Outcomes and Critical Factors for Successful Implementation of Organizational Health Literacy Interventions: A Scoping Review

Organizational health literacy (OHL)-interventions can reduce inequality and demands in health care encountered by patients. However, an overview of their impact and critical factors for organization-wide implementation is lacking. The aim of this scoping review is to summarize the evidence on: (1) the outcomes of OHL-interventions at patient, professional and organizational levels; and (2) the factors and strategies that affect implementation and outcomes of OHL-interventions. We reviewed empirical studies following the five-stage framework of Arksey and O’Malley. The databases Scopus, PubMed, PsychInfo and CINAHL were searched from 1 January 2010 to 31 December 2019, focusing on OHL-interventions using terms related to “health literacy”, “health care organization” and “intervention characteristics”. After a full-text review, we selected 24 descriptive stu-dies. Of these, 23 studies reported health literacy problems in relation to OHL-assessment tools. Nine out of thirteen studies reported that the use of interventions resulted in positive changes on OHL-domains regarding comprehensible communication, professionals’ competencies and practices, and strategic organizational changes. Organization-wide OHL-interventions resulted in some improvement of patient outcomes but evidence was scarce. Critical factors for organization-wide implementation of OHL-interventions were leadership support, top-down and bottom-up approaches, a change champion, and staff commitment. Organization-wide interventions lead to more positive change on OHL-domains, but evidence regarding OHL-outcomes needs strengthening.


Introduction
Almost one in every two people in Europe encounter problems handling health issues because of limited health literacy skills [1]. These problems are more prominent among people of a higher age and lower educational level [1]. Health literacy is defined as 'the degree to which people are able to access, understand, appraise and communicate information to engage with the demands of different health contexts' [2]. As Rudd et al. consistently point out [3][4][5], a health literacy gap is emerging between the abilities of patients and the demands placed by increasingly complex health services. This gap can contribute to a range of negative consequences for people with limited health literacy [1,6], who find it difficult to access and navigate health care organizations, communicate with health professionals, understand information, and engage in decision making and self-management [3,[6][7][8][9][10]. These consequences can have a profound impact on patients, affecting their safety, quality of care, and health outcomes [1,6]. In order to reduce and prevent these problems, it has been recommended to reduce the complex demands in health care organizations [5,[11][12][13].

Materials and Methods
To guide this scoping review we used the five-stage framework for scoping reviews developed by Arksey and O'Malley (2005) [21]. The five stages are: (1) Identify the research questions, (2) Identify and retrieve relevant articles, (3) Select articles, (4) Chart the data, (5) Collate, summarize and report. We structured the methods section in line with these stages.

Stage 1. Identify the Research Questions
Before conducting the review, within the group of authors we defined two preliminary research objectives and discussed the concepts to guide the literature search. We aimed at a sensitive search to catch all potentially relevant studies regarding the domains of OHL interventions, and criteria to specify the interventions regarding the phases of assessment and application of OHL interventions.

Stage 2. Identify and Retrieve Relevant Articles
First, to identify and retrieve relevant articles, we set up a literature search strategy based on search terms and inclusion criteria used in two previous reviews of OHL interventions [19,20]. Second, with the help of a librarian (TvI), we refined the research objectives and search strategy, and developed a protocol, all of which we discussed among the co-authors (MK, JS, SAR, AFdW). This was to ensure that methods and search strategies were consistent and comprehensive. We applied the final search strategy to the MEDLINE/PubMed databases and then adapted it for the other databases, covering all publications up to 31 December 2019. We searched the databases PubMed, Scopus, Psych-Info and CINAHL. In the literature search we included keywords and MESH terms related to the concept of "health literacy"; we combined these with Boolean operator AND search terms related to the health care setting, and Boolean operator OR search terms involving intervention characteristics. The complete search string is provided in Table S1 as supplementary material.
To ensure inclusion of all relevant studies in the review we used reference searches of retrieved articles to complement the electronic searches. Inclusion criteria were: (1) publication between January 2010 and December 2019; (2) inclusion of an abstract written in English; (3) an OECD country as geographical setting; (4) a study setting involving a health care setting in primary or secondary care; (5) a study aimed at assessment of organizational barriers and improvement of outcomes for adults with limited health lite-racy; (6) a study design involving an intervention, evaluation of a program, a pilot-study or needs assessment; (7) an intervention focused on assessing problems or changing two or more domains of organizational health literacy: changes at patient level (oral, written and digital communication and health literacy levels); changes at professional level (health literacy capacities and communication practices); or changes at organizational level (leadership and culture, organizational policies, systems processes, and structures).

