The development of practice standards for patient education in nurse-led clinics: a mixed-method study

Introduction Educating patients and families about self-care is one of the important roles of nurses in Nurse-led clinics (NLCs). NLCs need standards for guiding the practice of nurses. A standard is an authoritative statement that sets out the legal and professional basis of nursing practice. This paper seeks to report the development of practice standards for patient and family education in NLCs. Methods This project used a Sequential-Exploratory mixed methods design. Before the study, we conducted a literature review to identify gaps. Directed content analysis was used in phase 1. The second phase involved two focus groups. The third phase involves two rounds of modified Delphi. Results Twenty-nine participants were interviewed, and 1816 preliminary codes were formed in phase 1. 95 standards were grouped into three main categories (structure, process, and outcome). In the first focus group, experts eliminate 32 standards. Experts eliminate 8 standards after the second stage of the focus group. After two rounds of Delphi, the final version of the standard consists of 46 standards (13 structure, 28 process and 5 outcome). Conclusions Nurses and institutions could benefit from practice standards for patient education in the NLCs, which consist of 46 statements in three domains, as a guide for clinical activities and a tool to gauge the quality of patient education in NLCs. The developed standards in this study can guide new and existing NLCs and help them evaluate ongoing activities. Providing patient education in NLCs based on standards can improve patients’ outcomes and promote their health. Supplementary Information The online version contains supplementary material available at 10.1186/s12912-023-01444-0.


Background
Nursing has evolved to meet the dynamic needs of individuals, communities, and healthcare services.Aging populations are creating a greater demand for health resources, causing changes in service delivery and higher rates of chronic disease in the community [1].As health services are increasingly focused on keeping people in their communities and minimizing hospitalizations, Nurse-led Clinics (NLCs) are well-suited to accomplish this goal [2].At the same time, it has been argued that NLCs can provide cost-effective, high-quality care and improve patient access to services [3].There is evidence that NLCs improve healthcare, patient, and quality care outcomes [4], patient satisfaction [5], and treatment adherence [6].These clinics are equipped with nurses who assess, admit, educate, treat, monitor, discharge, and provide the patients with psychological support and refer them to other healthcare professionals [7].Training and educating patients and families about self-care is one of the important roles of nurses in NLCs.Also, NLCs tend to be specialized [8].For this purpose, NLCs were established for different diseases such as liver cirrhosis [9], atrial fibrillation [10], ulcer care [11], diabetes [12], thyroid cancer [13], rheumatology [14], heart failure [15], and other chronic diseases.It has been found that NLCs can improve chronic disease management, reduce treatment burden [16], and positively impact patient outcomes such as satisfaction, access to care, and cost-effectiveness [1].
Nurse-led clinics need standards for guiding the practice of nurses.Nursing standards are authoritative statements that outline the legal and professional basis for nursing practice.Safe and effective practice requires knowledge, skills, judgment, and attitudes outlined in all standards of practice.A clinician's performance, attributes, and expected outcomes are guided by practice standards [17].The Joint Commission (TJC) delineated nursing standards for patient education as early as 1993.As mandates, these standards describe positive outcomes of patient care.They must be met through teaching activities by nurses in the hospital that must be patient and family-oriented [18].TJC has established nursing standards for patient education in ambulatory care, home care, and primary care centers.These standards define the performance expectations, structures, or functions that must be in place for an organization to be accredited by TJC [18].
The importance of addressing the educational needs of patients and the impact of education on enhancing patient outcomes, especially for those with chronic conditions and those receiving outpatient care, led to the establishment of independent nurse-led clinics in Iran in 2010.These clinics aim to provide education and counseling services to patients in hospital outpatient wards in major cities across Iran.The provision of services in these centers has been voluntary and creative.Given that the educational role of nurses is expanding, starting and continuing the activities of these clinics has always faced barriers.Some of these barriers include not defining the position of these centers in the hospital organizational structure [19], lack of independence in providing services, and difficulty providing human resources [20].Some concerns are related to unclear patient education work processes and interdepartmental cooperation, which affect the provision of patient education.Other concerns pertain to the societal culture and the level of trust patients have in nurses to deliver highquality and reliable education [21].In this regard, Farahani et al. 's (2007) study found that the nurses and their roles were not recognized well, and most individuals in society were unaware of nurses' scientific and practical competencies [22].
Following international trends and the evolution of patient education from hospitals to outpatient centers, as well as home and community care, the development and promotion of patient and family education programs became a research priority for the Nursing Deputy of the Ministry of Health in 2019.In June 2022, the Nursing Deputy of the Ministry of Health, Treatment, and Medical Education officially announced the "executive instruction of nurse-led clinics for patient education and follow-up" to the entire country [23].
For this newly developed service and its standards to perform perfectly in implementation and evaluation, it should be explained based on one of the quality evaluation models.Donabedian's (1966) Structure-Process-Outcomes (SPO) conceptual framework was used to examine health services and evaluate the quality of care.The model comprises three elements.The structure is described as the setting in which care is delivered that encompasses resources, quality client care standards, staffing, policies, and structural elements that lay a foundation for quality healthcare services.The process focuses on how things work within an organization and the framework that guides the design of the organization.Processes define the mechanisms for producing intended outcomes and include continuity of care, professional models of care delivery, and interpersonal management of patient care.The outcomes focus on client status after healthcare delivery, including client knowledge and behavior, patient satisfaction, and health-related quality of life [24].All three elements of Donabedian's framework must be in place and monitored for quality to occur.A good structure increases the likelihood of good processes that can ultimately result in good outcomes [25][26][27].Organizations and professions must set standards and objectives to provide safe and effective care [28].Nurses need to set standards for patient education in this new setting.

