Clinical trial NCT06901882: Nursing Interventions in Communication for the Critically Ill Patient: CONECTEM Programme
Official title: Evaluation of the Effectiveness of Training in Basic and Assisted Communication Techniques for Intensive Care Nurses: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Nurse-patient Communication
Keywords: augmentative and alternative communication
training program
psicoemotional effects
nurse-patient relationship
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental design with two groups, Intervention group and control group with a pre-post test model.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this quasi-experimental study is to find out whether the effectiveness of a communication intervention based on basic and assisted communication techniques improves the psycho-emotional effects of critical patients admitted to an ICU. The nurses' knowledge of BCS and CAA and their usefulness in daily practice will also be investigated. The main questions to be answered are:

Does effective communication based on BCS and CAA reduce pain, anxiety and stressful impact of the critically ill in the ICU? Do nurses who apply these communication techniques believe that they are useful in their daily practice?

The researchers will compare the communicative intervention called 'CONECTEM' with the usual nurse-patient communication process to observe whether CBT and CCT are effective in decreasing the psycho-emotional effects of these patients.

Participants will:

Participants will be classified into 3 groups according to the Glasgow Coma Scale, for each group different communicative strategies based on scientific literature will be applied. In each strategy, different theories such as Carkkuff, Light and different levels of support (no technology, low technology) will be used. The intervention has a minimum duration of 15 minutes and before and after the 3 variables studied will be evaluated. The intervention will be carried out during the first 72 hours after admission.

Prior to the intervention, a formal training in BCS and ACC will be given to the nurses who will then apply the intervention.

Detailed description: CONECTEM Training Programme: This programme is aimed at nurses in the intensive care unit who will carry out communicative intervention with critically ill patients. It consists of 4 blocks, with a theoretical part and a practical part, in which the nurses acquire knowledge, skills and attitudes related to basic and assisted communication with the critically ill. The theoretical part is based on the theories of R Carkuff (2008)(1), and the Augmentative Assistive Communication model (2,3), and the practical part consists of a series of verbal and non-verbal communication exercises, and of experiencing communication simulations with the critically ill patient using the appropriate techniques and material.

The training programme also explains how the CONECTEM Communicative Intervention is carried out in Phase II. This training programme consists of two 2-hour sessions and will be evaluated by means of a theoretical-practical test to see if the nurses who carry out the intervention in phase II are able to carry it out.

CONECTEM Communication Intervention: This consists of applying basic and assisted communication techniques, already validated by experts (4) to the critical patient admitted to the ICU. The intervention is divided into 3 strategies according to the level of patient awareness. Each strategy presents both verbal and non-verbal communication skills and appropriate material for patients with communication difficulties (physical or cognitive). Each strategy includes details of the specific communication techniques to be used by the therapists and a description of how they are to be used.

Procedure and data collection Phase I: Procedure for the selection of participants. Depending on the participation of the ICU nurses of the study hospital who meet the inclusion/exclusion criteria, they will be given a folder made up of: a) full information and informed consent, b) a form to collect socio-demographic variables c) forms to collect the variables of knowledge on communication with the critically ill. Of all the nurses participating in this phase, 16 nurses will be selected by agreement to participate in phase II, who will be assigned to the control group or the intervention group. Training in the CONECTEM programme will be given to the 8 nurses who form part of the intervention group. Once the training has been completed, a test will be used to assess whether the nurses are able to carry out the CONECTEM Communicative Intervention with critical patients . The questionnaire on perceived satisfaction with the training programme will also be completed . All these data will be collected by the research team.

Phase II:

The selection of patients will be by consecutive cases, as they enter the ICU. Participants will have to comply with the specified inclusion and exclusion criteria and will have to sign the informed consent form (either on their own or delegated). The data collection will be carried out by the IG and CG nurses. The IG nurses will be given a folder that will include: a) a form of socio-demographic and health variables of the patient , b) the detailed CONECTEM Communicative Intervention, c) the scales for the evaluation of the psycho-emotional variables studied and d) a questionnaire on the usefulness of the CONECTEM training programme . The CG nurses will be given a folder with a) a form of socio-demographic and health variables of the patient and b) scales for the evaluation of the psycho-emotional effects. Data collection will be carried out twice a year until the patient is discharged from the ICU. In the IC, the nurse will collect the data pre-post CONECTEM communicative intervention, which lasts a minimum of 15 minutes. The nurses of the CG will collect the pre-post data pre-post nurse-patient interaction on a regular basis.

