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Optimizing treatment initiation: Effects of a patient education program about fingolimod treatment on knowledge, self-efficacy and patient satisfaction
Multiple Sclerosis and Related Disorders, Volume 4, Issue 5, September 2015, Pages 444 - 450
Satisfaction with information on medication is linked to adherence, but patients are often dissatisfied with information about medication. Information about treatment with fingolimod is important for MS patients since an active role in managing treatment is required from them. To facilitate optimal treatment initiation, a nurse-led patient education program on fingolimod was implemented in a Swiss MS center.
To evaluate the impact of the evidence-based comprehensive patient education program on knowledge, self-efficacy and patient satisfaction.
Knowledge gain, subjective perception of being informed about the new treatment, self-efficacy in handling it and satisfaction with the program were evaluated in a pretest–posttest design. Patient reported outcomes were collected before and after an educational session on the first-dose day at the MS Center in a consecutive sample of 98 people with MS. Data was analyzed descriptively, score comparisons were done by Wilcoxon tests, and associations were estimated with Spearman's correlation coefficient.
Knowledge increased significantly from pre- to posttest. Similarly, perception of being informed and self-efficacy increased significantly. Satisfaction with the program was high. Pretest-differences in knowledge concerning gender and marital status were balanced after the educational session. Results did not differ between patients with fingolimod as first treatment and those switching from other MS treatments. At posttest perception of being informed and self-efficacy were significantly related to satisfaction.
An evidence-based comprehensive treatment education program is suitable to satisfy MS patients' information needs at treatment initiation. It enhances short-term treatment knowledge and self-efficacy in handling a new treatment in daily life. MS Nurses can thus contribute to effective treatment education and potentially to medication safety and adherence.
- Effective treatment education supports MS-patients with fingolimod treatment.
- Treatment education needs to be comprehensive and tailored to patients' needs.
- It satisfies patients' information needs at treatment initiation.
- It enhances knowledge and self-efficacy in handling a treatment in daily life.
- Nurse-led information programs contribute to effective treatment education.
Keywords: Patient education, Nurse-led, Medication information, Patient satisfaction, Multiple sclerosis, Self-efficacy.
Providing knowledge on medication is one of the cornerstones of patient education and self-management programs for patients with chronic conditions (Holman and Lorig, 2004 and Lorig, 2001). However, information on medication is often considered insufficient by patients, whether provided in a hospital setting, by the family physician, the specialist, or the pharmacist (Barber et al, 2004, Borgsteede et al, 2011, Dickinson and Raynor, 2003, Luethi, 2012, and van Geffen et al, 2011). Patients are particularly dissatisfied with information on potential medication-related problems (Auyeung et al, 2011 and Mahler et al, 2012). In a qualitative study by Modig et al. (2012) , frail elderly were comfortable with information when they trusted the physician or the information they received. They felt comfortable with information when they were satisfied with the information about their medicines and felt in control of them. Trust and confidence made them feel safe with their medication. In contrast, they felt insecure with information when they distrusted the health care system or drugs in general. Insecurity was also felt when information was poor and when healthcare professionals demonstrated little availability. In general, medication safety is increased when patients are well-informed about their treatments ( Coulter, 2011 ). Satisfaction with information about medication and better physician-communication are linked to better adherence (Horne et al, 2001 and Zolnierek and Dimatteo, 2009). In two systematic reviews some evidence was found that educational activities combined with behavioral support or counseling can enhance medication adherence (Ryan et al, 2014 and Viswanathan et al, 2012).
In MS, treatment knowledge has played an important role since more than 20 years, when injectable beta-interferons (IFN) and Glatirameracetat (GA) were introduced. In a life-long chronic and potentially debilitating disease, treatments that can reduce the burden of disease or slow the disease to any extent seem highly valuable. A survey of needs among Swiss people with MS showed that information about treatments and the results of latest research ranked among the top five needs ( Egger et al., 2012 ).
