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The effects on knowledge of the systematic education of patients with joint diseases treated with NSAIDs and diuretics
Patient Education and Counseling 42 (2001) 165–174 www.elsevier.com / locate / pateducou
The effects on knowledge of the systematic education of patients with joint diseases treated with NSAIDs and diuretics ¨ Agneta Bjorck Linne´ a , *, Hans Liedholm a , Lennart Jacobsson b a
Department of Community Medicine, Malmo¨ University Hospital, S-205 02 Malmo¨ , Sweden b Department of Rheumatology, Malmo¨ University Hospital, S-205 02 Malmo¨ , Sweden
Received 20 June 1999; received in revised form 20 January 2000; accepted 21 February 2000
Abstract In a randomised, controlled trial, patients with joint diseases and concomitant treatment with NSAIDs and diuretics received systematic education. The intervention group was given information by a self-conducted, interactive Kodak Photo-CD program in addition to personal drug information and non-commercial drug leaflets. Awareness of drug interactions and encouragement of self-adjustment of treatment was focused on. Control patients received conventional information. Three months after randomisation, knowledge was tested by means of a questionnaire. At 3 months there was a significant difference in attained score between the intervention group and the control group. Greater knowledge was achieved, especially on drug interaction, in the intervention group. In conclusion, less than 1 h of systematic education significantly improved patients’ knowledge on essential issues of concomitant treatment with NSAIDs and diuretics. Knowledge of effects, side-effects and interactions of drugs is essential for self-adjustment of treatment. The method employed, which is standardised and produces a reproducible quantity of education, might be applicable to several other medical conditions. 2001 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Patient education; Drug interaction; Randomised trial; Compact disc; Joint disease
1. Introduction During the course of their disease, patients with chronic diseases often need to take several types of drugs and are treated by different physicians for their diseases. With multi-drug treatment there is an *Corresponding author. Tel.: 146-40-333-449; fax: 146-40336-215. ¨ E-mail address: [email protected] (A. Bjorck ´ Linne).
0738-3991 / 01 / $ – see front matter PII: S0738-3991( 00 )00105-1
increased risk for drug interactions. The specific interaction between diuretic drugs and non-steroidal antiinflammatory drugs (NSAIDs) is well known and NSAIDs may counteract the intentioned effect of the diuretics [1,2]. In the newly published consensus recommendation for the management of chronic heart failure this interaction was highlighted [3]. Furthermore, patients with inflammatory chronic joint diseases have an increased comorbidity in cardiovascular and other diseases [4] and often use NSAIDs, which puts them at risk for these interac-
2001 Elsevier Science Ireland Ltd. All rights reserved.
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tions. One way to decrease the risks for interactions is to educate both health professionals and patients on this issue. Before an evaluation of the clinical outcome can be made the method of education has to be properly evaluated. In order to study the effects of patient education on knowledge of this drug interaction we recruited patients with chronic joint diseases who were treated with a combination of diuretic and NSAID therapy. The aim was to see if a randomised, controlled study employing an interactive training program in addition to including oral and written information, could improve knowledge on the drugs involved and their interaction 3 months after education. The technique employed, an interactive Kodak Photo-CD technique, has been successfully used recently in a study of education of heart failure patients [5].
2. Methods
2.1. Inclusion criteria Patients of both sexes and of any age treated for rheumatological diseases (1) at the Department of Rheumatology at the University Hospital of Malmo¨ and (2) by rheumatology specialists at cooperating out-patient clinics in the cities of Malmo¨ and Trelleborg were eligible if they were regularly treated with daily doses of NSAIDs and diuretic drugs. With this basis of recruitment, practically all eligible patients treated by rheumatologists in the catchment area were identified. Patients were recruited postoperatively after rheumatic joint surgery or at routine visits at the rheumatological out-patient clinics. No specified indications for given drugs were required.
2.2. Exclusion criteria Patients with somatic disease or physical handicap with difficulties in communicating or handling the technical equipment used in the interactive part of the study, patients with expected problems with compliance due to alcohol / drug abuse or major psychiatric illness, or participation in another drug trial were excluded.
2.3. Design At the department during the hospitalisation and / or at the regular control visits to the out-patient clinics, all patients received general information regarding their disease and medication. During the study the organisation of the care and the content of standard information were kept unchanged. Additional education was randomly given to a group of patients (intervention group) before discharge from the hospital or at out-patient visits. All patients were then tested with a questionnaire (described here, and in Appendix A) for knowledge regarding diuretic, analgesic and antiinflammatory drugs 1 and 3 months later. The design and the actual time schedule of the study are given in Fig. 1.
2.3.1. Intervention group Oral information was given by the pharmacist on diuretic, analgesic and antiinflammatory drugs to the patients in the education group. Non-commercial leaflets with the same information were also given. The main part of the information consisted of an interactive CD program, in which patients trained their knowledge. The technique and the equipment, which consists of a Kodak Photo-CD player connected to a mini-TV (140), has been described previously [6]. The actual program consisted of three sequences. One sequence dealt with diuretic drugs, such as mode of action, side-effects, and interactions. Special attention was given to interaction with NSAIDs and the need for self-adjustment of the diuretic dose. The other two sequences dealt with the action and side-effects of NSAIDs and the common analgesics paracetamol and dextropropoxyphene, respectively. Patients actively commanded new pages of information with the remote control. In certain parts, questions with proposed (numbered) answers were displayed. The patients responded by pressing the corresponding button on the remote control. The question was repeated until the correct answer was selected. No part of the program could be omitted. During the CD session, patients were observed by the pharmacist for their ability to take instructions (from the program) and handle the equipment. The complete information session took less than 1 h. Although the primary aim was to measure knowl-
¨ Linne´ et al. / Patient Education and Counseling 42 (2001) 165 – 174 A. Bjorck
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Fig. 1. Design and time schedule of the study.
