious disease specialist.
On the third day, a week after the first visit, the infectious disease specialist reports the multidisciplinary evaluation to the patient and provides recommendations for follow-up.
All the data are collected through an electronic Case Report Form, implemented in the RedCapCloud platform.
Statistical analysis
Patients’ characteristics were described using median and interquartile range (IQR), if in a continuous scale, or frequency and percentage, otherwise.
Association between patients’ characteristics and presence of SC at follow-up visit was estimated by a logistic multivariable regression model. The included regressors were gender, age, BMI and presence of comorbidities at diagnosis, ICU admission and presence of disorders at discharge. The model was adjusted for the time between discharge and follow-up visit, to take into account different follow-up times. Patients’ characteristics effects were reported in terms of odds ratios (OR) and 95% confidence intervals (95% CI). P-values were considered statistically significant if lower than 0.05.
All analyses were performed using SAS software version 9.4 (SAS Institute, USA).