Clarification of Nurses' Expected Role in Health Promotion (ROLE-AP)

Clarification of Nurses' Expected Role in Health Promotion: Study Protocol of an Exploratory Clustered Randomised Controlled Trial for the ROLE-AP Program

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.

Study Overview

• Status: Unknown
• Conditions: Role, Nurses
• Intervention / Treatment: Behavioral: ROLE-AP programme

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • University of Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; None intervention to be administered, they continue their normal routine.
Experimental: Intervention group; ROLE-AP is a multifaceted program offered over a month period to participating primary care nurses and includes three interactive workshops. Each workshop will be 4 hours long.	Behavioral: ROLE-AP programme; The intervention group will be split in two groups of 7-8 primary care nurses each. These two groups will receive the ROLE-AP program over a three weeks period. Each workshop will be divided into two sessions of 90-120min. The first workshop focuses on the clarification of health promotion concepts and the discussion of the state of nursing practice in health promotion. Participants will discuss the misalignments between this description of nursing practice and the ideal one portrayed by the Ottawa Charter. The second workshop will allow the presentation of the objectives of the health care organization, showing its alignment with the Ottawa Charter areas of action. In addition, it will present a standardized instrument that reflects expectations about nurses' activities in health promotion that will serve for discussing and realigning participants' expectations on nurses' role in health promotion. The third workshop will continue with the discussion of nurses' expected activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on nurses' agreement on their role using the Spanish version of "Nurses' Role in Health Promotion Questionnaire"	Nurses will complete the questionnaire at 3 time points.	Baseline (T0), immediately after intervention (T1) and 3 months follow up (T2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to program implementation assessed by the researcher's field diary (Feasibility)	Explored by the researchers' field diary, without using any scale. It will collect qualitative data related to barriers/facilitators to the randomization and recruitment process, degree of collaboration of the primary care managers, resources and materials used and characteristics of the context in which the intervention takes place.	Baseline (T0)
Fidelity of the program assessed by the "ROLE-AP program checklist" (Quality)	Fidelity will be evaluated through structured observations of each program session. The checklist will contain the following information: compliance with the programmed activities, order of activities and time spent for each activity.	During the intervention
Acceptability of the program by nurses, assessed by the "Nurses' satisfaction with the ROLE-AP program questionnaire"	The acceptance and satisfaction of the participants with the program will be measured through a questionnaire prepared for this purpose. Three closed questions will assess the degree of satisfaction with the program, the recommendation and need for programs of these characteristics.	Immediately after intervention
Quality of the program assessed by the "Nurses' satisfaction with the ROLE-AP program questionnaire" and debriefing sessions.	The questionnaire contains three open questions to know nurses' opinions about the materials used, the role of the facilitator and possible suggestions for the improvement of the program. The debriefing sessions will take place after each session of the program. The script will contain questions about positive and negative aspects of the program perceived by the research team.	During the intervention and Immediately after intervention
Effect size assessed by the Cohen's formula	The Cohen's formula will be used to estimate the size effect for a definitive randomized clinical trial.	Immediately after intervention

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: Universidad Pública de Navarra; Gobierno de Navarra
• Investigators: Principal Investigator: Iriarte, University of Navarra

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Health promotion; Prevention; Role clarification; Nurses' role
• Other Study ID Numbers: GºNa15/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No