edge 3 months after the education program, all patients were also tested after 1 month in order to obtain information on the change in knowledge over time. Patients were tested individually for knowledge on analgesics and diuretics as well as drug interactions. On every test occasion, one to four patients attended, but the test was strictly individual. The test consisted of a questionnaire with 30 questions and was done at the hospital. Answers were put in envelopes, which were sealed, stored and later reviewed by a secretary. Patients’ latest lists of drugs were photocopied. Seventeen of the 30 questions concerning general knowledge of analgesics and diuretics had been chosen in advance for evaluation of knowledge. Items were based on the content of the CD program and corresponded to the general information usually given about these treatments. In advance, correct answers to some questions had been assigned two points, other questions one point. Correct answers to questions dealing with self-management of the interaction (questions 7, 9, and 17) were given two points. In addition, a correct answer to question 15 was given two points because two of five alternatives were correct. No points were given if the patient answered ‘do not know’ or gave an incorrect answer. The questions contained the locally most prescribed
trade names of NSAIDs and diuretics. Drugs not mentioned in the questions but used by a minority of patients were described to the patient as equivalent to those mentioned. During the knowledge test, emphasis was placed on answering all questions. The maximal attainable score was 21 points. A translation of the questionnaire is given in Appendix A. The test procedure was repeated 2 months later, i.e. 3 months after randomisation, the primary end point. Correct answers to the questions were provided at the end of the session. Patients’ latest lists of drugs were photocopied. Diagnosis and use of analgesic and diuretic drugs at randomisation were collected from patient records.
2.3.2. Control group Control patients received non-systematic, conventional information at the department during the hospitalisation and / or at regular control visits to the out-patient clinics. One and 3 months after randomisation, patients were tested for knowledge in the same way as the intervention patients. Correct answers to the questions were provided at the end of the last session, where patients also provided a copy of their latest personal list of drugs. All practical issues regarding the patients in the
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study were cooperatively taken care of by a specialist nurse from the Department of Rheumatology. All patients gave informed consent. The study was approved by the Committee on Ethics of the University of Lund, Sweden.
2.4. Randomisation Patients were randomised according to a computer-generated randomisation list. One list was produced for the in-patients and another for the out-patients since the out-patients were included (added) at a later stage in order to increase the sample. Patients were stratified by age in three age strata ( , 65, 65 to 75 and . 75 years). Allocation numbers were kept in sealed envelopes at the ward.
2.5. Statistics Conventional parametric and non-parametric statistical methods were used. Scores were tested for normality with the Kolmogorov–Smirnov test. Arithmetic mean, standard deviation (S.D.), 95% confidence interval (CI), median and range were used when appropriate. To estimate the reliability of the questionnaire, intraclass correlation between the attained score at 1 and 3 months in the control group was calculated for test–retest reliability. There had not been any pilot study with the questionnaire used, nor were there any studies in the literature to rely on for power estimation. The necessary number of patients to complete the study was initially calculated from the hypothesis that a realistic difference in points between the groups according to the questionnaire would be 6 points with an estimated standard deviation of 10, an alfa of 5% and a power of 90%. The number of patients in both groups was then calculated to be 116 using a two-sided test. An estimation of eligible patients in the catchment area performed during the course of the study made it clear that this large number of patients was unrealistic to attain and a recalculation had to be done. At this moment, results from our heart failure trial were analysed. The trial had a similar design, used the same technique and the same equipment. Based on this study we assumed we could find a mean value of 11 points (maximal value 21 points) and a
standard deviation of 3.9 points in the control group of the actual study. This calculation assumed that the score passed a normality test. Computerised simulations of effects of realistic group differences in attained score on sample sizes were then performed [7]. To detect a difference in mean values of 2, 3 or 4 points with a calculated standard deviation of 3.9 points (two-tailed test) the sample size of each group should be 61, 28 or 16 patients if the power was set to 80%. The primary endpoint of the study was a difference in attained score between the intervention group and the control group at 3 months. If this result was significant, an analysis could also be performed on data at 1 month after correction for the double comparison. This analysis was done to obtain information on change of knowledge over time and was based on the same design as the heart failure study [5] and was a secondary aim of the study.
3. Results Patients were randomised from October 1996 to May 1998. Most patients not eligible were excluded for reasons such as other severe disease and insufficient knowledge of the Swedish language. Participant flow of the patients is given in Fig. 2. Eighteen patients were randomised to the intervention group and 30 to the control group. Due to the enlargement of the study with the inclusion of outpatients and the use of a second computer-generated randomisation list, the distribution became skewed. Patient characteristics at randomisation were similar and are presented in Table 1. There were no major differences in drug treatment concerning NSAIDs and diuretics between the groups. Details of drug treatment at randomisation are presented in Table 2. There was no difference between the intervention and the control group regarding the time schedule of the study. Actual time intervals are presented in Table 3. At the end of the study (3 months) there was a significant difference in attained score between the intervention group (n 5 14), 12.5 points (median), and the control group (n 5 21), 6 points (median), P 5 0.0037 (Mann–Whitney U-test). The median difference was 6.5 points (95% CI, 2 to 10). For each item, i.e. interaction diuretics, action and
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169
Fig. 2. Participant flow of the study. *One patient in the control group missed the first test and completed the second test.
side-effects of NSAIDs, the intervention group achieved a higher score than the control group (data not shown). Since the difference in test score at 3 months was highly significant a second analysis of differences between the two groups after 1 month was allowed and consequently performed. The difference between the intervention group (n 5 16) and the control group (n 5 23) was not significant after 1 month. The intervention group attained 6.5 points (median) and the control group 5 points (median), P 5 0.1667. However, the estimated power of this result was low. The reliability of the questionnaire was tested with intraclass correlation on control patients participating in both tests, r 5 0.74 (95% CI, 0.45 to 0.89).