During more than a decade, specially trained MS nurses have instructed people with MS how to apply injectable treatments and how to cope with side-effects. They became an important source of information for treatment-related issues. In 2010 fingolimod, the first oral MS treatment was registered ( Kappos et al., 2010 ). Fingolimod and other new MS treatments have highly specific modes of action and are complex in management. They have multiple facets like concerns about efficacy, safety, tolerability, monitoring etc. With the new oral drugs, patients are more independent from health care professionals on the one hand; on the other hand they have to take a more active role in treatment management, especially with regard to monitoring safety-issues. Given this development, providing treatment knowledge becomes a prominent feature in MS patient education.
To satisfy patients' need for information at treatment initiation, a nurse-led evidence-based patient education program on fingolimod treatment was developed at the MS Center of University Hospital Basel, Switzerland, and was provided to all patients starting on fingolimod. Aims are to provide basic knowledge about fingolimod treatment that is applicable in daily life, combined with sufficient self-efficacy in handling all treatment aspects. Optimal treatment initiation is intended, fostering trust into the new medication and a feeling of safety with it. At the same time vigilant attention to potential side-effects and limitations in effectiveness are to be conveyed. Clarification of misconceptions, often resulting from internet searches and discussions with other people, is a further objective.
1.1. The patient education program
The education program is based on an “information talk” delivered by a nurse on the day of the first dose during the six hours cardiac safety monitoring.
The information talk comprises six main topics about fingolimod, titled in every-day language:
- ● How it works (efficacy and mode of action)
- ● How to take it (all aspects of administration, pauses and non-adherence)
- ● How to store it and how to travel with it
- ● How to get it (pharmacy, costs and insurance)
- ● Potential side-effects and how to understand the patient information leaflet
- ● Safety issues, risks and their prevention, monitoring over time
The content is written on text cards which are complemented by picture cards. Pictures and cartoons underline the spoken words to make those easier to understand and memorize. At the end of the talk, four pocket “memory cards” are handed over to the patient, showing the essential key points that should be kept in mind, reinforced by a manufacturer’s booklet.
The session takes approximately 60 min for treatment-experienced patients, or 90 min for newly-diagnosed patients. Significant others are welcome. Though much information is delivered, the nurse aims at creating a dialog, in which the patient has a significant part of the talking time and expresses his/her considerations, questions and concerns about the new treatment. Emotions or coping themes coming up during the talk are given first priority, as factual information can hardly be absorbed then. The talk is tailored to the patients’ needs. For example, discussion of side-effects is reduced if patients do not want to know about it to avoid negative influence on their attitude towards treatment. The information talk is at the same time a standardized and an individualized program.
The program was developed by a master-prepared nurse (first author), and was delivered by her and two other MS Nurses. To ensure know-how and consistency of information-giving, regular educational training had extended over a period of about six months. Intervention fidelity was assured by half-yearly mutual observations during an information talk according to a quality-standard.
1.2. Study objectives
Using a one-group pretest–posttest design, we aimed to evaluate the effects of the information talk on knowledge gain, the patients’ perception of being informed about their new treatment, their current certainty and future confidence in being able to handle all treatment aspects and their satisfaction with the information talk.
2. Materials and methods
2.1. Subjects and setting
The day starting on fingolimod at the MS center, patients gave written consent for the study. Eligible participants had to start fingolimod at the center, had to be at least 18 years old and to speak sufficient German for understanding the patient information. Patients with moderate to severe cognitive deficits were excluded.
2.2. Data collection
The informed consent process, as well as distribution and collection of questionnaires, was done by a nurse investigator, whereas an MS-Nurse performed the information talk. The roles were separated to reduce response bias resulting from dependency.
2.3. Outcome measures
Outcomes to be tested were knowledge gain on fingolimod treatment, three self-assessment ratings and satisfaction with the information talk. The three self-assessment ratings were participants' subjective perception of being informed about the new treatment (“information”) and two self-efficacy ratings: their current certainty of being able to handle all treatment aspects (“certainty”) and their confidence in being able to handle all treatment aspects in future (“confidence”). Self-efficacy is defined as “people's judgments of their capabilities to organize and execute courses of action to attain designated types of performances” ( Bandura, 1986 , p. 391). High self-efficacy increases the probability that a person will perform an intended action. In patient education self-efficacy is a relevant outcome ( Klug Redman, 2009 ).
