Trial design and settings
We will implement a pilot prospective RCT design among single-blind and parallel-groups. PHNs who register for this study will be randomly allocated to the intervention or wait-listed control groups [1:1]; as such, a double-blind design was not possible. However, we will ensure equal learning opportunities for both groups following data collection. All PHNs will be exposed to the same self-learning program. The intervention group will participate in the program first and then the wait-listed control group will be offered the same program contents. All participants will answer a post-test survey.
The Institutional Review Board (IRB) at the organization affiliated with the primary researcher approved of the protocol for this study on February 17, 2021 (ID: NIPH-IBRA#12313). The IRB of the third researcher also approved of the study protocol on March 16, 2021 (ID: C1516).
This pilot study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) following the International Committee of Medical Journal Editors (No. UMIN000043628, March 23, 2021). Explanations of the study’s aims and procedures will be provided to the participants through the study website, where the results will also be published. All eligible PHNs will provide written web-based informed consent prior to the study registration. Only those who meet the inclusion criteria and agreed to participate will be included in the study. To ensure privacy, no personal information, including place of employment, will be collected.
Participant eligibility criteria
Eligible participants will include PHNs who are full-time public servants in Japan. PHNs who have experience in local healthcare planning will not be excluded. Exclusion criteria include those who do not have Internet access, are employed on a part-time basis, and have no opportunity to be involved in the local healthcare planning process.
The sample size has not yet been calculated based on a power analysis due to feasibility and a limited research budget . Further, previous research has indicated that sample size do not need to be calculated for pilot studies . Owing to ethical considerations, we will not over-recruitment participants. Further, we expect the participant pool to be limited due to the COVID-19 pandemic, which has resulted in a general shortage of PHNs because most were involved in frontline activities .
Sampling, informed consent and randomization
In this pilot study, we will focus on a prefecture in the Kanto region in Japan, which has approximately 600 PHNs. The research team will send 36 letters (i.e., one to the prefectural government and 35 to the municipal governments) to public health nursing directors in May 2021. We will send a reminder letter to them in early June 2021. These directors are expected to share information about this study with their PHNs. Those who express interest in participation will be given access to our study website, which will contain a study explanation sheet and written web-based informed consent forms for completion. Only those who agree to these conditions and meet the eligibility criteria (as determined by the researchers) will be allowed to participate. The registration period will begin in May and last until the end of June 2021. To ensure privacy, participants will register using pseudonyms and their e-mail addresses.
Figure 1 illustrates a flowchart for the Consolidate Standards of Reporting Trial (CONSORT) design, which will be used throughout the study process. Randomization will be conducted by the researcher who specializes in statistics, and the co-author, via an equal computer-based randomization table. A permuted-block method will be adopted to ensure that participants are equally divided between the intervention and control groups. We will send e-mail to all participants informing them of which group they have been assigned to allocate.
All data will be anonymized; we will not collect any personal information or the names of the local governments where participants are employed. Data collection will be conducted through the study website, where participants will enter all relevant information and complete any required elements (e.g., demographic data and the outcome scales), which will be evaluated as baseline and post-test data. The intervention group will also be asked to keep the contents of the web-based self-learning program confidential so that the control group will not be exposed to any such information. We will explain the risks of contamination to the intervention group on the study website. The intervention group will receive a URL address where they can view the learning modules, which will be password protected (passwords sent via e-mail).
Description of the intervention: Overview of the web-based self-learning program
We designed an outline of the web-based self-learning program, which included six modules for acquiring knowledge and skills related to local healthcare planning based on the adult learning theory , a review of the relevant Japanese literature , and several specific studies [5, 15, 16, 20, 23, 26, 32]. In the pre-test, we asked five PHNs with previous involvement in local healthcare planning to confirm all modules and its contents. We then added explanations for each module and confirmed that the newly developed web-based self-learning program would include knowledge and skills that PHNs could use to promote local healthcare planning both effortlessly and effectively. Each module takes approximately 10-20 minutes to complete.
