Summary
Background
Much attention is being paid to the education of and provision of medical information to patients, to optimize their understanding and acceptance of their disease.
Aims
To ascertain the impact of educating recent recipients of an implantable cardioverter defibrillator (ICD) on their perception and acceptance of a home monitoring (HM) system.
Methods
Questionnaire 1, completed one month after ICD implantation, was designed to assess: the quality of patient preparation for HM; patient comprehension of HM; and patient anxiety experienced during its installation. The comprehension questions were assigned a score of –2 for an incorrect answer, +1 for a correct answer and 0 for neither (total score ranging from –40 to +20). Questionnaire 2, completed six months after ICD implantation, assessed patient acceptance of and anxiety about HM.
Results
The registry included 571 patients (mean age 63.9 ± 12.8 years; 83% men; 76% of ICDs implanted for primary prevention) followed by HM for 6.2 ± 1.2 months. Questionnaire 1 was completed by 430 (75.3%) patients and questionnaire 2 by 398 (69.7%) patients. Younger patients had a better comprehension of HM than older patients. High-quality training conditions improved the comprehension score, and a positive association was observed between anxiety and acceptance levels and the comprehension score. The 80 ± 20% mean data transmission rate (days of transmission/days of follow-up ratio) was unrelated to the comprehension scores.
Conclusion
A clear understanding was associated with a higher acceptance of HM, although it was unrelated to the data transmission rate.
Résumé
Contexte
Un grand intérêt est porté à l’éducation et l’information des patients et de leur entourage, afin d’améliorer leurs connaissances de la maladie.
Objectifs
Déterminer l’importance de l’éducation des porteurs de défibrillateurs automatiques implantables (DAI) concernant leur perception et acceptation de la télécardiologie.
Méthodes
Le premier questionnaire (Q-1) complété 1 mois après l’implantation des DAI, fut conçu pour examiner (1) la qualité de la formation des patients en télécardiologie, (2) leur compréhension du système, et (3) l’anxiété qu’ils ressentirent lors de l’installation. Un score de compréhension s’étendant de –40 à +20 fut calculé en attribuant –2 aux réponses incorrectes, +1 aux réponses correctes et 0 aux réponses manquantes. Le questionnaire 2 (Q-2), complété 6 mois après l’implantation des DAI, fut conçu pour évaluer l’acceptation et l’anxiété de la télécardiologie.
Résultats
Le registre a inclus 571 patients (âge moyen = 63,9 ± 12,8 ans, 83 % d’hommes, 76 % de prévention primaire) suivis par télécardiologie pendant 6,2 ± 1,2 mois. Q-1 fut complété par 430 (75,3 %) et Q-2 par 398 (69,7 %) patients. Les plus jeunes avaient une meilleure compréhension de la télécardiologie que les plus âgés. Une formation dans de bonnes conditions a amélioré le score de compréhension et une association significative fut identifiée entre le niveau d’anxiété et d’acceptation, et le niveau de compréhension. Le taux de transmission moyen (nombre de jours de transmission/nombre de jours de suivi) fut 80 ± 20 % et n’était pas lié à la compréhension.
Conclusion
Indépendamment du taux de transmission, la compréhension de la télécardiologie était associée avec son acceptation.
Introduction
The remote monitoring of implantable cardiac devices is safe and effective, and is fast becoming the standard of care for the follow-up of pacemaker and implantable cardioverter defibrillator (ICD) recipients . However, there are few published reports pertaining to patient acceptance of these systems and the fear that they might cause . On the other hand, caregivers and investigators have recognised the need to include patient perceptions and preferences when making health management decisions. Consequently, growing attention is being paid to educating and informing patients, with a view to promote their understanding of their disease – a perspective that might help in the development of innovative strategies and improve the delivery of specialized health care.
Biotronik Home-Monitoring ® (HM; a system developed by Biotronik SE and Co. KG, Berlin, Germany) provides diagnostic information, periodic trends and event-triggered ICD data, which are transmitted to a secure website accessible remotely by physicians. To reach this objective, we hypothesized: that patients must understand the main goals and operating principles of the technology to ensure regular data transmission; and that focusing on patient anxiety and comprehension would improve their training and successful participation in the use of this technology. Therefore, the EDUCAT observational study was designed to examine whether a correlation exists between understanding and clinical acceptance of HM.
