3.1. Design
A 6-month non-randomized, single-arm trial was used to test the effectiveness of the education program among hemodialysis patients. Data were collected before the education program and 6 months followed-up after the intervention.
3.2. Participants and Setting
We enrolled patients who were treated with maintenance hemodialysis in a hemodialysis center in a teaching hospital in Zhuhai, China, from January to June 2019. Patients were included in the education program if they were: (a) aged ≥ 18 years old, (b) received regular sufficient dialysis (2–3 times a week) for 3 months or longer, and (c) with pre-dialysis serum phosphorus level > 1.78 mmol/L or prescribed with oral phosphate binder (e.g., calcium carbonate, calcium acetate, lanthanum carbonate, svalam hydrochloride, etc.) to control serum phosphorus. Patients were excluded if they: (a) were hospitalized during the program, (b) had disturbance of consciousness, visual or hearing impairment, inability to communicate verbally or complicated with severe disease of heart, brain, lung, liver and other vital organs, and (c) had a history of total parathyroid resection/subtotal resection. Through cluster sampling, a total of 366 eligible patients were enrolled in this study, and 346 patients completed the 6-month education program while 20 patients who were initially enrolled in, dropped out of the study because they were hospitalized or transferred to other dialysis centers during the program.
3.2. Implementation
This study involved an intensive education program, which was guided by The First Principles of Instruction model and was tailored, focusing on phosphate control among hemodialysis patients with hyperphosphatemia. The strategies used in the education program are described below.
1) Establishment of the phosphate control team
The phosphate control team was built by the health care professionals in the hemodialysis center at the program planning stage, which consisted of three nephrologists and eight registered nurses, and all the team members had been involved in hemodialysis for >5 years. Two training sessions for nephrologists and nurses in the center were organized by the team, in which phosphate control was focused. During the training sessions, the nephrologists in the team introduced the KDIGO guidelines, the Chinese CKD-MBD guidelines, and related literature on diet and nutrition management of hemodialysis patients, and the First Principles of Instruction model and relevant theory were also introduced. A quiz was conducted after training, and those who passed the quiz were qualified to implement hyperphosphatemia intervention. The team was also responsible for preparing the materials such as posters, presentation slides, social media and videos, patient booklet, the patient education form, and the questionnaire assessing patients’ knowledge of phosphate Control. These materials were featured phosphate control and were used for recording and evaluating during the education program. The teaching materials were updated every three months by the team.
2) Problem-centered approach
The First Principles of Instruction model holds that learners can effectively learn only when they become engaged in, analyze, and solve a series of practical problems in life[17]. During the implementation of this program, health care professionals delivered a patient booklet on phosphate control to the patients with hyperphosphatemia, and they took the responsibilities to guide patients to realize the importance of maintaining the serum phosphorus at a normal level and help them focus their problems on how to control serum phosphorus effectively in the daily life.
3) Activation
The model holds that the learners' prior knowledge should be activated during instruction, and knowledge recollection can effectively promote learning[21]. During this stage, the patients with hyperphosphatemia were guided to recall and think about their existing knowledge of phosphate control. The Patient Questionnaire on Phosphate Control Knowledge was used to assess patient knowledge about hyperphosphatemia, including the definition, clinical manifestations, risks of hyperphosphatemia, and measures to control the serum phosphorus at a normal level. Informed by the questionnaire answers, the health care professionals collected the information on knowledge areas that the patients lacked in phosphate control, the most interesting questions regarding phosphate control, and the adherence of using phosphate binders. Discussion about these topics would be addressed between health professionals and patients, which aroused the attention of patients and stimulated their desire to learn the relevant knowledge.
4) Demonstration
The First Principles of Instruction model emphasizes that the demonstration of what is to be learned is more effective at promoting learning than merely imparting the relevant information[21]. Health care professionals employed multiple strategies to conduct comprehensive health education for patients with hyperphosphatemia.
First, a poster of the education program on phosphate control was designed and placed on the hemodialysis center bulletin board by the team member, and nurses notified the patients and their families about the health education program one by one to increase their enthusiasm.
Second, group-based lectures were given to patients and their family members in the waiting area of the hemodialysis center. The content of the lectures included four topics: calcium and phosphorus regulation and the formation of hyperphosphatemia, the harm of hyperphosphatemia, hemodialysis, and medication on hyperphosphatemia, and dietary management (Table 1). The presentation slides and relevant materials for the lectures were prepared by the phosphate control team. The speakers in the lectures were selected from the qualified nephrologists or nurse specialists who passed the quiz after the training for the phosphate control and would like to give the lecture voluntarily. One topic was given in two fixed times every week, with each lecture lasting about 30-40 minutes, and the topic was changed to another one next week. The lectures on the four topics were repeated in the second month.