Potential study confounders were gender, age, marital status, education, disease duration (time since diagnosis) and treatment status. Treatment status was subdivided in “treatment-experienced” or “fingolimod as first treatment”, in years of treatment, number of previous MS treatments and in switching to fingolimod from IFN/ GA or from natalizumab.
Participants filled out a knowledge questionnaire containing four multiple choice questions, two true–false-questions and eight crossword-terms before (pretest) and after (posttest) the information talk. Each correct answer was scored “one”, each incorrect answer “minus one”. Unanswered questions were scored “zero”. Scores were summed up to a total score of maximum 18 points. Information, certainty and confidence were assessed on visual analog scales (VAS), scaled from zero (not all at informed/certain/confident) to 10 (totally informed/certain/confident). Number of values ≥7 are regarded as sufficient for self-efficacy if measured on VAS ( van der Bijl and Shortridge-Baggett, 2001 ). Satisfaction was assessed by six questions: (1) on the amount of information received, (2) how satisfyingly questions were answered, (3) how understandable information was, (4) to what extent the patient's considerations and concerns were acknowledged, (5) overall quality of the information talk and (6) overall satisfaction with it. Each question was answered on a five point Likert scale, summed up to a total score from 6 to 30, higher scores indicating higher satisfaction. The questionnaire containing all posttest evaluations was done immediately or up to one hour after the information talk. All evaluation questions were created for the study's purpose and were tested for face validity with several peers and eleven patients before study start.
2.5. Statistical analysis
The analysis set consisted of all participants who had signed the informed consent. Knowledge scores are reported as median and inter Quartile range (IQR; i.e. first and third quartiles of the distribution) if not otherwise mentioned. Comparisons of pre- and posttest scores and of VAS-data were done by two-sided, paired Wilcoxon tests. Satisfaction scores were summarized as total numbers and as percentage grouped by question. Subgroup analyses for differences between pre- and posttest scores and potential confounders were done by Wilcoxon tests, if two groups were compared, and by Kruskal–Wallis tests, if three groups were compared. Associations between main outcomes or main outcomes and potential confounders were estimated with Spearman's correlation coefficient.
2.6. Ethics statement
The study was approved by the Ethics Committee of North Western Switzerland.
3.1. Subjects' characteristics
Out of 160 consecutive patients starting on fingolimod between June 2012 and September 2014, 112 were eligible for study participation. Fourteen patients refused participation and 98 participants were recruited. Seventy-eight of recruited patients were women (79.6%). Age ranged between 22 and 71 years with a median of 41 years [IQR=31–46]. Median time since diagnosis was 4.6 years [IQR=1.0–11.4], with a minimum of 2 months and a maximum of 36.4 years. For about one third (32.1%) of participants fingolimod was the first MS treatment. Forty-one percent lived alone and 59% had a partner. Forty percent had a university degree; all others had high school or college degrees and vocational trainings. Demographic and clinical characteristics of study participants are summarized in table 1 .
|Living with a partner||57||58.2|
|Number of previous MS drugs|
|Age (years)||41.0||31.0, 46.0||22.0–71.0|
|Years since diagnosis||4.6||1.0, 11.4||0.2–36.4|
|Number of treatment years||2.2||0.0, 8.8||0.0–25.0|
Note. IQR=inter Quartile range.
3.2. Gain of knowledge
The median score achieved in the knowledge pretest by all participants was 6 [IQR=4–8] out of 18. Knowledge increased significantly to a median of 14 points [IQR=13–16] in the posttest (p<0.001, n=97). No posttest knowledge score was lower than the corresponding pretest score. Knowledge gain is presented in Fig. 1 .
Significant differences were seen for gender and marital status in the pretest: women had significantly more knowledge before the information talk than men (p=0.02), and so did patients in a relationship compared to singles (p=0.03). After the information talk no subgroup differences were present.