Methods
Study objective
The aim of this study was to assess patients’ understanding of an ICD and their acceptance of and anxiety about HM, using two dedicated questionnaires (Q-1 and Q-2). The scores were compared to determine whether a relationship exists between comprehension and overall acceptance of HM.
Patient selection
Patients were included in the EDUCAT registry after they had undergone a first implantation of a LUMAX VR-T ICD, a DR-T ICD or an HF-T ICD (Biotronik), with HM activated. Patients in New York Heart Association functional class IV at the time of ICD implantation were excluded from the registry. All patients gave written informed consent to their participation in the EDUCAT study, which complied with the Declaration of Helsinki.
Monitoring system and training
HM transmits data daily and automatically to the Biotronik Service Centre. The encrypted messages are transmitted by the Biotronik CardioMessenger ® device (CM; Biotronik SE and Co. KG, Berlin, Germany) over a wireless global system for mobile communications network. The data are analysed automatically and posted on a secure website accessible to the caregivers. Notifications are issued by the service centre to the designated recipient in case of clinical or technical issues. Patients signed an informed consent form for the HM system and were trained on its use during the index hospitalization, after the ICD implantation. Depending on the centre’s usual practice, the training was the responsibility of a physician or a nurse, or an ICD manufacturer’s representative. All pertinent information regarding the use of HM and the CM was delivered orally as well as in a printed manual, which included a toll-free telephone number available to the patients 10 hours/day, 5 days/week, should they be in need of more information or technical support.
Study protocol
This observational study, in which 27 public (387 patients) and 19 private (184 patients) French medical centres participated (see Appendix ), was sponsored by Biotronik, which contributed to the study design and data monitoring. The patients were enrolled in the study at the time of their discharge from the hospital, after implantation of the ICD. Patients were registered on a secure website and followed remotely for approximately six months. Follow-ups were left to the physician’s discretion, although they had to comply with the Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (i.e. face-to-face visits within 72 hours and between two and 12 weeks after device implantation, and every 3–6 months thereafter, either face-to-face or remotely) .
Questionnaires
Q-1, handed to the patient at the time of study enrolment, was to be completed anonymously one month after ICD implantation and returned by mail in a prepaid envelope, to evaluate the quality of the training delivered at individual implantation centres. The first section of Q-1 examined the quality of the training from the patient’s perspective, including the training conditions and level of interest in the content ( Table 1 ). In 20 multiple-choice questions, the next section of Q-1 tested the patient’s skills in the use of HM ( Fig. 1 ). The last section of Q-1 evaluated whether the patient found home installation of the CM simple or complicated.
| Analysis | ||||
|---|---|---|---|---|
| Univariate | P | Multivariable | P | |
| Clinical characteristics | ||||
| Age | –0.11 (–0.16; –0.07) | < 0.001 a | –0.08 (–0.14; –0.01) | 0.023 |
| Training conditions | ||||
| Reading of consent form (yes/no) | –1.43 (–2.59; –0.28) | 0.040 a | –2.85 (–4.84; –0.86) | 0.005 |
| CM delivery (within hours of implantation versus during hospitalisation) | –0.12 (–0.82; –0.59) | 0.863 | ||
| Qualification of the trainer (medical staff versus manufacturer’s representative) | 1.27 (0.20; 2.34) | 0.026 a | ||
| Presence of a close relative (yes/no) | –0.24 (–1.46; 0.98) | 0.914 | ||
| Quality of the presentation (brief versus detailed/with versus without device handling) | 0.19 (–0.21; 0.58) | 0.023 a | ||
| > versus < 5-minute training session | –0.04 (–1.13; 1.05) | 0.893 | ||
| All patient’s questions answered by trainer (yes/no) | 1.47 (0.40; 2.53) | 0.012 a | ||
| Clarity of presentation (did/did not understand the value of HM) | –1.41 (–1.96; –0.87) | < 0.001 a | –1.42 (–2.50; –0.33) | 0.011 |
| Familiarity with the user manual (yes/no) | –2.82 (–4.29; –1.36) | < 0.001 a | ||
| Awareness of access to a toll-free telephone number (yes/no) | –4.53 (–6.16; –2.90) | < 0.001 a | –3.90 (–6.14; –1.65) | 0.001 |
| Presentation was interesting (yes/no) | 4.08 (–0.34; 8.49) | 0.089 a | ||
| Home installation of the CM | ||||
| Simple (yes/no) | –3.48 (–6.59; –0.36) | 0.108 a | ||
| Stressful (yes/no) | 2.86 (0.72; 4.99) | 0.009 a | 4.62 (1.73; 7.50) | 0.002 |
Q-2, completed six months after ICD implantation and returned anonymously by mail in a prepaid envelope, measured the anxiety generated by the technology and the patient’s acceptance of HM ( Fig. 2 ).