The results of the two tests are displayed in Fig. 3. Regarding individual items in the questionnaire, there were differences regarding achieved correct answers. The number of patients that gave correct answers varied from two of 14 (item Nos. 14 and 15) to 12 of 14 (item Nos. 2, 12 and 13) in the intervention group at 3 months. In the control group the range varied from 0 (item No. 14) to 17 of 21 patients (item No. 13). Constipation (item No. 14) and dizziness (item No. 15) were not identified as side-effects of drug treatment. Concerning items 7 and 9, which dealt with interactions between NSAIDs and diuretics, considered the most important questions, nine of 14 patients and eight of 14 patients, respectively, in the
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Table 1 Patient characteristics at randomisation
Age (years) (mean, range) Sex, F / M a
Intervention group (n 5 18)
Control group (n 5 30)
68.9 (50–79) 15 / 3
72.5 (58–93) 24 / 6
Age strata ,65 65–75 .75
5 6 7
5 14 11
Out-patients (No.)
8
16
16 – – 1 1
24 3 1 2 –
4 3 2 2 1
10 4 4 3 0
Diagnosis Rheumatoid arthritis Osteoarthritis Gout Arthralgia Osteoporosis Hypertension Coronary disease Heart failure Diabetes Atrial fibrillation a
Table 3 Time schedule and actual time intervals (days expressed as median and 25 to 75 percentiles) of the study. C, control group; I, intervention group Study group
Time from randomisation to first test Time from randomisation to second test
I
C
36 (28.5–45.5) 105 (97–110)
35 (27–49) 99 (91–105)
of heart failure patients [5], which is one of the few randomised studies on patient education and certainly the first using the interactive CD technique. The systematic education in both these studies consisted of a combination of oral information, non-commercial leaflets with drug information and a main part consisting of an interactive Kodak Photo-CD program. The leaflets and the Photo-CD programs were produced solely for the studies. The aim of both studies was to measure the effect on knowledge by this combination. We have previously shown that such equipment and a similar program are simple to handle, almost self-instructive, interactive and inexpensive, which makes them an alternative to computer programs. Furthermore, most elderly patients are still unfamiliar with the use of computers. Although many patients both in the present and the previous study were old, they had only minor problems running the program, as observed by the pharmacist. In both trials no patients reported problems understanding the text and there were no complaints about the time spent at the session. In both studies we used this new technique together with more traditional techniques, i.e. oral informa-
F, female; M, male.
intervention group achieved correct answers. Corresponding results in the control group were given only by three of 21 and one of 21, respectively.
4. Discussion In this study we have demonstrated that systematic education increases knowledge in patients with joint diseases compared to controls. We have recently obtained a similar result in a study of the education
Table 2 Drug treatment of patients at randomisation. Figures in the first column denote the number of patients in the intervention group and control group, respectively. Figures in the other columns denotes numbers of patients in the intervention group over control group (in parentheses) and range of daily doses of drugs (mg) Diuretics
Intervention group (18) Control group (30) a
NSAID
Furosemide (15/29)
Bendroflumethiazide (3/1)
Naproxen (4/10)
Diclofenac (4/8)
Ibuprofen (4/2)
Indomethacin (2/3)
Aspirin (2/0)
Nabumeton (2/0)
20–160 (40)a
2.5
500
50–150
1200–1800
100
600–1000
500–2000
10–160 (40)a
2.5
250–1000
50–100
400
50–100
Median dose of furosemide.
Sulindac (0/1)
Ketoprofen (0/6)
400
200
¨ Linne´ et al. / Patient Education and Counseling 42 (2001) 165 – 174 A. Bjorck
Fig. 3. Achieved results for control (open symbols) and intervention group (solid symbols) at 1 and 3 months. Values are means and 95% confidence intervals.
tion and non-commercial leaflets. In order to evaluate the separate role of this technique, further studies have to be performed. In a previous randomised trial, patients with chronic arthritis, recruited from a rheumatology clinic, were evaluated regarding their knowledge after verbal and printed information [8]. This study (n 5 150) reported similar and statistically significant effects of a booklet on the one hand and a combination of booklet and oral information on the other compared with controls (routine care) after 6 weeks, but no difference was found between the two intervention groups. The booklet contained general information about arthritis, activities of daily living, joint protection, etc. The patients’ health status and functional disability were measured by the Nottingham Health Profile (NHP) and the Health Assessment Questionnaire (HAQ). However, the duration of the study was short and increased knowledge was not associated with change in NHP and HAQ scores.
171
No correction for multiple statistic test was done and no details about the questions used in the knowledge test was presented. In another study, 120 out-patients with inflammatory joint diseases were randomised to three groups; one group received an information leaflet on joint disease and NSAID treatment, the second group received only verbal information and the third group received a combination [9]. Patients were tested before and 8–12 weeks after receiving the information. In contrast to our study, which had its main focus on drug interactions, the questions dealt with items such as names, action and side-effects of NSAIDs and how the drugs should be taken. No practical outcome was evaluated. There was no calculation of statistical power, nor was there any correction for multiple statistical tests. Knowledge increased in all groups, but no significant differences were seen between the groups. In contrast to the above two studies our study intentionally did not evaluate the pretest knowledge of the patients as this was thought to influence the result (test–retest phenomenon) [10]. Our study dealt with interaction issues and was focused on knowledge of self-management. The intervention group in our study attained a higher knowledge score than the control group, in spite of the small sample size, consisting of both in-patients and out-patients with higher age than in the other studies. The test results varied greatly in both patient groups, e.g. attained score varied from 2 to 18 points (maximum attainable score 21 points) in the intervention group at 3 months. Similar large variations in knowledge have been shown in studies of patients with different types of arthritis [11–13]. The difference in attained score in our study could not be clinically evaluated. However, a difference of that magnitude could be relevant as most of the difference was observed in items related to the interaction of drugs. In order to show the clinical effects of education, a large sample of patients has to be used. In a recent study (n 5 252) using a computer-based education program, only minor clinical effects could be shown despite significant differences regarding medication knowledge [13]. The size of our study may seem rather small. However, we estimate that the external validity is high as we managed to screen almost all patients
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treated by rheumatologists with the actual concomitant treatment in the catchment area. The actual power of the present study was calculated to be 88% (post hoc) [7]. Our study concerned the effects on knowledge. If a new didactic method is to be introduced, e.g. an information leaflet, a video film, a nurse-led information program, a proper evaluation of its effects on patients’ knowledge should first be performed. The clinical impact of the proven knowledge could then be tested in a trial. However, it is not evident that increased knowledge per se has a positive impact on the clinical outcome in the long run. It may well be the contrary, i.e. better knowledge may lead to a demand for better care [14]. In the present study the difference was significant at 3 months but not at 1 month. The absence of an effect at 1 month cannot be easily understood. In our study with heart failure patients the difference was significant already after 1 month. As heart failure is mostly characterized by daily symptoms of edema and breathlessness, patients with this condition are more in acute need of knowledge pertaining to selfmanagement and care. In contrast, patients with joint diseases with an existing drug interaction between NSAIDs and diuretics, as described in our study, have a more stable condition and the focus on the interaction problem may be less evident for the patient. Contributing factors to a significant difference in knowledge at 3 months include enhancement of knowledge by the media, nurses, doctors, and patients with similar conditions [9]. Increased aware-
ness of the interaction due to personal experience may also have contributed. There was a principal difference in the focus of education in our two studies which may have influenced the difference in outcome. In conclusion, our study has shown that less than 1 h of systematic education with personal drug information, printed drug leaflets and use of an interactive Photo-CD technique improved patients’ knowledge on essential issues of concomitant treatment with NSAIDs and diuretics. Knowledge on the effects and side-effects of drugs and their interactions is important for the possibility for patients to adjust their treatment themselves. The method employed might be applicable to several medical conditions and could easily be adopted by various health professionals for patients of most ages.
