Tele-assistance Respiratory Card: Feasibility of Self-Reporting in Patients with Severe COPD

Abstract

Objective: Respicard is a clinical scoring system used during tele-assistance of patients with chronic obstructive pulmonary disease (COPD) in order to assess variations during nurse phone contacts. Strategies to prevent occurrence of unreported COPD exacerbations are needed. We evaluated (1) comparison between administration of Respicard by the nurse during phone calls with self-administration by the patient and (2) patient compliance with Respicard use. Subjects and Methods: From January to June 2011, every week for 6 months, patients with COPD enrolled in a tele-assistance program in Italy were invited to fill in Respicard at home according to their symptoms. Concurrently, on a weekly basis, a nurse telephoned the patients and filled in a similar card. The scoring of both Respicards was compared. At the end of the study, the patient's subjective utility and ease in implementing or discomfort in recording Respicard was assessed. Results: In the 39 patients studied, the mean value of recorded nurse cards was 3.7±2.9, and the mean time spent by nurses to measure the first 52 cards was 7.7±2.7 min. Patient compliance was 78.2±33.4%. There was a significant positive correlation between nurse and patient card scores (R=0.98; p<0.0001). A similar correlation was observed when data from patients with or without exacerbations and with high or poor adherence to the program were considered (p<0.0001). Patients' acceptance of the self-recording was good. Conclusions: In patients with COPD with sufficient self-autonomy and followed up with tele-assistance, Respicard is a reliable system for recording symptoms of COPD and could be a good cost-cutting modality for continuing management of patients.

Introduction

Chronic obstructive pulmonary disease (COPD) has a high burden, and its management has important implications for health and social issues.¹ An important strategy for management of COPD is to encourage self-management of patient through a formalized education system.¹ Introduction of teaching strategies to guide the patient on how to apply specific medical regimens, alert the patients to possible changes in their health status, and provide an adequate action plan during relapses are being currently tested.^2,3 Nevertheless, self-management may not be appropriate for all subsets of patients, failing to yield a structural behavioral change in some COPD patients who were expected to initiate sooner their home action plan during worsening of respiratory symptoms.⁴

A recent Cochrane review has confirmed that self-management education in COPD is associated with improvement either in quality of life or in reduction of hospital admissions with no indications of any side effect in other outcome measures.² However, this review emphasizes that—because of the heterogeneity of studies that include different interventions, populations, follow-up, and outcome measures—the actual data are still insufficient to formulate clear recommendations regarding type and content needed to provide effective self-management education programs.

Exacerbations of COPD are relatively common and lead to significant morbidity and mortality.^5
–7 Unreported exacerbations, although associated with less worsening of symptoms than reported exacerbations, have a non-negligible negative impact on quality of life at 1 year.⁸ Impacts of both unreported and reported exacerbations call for further investigations to find interventional strategies that prevent and manage early COPD exacerbations.⁸ It has been recently demonstrated that patients with COPD have poor knowledge or understanding of their symptoms, especially regarding the warning signs for an impending exacerbation and what actions should be taken at home.⁹

Patients' diaries have been proposed to measure signs or symptoms of exacerbation.¹⁰ Advantages of this approach include standardization of the data and reduction in recall bias, which increase the potential possibility to identify events and to determine resolution based on a predefined scoring algorithm. Up to now, diary cards have varied in content and scoring, and previous articles have demonstrated their ability/validity to quantify the frequency of exacerbations.^11,12 Currently, new technologies and remote monitoring programs for chronic care using tele-assistance (TA) systems are used for management of the disease progression and disease exacerbations remotely, thus streamlining access to healthcare without sacrificing quality of care.^13,14

The role of the nurse as the main figure of case manager during the TA process is widely recognized.^15,16 Recently, a multidimensional Respicard clinical scoring system has been developed and described by our group.¹⁷ It was administered by nurses to respiratory patients during TA phone contacts in order to follow up their clinical conditions (i.e., stability or variations).^14,17 Self-use of this TA diary card by patients at home has not been applied yet.

The aims of the current study were:

1. to compare two different ways of using Respicard: (a) by the nurse through phone calls and (b) by patients themselves at home

2. to evaluate patient compliance and satisfaction with Respicard

Subjects and Methods

Patients

All consecutive patients with severe COPD (III–IV Global Obstructive Lung Disease stage) enrolled in a TA program, between January and June 2011, by two different respiratory rehabilitative units were studied for a period of 6 months. The study ended in December 2011.

Exclusion criteria were (1) participation in other studies, (2) limited life expectancy (<12 months), and (3) unavailability of a telephone.

Patients with a low level of understanding and attention as assessed by the Mini-Mental State Examination (MMSE) test were excluded.¹⁸

The study was approved by the local technical and scientific committee.