Aim
This paper reports the development of practice standards for patient education in NLCs in three phases.

Phase 1
Developing patient education standards for NLCs.

Phase 2
Validation of Practice standards for patient education in NLCs from perspective of experts.

Phase 3
Determining the agreement, appropriatness, relevance and clarity of practice standards for patient education in NLCs from the perspective of experts.

Design
This study used a sequential exploratory mixed-method design [29] (Fig. 1).Before the study, we conducted a literature review to identify the gaps.We did not find practice standards for patient education in NLCs, but we found patient and family education standards and used them to develop practice standards.Phase 1 involved a qualitative study using directed content analysis based on Assarroudi et al. (2018) [30].We performed content analyses in three main phases: Preparation, organizing, and reporting [31].Based on Asarroodi et al. 's (2018) inductive content analysis method, the preparation phase was performed by going through seven stages including acquiring the necessary general skills, selecting the appropriate sampling strategy, deciding on the analysis of manifest and/or latent content, developing an interview guide, conducting interviews and transcribing interviews, specifying the units of analysis, and being immersed in the data [30].At this stage, after transcribing each interview and considering its transcribed text as the unit of analysis, each text was read several times until the data immersion occurred.During this stage, the answer to these questions was always taken into consideration by the researcher: What event is happening?Who is speaking?Where is it happening?When did it happen?What is happening and why?.
Based on Asarroodi et al. 's (2018) content analysis method, the organizing phase consisted of developing a formative categorization matrix, the theoretical definition of the main category and subcategories, determining coding rules for the main category, pre-testing the categorization matrix, choosing and specifying the anchor samples for each main category, performing the main data analysis, the inductive abstraction of the main categories from preliminary codes, and establishing links between the generic categories and main categories [30,32].The researchers, in the organizing phase, created a constrained matrix for analysis based on Structure-Process-Outcome Donabedian's model.In this matrix, the creation of new main categories is not allowed.The data were reviewed several times to find content that matched predefined categories or could be a sample for them, and preliminary codes were assigned to them.Afterward, the stages of grouping, categorization, and abstraction were performed so that the generic categories were created, and the possibility of placing these generic categories in the main categories in the matrix was then examined conceptually and logically [33].
Phase 2 involved two focus groups, and Phase 3 consisted of two rounds of modified Delphi [34].The Ethics Committee approved this study.All participants in the study signed an informed consent form.

Phase 1: Directed Content Analysis (DCA)
In phase 1, three groups of participants were eligible to participate.The first group consisted of hospital Fig. 1 The exploratory sequential design managers and supervisors, the second group comprised physicians and nurses, and the third group included patients and their caregivers.

Phases 2 and 3: focus group and modified Delphi
The eligibility criteria for phases 2 (focus group) and 3 (modified Delphi) included (a) faculty members and policymakers in patient education, (b) managers and policymakers in patient education, (c) physicians participating in patient education planning, (d) nurses participating in patient education planning, (e) nursing faculty members designing and editing patient education content or authoring a book on patient education, and (f ) health education supervisors with at least one year of experience in their position.

Study setting
This study was performed at the Mashhad University of Medical Sciences and the Deputy Minister of Nursing, Ministry of Health, Treatment, and Medical Education.Mashhad is one of Iran's largest and leading cities conducting patient education programs.