Acknowledgements ¨ The help of Kathe Nilsson, RN, secretary Christina Bengtsson, the staff at the Department of Rheumatology at Malmo¨ University Hospital and the rheumatologists at the out-patient clinics in Malmo¨ and Trelleborg is much appreciated. The important ´ contribution by Lars Agelii, Meditor AB, Gothenburg, is also much appreciated. The study was supported by grants from Malmo¨ University Hospital, Council for Medical Care Research in South ¨ Sweden, Ernhold Lundstrom’s fund and the Swedish National Corporation of Pharmacies.
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Appendix A. Questionnaire. Points obtainable are given in parentheses Item No.
(Maximum points per item)
1. How does an analgesic drug such as NSAID work? Tick one alternative NSAID works by reducing pain and temperature NSAID works by reducing inflammation NSAID works by reducing pain and temperature and to some extent by reducing the inflammation 2. Which drug can reduce the swelling of your legs? 3. Which drug affects the blood so that you can bleed easily? Tick one alternative NSAID (Naprosyn, Voltaren, Relifex, Orudis, Arthrotec) Diuretic drugs (Impugan, Lasix) Analgesic drugs (Alvedon, Doloxene, Distalgesic) 4. Which drug gives you a dry mouth? 5. If your legs get swollen or your weight increases, what can you do with your diuretic? 6. Give an example of an analgesic drug other than cortisone which can reduce morning rigidity 7. If you increase the dose of NSAID, what may you need to do with your diuretic? 8. Which drug can cause stomach problems? Tick one alternative Doloxene Alvedon Naprosyn 9. Which drug can reduce the effect of the diuretic drug? 10. Can you mention an occasion when you can increase the dose of NSAID? 11. On which occasions can you increase your diuretic drug? 12. Why are you taking a diuretic drug? 13. Why are you taking a NSAID?
(1) (1)
(1) (1) (1)
(1)
(2)
(1) (2)
(1) (1) (1) (1)
Item No.
14. Which of the following drugs can cause problems with constipation? Do not know None of the following drugs Drug containing paracetamol, Alvedon Drug containing codeine, Citodon and Treo Comp Drug containing NSAID, Arthrotec, Naproxen, Orudis Drug containing dextropropoxifen, Doloxene, Distalgesic 15. Which of following drugs can cause problem with dizziness? Do not know None of the following drugs Drug containing paracetamol, Alvedon Drug containing codeine, Citodon and Treo Comp Drug containing NSAID, Arthrotec, Naproxen, Orudis Drug containing dextropropoxifen, Doloxene, Distalgesic 16. Which of the following drugs can cause problems with diarrhoea? Do not know None of the following drugs Drug containing paracetamol, Alvedon Drug containing codeine, Citodon and Treo Comp Drug containing NSAID, Arthrotec, Naproxen, Orudis Drug containing dextropropoxifen, Doloxene, Distalgesic 17. Which of following drugs can cause problems with swelling of the legs? Do not know None of the following drugs Drug containing paracetamol, Alvedon Drug containing codeine, Citodon and Treo Comp Drug containing NSAID, Arthrotec, Naproxen, Orudis Drug containing dextropropoxifen, Doloxene, Distalgesic Maximum score
(Maximum points per item)
(1)
(2)
(1)
(2) 21
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References [1] Furst DE. Clinically important interactions of nonsteroidal antiinflammatory drugs with other medications. J Rheumatol 1988;17(Suppl):58–62. [2] Feenstra J, Grobbee DE, Remme WJ, Stricker BH. Druginduced heart failure. J Am Coll Cardiol 1999;33:1152–62. [3] Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Am J Cardiol 1999;83(2A):1A–38A. [4] Berkanovic E, Hurwicz M-L. Rheumatoid arthritis and comorbidity. J Rheumatol 1990;17:7. ¨ [5] Bjorck Linne´ A, Liedholm H, Israelsson B. Effects of systematic education on heart failure patients’ knowledge after 6 months. A randomised, controlled trial. Eur J Heart Failure 1999;1:219–27. ¨ ´ L. The development of [6] Liedholm H, Bjorck Linne´ A, Agelii an interactive education program for heart failure patients: the Kodak Photo CD Portfolio concept. Patient Educ Couns 1996;29:199–206. [7] nQuery2 Advisor (computer program). Version 2.0. Cork (Ireland): Statistical Solutions Ltd., 1997.
