Impact of a Communication Strategy in the Prevention of Depressive Symptoms in Patients With Covid-19
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the effect of an early and integral communication strategy (EICS) versus standard care, on the rate of depressive symptoms at 3 months after discharge from the ICU, in patients with severe Covid-19, their family members and health personnel.
Evaluating the rate of depressive symptoms at 3 months after discharge from the ICU, with a) Hospital Anxiety and Depression, b) Posttraumatic Stress Disorder Checklist (S)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
We designed a pre-post intervention study, the groups were non-randomly allocated.
The study is implementation in 10 Chilean hospitals, admitting 350 patients.
Pre-intervention: The practices of each ICU will be maintained, until the moment that according to randomization corresponds the beginning of the intervention, in each center.
Post-intervention: EICS to facilitate communication between the family, patient and health team, through written material, via the web (tablet and webmaster) and by telephone.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Traditional communication management (Pre-intervention) Traditional communication practices are maintained, which consists of reporting the patient's medical conditions or specific requirements of the case, between the health team and the family. According to the social and administrative conditions of each centers, medical telephone information is provided on the conditions of the patients. |
|
| Experimental: Early and integral communication strategy (EICS) (Post-intervention) EICS that includes a bundle of various strategies that allow to favor communication and contact between family members, patients and health team. That considers the delivery of: (1) Receive timely and understandable information; (2) Receive visits, companionship, and spiritual assistance |
Behavioral: Intervention. Early and integral communication strategy (EICS)
This intervention will be implemented in patients since they are hospitalized in the ICU where is expected:
Facilitate contact and communication between patients, families and the health team.
Respond to the communication needs of family members.
Reduce equipment overload and facilitate communication with families and patients, providing tools and timely support.
Build a positive and trusting relationship of relatives and patients with health teams.
The intervention considers the following actions:
- Training in communication to the health team
- Written material
- Family website
- Standardized and daily telephone information
- Health Team Support Strategy
- Weekly multidisciplinary virtual meeting with the family
- ICU diaries for family members
|
Outcome Measures
Primary Outcome Measures
- Rate of depressive symptoms [Third month post-discharge from ICU]
The rate of depressive symptoms after discharge from the ICU will be evaluated in patients with severe Covid-19, their relatives and health personnel with the instrument HADS (Hospital Anxiety and Depression Scale)
Secondary Outcome Measures
- Risk factors of depressive symptoms [Third month post-discharge from ICU]
Identify risk factors associated with depressive symptoms at 3 months post ICU in patients with severe Covid-19, their relatives and health team. Considering physical health, mental health and sociodemographic factors. To measure depressive symptoms will be used Hospital Anxiety and Depression Scale (HADS), total scores for depression range from 0 to 21, categorized as: normal (0-7), mild (8-10), moderate (11-14) or severe (15-21)
- Functional independence post-ICU [Third month post-discharge from ICU]
Barthel will be used in patients, the score are ordered: 0-20 suggests total dependence, 21-60 severe dependence, 61-90 moderate dependence and 91-99 slight dependence, 100 independence
- Functional independence post-ICU [Twelfth month post-discharge from ICU]
Barthel will be used in patients
- Functionality Status post-ICU [Third month post-discharge from ICU]
Post-COVID-19 Functional Status (PCFS) will be used in patients, the score are : 0 = No functional limitations, 1=Negligible functional limitations, 2=Slight functional limitations, 3=Moderate functional limitations,4=Severe functional limitations, 5=death
- Functionality Status post-ICU [Twelfth month post-discharge from ICU]
Post-COVID-19 Functional Status (PCFS) will be used in patients
- Post traumatic stress post-ICU [Third month post-discharge from ICU]
This mental health condition will be evaluated in patients, family members and the health team, with the instrument Impact of Event Scale Revised (IES-R). Score Interpretation: 24-32: PTSD is a clinical concern, 33-38: This represents the best cutoff for a probable diagnosis of PTSD, 39 and above: This is high enough to suppress your immune system's functioning
- Post traumatic stress post-ICU [Twelfth month post-discharge from ICU]
This mental health condition will be evaluated in patients, family members and the health team, with the instrument Impact of Event Scale Revised (IES-R).
- Cognition status post-ICU [Third month post-discharge from ICU]
MOCA blind instrument will be applied to patients. The total possible score is 22 points; a score of 18 or above is considered normal
- Cognition status post-ICU [Twelfth month post-discharge from ICU]
MOCA blind instrument will be applied to patients.
- Quality of life post ICU [Third month post-discharge from ICU]
Euro Qol (EQ-5D) will be applied to patients. An EQ-5D summary index is derived by applying a formula that essentially attaches values (weights) to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1, the value for full health
- Quality of life post ICU [Twelfth month post-discharge from ICU]
Euro Qol (EQ-5D) will be applied to patients.
- ICU memories post ICU [Third month post-discharge from ICU]
ICU Memory Tool (ICUMT) will be applied to patients.In ICUMT, memories are categorized in subscales of factual memories, memories of feelings, and memories of delusion
- ICU memories post ICU [Twelfth month post-discharge from ICU]
ICU Memory Tool (ICUMT) will be applied to patients.In ICUMT, memories are categorized in subscales of factual memories, memories of feelings, and memories of delusion
- Anxiety post ICU [Third month post-discharge from ICU]
This mental health condition will be evaluated in patients, family members and the health team, with the instrument HADS total scores for anxiety range from 0 to 21, categorized as: normal (0-7), mild (8-10), moderate (11-14) or severe (15-21)
- Anxiety post ICU [Twelfth month post-discharge from ICU]
This mental health condition will be evaluated in patients, family members and the health team
- Rate of depressive symptoms [Twelfth month post-discharge from ICU]
The rate of depressive symptoms after discharge from the ICU will be evaluated in patients with severe Covid-19, their relatives and health personnel with the instrument HADS (Hospital Anxiety and Depression Scale)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults> 18 years old
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Admitted to the ICU
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Requiring Mechanical Ventilation> 12 hrs due to COVID-19
Exclusion Criteria:
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Patients with therapeutic proportionality is defined early
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Patients with communication limitations (they do not speak Spanish) are excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pontificia Universidad Católica de Chile - Medicina | Santiago | Metropolitana | Chile |
Sponsors and Collaborators
- Pontificia Universidad Catolica de Chile
- University of Chile
- Universidad de La Frontera
Investigators
- Principal Investigator: Leyla Alegria, Pontificia Universidad Catolica de Chile
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COVID0921