Sampling and sample size Phase 1: directed content analysis
A purposive sampling method was used for sampling, which continued until data saturation.Group 1 consisted of 4 educational supervisors, 4 health education supervisors (the health education supervisor and educational supervisor are the middle managers responsible for designing, implementing, and supervising educational programs for staff, patients, and clients), 2 nursing managers, 2 chief executive officers, and 1 deputy medical specialist.Group 2 consisted of 5 nurses, 3 doctors, and 2 nursing faculty members, and group 3 consisted of 4 patients and 2 patient caregivers.

Phase 2: focus groups
There are no universally accepted criteria for selecting experts in focus groups [35].A multi-professional panel was created with faculty members having adequate experience as a member of a patient education or policy-making team in patient education.Thus, we invited 15 nursing faculty members and policymakers from Iran's Ministry of Health, Treatment, and Medical Education.

Phase 3: modified Delphi
There were two Delphi phase rounds, each lasting four weeks with four-week intervals.Non-respondents received weekly e-mail reminders.We did not provide any financial incentives.Based on Drisko, quoted from Wellar (2008), a panel of fewer than 10 people provides diversity in expert opinions, and Jones and Twiss (1978) recommend 10 to 50 participants [36].Therefore, 47 nursing and policy-making experts participated in this phase.We mailed each panelist a questionnaire outlining patient education standards during the first survey round.Using a five-point Likert scale, each member rated their agreement with each standard: (1) Strongly disagree, (2) disagree, (3) neither agree nor disagree, (4) agree, and (5) strongly agree [37].We asked the participants to provide a reason for each disagreement.A consensus was defined a priori in this study when at least 80% of the experts agreed.First-round survey results were sent to the research team, and disagreements were discussed.To conduct the second round of surveys, we mailed questionnaires to each panelist indicating the standard of patient education.Based on a nine-point Likert scale, each member rated each statement's relevancy, appropriateness, and clarity (1-3 inappropriate, 4-6 intermediate, and 7-9 appropriate).

Statistical analysis
All statistical analyses were done using the SPSS software package, version 11.0.

Participant characteristics
Table 1 summarizes the characteristics of participants in the three phases of the study.All nurses and experts in this study had experience in patient education.Among 47 experts surveyed, 40 (85.1%)responded in over two rounds.
In the initial review, we did not find specific standards for patient education in NLCs.Facilities and staff were among the reviewed standards in the structure dimension for other healthcare centers (hospitals, home care, and ambulatory care setting).Preliminary assessment, the target group of education, determining and prioritizing the learning needs, the content of patient education, methods and conditions of education, designing programs and materials for patient education, patient participation in education, and referral to specialized organizations were mentioned in the process dimension.The evaluation of educational programs, materials, and learners was mentioned in the outcome dimension (Table 2).

Results of phase 1: directed content analysis
In phase 1, 29 participants were interviewed, and  used as the data analysis framework.The structure's main category included six generic categories (equipment, facilities, staff, specifications of the clinic environment, organizational communications, and nursing characteristics).Also, 12 generic categories were found in the process main category (content of patient education, target group of education, nurse job description, training method, referral form, method of determining patients' educational priorities, referral of patients to the clinic, process of educational pamphlet preparation, patient education expenditure, patient follow-up, physicians' cooperation, and promotion performance of the clinic).There was one generic category (i.e., evaluation) in the outcome main category (Table 2).Data comparison was made at the end of this phase to compare data from different sources [29].Based on data comparison, we developed 15 standards in the structure (7 standards based on DCA, 7 based on review, and one standard based on review and DCA), 73 standards in the process (15 standards based on review, 27 standards based on DCA, and 31 standards based on review and DCA), and 7 standards in the outcome (5 standards based on DCA and two standards based on review).

Results of phase 2: two rounds of focus group
Step 1 In the focus group, experts eliminated standards related to patient education during hospitalization.At the end of this session, 13 standards in the structure, 43 standards in process, and 7 standards in the outcome remained.
Step 2 Before this session, the standards were sent to the participants for review and comment.Based on expert opinions, some standards were written and revised entirely.Also, 9 process standards were not agreed upon by the experts and were removed and merged with other standards.After the focus group, 13 standards in the structure, 37 in the process, and 5 in the outcome remained.

Results of phase 3: two rounds of modified Delphi
Step 1 At this stage, experts' agreement with the standards was determined.Development standards were sent to 47 experts in nursing and policy-making.During the first round of the survey, 40 panelists responded; 46 statements (83.63%) were judged appropriate by more than 80% of the respondents, and 9 statements (16.36%) were disagreed upon (Table 3).According to the experts, some standards were completely rewritten, especially in the process domain.Based on the experts, 13 standards in the structure, 28 in the process, and 5 in the outcome remained.
Step 2 All panelists responded in the second round; 46 statements (100%) were relevant, appropriate, and clear (Table 4).The final standard inventory consisted of 46 statements (13 in the structure, 28 in the process, and 5 in the outcome; Additional file 1).