Stage 3. Selection of Articles
After removing duplicate articles, we reviewed the title and abstract of identified articles against the following exclusion criteria: (1) health literacy was assessed or addressed only at the individual or family level (e.g., validation of screening tools or educational interventions for patients); (2) the only focus was to investigate determinants associated with health literacy and health outcomes; (3) the aim was to develop and validate instruments to measure organizational health literacy without investigating their implementation in organizations.
One investigator (MK) did the initial screening. In cases of uncertainty, a second investigator (AFdeW) reviewed the abstract or full text of an article; together consensus was reached on inclusion or exclusion in the review. Articles identified for inclusion underwent full text screening and two investigators screened a sub-section to ensure fit to criteria and consistency.

Stage 4. Charting the Data
In three steps we extracted the data from the selected studies in Excel, sorted them in tables, and analysed them based on the study purpose. First we extracted descriptive data: author, year and country, design and evaluation method, aim, setting, sample, and OHL-intervention components. Second, we extracted data on outcomes of OHLinterventions at patient, professional and organizational levels. Third, we extracted data on whether critical factors and strategies were considered to be facilitators or barriers to implementation processes.

Stage 5. Collate, Summarize and Report
In three steps we extracted the data from the selected studies, sorted them in tables and analysed them based on key themes informed by the study purpose, to: (1) assess the outcomes of OHL-interventions, and (2) to unravel the factors and strategies affecting the implementation and outcomes of OHL-interventions. First, we tabulated the selected studies by author, year and country, research design, setting, sample, OHL domains addressed, and focus of the study, i.e., assessment or application of OHL-interventions. Second, we summarized and reported the outcomes of OHL-interventions following their assessment or application, and the level to which the outcome applied: patient, professional, and/or organization. Third, we summarized and reported factors and strategies which influenced the assessment and application of OHL-interventions, and analysed whether these were facilitators or barriers at patient, professional, and/or organizational level.