[8] Maggs FM, Jubb RW, Kemm JR. Single-blind randomized controlled trial of an educational booklet for patients with chronic arthritis. Br J Rheumatol 1996;35:775–7. [9] Arthur V, Clifford C. Evaluation of information given to rheumatology patients using non-steroidal anti-inflammatory drugs. J Clin Nurs 1998;7:175–81. [10] Andersen B. Methodological errors in medical research, Oxford: Blackwell Scientific, 1990. [11] Hill B, Bird H, Hopkins R, Lawton C, Wright V. The development and use of a patient knowledge questionnaire in rheumatoid arthritis. Br J Rheumatol 1991;30:45–9. [12] Lubrano E, Helliwell P, Parsons W, Emery P, Veale D. Patient education in psoriatic arthritis: a cross sectional study on knowledge by a validated self-administered questionnaire. J Rheumatol 1998;25:1560–5. [13] Helliwell PS, O’Hara M, Holdsworth J, Hesselden A, King T, Evans P. A 12-month randomized controlled trial of patient education on radiographic changes and quality of life in early rheumatoid arthritis. Rheumatology 1999;38:303–8. [14] Lindroth Y, Bauman A, Brooks PM, Priestley D. A five-year follow-up of a controlled trial of an arthritis education programme. Br J Rheumatol 1995;34:647–52.
The effects on knowledge of the systematic education of patients with joint diseases treated with NSAIDs and diuretics ¨ Agneta Bjorck Linne´ a , *, Hans Liedholm a , Lennart Jacobsson b a
Department of Community Medicine, Malmo¨ University Hospital, S-205 02 Malmo¨ , Sweden b Department of Rheumatology, Malmo¨ University Hospital, S-205 02 Malmo¨ , Sweden
Received 20 June 1999; received in revised form 20 January 2000; accepted 21 February 2000
Abstract In a randomised, controlled trial, patients with joint diseases and concomitant treatment with NSAIDs and diuretics received systematic education. The intervention group was given information by a self-conducted, interactive Kodak Photo-CD program in addition to personal drug information and non-commercial drug leaflets. Awareness of drug interactions and encouragement of self-adjustment of treatment was focused on. Control patients received conventional information. Three months after randomisation, knowledge was tested by means of a questionnaire. At 3 months there was a significant difference in attained score between the intervention group and the control group. Greater knowledge was achieved, especially on drug interaction, in the intervention group. In conclusion, less than 1 h of systematic education significantly improved patients’ knowledge on essential issues of concomitant treatment with NSAIDs and diuretics. Knowledge of effects, side-effects and interactions of drugs is essential for self-adjustment of treatment. The method employed, which is standardised and produces a reproducible quantity of education, might be applicable to several other medical conditions. 2001 Elsevier Science Ireland Ltd. All rights reserved. Keywords: Patient education; Drug interaction; Randomised trial; Compact disc; Joint disease
1. Introduction During the course of their disease, patients with chronic diseases often need to take several types of drugs and are treated by different physicians for their diseases. With multi-drug treatment there is an *Corresponding author. Tel.: 146-40-333-449; fax: 146-40336-215. ¨ E-mail address: [email protected] (A. Bjorck ´ Linne).
0738-3991 / 01 / $ – see front matter PII: S0738-3991( 00 )00105-1
increased risk for drug interactions. The specific interaction between diuretic drugs and non-steroidal antiinflammatory drugs (NSAIDs) is well known and NSAIDs may counteract the intentioned effect of the diuretics [1,2]. In the newly published consensus recommendation for the management of chronic heart failure this interaction was highlighted [3]. Furthermore, patients with inflammatory chronic joint diseases have an increased comorbidity in cardiovascular and other diseases [4] and often use NSAIDs, which puts them at risk for these interac-
2001 Elsevier Science Ireland Ltd. All rights reserved.
166
¨ Linne´ et al. / Patient Education and Counseling 42 (2001) 165 – 174 A. Bjorck
tions. One way to decrease the risks for interactions is to educate both health professionals and patients on this issue. Before an evaluation of the clinical outcome can be made the method of education has to be properly evaluated. In order to study the effects of patient education on knowledge of this drug interaction we recruited patients with chronic joint diseases who were treated with a combination of diuretic and NSAID therapy. The aim was to see if a randomised, controlled study employing an interactive training program in addition to including oral and written information, could improve knowledge on the drugs involved and their interaction 3 months after education. The technique employed, an interactive Kodak Photo-CD technique, has been successfully used recently in a study of education of heart failure patients [5].
2. Methods
2.1. Inclusion criteria Patients of both sexes and of any age treated for rheumatological diseases (1) at the Department of Rheumatology at the University Hospital of Malmo¨ and (2) by rheumatology specialists at cooperating out-patient clinics in the cities of Malmo¨ and Trelleborg were eligible if they were regularly treated with daily doses of NSAIDs and diuretic drugs. With this basis of recruitment, practically all eligible patients treated by rheumatologists in the catchment area were identified. Patients were recruited postoperatively after rheumatic joint surgery or at routine visits at the rheumatological out-patient clinics. No specified indications for given drugs were required.
2.2. Exclusion criteria Patients with somatic disease or physical handicap with difficulties in communicating or handling the technical equipment used in the interactive part of the study, patients with expected problems with compliance due to alcohol / drug abuse or major psychiatric illness, or participation in another drug trial were excluded.
2.3. Design At the department during the hospitalisation and / or at the regular control visits to the out-patient clinics, all patients received general information regarding their disease and medication. During the study the organisation of the care and the content of standard information were kept unchanged. Additional education was randomly given to a group of patients (intervention group) before discharge from the hospital or at out-patient visits. All patients were then tested with a questionnaire (described here, and in Appendix A) for knowledge regarding diuretic, analgesic and antiinflammatory drugs 1 and 3 months later. The design and the actual time schedule of the study are given in Fig. 1.
