Clinical trial NCT04726696: Clarification of Nurses' Expected Role in Health Promotion
Official title: Clarification of Nurses' Expected Role in Health Promotion: Study Protocol of an Exploratory Clustered Randomised Controlled Trial for the ROLE-AP Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Role, Nurses
Keywords: Role clarification
Nurses' role
Health promotion
Prevention
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Gobierno de Navarra
name: Universidad Pública de Navarra
First posted: 2021-01-27
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted in the province of Navarra (Spain), in the primary health care service. The study will follow a cluster randomised design with primary care teams (PCT) as sampling units. A PCT consists of a group of family physicians who work in close cooperation with nurses and social workers to offer primary care services to registered individuals in the area. Each cluster will be randomly assigned to one of the two groups, control or intervention. The main reason for using a cluster design is to avoid contamination, which could occur among nurses working in the same PCT. This is more likely given the particular characteristics of this complex intervention in which masking is not possible. The R software (version 3.3.0) will be used to choose an allocation at random. The randomisation of the study groups will be stratified according to the scope of work (rural / urban), to guarantee the representativeness of the different segments of the study population.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to implement and evaluate ROLE-AP, a multi-component program to clarify primary care nurses' expected role in health promotion. It is hypothesized that, in comparison with the control group, participants in the experimental group will increase their degree of agreement on nurses' role in health promotion.

Detailed description: Role confusion is hampering the development of primary care nurses' capacity for health promotion. Organizations can implement role clarification programs to develop the description of an expected role in the organization and reduce the negative effects of role confusion. Literature on role clarification interventions reveal that they are complex interventions seeking discussion to reach agreement between professionals about the expected role activities. However, such interventions have shown several methodological shortcomings. This study aims to implement and evaluate a multi-component program to clarify primary care nurses' role in health promotion. An exploratory clinical trial will help evaluate the preliminary efficacy and understand if an intervention of these characteristics is feasible, if its components are appropriate and / or if it is accepted by the participants. This is a pilot cluster randomized exploratory trial, which corresponds to Phase II of the Medical Research Council (MRC) framework for the development and evaluation of clinical trials in complex interventions. The study will be conducted in the province of Navarra (Spain), in the primary health care service. The study will follow a cluster randomised design with primary care teams (PCT) as sampling units. A PCT consists of a group of family physicians who work in close cooperation with nurses and social workers to offer primary care services to registered individuals in the area. Each cluster will be randomly assigned to one of the two groups, control or intervention. The main reason for using a cluster design is to avoid contamination, which could occur among nurses working in the same PCT. The randomisation of the study groups will be stratified according to the scope of work (rural / urban), to guarantee the representativeness of the different segments of the study population. It has been considered that nurses' activities and the perception they may have about their health promoting role may be conditioned by two factors: the organization and structure of the PCT and the characteristics of the populations they attend. These two factors may vary depending on the team attending rural or urban population, so it will be considered as a possible confusing variable. The control group will continue with their routine.

Eligibility criteria: Inclusion Criteria:

* being a primary care nurse in the Navarre health service.
* have two years of professional experience in primary health care
* be a nurse attending either adult or pediatric population
* have signed the consent form for participation in the study

Exclusion Criteria:

- not planning to be in clinical practice for the whole duration of the study.

Primary outcomes:
measure: Changes on nurses' agreement on their role using the Spanish version of "Nurses' Role in Health Promotion Questionnaire"
timeFrame: Baseline (T0), immediately after intervention (T1) and 3 months follow up (T2)
Secondary outcomes:
Other outcomes:
measure: Barriers to program implementation assessed by the researcher's field diary (Feasibility)
timeFrame: Baseline (T0)
measure: Fidelity of the program assessed by the "ROLE-AP program checklist" (Quality)
timeFrame: During the intervention
measure: Acceptability of the program by nurses, assessed by the "Nurses' satisfaction with the ROLE-AP program questionnaire"
timeFrame: Immediately after intervention
measure: Quality of the program assessed by the "Nurses' satisfaction with the ROLE-AP program questionnaire" and debriefing sessions.
timeFrame: During the intervention and Immediately after intervention
measure: Effect size assessed by the Cohen's formula
timeFrame: Immediately after intervention
Locations:
city: Pamplona
country: Spain
facility: University of Navarra
state: Navarra
Study officials:
affiliation: University of Navarra
name: Iriarte
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iriarte-Roteta A, Lopez-Dicastillo O, Mujika A, Antonanzas-Baztan E, Hernantes N, Galan Espinilla MJ, Pumar-Mendez MJ. Building capacity for health promotion by addressing nurses' role confusion: Study protocol of a pilot clustered randomised controlled trial. J Adv Nurs. 2021 Nov;77(11):4574-4585. doi: 10.1111/jan.15018. Epub 2021 Aug 21.