All three self-assessment scores increased significantly from pre- to posttest:
- Perception of being informed about the new treatment (p<0.001)
- Current certainty of being able to handle all treatment aspects (p<0.001)
- Confidence in being able to handle all treatment aspects in future (p<0.001)
Score changes from pre- to posttest and their change are displayed in Fig. 2 .
Self-assessments showed a sufficient level after the information talk ( Table 2 ). Whereas 78 out of 97 participants indicated a score <7 for information before it, all scored ≥7 after it. With regard to certainty and confidence, 64 respectively 19 participants scored <7 at pretest. At posttest only one scored <7 at each.
|Perception of being informed about treatment|
|Current certainty of being able to handle all treatment aspects|
|Confidence in being able to handle all treatment aspects in future|
Subgroup analyses for gender, education, marital status and treatment status did not show any significant differences, neither at pre- nor at posttest.
Pretest knowledge score showed a weak but significant correlation with perception of being informed before the session (ρ=0.23, p=0.02), meaning that participants rated their pretest-knowledge on fingolimod quite realistically.
At posttest, three patients scored lower for certainty and five for confidence than at pretest ( Table 3 ).
|VAS-score pretest||VAS-score posttest||Score-difference|
Satisfaction with the information talk was very high. More than half of participants (53/97) (51.4%) assigned the maximum of 30 points ( Table 4 ).
|Overall satisfaction score||30||29||28||27||26||25||24||23||22|
|Number of ratings||53||13||10||11||4||3||1||1||1|
Quality of the information session and overall satisfaction were rated with only the two best scores. Number and percentage of ratings for each satisfaction question are given in Table 5 .
|The amount of information was...|
|Somewhat too much||8||8.2|
|Somewhat too few||1||1.0|
|My questions were answered satisfactorily.|
|I fully agree||72||74.2|
|I agree by and large||3||3.1|
|Information was provided in an understandable format.|
|I fully agree||71||74.0|
|I agree by and large||3||3.1|
|I felt acknowledged with my considerations and concerns.|
|I fully agree||76||78.3|
|I agree by and large||3||3.1|
|How would you rate the quality of the information talk?|
|How satisfied are you with the information talk?|
No significant differences concerning satisfaction were found in subgroup analysis for education, marital status and treatment status.
Significant positive correlations were found for all three posttest self-assessments and satisfaction ( Table 6 ). Patients who expressed higher perception of being informed, certainty and confidence were more satisfied with the information talk.
|Perception of being informed (pre)||−0.1170||0.2564|
|Perception of being informed (post)||0.3855||0.0001|
|Current certainty in handling treatment (pre)||−0.0720||0.4860|
|Current certainty in handling treatment (post)||0.3150||0.0018|
|Future confidence in handling treatment (pre)||0.1980||0.0532|
|Future confidence in handling treatment (post)||0.3465||0.0005|
In the current study a nurse-led evidence-based patient education program on the oral MS treatment fingolimod was evaluated. Testing patients before and after the educational session revealed that the information talk fulfilled its main intentions to increase knowledge about fingolimod treatment, to satisfy patients' information needs and to increase self-efficacy in handling the new treatment to a sufficient level. All participants benefitted to a similar extent from the information talk and were highly satisfied with it.
