Exploring health literacy pertaining to general wellbeing and chronic disease management among population registered within Primary Healthcare System: A Study protocol

Study settings

‘Qatar, a peninsular Arab country (with having world’s third-largest natural gas and oil reserves) has recently emerged as a leading primary healthcare provider country that aims to provide comprehensive primary care with due consideration of the fundamental principles outlined within the concept by the World Health Organization. This was mainly achieved by the development of a universal publicly funded primary healthcare service delivered by the PHCC. PHCC is one of the main and most significant primary care providers in the country publicly with 32 health centers. Importantly all the primary health centers are accredited by Accreditation Canada International and distributed across three geographical regions [16].’

Study design

The study design will be mixed methods (include both quantitative and qualitative elements). The HLQ survey (Arabic and English versions) will be sent online (text messages) to the population registered with PHCC and to capture service users’ perceptions and preferences pertaining to health literacy channels. The qualitative method will be utilized to gain an in-depth understanding of the various health literacy channels, challenges and barriers pertaining to the implementation of the health literacy strategies from both the healthcare provider and service users’ perspective. This will include interviews with services users accessing primary health care centres and focus group discissions with health care providers (HCPs) who are providing health care services within primary care settings.

Sampling strategy and recruitment plan for service users registered with PHCC to participate in online HLQ

A full list of adult individuals aged 18 + years registered at Primary Health Care Corporation (PHCC) will be requested from Business Health Intelligence (BHI). The data will be extracted and stratified according to five age bands, two genders and the six major national categories (based on data shared by PHCC’s health information management team). The registered population is stratified into 60 strata. To represent the PHCC population a stratified random sample not proportional to size is planned. This sampling technique allows calculating a valid relative frequency estimate for each of the 60 strata individually, while maintaining the representation of the population estimates using a weighting approach based on the sampling fraction. A fixed strata size of 100 is targeted to obtain a total sample size of 6000. Since it is an online administered questionnaire survey the response rate is expected to be as low as 2% [17,18]. The targeted sample size has therefore increased to 300,000 to account for the non-response rate. A sample size of only 2000 will detect a very small difference of 0.1 in the mean score of a specific domain (ranging between 1 and 4 with a standard deviation of 1) between two groups with an estimated Beta power of 0.99 at alpha of 0.05. Therefore, the targeted sample size of 6000 will detect virtually any difference or effect. The respondents will be sent reminder text messages after two weeks to increase the response rate. Regarding the potential on-response bias, the sampling method used will enable valid subgroup analysis by ensuring an adequate sample size in each subgroup. However, any calculated summary measure for the population parameter will be biased by deviations from the sampling frame. This type of bias is addressed by using appropriate subgroup weights, Table 1. Sensitivity analysis (a type of quantitative bias analysis) may be considered to measure the magnitude of sample deviation from the planned sample. The identifying information (names phone numbers and HC numbers) of the targeted sample will be extracted by PHCC BHI department. The short message service (SMS) will be sent with an approved survey invitation text to the targeted sample. A reminder will be sent after a week. The invitation text message will contain a link to the online questionnaire form using Microsoft office Forms.

The HLQ consists of 9 scales derived from 44 items rated on either a 4 (scales 1–5; 1 strongly disagree – 4 strongly agree) or a 5-point Likert scale (scales 6–9; 1 cannot do or always difficult − 5 always easy) [19]. The overall HLQ has a Cronbach’s alpha of 0.8, demonstrating good internal consistency. [19]The five domains encompassing section 1 of the HLQ scale will be calculated by addition of individual item scores that comprise each domain divided by the total count of those items, as depicted in Table 1 [20]. The scale utilized for section 1 ranged between 1 for “strongly disagree”, 2 for “Disagree”, 3 for “Agree” and 4 for “Strongly agree”. The score for each domain ranges between a minimum of 1 and a maximum of 4. Hence, a high level of the construct, measured in each HLQ domain is verified by having a score >3 as demonstrated in Table 2. The four domains included in section 2 of the HLQ scale will be calculated similarly as demonstrated in Table 2.