Discussion
Using a mixed-method design, we developed practice standards for patient education in NLCs in Iran.The findings are likely to be helpful for both new and existing NLCs, as they can use them to evaluate their ongoing activities in light of the standard.This evaluation will contribute to the improvement of patient education in nurse-led clinics.Based on the review of documents and articles, we found no structure, process, or outcome standards for patient education in NLCs.Concerning other settings, most standards in the literature were related to the patient education process, and there was a need to develop standards for the structure and outcome domains.Also, the current process standards regarding referrals to other centers and patient followup are inadequate.
Concerning developing standards in this study, we defined the structure of NLCs for patient education in 6 domains (Table 4, Additional file 1) and the patient education process in four domains: (1) Organizational processes, (2) group processes, (3) individual training processes, and (4) the process of preparing educational content.Also, we defined the outcomes of patient education in 5 domains (Table 4, Additional file 1).In our context, one of the barriers to patient education is unsupportive organizational culture [38].Developing NLCs need managerial support, development role, providing facility to play this role, control, and teamwork.Therefore, most agreements have been about standards related to the role of management.
Based on the results, there was the greatest level of agreement among the standards in the structure domain with standards 1 and 2, which discussed forming a working group/committee for patient education and the involvement of managers in setting up NLCs.During a change process, managers and employees are divided into two groups: Change agents (usually managers) and change recipients (usually employees).A change agent aims to identify strategies to facilitate the change process, while a change recipient aims to determine how the change directly impacts them [39].Buick et al. (2018) confirmed that middle managers and leaders know their central roles in managing organizational changes.They interpret the communication from  senior management regarding the changing intentions and translate it to clarify roles for employees, address the areas of resistance, and implement the changes [40].
Based on the results, the standards related to educational programs, materials, and content, methods of educating patients, and evaluating patients' perception of education received the highest level of agreement in the process domain.Unlike verbal instructions, patient education materials serve as popular and permanent records of patient instructions [41].Therefore, they should be accurate and include only treatments that are accepted in common practice.Patient education materials designed correctly and appropriately can augment other educational efforts and improve patient care [42].Various methods can provide education, but direct interactions between the patient and the provider are perhaps the most common or face-to-face education.There is, however, evidence that written educational materials can help patients become more knowledgeable about medical conditions and possible treatments [43].There is some evidence that written materials and other forms of patient education can significantly improve knowledge retention over time [44].
Regarding the outcome domain, the standards related to primary prevention and improving the performance of the NLC had the highest level of agreement.There are more deaths from chronic diseases than all other causes combined in developed and developing countries, accounting for approximately 43% of the global disease burden [45].Approximately 60% of people over 65 have two or more chronic diseases [46].There is a need for reforms to healthcare systems so that patients with multi-morbidity can access integrated, efficient, and effective healthcare [47].Nurse-led clinics are especially ideal for preventing chronic diseases because patients and their families refer to such clinics, and primary prevention applies to the families.Improving the performance of the NLC can help with education and disease prevention in society.

Conclusion
Following a well-established and clear methodology, we developed practice standards for patient education in NLCs.The standard inventory consisted of 46 statements in three domains (structure, process, and outcome), which might serve as a useful guide for clinical activities and a tool to assess the quality of patient education in NLCs.One of the strengths of this study was the participation of different groups of managers, service provider (physicians and nurses) and service recipients (patients and their care givers) in the development of the standard.

Practice implications
Standard development for nursing practice can expand nursing roles and professionalism.Developed standards in this study can guide new and existing nurse-led clinics and help them evaluate ongoing activities, all of which contribute to improving patient education and performing safe and effective care in these clinics.

Limitations
Our study had several limitations.First, most of our study participants were female because most nurses are female in our healthcare system.Second, at the beginning of the COVID-19 pandemic, the activities of NLCs were limited, and access to patients for interviews was difficult.However, all patients and caregivers participating in the qualitative phase were female; data saturation was the criterion for the end of sampling.

Table 1
Characteristics of the participant in 3 phases of the study

Table 2
Patient and family education categories based on review and directed content analysis • patient follow-up • physicians' cooperation and promotion performance of the ClinicOutcome• evaluation of educational programs and materials • learner evaluation• evaluation of educational programs and materials • learner evaluation

Table 3
Experts' agreement about developed standards for patient education in NLCs

Table 4
Experts' openion about appropriateness, clarity and relevancy of developed standards for patient education in NLCs