4.1. Satisfaction and patient-provider communication
Provision of treatment knowledge is usually considered to be part of the treatment decision that patients take together with their physicians. It is assumed that patients are fully informed once they initiate a treatment. This study shows that patients of an MS Center-despite having discussed their new treatment with their physicians before treatment start-clearly improved their treatment knowledge, felt better informed and showed higher self-efficacy after a dedicated information session at treatment start. However, knowledge necessary for treatment decisions has to be distinguished from knowledge about handling a treatment in daily life. Whereas the first comprises mainly efficacy, potential side effects, risks and basic application, the latter concentrates on practical aspects such as detailed information on intake, storage, and others. During consultations retention of information is often hindered by stress, time constraints and medical language. The strength of this program is that all treatment-relevant aspects are comprised in a detailed format, including potential side-effects and safety issues. This responds to research showing that patients often wish more information on potential medication-related problems, whereas they usually are given more information on “action” and “usage” (Auyeung et al, 2011 and Mahler et al, 2012). The dedicated information program presented here complemented previous information-giving by physicians and led to high satisfaction. This is in line with research literature showing that additional and specially trained communication programs on medication are more successful in satisfying patients’ information needs than usual care (Ekman et al, 2007, Kooy et al, 2015, and Mahler et al, 2012). However, consensus is lacking between physicians, nurses and pharmacists who is responsible for information provision ( Auyeung et al., 2011 ). This study’s comprehensive nurse-led program at treatment initiation in addition to physicians’ information-giving at treatment decision is one possible answer. For MS patients such programs are important and represent an opportunity to continue the well-established care-relationships with MS Nurses that result from former treatment application support.
4.2. Satisfaction and quality of information-giving
The high satisfaction scores of this evaluation cannot be unambiguously assigned to the quality of the information talk, nor can the study design decipher for cause and effect. In spite of role separation between MS Nurse and investigator, results have probably been influenced by response bias resulting from dependency of participants on the clinical team and from social desirability bias. However, considering the setting of a university hospital, where consultations with doctors take 60 minutes and must include all relevant issues, it is reasonable to assume that investing such time for one specific aspect – handling the new treatment – was indeed very much appreciated by the patients and fulfilled a subsistent need. In spite of high overall satisfaction, non-maximal scores hint at critical appraisals as well. The information talk can be improved with regard to didactics and response to information needs, as shown by non-maximal ratings for understandability of information and for perception how satisfyingly questions were answered. Answering questions in detail is crucial for patient satisfaction with medication information (Luethi, 2012, Modig et al, 2012, and Nair et al, 2002). Higher confidence in taking a medicine as prescribed was shown to be significantly related to satisfaction with getting one’s questions answered in a study by Burge et al. (2005) . Tailoring information is seen as a key to respond to patients' information needs (Linn et al, 2012 and Thurmann, 2006). Responding to patients' information needs requires careful attention as shown in the study by Ekman et al. (2007) : after an information program for patients with heart failure, nurses rated patients to be appropriately informed, whereas patients reported a persistent need for further information. In that study, nurses were observed in their daily routine of information-giving. The current study demonstrates that standardized programs with evaluative self-assessments are helpful to ensure that patients' information needs are satisfied.
4.3. Satisfaction, knowledge and adherence
Satisfaction with information about medication is linked to adherence, and so are treatment knowledge and confidence in taking a medicine as prescribed. In a study by Kim et al. (2007) lower hypertension treatment knowledge was significantly associated with higher intentional non-adherence. In the study by Burge et al. (2005) patient satisfaction, confidence and educational level were significantly related to better medication knowledge. Also, higher confidence was significantly linked to higher adherence. In a Puerto Rican medication program for elderly, adherence, knowledge and satisfaction improved significantly after an information program by community pharmacists ( Rivera-Sarate et al., 2009 ). In a study by Linn et al. (2014) , however, satisfaction and the extent of tailoring information delivered by nurses at treatment initiation were not directly related to adherence but related to adherence via the patient’s beliefs about medicines. What the current study adds is a significant relationship between satisfaction with a nurse-led information program and patients' subjective perceptions of being informed and their confidence in handling a new treatment.
Adherence is the premise for the effectiveness of MS treatments. Providing detailed treatment knowledge to patients tailored to their needs at treatment initiation can be seen as a way of increasing adherence in the long-term.
Adherence in this study cohort is being investigated in a separate, longer-termed study.
4.4. Treatment-experienced vs. fingolimod as first treatment
No differences were observed between treatment-experienced participants and those starting their first MS treatment. Specifically, no differences were found between patients switching from IFN/GA to fingolimod and those switching from natalizumab to fingolimod. This seems somewhat surprising: one could have assumed an advantage of treatment-experienced persons. Facing a new treatment seems to put all patients at the same starting point of learning about it.