Results
We identified 5420 records from the literature search and one record through reference searching (we retrieved 1511 records from Pubmed; 1351 from Scopus; 1750 from Cinahl; and 808 from Psychinfo). After removing 2223 duplicates, we screened 3197 titles and abstracts and included 82 articles for full-text review. After reading the full text, we selected and excluded articles based on the criteria specified above. We included twentyfour articles in the data extraction. This results section presents: (1) description of the studies, (2) outcomes of OHL-interventions, and (3) strategies and factors that influence the implementation of OHL-interventions. Figure 1 presents the results of the literature search and study selection.
The majority of the studies used a mixed-method approach (n = 16), or qualitative (n = 4) or quantitative approaches (n = 4). Multiple informants and methods were used to report on the assessment and application of OHL-interventions; these included managers, professionals, patients and observers who had taken part in surveys, interviews, focus group discussions, and observation and review of documents. The interventions targeted a variety of OHL domains using different tools and approaches. Domains most frequently addressed were the comprehensibility of written patient information materials, digital communication, oral communication, and navigation. Fewer studies targeted OHL as a strategic priority, health literacy policies, and capacity building of staff [17,25,[30][31][32]35]. A number of studies [3,17,31,36,40,42] used or adapted the toolkit "The Health Literacy Environment of Hospitals and Health Centers. Partners for Action: Making Your Healthcare Facility Literacy-Friendly" (HLEHHC Toolkit) developed by Rudd and Anderson [44]. Other studies used, e.g., the HLUP toolkit [28,29,34] or the Agency for Healthcare Research and Quality (AHRQ) Health Literacy Assessment Tool [39,43]. The majority of the studies used a mixed-method approach (n = 16), or qualitative (n = 4) or quantitative approaches (n = 4). Multiple informants and methods were used to report on the assessment and application of OHL-interventions; these included managers, professionals, patients and observers who had taken part in surveys, interviews, focus group discussions, and observation and review of documents. The interventions targeted a variety of OHL domains using different tools and approaches. Domains most frequently addressed were the comprehensibility of written patient information materials, digital communication, oral communication, and navigation. Fewer studies targeted OHL as a strategic priority, health literacy policies, and capacity building of staff [17,25,[30][31][32]35]. A number of studies [3,17,31,36,40,42] used or adapted the toolkit "The Health Literacy Environment of Hospitals and Health Centers. Partners for Action: Making Your Healthcare Facility Literacy-Friendly" (HLEHHC Toolkit) developed by Rudd and Anderson [44]. Other studies used, e.g., the HLUP toolkit [28,29,34] or the Agency for Healthcare Research and Quality (AHRQ) Health Literacy Assessment Tool [39,43].  Planning and delivery of interventions to enhance health literacy: staff orientation to increase knowledge of HL and HL-friendly practices formation of task force from several staff levels development of a logic model and strategic planning of activities to enhance HL improvement of complicated patient forms, and plain language diabetes self-care patient education materials implementation of HL practices with staff at each level identification of criteria for HL outcomes for program evaluation: increased HL awareness and capacities, HL practices, and sustainability in these practice
The application of organization-wide OHL-interventions resulted in some improvement of patient outcomes [25][26][27]30,41], and greater changes in intermediate outcomes at professional and organizational levels [25][26][27]30,32,33,41,42]. Despite relatively small sample sizes, two research projects reported some improvement in patient-related outcomes [25][26][27]30,41], such as increased health literacy skills, participation in health care, and increased self-management abilities following interventions involving peer community members. Although not evaluated by patients, independent assessors reported both improved comprehensibility related to patient information materials [30,41], and some li-mited changes in the complexity of materials [29]. Improved health outcomes were not reported. Studies which reported greater change on intermediate outcomes at professional and organizational levels [25][26][27]30,32,33,41,42] used an organization-wide and long-term approach to deliver OHL-interventions. After training, (health) professionals in these studies reported increased competency to address health literacy and application of recommended practices [25][26][27]30,32,41,42]. Intermediate outcomes at the organizational level included integration of OHL into policies and systems, redesign of services, organization-wide programs to promote staff capacity building, and promotion of health literacy strategies by professionals in written, digital, and spoken communication [25][26][27]30,32,41]. Limited impact was reported regarding routine organizationwide application of practices [25,32,42], navigation, and distal outcomes such as health indicators, quality of care, patient safety, and cost-effectiveness [25,28,29,32,42,43]. A few studies with only brief implementation periods struggled with defining priorities and action plans, and reported limited changes among professionals and organizations [28,29,43], although they undertook preliminary attempts to improve written communication and train staff.

