Clinical trial NCT05220566: Impact of the 'Reserved Therapeutic Space' Nursing Intervention: an Intervention Study in Acute Mental Health Units
Official title: Impact of the 'Reserved Therapeutic Space' Nursing Intervention on Patient Health Outcomes: an Intervention Study in Acute Mental Health Units in Spain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse-Patient Relations
Psychiatric Hospitalization
Keywords: Nurse-Patient therapeutic relationship
Quality of psychiatric care
Mental health nursing
Acute psychiatric care
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Campus docent Sant Joan de Déu-Universitat de Barcelona
name: Hospital Universitario Fundación Alcorcón
name: Hospital Regional de Malaga
name: Hospital Gil Casares de Santiago de Compostela
name: Hospital Universitario Infanta Leonor
name: Hospital Virgen de los Lirios de Alcoi
name: Hospital Universitari de Bellvitge
name: Hospital de Galdakao
name: Hospital de Mataró
name: Hospital del Mar
name: Complejo Hospitalario Universitario de Vigo
name: Hospital Universitario San Juan de Alicante
name: Instituto de Salud Carlos III
name: Colegio Oficial de Enfermeras y Enfermeros de Barcelona
name: Hospital Clínico Universitario de Valencia
First posted: 2022-02-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aims:

To evaluate the effectiveness of the "Reserved Therapeutic Space" intervention for improving the nurse-patient therapeutic relationship in acute mental health units in Spain, as well as its impact in terms of quality of care and patients' perceptions of coercion.

Design:

Multicenter intervention study with control group.

Methods:

The study will be carried out in 12 mental health units in Spain. Given the conditions of evaluation in real clinical practice, paired randomization will be performed to assign centers to intervention and control groups. The "Reserved Therapeutic Space" intervention to be tested has been co-designed and validated by both nurses and patients. The quality of the therapeutic relationship, the care received, and perceived coercion among patients will be assessed at baseline and at discharge using instruments validated in our context. An estimated 131 patients per group are expected to participate. Funding was granted in July 2021 by the Institute of Health Carlos III (PI21/00605, Ministry of Science and Innovation) and in October 2021 by the College of Nurses of Barcelona (PR-487/2021). The proposal was approved by all the Research Ethics Committees of participating centers.

Discussion:

This study is expected to demonstrate the effectiveness of a specific nursing intervention on patient health outcomes including the level of the therapeutic relationship, the quality of care, the level of coercion and other specific indicators for acute mental health units.

Impact:

This project will lead to changes in clinical practice, transforming the current models of organization and care management in mental health hospitalization units, promoting the quality of the therapeutic relationship and, ultimately, the quality of person-centered care.


Eligibility criteria: Inclusion Criteria:

* Adults hospitalized in mental health inpatient units who voluntarily consent to participate in the study

Exclusion Criteria:

* Adults hospitalized in mental health inpatient units who present a language barrier, mechanical restraint, contraindication by the clinical referent, cognitive impairment, or intellectual disability at the time of recruitment.

Primary outcomes:
measure: Change from baseline Nurse-patient therapeutic alliance at discharge assessed by WAI-Short patient version
timeFrame: At baseline and at discharge from the inpatient unit (an average of 16 days)
Secondary outcomes:
measure: Change from baseline Quality in Psychiatric Care at discharge assessed by QPC
timeFrame: At baseline and at discharge from the inpatient unit (an average of 16 days)
measure: Experience of coercion assessed by CES-18
timeFrame: At discharge from the inpatient unit (an average of 16 days)
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Hospital Gil Casares
state: A Coruña
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Málaga
country: Spain
facility: Hospital Universitario Regional
city: Valencia
country: Spain
facility: Hospital Clinic Universitari de Valencia
Study officials:
References:
citation: El-Abidi K, Moreno-Poyato AR, Canabate-Ros M, Garcia-Sanchez JA, Lluch-Canut MT, Munoz-Ruoco E, Perez-Moreno JJ, Pita-De-La-Vega J, Puig-Llobet M, Rubia-Ruiz G, Santos-Pariente C, Lopez AMR, Golmar LJ, Lopez CE, Roldan-Merino JF. The therapeutic relationship from the perspective of patients and nurses in the first days of admission: A cross-sectional study in acute mental health units. Int J Ment Health Nurs. 2024 Feb;33(1):134-142. doi: 10.1111/inm.13227. Epub 2023 Sep 24.
citation: Moreno-Poyato AR, El Abidi K, Lluch-Canut T, Canabate-Ros M, Puig-Llobet M, Roldan-Merino JF. Impact of the 'reserved therapeutic space' nursing intervention on patient health outcomes: An intervention study in acute mental health units. Nurs Open. 2023 Aug;10(8):5749-5757. doi: 10.1002/nop2.1750. Epub 2023 Apr 21.