2.3.1. Intervention group Oral information was given by the pharmacist on diuretic, analgesic and antiinflammatory drugs to the patients in the education group. Non-commercial leaflets with the same information were also given. The main part of the information consisted of an interactive CD program, in which patients trained their knowledge. The technique and the equipment, which consists of a Kodak Photo-CD player connected to a mini-TV (140), has been described previously [6]. The actual program consisted of three sequences. One sequence dealt with diuretic drugs, such as mode of action, side-effects, and interactions. Special attention was given to interaction with NSAIDs and the need for self-adjustment of the diuretic dose. The other two sequences dealt with the action and side-effects of NSAIDs and the common analgesics paracetamol and dextropropoxyphene, respectively. Patients actively commanded new pages of information with the remote control. In certain parts, questions with proposed (numbered) answers were displayed. The patients responded by pressing the corresponding button on the remote control. The question was repeated until the correct answer was selected. No part of the program could be omitted. During the CD session, patients were observed by the pharmacist for their ability to take instructions (from the program) and handle the equipment. The complete information session took less than 1 h. Although the primary aim was to measure knowl-
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Fig. 1. Design and time schedule of the study.
edge 3 months after the education program, all patients were also tested after 1 month in order to obtain information on the change in knowledge over time. Patients were tested individually for knowledge on analgesics and diuretics as well as drug interactions. On every test occasion, one to four patients attended, but the test was strictly individual. The test consisted of a questionnaire with 30 questions and was done at the hospital. Answers were put in envelopes, which were sealed, stored and later reviewed by a secretary. Patients’ latest lists of drugs were photocopied. Seventeen of the 30 questions concerning general knowledge of analgesics and diuretics had been chosen in advance for evaluation of knowledge. Items were based on the content of the CD program and corresponded to the general information usually given about these treatments. In advance, correct answers to some questions had been assigned two points, other questions one point. Correct answers to questions dealing with self-management of the interaction (questions 7, 9, and 17) were given two points. In addition, a correct answer to question 15 was given two points because two of five alternatives were correct. No points were given if the patient answered ‘do not know’ or gave an incorrect answer. The questions contained the locally most prescribed
trade names of NSAIDs and diuretics. Drugs not mentioned in the questions but used by a minority of patients were described to the patient as equivalent to those mentioned. During the knowledge test, emphasis was placed on answering all questions. The maximal attainable score was 21 points. A translation of the questionnaire is given in Appendix A. The test procedure was repeated 2 months later, i.e. 3 months after randomisation, the primary end point. Correct answers to the questions were provided at the end of the session. Patients’ latest lists of drugs were photocopied. Diagnosis and use of analgesic and diuretic drugs at randomisation were collected from patient records.
2.3.2. Control group Control patients received non-systematic, conventional information at the department during the hospitalisation and / or at regular control visits to the out-patient clinics. One and 3 months after randomisation, patients were tested for knowledge in the same way as the intervention patients. Correct answers to the questions were provided at the end of the last session, where patients also provided a copy of their latest personal list of drugs. All practical issues regarding the patients in the
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study were cooperatively taken care of by a specialist nurse from the Department of Rheumatology. All patients gave informed consent. The study was approved by the Committee on Ethics of the University of Lund, Sweden.
2.4. Randomisation Patients were randomised according to a computer-generated randomisation list. One list was produced for the in-patients and another for the out-patients since the out-patients were included (added) at a later stage in order to increase the sample. Patients were stratified by age in three age strata ( , 65, 65 to 75 and . 75 years). Allocation numbers were kept in sealed envelopes at the ward.
2.5. Statistics Conventional parametric and non-parametric statistical methods were used. Scores were tested for normality with the Kolmogorov–Smirnov test. Arithmetic mean, standard deviation (S.D.), 95% confidence interval (CI), median and range were used when appropriate. To estimate the reliability of the questionnaire, intraclass correlation between the attained score at 1 and 3 months in the control group was calculated for test–retest reliability. There had not been any pilot study with the questionnaire used, nor were there any studies in the literature to rely on for power estimation. The necessary number of patients to complete the study was initially calculated from the hypothesis that a realistic difference in points between the groups according to the questionnaire would be 6 points with an estimated standard deviation of 10, an alfa of 5% and a power of 90%. The number of patients in both groups was then calculated to be 116 using a two-sided test. An estimation of eligible patients in the catchment area performed during the course of the study made it clear that this large number of patients was unrealistic to attain and a recalculation had to be done. At this moment, results from our heart failure trial were analysed. The trial had a similar design, used the same technique and the same equipment. Based on this study we assumed we could find a mean value of 11 points (maximal value 21 points) and a
standard deviation of 3.9 points in the control group of the actual study. This calculation assumed that the score passed a normality test. Computerised simulations of effects of realistic group differences in attained score on sample sizes were then performed [7]. To detect a difference in mean values of 2, 3 or 4 points with a calculated standard deviation of 3.9 points (two-tailed test) the sample size of each group should be 61, 28 or 16 patients if the power was set to 80%. The primary endpoint of the study was a difference in attained score between the intervention group and the control group at 3 months. If this result was significant, an analysis could also be performed on data at 1 month after correction for the double comparison. This analysis was done to obtain information on change of knowledge over time and was based on the same design as the heart failure study [5] and was a secondary aim of the study.