Table 1 presents the themes and objectives for each module as follows: (1) Create a concrete vision of the ideal community; (2) Bridge the daily practices of PHNs’ with local healthcare planning; (3) Basic knowledge necessary for local healthcare planning; (4) Understand the steps of the healthcare planning process; (5) Hone coordinate skills with related parties; and (6) Accomplish goal setting and project evaluation. Participants will be able to use this worksheet to identify and summarize the objectives for local healthcare planning, community health needs, related government plans, legal issues, relevant staff and key persons in the community, and an evaluation index. The intervention will be conducted from July to August 2021. Once the post-test data are collected in September, the control group will participate in the program from October to November in 2021.
Outcomes and data collection
Using the study website, eligible participants will provide demographic data and complete the outcome scales both at baseline and post-intervention. More specifically, demographic data will include gender, age, years of PHN experience, job title, educational background, affiliation, previous experience with local healthcare planning education at the undergraduate level and/or on-the-job training after graduation, previous experience with local healthcare planning, whether they worked with colleagues who played active roles in healthcare planning, and information on promoting the daily practices of PHNs. To decrease the number of dropouts, we will send e-mails all participants with information about the study progress and remind them to answer the post-test questions.
Both at baseline and post-intervention, we will obtain participants data and investigate the following outcomes.
Competencies related to involvement in health policy
The primary outcome will be measured using a self-reported 16-item scale targeting PHN competencies in public health policy in the context of the Japanese local governments . The scale was confirmed as both reliable and valid for use in Japan and is only available in Japanese. The first eight items measure community partnership among PHNs when developing health policy, while the remaining items evaluate competencies related to the community nursing diagnosis cycle. All items will be measured using a 4-point Likert scale, ranging from 0 to 3: 0 (unable to do), 1 (partially unable to do), 2 (partially able to do), and 3 (able to do).
The necessity of healthcare activities
The secondary outcome will be measured using a self-reported 19 item scale designed to reveal information about the necessity of healthcare activities that are based on evidence and the promotion of decision-making with superiors as a way to improve planning . This scale was confirmed as both reliable and valid for use in Japan and is only available in Japanese. The 19 items listed in the scale are organized within four dimensions as follows: 1) three items measured the existence of health needs, 2) five items measure the necessity of addressing health needs based on evidence, 3) five items measure actual conditions that require solutions, and 4) six items measure priorities for resolution. All items will be measured using a 6-point Likert scale: 0 (never applicable), 1 (20% applicable), 2 (40% applicable), 3 (60% applicable), 4 (80% applicable), and 5 (100% applicable).
Knowledges, skills, and perspectives of PHNs involved in local healthcare planning
The third outcome will be measured based on 29 questions targeting the knowledge, skills, and perspectives of PHNs involved in local healthcare planning. All items will be measured using a 4-point Likert scale: 1 (never), 2 (not much), 3 (a little), and 4 (a lot).
We will assess the feasibility of this study based on the recruitment rate, dropout rate, and data completion rate. We will also ask the participants for their feedback on the feasibility of the trial and the web-based learning self-learning program itself, clarifying areas that need improvement and/or continual refinement. These responses will be obtained through free descriptions.
Without harmful interventions, this study will not establish a data monitoring committee. Researcher TK will be responsible for managing all data obtained through the study website, and will alert the research team about any problems related to recruitment or data collection. Researcher TK will also provide all data to the research team via Microsoft Excel (password locked). The research team will also conduct a quality assurance procedure.
We will conduct descriptive statistics (e.g., recruitment rate, dropout rate, and data completion rate) and analyze intergroup baseline differences in the data and primary outcomes using the Mann-Whitney U-test and the chi-square/Fisher’s exact test. Next, we will assess whether previous experience in local healthcare planning and other factors affected the study outcomes based on the results of the Mann-Whitney U-test and the chi-square/Fisher’s exact test. Analyses will be performed according to the intention-to-treat principle. We will use IBM SPSS for Windows (version 25; IBM Corp, Armonk, NY, USA) for analysis and p-values < .05 indicating statistically significant intergroup differences. This study is expected to have a power ≥.80 and α ≤.05, assuming a medium effect size (d = .30) .
A content analysis
We will conduct a content analysis using all participant feedback provided through the free descriptions mentioned earlier, specifically regarding their feasibility and the web-based self-learning program itself. This will be done by entering relevant information into a Microsoft Excel worksheet. We will code all data and sort the results based on their commonalities. These findings will be used to refine both the study website and the web-based learning self-learning program.