Annex 4

1. Training in basic and assisted communication techniques (CONECTEM)

   The theoretical part; Based on three theories on nurse-patient communication:

   Theory of 'Helping Human Relationships'(1): Based on a model of effective communication where 2 basic sets of skills are defined in the communicative activity: the initiation dimension and the response dimension. The nurse and the patient carry out a joint reflexive process in order to be successful in the therapeutic relationship.

   Theory of 'Interpersonal Relations in Nursing' (5): Based on therapeutic communication between nurse and patient, the foundations of which are: transparency, respect, dialogue and non-verbal communication. It proposes an integral vision of the infernal cures where effective communication is the essence.

   'Augmentative Assistive Communication (AAC) (2,3): A communication system for people with temporary or permanent communication difficulties and/or limitations who are unable to express and/or understand themselves verbally and/or in writing in their daily lives.It consists of classifying the real communicative needs of the disabled into 4 functions: expression of needs or desires, development of the close social circle, exchange of information and social behaviour routines.

   In this theoretical part, the psycho-emotional effects of the critically ill are also described, the particularities of the Care Unit are emphasised and the communicative intervention that will be carried out during phase II is explained (strategies, variables and measuring instruments).

   The practical part consists of exercises in trusting others, non-verbal communication exercises, emotional work and the application, in a fictitious situation, of basic and assisted communication techniques.

   Training objectives - To understand the importance of communication in critical illness.
   * Know how to recognise psychoemotional disorders (pain, stress and anxiety).
   * Learn new communication techniques with critically ill people who present communication difficulties of comprehension and/or expression.
   * To learn techniques for communicating with unconscious patients.
   * Improve basic communication skills. Assessment of the training
   * Theoretical-practical exam to see if nurses achieve the established objectives and can therefore participate in phase II of the project.
   * The perceived satisfaction of the training in basic and assisted communication techniques will be evaluated once it has been completed.
   * The perception of the usefulness of the training in basic and assisted communication techniques will be assessed 3 months after starting the CONECTEM communication intervention.

   Material and methodology
   * The course will last 2 hours and will be held in ten different times so that all nurses can attend.
   * Power Point support and audiovisual media such as some videos and images. Work in small groups to discuss the examples presented and emotional work will be done. Role-palying for the simulation of cases.
   * Non-verbal communication and confidence exercises with peers will be carried out using materials such as a snot-brush, a paper clipboard, cardboard and coloured paper.
2. CONECTEM Communicative Intervention It consists of applying a series of communicative strategies, previously validated in the literature (3,4). The intervention classifies the communicative techniques into three groups according to the patient's state of consciousness. Each group of strategies involves a level of verbal and non-verbal communication.

Strategy 1. Glasgow 15. The patient is conscious and oriented, has no difficulty in understanding or expressing him/herself in order to communicate.

We will use verbal and non-verbal communication. This strategy will be based on Carkhuff's 'Helping human Relation-ships theory', which shows the basis for achieving a positive relationship between the patient and the nurse by means of two key dimensions: The response dimension (empathy, respect, clarity in expression) and the initiative dimension (showing authenticity, open-mindedness/non-judgement, confronting one's own feelings, being concrete) (1).

Description and authors of the communicative actions of Strategy 1 of CONECTEM intervention STRATEGY/AUTHOR ACTION TO BE CARRIED OUT Gain attention and visual contact (2) Make sure that the patient and the nurse are focused on each other, both with their gaze and with the messages.

Confirm all the patient's messages (3).Validate that the message has been understood by repeating the message or what has been understood about the message.

Make pauses (2). Allowing more time between communication exchanges facilitates the patient's thought process.

Yes/no sentence ending strategy (3). Making sentences or questions with yes/no at the end alerts the patient that he/she will have to choose an option.

Clarity of expression (1). Clarify and verify the perception of the message. Paraphrasing, short and simple sentences.

Empathy and active listening (1). Understanding the patient's concerns, desires, worries, etc... helps the flow of communication.

Respect (1). Accepting others as they are without judging them. Assertiveness (1). Modulate the language, tone of voice, intentionality of the emitter allowing feedback with the other.

Own elaboration, based on the authors of the table. Strategy 2. Glasgow (14-9). Conscious, disoriented person with difficulties in communicating due to gravity.