3. Results Patients were randomised from October 1996 to May 1998. Most patients not eligible were excluded for reasons such as other severe disease and insufficient knowledge of the Swedish language. Participant flow of the patients is given in Fig. 2. Eighteen patients were randomised to the intervention group and 30 to the control group. Due to the enlargement of the study with the inclusion of outpatients and the use of a second computer-generated randomisation list, the distribution became skewed. Patient characteristics at randomisation were similar and are presented in Table 1. There were no major differences in drug treatment concerning NSAIDs and diuretics between the groups. Details of drug treatment at randomisation are presented in Table 2. There was no difference between the intervention and the control group regarding the time schedule of the study. Actual time intervals are presented in Table 3. At the end of the study (3 months) there was a significant difference in attained score between the intervention group (n 5 14), 12.5 points (median), and the control group (n 5 21), 6 points (median), P 5 0.0037 (Mann–Whitney U-test). The median difference was 6.5 points (95% CI, 2 to 10). For each item, i.e. interaction diuretics, action and
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Fig. 2. Participant flow of the study. *One patient in the control group missed the first test and completed the second test.
side-effects of NSAIDs, the intervention group achieved a higher score than the control group (data not shown). Since the difference in test score at 3 months was highly significant a second analysis of differences between the two groups after 1 month was allowed and consequently performed. The difference between the intervention group (n 5 16) and the control group (n 5 23) was not significant after 1 month. The intervention group attained 6.5 points (median) and the control group 5 points (median), P 5 0.1667. However, the estimated power of this result was low. The reliability of the questionnaire was tested with intraclass correlation on control patients participating in both tests, r 5 0.74 (95% CI, 0.45 to 0.89).
The results of the two tests are displayed in Fig. 3. Regarding individual items in the questionnaire, there were differences regarding achieved correct answers. The number of patients that gave correct answers varied from two of 14 (item Nos. 14 and 15) to 12 of 14 (item Nos. 2, 12 and 13) in the intervention group at 3 months. In the control group the range varied from 0 (item No. 14) to 17 of 21 patients (item No. 13). Constipation (item No. 14) and dizziness (item No. 15) were not identified as side-effects of drug treatment. Concerning items 7 and 9, which dealt with interactions between NSAIDs and diuretics, considered the most important questions, nine of 14 patients and eight of 14 patients, respectively, in the
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Table 1 Patient characteristics at randomisation
Age (years) (mean, range) Sex, F / M a
Intervention group (n 5 18)
Control group (n 5 30)
68.9 (50–79) 15 / 3
72.5 (58–93) 24 / 6
Age strata ,65 65–75 .75
5 6 7
5 14 11
Out-patients (No.)
8
16
16 – – 1 1
24 3 1 2 –
4 3 2 2 1
10 4 4 3 0
Diagnosis Rheumatoid arthritis Osteoarthritis Gout Arthralgia Osteoporosis Hypertension Coronary disease Heart failure Diabetes Atrial fibrillation a
Table 3 Time schedule and actual time intervals (days expressed as median and 25 to 75 percentiles) of the study. C, control group; I, intervention group Study group
Time from randomisation to first test Time from randomisation to second test
I
C
36 (28.5–45.5) 105 (97–110)
35 (27–49) 99 (91–105)
of heart failure patients [5], which is one of the few randomised studies on patient education and certainly the first using the interactive CD technique. The systematic education in both these studies consisted of a combination of oral information, non-commercial leaflets with drug information and a main part consisting of an interactive Kodak Photo-CD program. The leaflets and the Photo-CD programs were produced solely for the studies. The aim of both studies was to measure the effect on knowledge by this combination. We have previously shown that such equipment and a similar program are simple to handle, almost self-instructive, interactive and inexpensive, which makes them an alternative to computer programs. Furthermore, most elderly patients are still unfamiliar with the use of computers. Although many patients both in the present and the previous study were old, they had only minor problems running the program, as observed by the pharmacist. In both trials no patients reported problems understanding the text and there were no complaints about the time spent at the session. In both studies we used this new technique together with more traditional techniques, i.e. oral informa-
F, female; M, male.
intervention group achieved correct answers. Corresponding results in the control group were given only by three of 21 and one of 21, respectively.
4. Discussion In this study we have demonstrated that systematic education increases knowledge in patients with joint diseases compared to controls. We have recently obtained a similar result in a study of the education
Table 2 Drug treatment of patients at randomisation. Figures in the first column denote the number of patients in the intervention group and control group, respectively. Figures in the other columns denotes numbers of patients in the intervention group over control group (in parentheses) and range of daily doses of drugs (mg) Diuretics
Intervention group (18) Control group (30) a
NSAID
Furosemide (15/29)
Bendroflumethiazide (3/1)
Naproxen (4/10)
Diclofenac (4/8)
Ibuprofen (4/2)
Indomethacin (2/3)
Aspirin (2/0)
Nabumeton (2/0)
20–160 (40)a
2.5
500
50–150
1200–1800
100
600–1000
500–2000
10–160 (40)a
2.5
250–1000
50–100
400
50–100
Median dose of furosemide.
Sulindac (0/1)
Ketoprofen (0/6)
400
200
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Fig. 3. Achieved results for control (open symbols) and intervention group (solid symbols) at 1 and 3 months. Values are means and 95% confidence intervals.
tion and non-commercial leaflets. In order to evaluate the separate role of this technique, further studies have to be performed. In a previous randomised trial, patients with chronic arthritis, recruited from a rheumatology clinic, were evaluated regarding their knowledge after verbal and printed information [8]. This study (n 5 150) reported similar and statistically significant effects of a booklet on the one hand and a combination of booklet and oral information on the other compared with controls (routine care) after 6 weeks, but no difference was found between the two intervention groups. The booklet contained general information about arthritis, activities of daily living, joint protection, etc. The patients’ health status and functional disability were measured by the Nottingham Health Profile (NHP) and the Health Assessment Questionnaire (HAQ). However, the duration of the study was short and increased knowledge was not associated with change in NHP and HAQ scores.