Protocol

At the time of hospital discharge, all patients signed an informed consent and were enrolled in home TA. The TA program consisted of a structured assistance by phone through scheduled weekly nurse contacts for collection of clinical data, pulse oximetry recording, drug therapy, and administration of the clinical triage instrument named Respicard. Details on Respicard and the TA program have been described elsewhere.¹⁴ In brief, Respicard is a clinical score used during the follow-up telephone contact to assess any clinical variation from the baseline status. The score includes five worsening possibilities (scored from 0=best to 4=worse condition) according to 12 items (saturation of peripheral oxygen, heart rate, dyspnea, cough, sputum, symptoms, temperature, ventilator interaction, and walking ability).¹⁴ In the case of variation by 3 points of this score from the baseline value, the nurse had to contact the pulmonologist for consultation.¹⁴ Before the enrollment of patients in the TA program and during the in-hospital admission, they were informed about the purpose and rationale of the Respicard. They received a copy of the Respicard (patient self-Respicard [PR]) to be filled in identical to that used by the nurse, except for some wording changes related to medical terminology/language to allow for better comprehension of the parameters to be recoded and reported by the patient.¹⁴ During the last 4 days of hospitalization, the patient was invited to fill in the Respicard every day in order to learn the methodology and gain confidence with the instrument. Once at home and according to their symptoms, the patients were invited to fill in the PR once a week, early in the morning, for 6 consecutive months. Concurrently, the nurse tutor conducted a phone interview and filled in the equivalent nurse card (nurse Respicard [NR]).¹⁴ During each telephone contact, the patient's PR score was communicated, and both scores were recorded in a database.

Measures

At TA admission, the following clinical and demographic data were collected:

•; patients' anthropometric data (sex, age, weight)

•; level of cognitive status by means of MMSE

•; educational level

•; clinical severity (forced expiratory volume in the first second [FEV₁] as a percentage of the predicted value by means of spirometry, use of oxygen therapy and home mechanical ventilation)

•; presence of a caregiver

•; value of NR score

During the study, time (minutes) spent by the nurses during the phone administration of the first 52 cards was also computed.

At the end of the TA program, the following results were recorded:

•; compliance between nurse's card administration and patient's self-use. Compliance was evaluated as the ratio between the number of measured PR cards/number of potential PR cards that could have been measured in the whole project (expected 24 cards/6 months). High adherence was a patient with a PR number higher than the median of the whole group, whereas poor adherence was a patient with a PR number lower than the median value.

•; an interview assessing the patient's subjective utility and ease in implementing or discomfort in filling in the PR (0=minimum to 4=maximum)

•; number of hospitalizations or exacerbations, defining patients as with exacerbations (at least one exacerbation) or without exacerbations (if no exacerbations occurred)

•; number of deaths

Statistical Analysis

The data were expressed as mean±standard deviation values or frequency and percentage. A regression analysis (Prism software version 4; GraphPad, La Jolla, CA) between PR and NR values in the whole population was performed. A regression analysis for subgroups (between patients with high and poor adherence and between patients with exacerbations or without exacerbations) was also conducted.

Results

From January to June 2011, of a total of 45 patients who were enrolled in the TA program, 39 met the inclusion criteria. The other 6 patients (79±3 years old, weighing 71±4 kg, all with an elementary level of education, requiring a caregiver, receiving oxygen therapy, and with an MMSE score of 16.33±1.21 and FEV₁ of 35±7% of predicted) showed poor self-autonomy and adequate cognitive status and thus were excluded from the study.

Table 1 illustrates clinical data of the enrolled patients. Patients were quite old (mean age, 72±8.6 years) and mostly males (77%), with a low educational level and with severe COPD.

Table 1.

Characteristics of the Patient Population

PARAMETER	VALUE
Enrolled patients (n)	39
Mean age (years)	72±8.6
Weight (kg)	70±12
Males [n (%)]	30 (77)
Educational level (n)
Primary school	24
Secondary school	15
Caregiver necessary (n)	12
MMSE (score)	23.7±1.7
FEV₁ (% predicted)	37±15
GOLD IV class [n (%)]	32 (82)
Long-term oxygen therapy [n (%)]	28 (72)
Home mechanical ventilation [n (%)]	9 (23)
Deaths [n (%)]	3 (8)

FEV₁, forced expiratory ventilation in the first second; GOLD, global obstructive lung disease; MMSE, Mini-Mental Score Examination.

At TA admission, the mean value of recorded NRs was 3.7±2.9 (range, 0–13). The mean time spent by the nurses to measure the first 52 NRs was 7.7±2.7 min (range, 4–14 min).

Six hundred eighty-three PR values were filled out during the entire time of study. The compliance to the PR was 78.2±33.4%, with the mean number of measured PRs being 17.5±7.4 (range, 2–24) with a median value of 20. Twenty patients were considered to have high adherence, whereas the remaining 19 had poor adherence.

Fifteen patients (38.4%) showed exacerbations and/or hospitalizations during the follow-up. Three patients (7.6%) died after 15–17 weeks of follow-up.

Figure 1 shows a significant positive correlation found between NR and PR values (R=0.98; p<0.0001) in the whole group. A similar correlation was observed when data from patients with or without exacerbations ( Fig. 2 , top panel) and with high or poor adherence to the program ( Fig. 2, bottom panel) were considered (p<0.0001).

Fig. 1.

Correlation between nurse's and patient's score evaluated in the total population.

Fig. 2.