Data analysis plan for the HLQ questionnaire

Recruitment strategy, data collection & study tool for focus group discussion among HCPs

A focus group discussion (FGD) will be conducted in which multidisciplinary healthcare professionals will be recruited who are directly involved in providing care to service users accessing primary health centers and have a minimum experience of one year of working in various primary health care corporation affiliated primary health centers. To ensure the sample is representative a diverse cohort of HCPs will be recruited which will mainly include Radiologists, Physicians, Psychiatrist, Dietitians, Health Educators, Nurses, Lab Technologist & Pharmacists (including clinical pharmacist). The HCPs will be recruited by non-probability convenience sampling. The HCPs from the various primary health care centers will be included in the study by approaching the managers of the primary health centers who will help identify and provide their contact details for recruitment. The HCPs once identified will be provided with participant information leaflet and copy of FGD guide for a better understanding of the purpose of the study and the themes to be discussed during the discussion. The HCPs will be requested to further help identify other colleagues by snowballing technique. Prior to starting the FGD the participants will be briefly informed about the purpose of the study and key themes included in the discussion. The participants will be reminded that their participation in the FGD is voluntary, and they have the right to end the discussion at any point they feel uncomfortable or decide to no longer participate. The verbal consent will be recorded and a log with starting time and date will be entered in Microsoft Excel sheet. The FGD will be audio recorded, and notes will also be taken during the session utilizing an FGD guide. The FGD will last for approximately 75 minutes. It will be ensured by the principal investigator that there is active participation by HCPs from different specialties while conducting the FGD by referring to each participant while discussing a specific theme. The main themes of the topic guide (supplementary document (S1 file)) utilized for the focus group discussions were derived from the broader themes outlined literature and relevant published literature pertaining to the various domains of health literacy, associated channels and existing challenges and gaps in its implementation within primary care settings [22–27].

Recruitment strategy, data collection & study tool for interview with service users accessing primary health care centers

The healthcare managers of the primary health centers affiliated with Primary Health Care Corporation will be contacted via email to obtain permission to approach service uses by accessing the service to participate in face-to-face interviews while they wait for their consultation in the waiting area of the health center. A separate room will be requested to be allocated by the health manager of the primary health center to conduct the interviews. The service users will be approached by the principal investigator (MA) and invited to participate in the study. The interviews will be conducted by PI. The PI has the relevant academic qualifications and substantial experience of conducting qualitative research and publishing in high impact journals. This is in accordance with the criterion of COREQ and SRQR regarding standards required by the researcher conducting qualitative research. When a service user agrees to participate, they will be invited to the allotted interview room. Prior to starting the interview, the purpose of the study will be explained in detail to the service user, and they will be given the opportunity to ask further questions to ensure that their participation is voluntary, informed and non-coercive. The written consent will be taken by the interviewer before starting the interview. The interviews will be recorded with permission of the service user. Once the interview has taken place all contact information about the service user will be securely destroyed and all the data collected will be anonymised. The interviews are semi-structured and will be conducted utilising an interview guide and script (supplementary document). The interviews will last between 45–60 minutes.

Analysis of the qualitative data collected from FGD and interviews

The qualitative data once recorded will be transcribed verbatim, and then analyzed using thematic analysis. [28] This approach encompasses ‘interpreting, exploring, and reporting patterns and clusters of meaning within the given data’ [29] and will be facilitated by reading and re-reading the transcripts for a full familiarization. This will be followed by application of open codes to four transcripts to identify emerging themes of relevance by two researchers (MA AND ASA) [30]. A Computer Assisted Qualitative Data Analysis (CAQDAS) package (NVivo 12 for Windows) will be utilized for this process. This will be followed by agreement by the two researchers (MA and ASA) on a set of codes which will be used with the rest of the transcripts. During this stage categories will be constructed and defined by grouping of codes. This will lead to the development of a working coding framework which will be utilized with the rest of the data and amended as necessary. The study will report the results in accordance with ‘Consolidation criteria for reporting qualitative research (COREQ) and ‘Standards for reporting qualitative research ‘(SRQR) guidelines [31,32].

