Implementation of an intervention to improve the adoption of asthma self-management practices in Peru: Asthma Implementation Research (AIRE) randomized trial study protocol

Peru has a decentralized healthcare system administered by five entities, the largest being the Ministry of Health (MINSA), which provides health services for 60% of the population across Peru [10]. The Seguro Integral de Salud (SIS), as part of the MINSA health system, serves individuals without any other type of insurance, including those living in poverty or other vulnerable populations (e.g. pregnant women, children, etc.).

The MINSA health system is organized into three levels. Level I, which is sub-categorized into four levels, comprises health posts (I-1, I-2) and larger health centers (I-3, I-4). Individuals who cannot be managed by the staff at Level I health centers due to disease complexity are referred through the referral system to higher levels of care. Resources and personnel available for the acute and chronic management of asthma varies by level. Lower level health posts (I-1) generally do not have personnel able to manage either acute or chronic asthma cases. Higher level health posts (I-2, I-3) are able to resolve uncomplicated acute asthma exacerbations, while level I-4 health centers are equipped with nebulizers and a 24-h emergency room to resolve asthma attacks. Level I-4 centers also often have specialists (pediatricians, pulmonologists) on staff who may provide primary care for asthma, as well as a pharmacy. Levels II and III are referral facilities that, in addition to nebulizers and 24-h emergency care, also offer specialized clinics in pediatric pulmonology, and may offer diagnostic services such as spirometry.

This study will be carried out in the geographical area known as “Lima Norte” (North Lima) and will be based primarily at Cayetano Heredia Hospital, a level III referral hospital located in the district of San Martín de Porres. Cayetano Heredia Hospital is considered one of the main hospitals in northern Lima, in addition to Sergio Bernales and Carlos La Hoz Hospital. Cayetano Heredia is the hospital with the highest demand of referrals, with a catchment area comprising the districts of San Martin de Porres, Comas, Independencia, Los Olivos, and Puente Piedra. These districts are geographically adjacent; Cayetano Heredia Hospital is approximately 40 km from the center of the farthest district, Ancón, from which on public transport it may take as long as 2 h to arrive.

The content of the intervention was informed by a multi-phased formative research effort carried out during 2015–2019 (Fig. 1). In the first phase of formative research, we carried out in-depth interviews with key stakeholders (22 children–caregiver dyads and 20 local healthcare professionals and workers) to identify key barriers and facilitators to adoption of self-management practices in peri-urban communities of Lima.

Using the data collected in this first phase, we used the Capability, Opportunity, Motivation – Behavior/Behavior Change Wheel (COM-B/BCW), a theory-based framework for designing intervention strategies derived from a synthesis of 19 existing behavior change frameworks [11], to systematically develop a preliminary design for the intervention strategy. Using this framework, we first identified, prioritized, and categorized key barriers to adoption of self-management practices for asthma in our context. Barriers were prioritized based on potential impact, perceived importance, and feasibility of addressing during this stage of research. We then used the BCW to design intervention components grounded in theory-based behavior change techniques that would target these key barriers to adoption (Fig. 2).

In the second phase of formative research, we carried out two focus groups, one with caregivers of children with asthma (n = 7) and another with local pulmonary physicians (n = 3), to solicit feedback regarding the acceptability and perceived feasibility of each intervention component. Participants also had the opportunity to review preliminary versions of the instruments and materials and provided specific feedback as to how to improve upon the design and content. We then incorporated this feedback into the next version of the design.

In the final formative phase, we conducted two iterative pilots with child–caregiver dyads (n = 6, n = 10). For these pilots, we implemented the full intervention package over a period of 1 month and 2 months, respectively. The purpose of these pilot studies was to evaluate whether the intervention was acceptable, feasible, and effective in modifying key barriers to adoption of self-management practices. Following each pilot, we conducted in-depth interviews and surveys with participating families and gathered feedback regarding the acceptability and feasibility of each component. The data from each pilot study allowed us to further refine the specifics of intervention delivery and content in this context.

For the full intervention package, child–caregiver dyads are assigned a designated nurse manager who provides monthly home visits and are available via cell phone during established hours for the period of follow-up. All instruments used in this study were created or adapted to the Peruvian context through advice and iterative feedback from local general practitioners, pulmonologists, children with asthma, and their caregivers during the formative pilot phase. For details on the content of the components and methods for adaptation to the local context, see Table 1.

Nurse managers are licensed nursing professionals with experience in community health and health education. All nurses will have had experience treating children with asthma in a clinical setting. Nurses have prior experience working in the communities in which this study will be carried out. As such, nurse managers will also provide invaluable knowledge and expertise relevant to the appropriate and effective delivery of the intervention components in this setting.

Training will include three full-day sessions. Nurse managers will be trained in several basic competencies related to asthma pathophysiology, common treatments for asthma and their mechanism of action, international and Peruvian guidelines for the diagnosis, management, and treatment of asthma, and familiarization with project goals. They will also be trained in rapport building and interpersonal communication skills, research ethics and maintaining confidentiality, maintaining personal safety, and monitoring and feedback of key self-management behaviors. Finally, nurse managers will receive hands-on training and practice in the use of all components of the intervention, including delivering asthma education, the asthma action plan, and demonstrations of inhaler technique. Refresher trainings will occur periodically throughout the study period to provide continual reinforcement and feedback.

Children will be recruited from the pediatric pulmonary clinic at Cayetano Heredia Hospital, a level III referral hospital in Lima Norte. Children aged 5–17 years identified by physicians as meeting eligibility criteria will be referred to on-site study personnel and screened to confirm eligibility using a questionnaire. Before enrollment, study personnel will explain the goals of the study, what the study entails on the part of participating children and caregivers, and then asked if they are interested in participating. After answering any questions or concerns, we will obtain written informed consent from all caregivers and written informed assent from children before enrollment. On the consent form, participants will be asked if they agree to use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the universities taking part in the research or from regulatory authorities, where relevant. This trial does not involve collecting biological specimens for storage. To achieve maximum retention, we will offer inhaler medications to all study participants regardless of treatment assignment for the duration of the follow-up. We will also offer an interactive educational workshop at the end of the study for those who complete the follow-up.

Participants will be randomized 1:1 to the intervention or control groups using the “Sealed Envelope” program (www.​sealedenvelope.​com), which provides high-quality and easy-to-use online software applications for randomizing patients into clinical trials using block randomization (blocks of 4, 6, and 8). Only the local study lead and nurse managers have access to randomization assignment. Other study investigators and data analysts will be blinded to treatment assignment. Data collectors will be blinded whenever feasible, although blinding cannot be guaranteed due to the nature of the intervention.

All participants, regardless of group assignment, will be provided with medications prescribed by the local physician at their clinical discretion for the 6-month follow-up period. Individuals randomized to the intervention arm will receive the full case management intervention package. Individuals in the control group will receive the standard of care plus asthma education delivered by a nurse educator.

The primary objective of this pilot trial is to assess the feasibility, acceptability, and preliminary effectiveness of the intervention package in the Peruvian context. With a sample size of 100 participants, assuming a standard deviation of 3.6 and a type II error of 5%, we will be able to detect a difference of 2 in ACT score with 80% power. These calculations were based on preliminary data from a prior epidemiological study of children with asthma in this setting, in which the standard deviation of the ACT score was 3.6 [17]. In order to account for approximately 9% attrition, we arrived at a final sample size of 110 individuals.