Score calculations
The second part of Q-1 consisted of 20 true or false technical and medical queries. The score ranged from –40 to +20, with –2 assigned to an incorrect answer, +1 to a correct answer and 0 to an unanswered question ( Fig. 1 ).
The Q-2 acceptance score was based on questions pertaining to system ergonomics, device usefulness, technical support service, medical care delivered and overall system value. For each question, the score was –1 for a non-approval answer, +1 for an approval answer and 0 for an unanswered question. The acceptance score ranged from –5 to +5.
The Q-2 anxiety score was calculated from questions pertaining to: how the CM is perceived (score from –4 for favourable perception to +4 for unfavourable perception); the frequency with which the patient verified the proper functioning of the CM (score from –2 for high frequency to +2 for low frequency); trust in HM (score of –1 for an anxiety answer and +1 for a non-anxiety answer); the level of stress during home installation of the CM (score of –1 for an anxiety answer and +1 for a non-anxiety answer); the level of anxiety triggered by a phone call (score of –1 for an anxiety answer and +1 for a non-anxiety answer); and the eagerness to pursue HM-based follow-ups after the end of the study (score of –1 for an anxiety answer and +1 for a non-anxiety answer). With a score of 0 for an unanswered question, the anxiety score ranged from –10 to +10.
Statistical analyses
Clinical characteristics are expressed as mean ± standard deviations for continuous variables and as counts and percentages for categorical variables. The distributions of categorical variables were examined by the chi-square test or Fisher’s exact test, as appropriate. Continuous variables were compared using Student’s t test or the Mann–Whitney U test, as appropriate. The normal distribution of variables was tested using the Kolmogorov–Smirnov and Shapiro–Wilk tests. The data transmission rate was calculated by dividing the number of transmission days by the number of days between enrolment and the end of the study. The relationships between patient comprehension (dependent variable) and training conditions (independent variable), and between patient satisfaction with HM (dependent variable) and patient comprehension and other potential independent variables were assessed using a multivariable linear regression model. The relationship between patients who received ≥ one shock (dependent variable) and the approval score and other potential independent variables was then examined using a logistic regression model validated by the test of Hosmer and Lemeshow. A stepwise backward elimination was used for the three models. No statistically significant interaction was detected among the variables entered in the models. Variables emerging at a P < 0.2 level of significance by univariate analysis were entered into the multivariable model. A P value < 0.05 was considered statistically significant. A receiver operating characteristic curve was also plotted and the area under the curve was calculated, with its 95% confidence interval.
The questionnaires were validated by Cronbach’s alpha coefficient. The analyses were performed using SPSS software for windows, version 19.0 (IBM Corporation, Armonk, NY, USA) or R software, version 2.14.1.
Results
Sample population
Between February 2009 and February 2011, 571 patients (mean age 63.9 ± 12.8 years; 83% men) were included in the study; their baseline characteristics are shown in Table 2 . The mean duration of follow-up was 6.2 ± 1.2 months. The numbers of completed and returned Q-1s and Q-2s were 430 (75.3%) and 398 (69.7%), respectively. The clinical characteristics of the patients who completed Q-1 and Q-2 were similar. During the study, 33 patients (5.8%) died and 11 (1.9%) exited, including six whose ICDs were explanted, three who were lost to follow-up and two who withdrew their consent.