Interpretation of the qualitative findings

The qualitative analysis will be interpreted utilizing the Socioecological Model (SEM) which will provide to explore the wider determinants of health literacy of service users accessing the primary health care services. SEM is a widely accepted framework for comprehending and describing health determinants and in its entirety can be effectively utilized to explore the factors associated with health literacy of service users nested within the SEM [33]. Although the SEM is widely acknowledged as a framework for understanding wider health determinants, there are only a few examples embedding health literacy in socioecological context [33]. The existing literature only partially explores determinants nested within the SEM and does not investigate the model’s entirety when examining factors related to health literacy of service users accessing primary care services. The state of Qatar has a highly developed and extensive primary care health system, Primary Health Care Corporation (PHCC) which is composed of 32 primary health care centers which are scattered throughout the country. PHCC has the prime objective to deliver universal health coverage to its registered population. Each primary health care center is equipped with modern healthcare facilities managed by an international multidisciplinary team of health care professionals delivering the highest standards of primary health care services to a diverse multi-ethnic population (comprising of approximately 88% expats) [16,34]. However, studies report that despite the strong primary health care infrastructure, Qatar has a high prevalence of non-communicable disease and challenges associated with uptake of the services among the population registered with PHCC with diverse ethnic backgrounds [34,35] The model will be populated by the important themes emerging from the qualitative interviews with the patients and FGDs with HCWs to highlight the intrapersonal, interpersonal, Institutional, Community and Policy level factors [Fig 1].

Quality control and good practice measures

The REPORT statement, which is an extension of the STROB statement checklist (international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers and journal editors involved in the conduct and dissemination of observational studies, with the common aim of Strengthening the Reporting of Observational studies in Epidemiology) specially designed to assure the quality of reporting of secondary data analysis will be followed during analysis and writing of the report. For the qualitative component we aim to report the results in accordance with ‘Consolidation criteria for reporting qualitative research (COREQ) and ‘Standards for reporting qualitative research ‘(SRQR) guidelines [31,32].

To ensure the ethical and regulatory integrity of the study, oversight mechanisms will be implemented throughout its duration. A designated research monitor from the Clinical Research Department will conduct periodic monitoring and auditing activities. These will verify that the study is being conducted in accordance with the protocol approved by the Institutional Review Board (IRB), and in compliance with Good Clinical Practice (GCP) guidelines and Policies, Regulations and Guidelines for Research Involving Human as outlined by Ministry of Public Health (MoPH) Qatar. Monitoring will include the identification and documentation of any protocol deviations or instances of non-compliance. All findings will be addressed promptly to uphold participant safety and maintain the scientific validity of the research.

Timelines for study

The study is expected to be initiated in December 2024. The tentative timelines for the main study tasks are summarized in the table below:

Ethical considerations

Written consent will be obtained by the principal investigator (MA) prior to the start of the interviews with service users and will be recorded on the digital audio recorder with the participants’ permission. At all stages of the interview, it will be emphasised that participation is voluntary, and that the data generated will be anonymous. It will be ensured and made clear to the participants that they could withhold any information that they feel is too sensitive or withdraw from the study at any time. The interviews will be transcribed and anonymised soon after the interviews and the digital recordings of the interviews will be removed from the digital devices. The anonymised transcripts and digital recordings will be stored securely on a server within the clinical research department of Primary Health Care Corporation. Ethics approval was received to conduct the study from Institutional Review Board of Primary Health Care Corporation (supplementary document).

Patient and public involvement

There was no Patient and Public Involvement (PPI) while formulating the study tools and designing the research methodology. However, for future research and further exploration in designing innovative interventions to improve the health literacy of service users accessing primary health care services there will be active involvement of PPI in pilot testing and designing such interventions.

Dissemination plan of study findings

Upon completion of the study, findings will be disseminated through multiple channels to ensure broad and meaningful impact. Results will be submitted for publication in peer-reviewed journals and presented at relevant scientific conferences. In addition, tailored summaries will be shared with key stakeholders, including healthcare providers and policymakers, to inform practice and decision-making. Where appropriate, public-facing materials will be developed to communicate findings to the public, thereby enhancing transparency and promoting community engagement with the research outcomes.