Correlation between nurse's Respicard administration and patient's self-use score evaluated in two subgroups of patients: (top panel) with high adherence or low adherence and (bottom panel) with exacerbations (at least one exacerbation) or without exacerbations (if no exacerbations occurred).

Patients' acceptance of self-recording of the Respicard showed the following: “quite/very useful” (2.6±0.9), “easy in implementing” (2.5±0.7), and “without discomfort” (0.3±0.5).

Discussion

Telehealth encompasses a wide range of applications, including TA teleconsultations, telediagnosis, telepharmacy, e-health via the Web, telephone triage, telephone advice, tele-emergency support, disease management, and tele-homecare.¹⁹

During TA, the nurse tutor receives and manages a huge amount of data, many in electronic format and highly time consuming.²⁰

Strategies could be useful²¹ to help nurse managers in decision support, planning, or answering questions to support and to manage the growing complexity of the environment. On the other hand, nurses involved in TA may overtriage or undertriage the callers' need because of the increased and expected self-autonomy from medical doctors.²²

Previous studies showed that a patient-reported diary is consistent, reproducible, valid, and sensitive to changes occurring during recovery from a COPD exacerbation. These patients' diaries are focused on reporting of breathlessness, cough, chest symptoms, difficulty bringing up sputum, feeling tired or weak, sleep disturbance, and feeling scared or worried about their general condition.^11,12 Nevertheless, a recent article⁴ has stressed, as an important “caveat,” the fact that self-management may not be appropriate for all subsets of COPD patients being at risk of increased mortality.

The multidimensional NR clinical scoring system has been described and largely used by our group to measure, in patients with COPD, stability or variation of different clinical aspects. Our Respicard is a clinical interview instructing patients to rate the severity of symptoms directly or asking patients if their symptoms are changed. The card reported by nurse is a single and standardized method measuring frequency, severity, and duration of exacerbations. No study has demonstrated application of this TA diary card by patients themselves at home.

Unlike the negative study of Fan et al.,⁴ in which the patient is the main actor of his or her self-management drug action plan, in our protocol patients are invited to perform a strict monitoring of their clinical condition, delegating to nurses and/or doctors prescription of drugs.

The main result, the novel finding of the current study, is the remarkable relation between patient and nurse clinical score measures, irrespective of patients with or without exacerbation and with high or poor adherence to the program. Because Respicard was sensitive in detecting variations during exacerbations (Fig. 2) and because of close agreement between the patient and nurse assessment we might propose the use of this system for different clinical conditions.

It is interesting to note (Fig. 2) that patients showing poor adherence were also patients with worse Respicard values, whereas the opposite condition was found for patients with high adherence. We can speculate that the more severe disease the patients have, the worse is their attitude toward filling in their Respicard. Regarding adherence, we cannot conclude or propose definitive recommendation on the mandatory number of Respicard values necessary during long-term use. This fact is strictly linked to the type of patient, presence of a caregiver, real learning effect, clinical conditions, presence of frequent exacerbations, and, last but not least, the available nurse time in TA service.

It has been also demonstrated that perceived usefulness, ease of use, subjective norm, and healthcare knowledge, together, predict most of the variance in patients' acceptance and self-reported use of the Web-based self-management technology.²³

Our study showed a high compliance/adherence to the program but also very positive perceived usefulness, perceived ease of use, and no discomfort in this self-monitoring scoring. This result may be explained with the strong comprehensive involvement among hospital discharge, continuous educational program, and 24-h second opinion availability.

As far as time consumption is concerned, we have previously demonstrated that the mean time for a clinical interview by phone between the patient and the nurse tutor is 12±8 min (range, 1–40 min).¹⁷ In this study, the mean time spent by our nurse to obtain the Respicard was 7.7±2.7 min.¹⁷ Therefore, we can speculate on a time consumption of about 60%. This finding could increase efficiency of a TA service with an expected higher involvement of proactive patients.

Some limitations in this study have to be considered. Although the number of patients examined in this study is low, we believe the number of filled Respicards is sufficient to stress the strong relation between nurse and patient values according to the main aim of the study. The self-application is strictly conditioned by an adequate cognitive status, and this fact may reduce generalization of the results. We cannot exclude a learning effect during the entire study with the risk of repetition and have not verified data proposed by patients. On the other hand, the strong correlation also in patients with exacerbations reinforces the idea that the score was really measured according to different conditions. A learning effect was exactly what we expected because of the educational and proactive project. Our patients were highly selected, educated, and involved in the project, and this may reduce generalization of the results.

Conclusions

In patients with severe COPD, clinical information derived by self-administration of a dedicated TA respiratory card is not inferior to the same phone nurse interview. This information may be obtained with sufficient adherence irrespective of exacerbations and number of measured cards. A decrease in nurse time consumption during phone calls and reduction of extra phone calls might be also foreseen.

Footnotes

Acknowledgments

The authors thank Dr. Laura Comini for the critical revision of the manuscript, Dr. Alessandro Bettini for the English revision of the manuscript, and Mrs. Marilena Caprani for her professional help.

Disclosure Statement

No competing financial interests exist.

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