We will use verbal and non-verbal communication. If the patient has the ability to speak, we will use Strategy 1 plus Strategy 2. (1,3) We can see the communicative strategies in the following table.

Description and authors of the communicative actions of Strategy 2 of the CONECTEM intervention.

STRATEGY/AUTHOR ACTION TO BE CARRIED OUT Concreteness and precision in language (1). Use short phrases or simple sentences with yes/no at the end to make it easier for the patient to understand.

Establish a clear yes/no signal e.g.: moure el cap amunt/avall = yes. (2,3). Ensure that the yes/no signal can be carried out and remembered by the patient and understood by others.

Patient gestures or international signs - dictionary (4,6). Perform international signs to establish feedback with the patient.

Communicative assistance with drawings (3,4). Use the banners where there are a series of drawings with the patient's needs. The patient must point out the need and this will be repeated aloud by the nurse.

Own elaboration based on the authors of the table. b-1 Signs of the universal dictionary (4)

b-2 Patient Emotion Indicator Panel (4)

b-3 Patient needs indicator panel. (4)

Estratègia 3. Glasgow (≤8). Very ill patient, with indications for intubation, sedation and analgesia. We will basically use non-verbal communication, taking into account all external factors that may predispose to a change in the patient's condition. The communication strategies described in the following table can be observed.

. Description and authors of the communicative actions of Strategy 3 of the CONECTEM intervention.

STRATEGY/AUTHOR ACTION TO BE PERFORMED Facial expression and motor movements (3).Observe facial gestures and movements, especially those of the extremities. These will be the most reliable indicators of comfort/uncomfort, pain/non-pain expression, stress/non-stress...

Alteration of physical signs (7). Controlling changes in HR, BP, RR, sweating Tonality of voice and calm environment (4).

Musique (8,9). Modulate your voice, speak softly and slowly, respecting an atmosphere of silence, without intense lights or loud noises. Adjust the temperature of the ICU according to the needs of the patient.

Achieve a relaxing atmosphere, playing calm music during the journey (10). Make comforting movements for the patient, avoiding abruptness and trying to establish non-verbal communication.

Eligibility criteria: Inclusion Criteria:

* Critical patients admitted to the ICU's of the Hospital Vall d'Hebron who accepted to participate in the study on their own volition or by delegation of the family member, previously informed in writing.

Exclusion Criteria:

* Patients who do not understand Catalan or Spanish, critically ill patients admitted to the ICU for less than 24 hours and/or diagnosed with a psychiatric disorder prior to admission.

Primary outcomes:
measure: Level of pain
timeFrame: VAS: Pre-post intervention (0 -30 minutes), Pre-post Nursing care (0-30 minutes). Glasgow >9. BPS: Pre-post intervention (0 -30 min), Pre-post Nursing care (0-30 min). Glasgow <9
measure: Level of anxiety for responsable patients
timeFrame: Pre post intervention 0-30 minutes, pre post nursing usual care 0-30 minutes. Glasgow >9
measure: Level of sedation and agitation
timeFrame: Pre-post intervention 0 -30 minutes , Pre post nursing usual care 0-30 minutes ( glasgow <9)
measure: level of post-traumatic stress symptoms
timeFrame: Pre post intervention 0-30 minutes , pre post nursing usual care 0-30 minutes. Gasgow >9
measure: level of consciousness
timeFrame: Baseline
Secondary outcomes:
measure: perception of the usefulness of the CONECTEM intervention
timeFrame: 3 month post data collection
Other outcomes:
measure: Sex
timeFrame: Baseline
measure: Age in years
timeFrame: Baseline
measure: educational Level
timeFrame: Baseline
measure: Marital status
timeFrame: Baseline
measure: Origin/nationality
timeFrame: Baseline
measure: Employment situation
timeFrame: Baseline
measure: TYPE OF PATHOLOGY
timeFrame: Baseline
measure: patient on mechanical ventilation
timeFrame: Baseline
measure: communicative strategy used
timeFrame: Pre-intervention
measure: Hearing impairment
timeFrame: Baseline
measure: Visual Impairment
timeFrame: Baseline
measure: Motor impairment
timeFrame: Baseline
measure: Cognitive impairment
timeFrame: Baseline
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: University of Barcelona
state: Catalonia
Study officials:
affiliation: University of Barcelona
name: Marta Prats-Arimon, PHD
role: PRINCIPAL_INVESTIGATOR
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