Positive intermediate organizational outcomes after organization-wide OHL-interventions
-Embedding of OHL into organizational processes as strategic priorities, frameworks, and policies. Limited improvement reported [25,28,29,32,42,43]: -Struggle to define priorities and action plans -Navigation and protocols on communication. -Sustainable and routine application of HL practices.  Critical facilitators regarding the delivery of OHL-interventions were reported to be: leadership support, an organization-wide approach, a change champion and project committee, sufficient resources, professional commitment and competencies, and patient engagement, in order to achieve improvement at professional and organizational levels, see Table 3 [25][26][27][30][31][32][33]41,42]. An organization-wide approach, supported by senior management, was reported to stimulate the development of program logic models, strategic prioritization, and planning of OHL improvement [25,30,32]. These organizations often reported having simultaneously used top-down and bottom-up strategies to increase staff commitment to and knowledge of change strategies and quality improvement [25,30,32]. Co-design strategies and PDCA cycles were applied to develop, refine, and test interventions [25,30,32]. In contrast to the assessment phase, patients seemed to be less engaged in the application of interventions [25,42]. Only in the studies of Vellar et al. (2017) and Mastroianni et al. (2019) [30,41] were patients systematically involved in processes to improve navigation and patient-information materials. In the research project of Beauchamp et al. (2018) [25], small samples of patients were involved in the development and testing of interventions. Studies that found OHL-interventions to have only a limited impact reported that their implementation periods were brief, and affected by barriers such as lack of a change champion and coordinated planning processes [29,43], as well as limited time, resources and leadership support [22,28,29,43].
Compared with the earlier reviews of Farmanova et al. [19] and Lloyd et al. (2018) [20], our findings confirmed the evidence regarding identified OHL-related problems, and we observed greater progress on the impact of organization-wide OHL interventions [25][26][27][30][31][32][33]41,42]. A first point regarding our evidence is that the number of OHL-pro-blems identified across a variety of countries underlines the need to use comprehensive frameworks to improve organizational health literacy in health care settings [14,35,[46][47][48][49][50].The progress we observed related particularly to recent studies, which showed how a single health literacy project led to development of a health literate organization by employing a systematic and organization-wide approach. These studies strengthened the evidence particularly on three points: (1) patient outcomes showed some evidence of increased health literacy, understanding of information, and participation in health care [25][26][27]30,41]; (2) outcomes among health professionals showed evidence of improved competencies and practices to address health literacy [25,30,32,42]; (3) intermediate organizational outcomes showed evidence of embedding of OHL into policies and structures, staff training, and interventions to improve screening, communication and patient engagement [25][26][27][30][31][32][33]41,42]. This review thus indicates a growing awareness of how to achieve sustainable improvement on various OHL-domains, and supports the findings in recent reviews by Zanobini et al. (2020) [18] and Meggetto et al. (2020) [51].
Our review points to several critical facilitators and strategies that can promote health literacy friendly organizations in the long term: leadership support, an organization-wide approach, an innovation culture, a change champion, commitment and capacity of staff, and patient engagement [25][26][27][30][31][32][33]41,42]. These facilitators correspond with findings reported in other studies on innovation in health care settings [52][53][54][55][56] and universal processes for organizational change [19,20]. In our review, some studies reported limited outcomes because they had a shorter duration (six months) [28,29,43], struggled with coordination, staff turnover, and a lack of a change champion as well as leadership support and resources [28,29,43]. Other studies in our review suggest that a systematic organization-wide approach is more promising [25][26][27][30][31][32][33]41,42]. These implementation strategies involved simultaneous use of top-down and bottom-up strategies to engage staff and patients; such strategies have been widely used in the field of health promotion [32,57]. This observation underlines the frameworks of Trezona (2017) [47] and Zanobini (2020) [18] in the sense that various OHL-domains are interconnected and need to be targeted simultaneously in order to initiate a cyclical and widening process of improving the quality of health care by making organizations responsive to health literacy [51]. These findings have thus strengthened the evidence base for implementation of OHL-interventions.
However, our review also shows the evidence for OHL-interventions still to be generally weak, particularly regarding their effects on more distal outcomes like improved health or cost-effectiveness [18,20]. The first, general, issue regards the total lack of studies with an experimental design: studies conducted only baseline measurements, or had small samples when investigating change over time, and did not compare outcomes with control settings. Second, the instruments for measuring OHL outcomes did not include information on reliability and validity, although some instruments [34,44] indicated having face validity, and were used in different settings and countries [20]. Recently, several instruments were designed to assess a wide spectrum of OHL-domains [34,44,46,47], and one of these was reported to have satisfactory reliability and validity [49,58]. Although these instruments did not evaluate the outcomes of interventions, they may have the potential to be used for benchmarking and for investigating change over time [49].
The particular weakness of the evidence for OHL-interventions is that their impact is still unclear regarding more distal outcomes like patient health outcomes, quality of care, and cost reduction. This may be explained by several factors. First, in our review, mea-surement of more distal outcomes among larger samples of patients was lacking. However, we noted that, in some studies, small groups of patients were engaged in the development and evaluation of interventions [25,30,41], which resulted in improvement of health literacy levels, and in understanding and self-management of patients. Second, it seems plausible that the impact of organization-wide OHL interventions results first in intermediate outcomes among professionals and organizations, outcomes which may be influenced by many factors [14]. Zanobini [18] for example reports that (single) interventions directly targeted at patients result in improved outcomes in patient satisfaction, knowledge, and skills. In sum, promising outcomes may result from studies that combine patient-targeted interventions with systematic approaches directed at professional and organizational levels, and include measurement of distant patient outcomes, quality of care, and cost-effectiveness.