171
No correction for multiple statistic test was done and no details about the questions used in the knowledge test was presented. In another study, 120 out-patients with inflammatory joint diseases were randomised to three groups; one group received an information leaflet on joint disease and NSAID treatment, the second group received only verbal information and the third group received a combination [9]. Patients were tested before and 8–12 weeks after receiving the information. In contrast to our study, which had its main focus on drug interactions, the questions dealt with items such as names, action and side-effects of NSAIDs and how the drugs should be taken. No practical outcome was evaluated. There was no calculation of statistical power, nor was there any correction for multiple statistical tests. Knowledge increased in all groups, but no significant differences were seen between the groups. In contrast to the above two studies our study intentionally did not evaluate the pretest knowledge of the patients as this was thought to influence the result (test–retest phenomenon) [10]. Our study dealt with interaction issues and was focused on knowledge of self-management. The intervention group in our study attained a higher knowledge score than the control group, in spite of the small sample size, consisting of both in-patients and out-patients with higher age than in the other studies. The test results varied greatly in both patient groups, e.g. attained score varied from 2 to 18 points (maximum attainable score 21 points) in the intervention group at 3 months. Similar large variations in knowledge have been shown in studies of patients with different types of arthritis [11–13]. The difference in attained score in our study could not be clinically evaluated. However, a difference of that magnitude could be relevant as most of the difference was observed in items related to the interaction of drugs. In order to show the clinical effects of education, a large sample of patients has to be used. In a recent study (n 5 252) using a computer-based education program, only minor clinical effects could be shown despite significant differences regarding medication knowledge [13]. The size of our study may seem rather small. However, we estimate that the external validity is high as we managed to screen almost all patients
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treated by rheumatologists with the actual concomitant treatment in the catchment area. The actual power of the present study was calculated to be 88% (post hoc) [7]. Our study concerned the effects on knowledge. If a new didactic method is to be introduced, e.g. an information leaflet, a video film, a nurse-led information program, a proper evaluation of its effects on patients’ knowledge should first be performed. The clinical impact of the proven knowledge could then be tested in a trial. However, it is not evident that increased knowledge per se has a positive impact on the clinical outcome in the long run. It may well be the contrary, i.e. better knowledge may lead to a demand for better care [14]. In the present study the difference was significant at 3 months but not at 1 month. The absence of an effect at 1 month cannot be easily understood. In our study with heart failure patients the difference was significant already after 1 month. As heart failure is mostly characterized by daily symptoms of edema and breathlessness, patients with this condition are more in acute need of knowledge pertaining to selfmanagement and care. In contrast, patients with joint diseases with an existing drug interaction between NSAIDs and diuretics, as described in our study, have a more stable condition and the focus on the interaction problem may be less evident for the patient. Contributing factors to a significant difference in knowledge at 3 months include enhancement of knowledge by the media, nurses, doctors, and patients with similar conditions [9]. Increased aware-
ness of the interaction due to personal experience may also have contributed. There was a principal difference in the focus of education in our two studies which may have influenced the difference in outcome. In conclusion, our study has shown that less than 1 h of systematic education with personal drug information, printed drug leaflets and use of an interactive Photo-CD technique improved patients’ knowledge on essential issues of concomitant treatment with NSAIDs and diuretics. Knowledge on the effects and side-effects of drugs and their interactions is important for the possibility for patients to adjust their treatment themselves. The method employed might be applicable to several medical conditions and could easily be adopted by various health professionals for patients of most ages.
Acknowledgements ¨ The help of Kathe Nilsson, RN, secretary Christina Bengtsson, the staff at the Department of Rheumatology at Malmo¨ University Hospital and the rheumatologists at the out-patient clinics in Malmo¨ and Trelleborg is much appreciated. The important ´ contribution by Lars Agelii, Meditor AB, Gothenburg, is also much appreciated. The study was supported by grants from Malmo¨ University Hospital, Council for Medical Care Research in South ¨ Sweden, Ernhold Lundstrom’s fund and the Swedish National Corporation of Pharmacies.
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Appendix A. Questionnaire. Points obtainable are given in parentheses Item No.
(Maximum points per item)
1. How does an analgesic drug such as NSAID work? Tick one alternative NSAID works by reducing pain and temperature NSAID works by reducing inflammation NSAID works by reducing pain and temperature and to some extent by reducing the inflammation 2. Which drug can reduce the swelling of your legs? 3. Which drug affects the blood so that you can bleed easily? Tick one alternative NSAID (Naprosyn, Voltaren, Relifex, Orudis, Arthrotec) Diuretic drugs (Impugan, Lasix) Analgesic drugs (Alvedon, Doloxene, Distalgesic) 4. Which drug gives you a dry mouth? 5. If your legs get swollen or your weight increases, what can you do with your diuretic? 6. Give an example of an analgesic drug other than cortisone which can reduce morning rigidity 7. If you increase the dose of NSAID, what may you need to do with your diuretic? 8. Which drug can cause stomach problems? Tick one alternative Doloxene Alvedon Naprosyn 9. Which drug can reduce the effect of the diuretic drug? 10. Can you mention an occasion when you can increase the dose of NSAID? 11. On which occasions can you increase your diuretic drug? 12. Why are you taking a diuretic drug? 13. Why are you taking a NSAID?
(1) (1)
(1) (1) (1)
(1)
(2)
(1) (2)
(1) (1) (1) (1)
Item No.
14. Which of the following drugs can cause problems with constipation? Do not know None of the following drugs Drug containing paracetamol, Alvedon Drug containing codeine, Citodon and Treo Comp Drug containing NSAID, Arthrotec, Naproxen, Orudis Drug containing dextropropoxifen, Doloxene, Distalgesic 15. Which of following drugs can cause problem with dizziness? Do not know None of the following drugs Drug containing paracetamol, Alvedon Drug containing codeine, Citodon and Treo Comp Drug containing NSAID, Arthrotec, Naproxen, Orudis Drug containing dextropropoxifen, Doloxene, Distalgesic 16. Which of the following drugs can cause problems with diarrhoea? Do not know None of the following drugs Drug containing paracetamol, Alvedon Drug containing codeine, Citodon and Treo Comp Drug containing NSAID, Arthrotec, Naproxen, Orudis Drug containing dextropropoxifen, Doloxene, Distalgesic 17. Which of following drugs can cause problems with swelling of the legs? Do not know None of the following drugs Drug containing paracetamol, Alvedon Drug containing codeine, Citodon and Treo Comp Drug containing NSAID, Arthrotec, Naproxen, Orudis Drug containing dextropropoxifen, Doloxene, Distalgesic Maximum score
(Maximum points per item)
(1)
(2)
(1)
(2) 21
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