4.5. Potential adverse effects
Possible downsides of information programs like confusion, increased uncertainty, and loss of knowledge or confidence were few in this study: score decreases in confidence and certainty of one or two points from 10 units on the VAS may be considered a correction towards a more realistic appraisal of the new treatment’s characteristics, including risks and potential side-effects. However, score losses like the one observed from 4 to 2 in certainty-hint at a true potential adverse effect and requires follow-up by the clinical team.
4.6. Limitations and strengths
As with similar studies, the study design does not allow to account for potential biases through dependency and social desirability. A limitation of this study is the fact that it concentrates only on some major evaluation aspects using partially validated instruments. Strengths of the evaluation were its prospective design and the program's high intervention integrity.
The study showed a short-term effect. Whether a long-term effect exists remains unknown. A long-term effect on knowledge, at least, is not intended by the program as patients are supported with written material. Moreover it seems important not to overcharge patients with responsibility for treatment management. It is sufficient for them to retain cues that make them contact the center in case of problems.
The nurse-led evidence-based patient education program on fingolimod treatment is effective and successful in satisfying patients’ information needs at treatment initiation. It is also effective in enhancing treatment knowledge and self-efficacy in handling the new treatment in the short term. With standardized information programs that are tailored to patients’ needs MS Nurses can contribute to effective patient treatment education. Treatment education can be seen as investment in medication safety and adherence. Given the high costs of immunomodulatory MS treatments, such investment seems mandatory and rewarding for patients, providers and the healthcare system.
This investigator-initiated trial was funded by Novartis Pharma Schweiz AG (CFTY720DCH01T), who had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Conflicts of interest
Andrea Zimmer, Cornelia Blaeuer and Michael Coslovsky have no conflicts of interest to declare.
Ludwig Kappos' institution (University Hospital Basel) has received funds in the last 3 years and used exclusively for research and support: steering committee, advisory board, and consultancy fees ( Actelion, Addex, Bayer HealthCare, Biogen Idec, Biotica, Genzyme, Lilly, Merck, Mitsubishi, Novartis, Ono Pharma, Pfizer, Receptos, Sanofi, Santhera, Siemens, Teva, UCB, Xenoport); speaker fees (Bayer HealthCare, Biogen Idec, Merck, Novartis, Sanofi, Teva); support of educational activities (Bayer HealthCare, Biogen, CSL Behring, Genzyme, Merck, Novartis, Sanofi, Teva); royalties (Neurostatus Systems GmbH); grants (Bayer HealthCare, Biogen Idec, European Union, Merck, Novartis, Roche Research Foundation, Swiss MS Society, Swiss National Research Foundation).
Tobias Derfuss served on advisory boards for Novartis Pharma, Merck-Serono GmbH, Bayer Schering Pharma, Mitsubishi Pharma, Biogen Idec, GeNeuro, Genzyme, and TEVA. He received travel support from Biogen Idec, Bayer Schering Pharma, Genzyme, and Merck Serono GmbH. He received research and/or unrestricted grants from Novartis Pharma, Biogen Idec, Merck Serono GmbH, the German Research Foundation, the Swiss National Foundation, the Swiss MS Society, and the European Union.
We are very grateful to the people with MS who participated in the study. We are also grateful to the center's team of nurses and physicians who collaborated with the program. Special thanks to the MS Nurses and study investigators Suzana Miteva and Karin Wild, who performed the study visits and data collection procedures. We are also grateful to Lisa Herzog of the Clinical Trial Unit of University Hospital Basel who performed part of the study's statistics.
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a Department of Neurology, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland
b Department of Special Clinics, University Hospital Basel, Hebelstrasse 2, 4031 Basel, Switzerland
c Clinical Trial Unit, Department of Clinical Research, University Hospital Basel, Schanzenstrasse 55, 4031 Basel, Switzerland
d Departments of Neurology and Biomedicine, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland
⁎ Correspondence to: Neurologic Outpatient Department, University Hospital Basel, Petersgraben 4, CH-4031 Basel. Fax: +41 61 265 57 37.
© 2015 Elsevier B.V., All rights reserved.