Table 1 The topics of group-based lectures on hyperphosphatemia for hemodialysis patients
Topic
|
Knowledge
|
Calcium and phosphorus regulation and the formation of hyperphosphatemia
|
· The physiological effects of calcium and phosphorus on the human body
· The role of the kidney in maintaining the calcium and phosphorus balance
· Causes of hyperphosphatemia in dialysis patients
· The role of hyperphosphatemia in mineral and bone disorders
· Comprehensive management for hyperphosphatemia in dialysis patients
|
Harm of hyperphosphatemia
|
· The incidence of hyperphosphatemia in dialysis patients
· Symptoms of hyperphosphatemia
· Effects of hyperphosphatemia on bone and joints
· Effects of hyperphosphatemia on the function of other organs
|
Hemodialysis and medication on hyperphosphatemia
|
· The significance of using phosphate binder in patients with hyperphosphatemia
· The mechanism of phosphate binder
· Major types of phosphate binders
· Administration of phosphate binder
· Adverse reactions to phosphate binder and medication for prevention
|
Dietary management on hyperphosphatemia
|
· Recommended phosphorus intake for dialysis patients
· The advantages and disadvantages of dietary phosphorus control
· How to control phosphate intake in a reasonable diet
· What are the phosphorus-rich food and low phosphorus foods
· Tips for reducing phosphorus in food during cooking
|
Third, one-on-one bedside education (one session per month) was performed by the nurses who in charge of the patients with hyperphosphatemia. The nurses evaluated patients’ knowledge on phosphate control every month according to patients’ answers from the Patient Questionnaire on Phosphate Control Knowledge, and then identify the knowledge gaps which should be strengthened. Then with the guidance of the Patient Education Form on Phosphate Control, which included the essential points for phosphate control that patients should grasp, related Q&A questions from the education form were selected, and patients were asked accordingly during dialysis sessions. When the responses were incorrect or not given, the individualized education for these points was conducted immediately. Each one-on-one bedside education session was recorded by the nurse providing the education in the patient education form, which was collected and checked by the phosphate control team every three months.
Fourth, bulletin board and social media were used to carry out patient education on hyperphosphatemia. Posters on phosphate control were created and placed at the bulletin board of the dialysis room. Additionally, a WeChat public account concerning relevant knowledge about phosphate control was created. The nephrologists, nurses, patients, and at least one family member per patient were invited to follow this account. Tips for phosphate control and the updated information on hyperphosphatemia and CKD-MBD were regularly pushed to the patients. Patients could ask relevant questions and get feedback from the health care professionals from this WeChat public account. Moreover, 30-minute multimedia videos related to management on hyperphosphatemia were produced and played on TV in the hemodialysis center twice a day so that patients can watch the videos during dialysis.
4) Application of skills
The First Principles of Instruction model argues that learners need to apply their knowledge or skills to solve problems in order for the intervention to be effective[21]. After the first round of group-based lectures, the patients were coached by in-charged nurses to learn the related skills to control phosphorus intake in their daily life, such as how to control the amount of phosphate in different food items, how to prepare for low phosphorus diets during cooking, how to plan the low phosphorus recipes, and how to choose the ingredients for three meals according to their taste. The patients were also guided to learn how to take phosphate binders exactly as prescribed, including correct timing, dosage, and administration.
5) Integration of skills into real-world activities
The First Principles of Instruction model proposes that it is necessary for learners to receive encouragement and to be able to integrate and transfer knowledge and skills into real-world activities. Experience sharing meetings were organized every 3 months for patients to enable them to communicate with each other and increase their enthusiasm for self-management. The patients who controlled serum phosphorus successfully were encouraged to share their experiences during the meeting(Figure 1).
3.3. Measurements
Sociodemographic and clinical data of the participants We developed a questionnaire to collect the participants' sociodemographic and clinical data. Sociodemographic data, including gender, age, educational level, were provided by the participants. Clinical data of the participants including primary disease, dialysis frequency, dialysis mode, and pre-dialysis serum phosphorus were obtained from medical records.
Knowledge of phosphate control The Patient Questionnaire on Phosphate Control Knowledge was developed by the phosphate control team by focus group discussion and two rounds of revisions. The questionnaire includes hyperphosphatemia associated knowledge, selection of low phosphorus diet and cooking skills to lowering phosphorus, and the role and administration of phosphate binders. The questionnaire consists of 25 questions, including 20 single choice questions and five multiple-choice questions with 4 points for each question, and the total score ranges from 0 to 100 points.
Adherence to phosphate binder Patient’s adherence to phosphate binder was assessed by the Medication Adherence Report Scale(MARS), which consists of five items describing non-adherent behaviour[22]. Each item is scored with 1 (‘always’) to 5 points (‘never’), leading to a sum score ranging between 5 and 25 points. Adding up all items yields a total score with a score equal or greater than 24 suggesting medication adherence[23].MARS is applied in this study with a higher test-retest reliability for 1 week(r=0.987,P<0.001)
3.4. Data collection
The nurses in the phosphate control team distributed the medication adherence scale to the participants before and 6 months after the program. Patients who participated in the study completed the scale during dialysis, and the nurses would help them to fill out the scale if needed. The data of knowledge phosphate control before and after the 6-month program were collected by in charged nurses and downloaded by the phosphate control team from the online survey tool Wenjuanxing (https://www.wjx.cn/) and the sociodemographic and disease characteristics were collected from the patients’ medical records.
3.5. Statistical analysis
SPSS 21.0 software was used to analyze the data. The descriptive statistics were used to describe the patients’ characteristics, serum phosphorus level, knowledge on phosphate control, and adherence to phosphate binder, in which mean and standard deviation were used to describe the continuous data, and frequency and percentage were used to describe the categorical data. The chi-square test was used to analyze the changes of the controlled rate of serum phosphorus and the percentage of adherence to phosphate binder after the program. The paired sample T test was used to compare the changes of the patients’ scores on knowledge of phosphate control and the changes of scores on adherence to phosphate binder after the program. P<0.05 indicated statistical significance.
3.6. Ethics of the study
This study was approved by the ethics committee of the fifth affiliated hospital of Sun Yat-sen University. All the patients who participated in the study had fully informed the rights in the study in accordance with the Declaration of Helsinki and had signed an informed consent form before participated in the study.