Strengths and Limitations
Several strengths of this study can be noted. We conducted a comprehensive search strategy and selection procedure to include relevant studies in the review. The fact that the selected studies were conducted in various health care organizations and countries is promising for the generalizability of the results. However, several limitations should be mentioned. First, the approach of a scoping review did not include a quality assessment of the selected studies; this limited the potential to connect content and quality. Second, we focused on peer-reviewed articles which had abstracts in English; this may have led to missing relevant studies from the grey literature or studies published in other languages. We are, however, confident that we have selected the most relevant ones. A final limitation is that publication bias may have influenced this review: studies reporting negative results could be difficult to get published. However, we identified several studies which explicitly reported the problems encountered, and consider the influence of publication bias to be limited.

Implications
Organization-wide implementation of OHL-interventions can improve intermediate outcomes among professionals and organizations, and has the potential to mitigate health literacy problems among patients. We recommend: (1) assessing OHL problems using a comprehensive and valid instrument; (2) starting with implementation of easy-toachieve interventions; (3) using a systematic approach to achieve greater organizational change, simultaneously applying bottom-up and top-down approaches; (4) taking into account the critical facilitators of implementation: a change champion vs a project committee, lea-dership support, sufficient resources, patient involvement, and competent and committed staff.
In order to strengthen evidence on OHL-interventions, we need studies with a more rigorous design to evaluate their effectiveness, and which use OHL-instruments that have adequate reliability and validity and are suitable for the European context [14,18,20]. Furthermore, more distal patient-related outcomes like quality of care, safety, and costeffectiveness should be evaluated.
Health care organizations have primarily focused on treatment, but there is an increasing recognition of their role in health promotion and prevention in order to address health inequalities in the broader social context [14,15,25]. OHL-interventions are one approach to improve outcomes for individuals with limited health literacy. Other effective strategies may be school-based health literacy education, mass-media communication or empowering individual people as well as communities, and building health literacy competencies of (future) health professionals [59]. As such, OHL-interventions are probably most effective in combination with these other approaches, but this evidently requires further study.
A contextual factor that must be acknowledged in relation to this scoping review is that the period of the literature search preceded the start of the COVID-19 pandemic. The importance of health literacy came to the fore during the COVID-19 pandemic, as the resilience of communities and the relationship of citizens to health care providers depend on it, particularly in crisis situations. This underlines the relevance of this scoping review on OHL-interventions. The COVID-19 pandemic is likely to have influenced the field of OHL-intervention research as health care organizations have, to a greater or lesser extent, faced several periods of crisis due to exceptional service demands. The nature of this influence is unknown. Therefore, we recommend that future studies investigate the influence of the COVID-19 pandemic on the research related to organizational health literacy. Organization-wide OHL-interventions have previously required longer time periods, of several years, for changes to be implemented successfully and sustained. Since the onset of the pandemic in March 2020, health care organizations may have responded in one of two ways: putting the implementation of OHL-interventions on hold or embracing OHL quickly in response to the situation. The COVID-19 pandemic has shown that health settings can accelerate innovation, but whether this holds for OHL-interventions is to be determined.

Conclusions
Delivery of organization-wide OHL-interventions resulted in some improvement in patient-related outcomes and changes at the professional and organizational levels and may be a promising approach to mitigate health literacy problems. Critical success factors for organization-wide implementation are leadership support, simultaneous topdown and bottom-up approaches, a change champion and project committee, and staff commitment. Efforts to implement organization-wide OHL-interventions should take into account these critical success factors. Organization-wide interventions were reported to achieve more positive change on OHL-domains, but evidence regarding OHL-outcomes needs strengthening.