COVID-19 (coronavirus 2019) disease has led to a large number of hospital admissions, many of which require admission to intensive care (ICU). Post-intensive care syndrome (PICS) is defined as deterioration or worsening of previous deterioration in the mental, physical or cognitive status that appears as a consequence of a critical illness and which persists after acute hospital care. Also, there is evidence that patients who survive a critical illness have a high prevalence of moderate to extreme chronic pain. Patients with COVID-19 disease are an especially susceptible population to develop PICS due to acute respiratory distress syndrome (ARDS) survivors have significant long-term deterioration in mental, cognitive, and functional health. This study hypothesis is that a specific care program based on early therapeutic education and psychological intervention improves the quality of life of patients at risk of developing PICS and chronic pain after COVID-19 disease.
A randomized, controlled, and single-blind trial will be performed. Patients over 18 years
who have been admitted to intensive care units with the diagnosis of COVID-19 disease at risk
of presenting PICS will be recruited.
The study subjects will be divided into two arms, and the intervention program will be
compared to the standard care clinical practice.
The program will consist of early care (first visit at one month of hospital discharge),
therapeutic education on prevention and management of PICS and chronic pain during three
medical visits in six months, and psychological treatment in patients at risk for emotional
distress.
The main objective is to evaluate the impact of the program on health-related life quality at
six months after hospital discharge.
The secondary objectives are:
1. To assess the health-related life quality at three months after hospital discharge.
2. To quantify the incidence of chronic pain, its characteristics, and the degree of
functional limitation at three and six months after hospital discharge.
3. To quantify the incidence of anxiety and depression at three and six months after
hospital discharge.
4. Quantify the incidence of post-traumatic stress syndrome at 3 and 6 months after
hospital discharge.
Behavioral: Intervention program
Medical visits:
There will be three medical visits stipulated as follows:
Visit 1 Intervention Group, four weeks after hospital discharge.
Visit 2 Intervention Group, eight weeks after hospital discharge.
Visit 3 Intervention Group, 18 weeks after hospital discharge.
Components of visits:
Interview and physical examination.
Therapeutic education about the intensive care syndrome orally and with a specific document that will be delivered at the end of the visit.
Therapeutic education around pain. If the patient reports pain, a specific document will be prepared that will be delivered at the end of the visit.
Psychological intervention:
Inclusion criteria for psychological intervention: Patients with a score higher than 8 on the HAD (hospital anxiety and depression) test depression subscale.
Description :
The intervention protocol consists of 7 weekly sessions lasting one hour and a half. The intervention in depression is based on Rehm's model of self-control.
Inclusion Criteria:
- Admitted to the ICU due to COVID infection19.
- APACHE II score> 14 or ICU stay> 10 days or Duration of mechanical ventilation> 7 days
or Acquired weakness in ICU or Delirium during ICU admission.
- Accept to participate in the study and sign informed consent.
Exclusion Criteria:
- Central Nervous System degenerative diseases. Examples: Alzheimer's disease,
Amyotrophic lateral sclerosis, Lewy body dementia, Parkinson's disease, among others.
- Terminal illness: Definition according to the palliative care guide, Spanish Society
for Palliative Care. "Advanced, progressive, and incurable disease with a lack of
reasonable possibilities of specific treatment, with a life prognosis of less than 6
months.
- Insufficient understanding of the Spanish language.
- Patients in whom it would be difficult to complete follow-up.
- Not having informed consent.
Tomás Cuñat
Barcelona, Spain
Antonio José Ojeda Niño, MD, Principal Investigator
Pain unit physician