Abstract
Background: A supply–demand mismatch with respect to cardiac catheterization (CATH) often results in patients experiencing waiting times that vary from a few weeks to several months. Long delays can impose both physical and psychological distress for patients. Purpose: The purpose of this study was to examine the effect of a psychoeducational nursing intervention at the beginning of the waiting period on patient anxiety during the waiting time for elective CATH. Methods: This was a 2-group randomized controlled trial. Intervention patients received a nurse-delivered, detailed information/education session within 2 weeks of being placed on the waiting list for elective CATH. Control group patients received usual care. Results: The mean waiting time for CATH was 13.4±7.2 weeks, which did not differ between groups (P=0.509). Anxiety increased in both groups over the waiting time (P=0.028). Health-related quality of life deteriorated over the waiting time in both groups (P<0.05). On a visual analogue scale, there was a significant difference (P=0.002) between the intervention (4.0±2.7) and control (5.2±3.0) groups in self-reported anxiety 2 weeks prior to CATH. Conclusions: The waiting period prior to elective CATH has a negative impact on patients’ perceived anxiety and quality of life and a simple intervention, provided at the beginning of the waiting period, may positively affect the experience of waiting.
Introduction
In recent years, the increasing demand for diagnostic cardiac catheterization (CATH) has exceeded the supply of services throughout most of Ontario (Canada) and it is anticipated that demand will increase further. The result of this supply–demand mismatch is that patients scheduled for elective cardiac catheterization (CATH) are experiencing waiting times that vary from a few weeks to several months. The impact of lengthy waiting periods on patients is not fully understood. Though some evidence exists related to the morbidity and mortality associated with waiting, long delays can also impose physical and psychological distress.
Prior to the present study, a small pilot investigation was conducted to examine patient-related issues with respect to waiting for elective CATH. Seventy-five individuals on the elective CATH list responded to a short, investigator-developed, survey asking them about their perceived anxiety while waiting and their opinions on possible nursing interventions to assist with the wait. Respondents identified generalized feelings of anxiety during the waiting period and 60% stated their anxiety increased over time. Only one person felt his/her anxiety decreased over this period. Moreover, 54% reported that they would find telephone contact with a Registered Nurse to discuss the CATH procedure helpful; 68% preferred to have this contact within the first 2 weeks of learning about their need for a CATH.
Despite recent decisions by the Ontario Ministry of Health and Long-Term Care to increase resources for CATH, there will likely always be some period of waiting for elective cardiac services in a health care system that values equal access and rationalization of health services. Therefore, it behoves us to determine effective, low-cost interventions that will help patients to manage this and other waiting periods.
Literature review
Emotional stress has been identified as a contributor to atherosclerosis, plaque rupture and thrombus formation. Increased circulating catecholamines, resulting from the stress response, may pre-dispose individuals to clinical events by promoting endothelial dysfunction, influencing extrinsic factors that trigger plaque rupture, increasing platelet aggregation, increasing myocardial oxygen demand, decreasing coronary blood supply or triggering lethal arrhythmias [1]. These physiological consequences of psychological stress could be disastrous for patients awaiting CATH.
Evidence clearly shows that patients experience anxiety when scheduled for cardiac catheterization [2–8]. In a qualitative investigation, Beckerman et al. [3] found that fear of the unknown and the desire for information were common to all participants. Bengtson et al. [2] corroborated the work of Beckerman et al. [3] by showing that 56% of 904 patients awaiting CATH, angioplasty or coronary artery bypass surgery reported uncertainty and fear about survival. These concerns, rather than chest pain, were their most distressing symptoms.
A number of approaches have been identified to try and alleviate patient anxiety in the immediate pre-CATH period [9–13]. Typically, these approaches have focused primarily on educational interventions in the 24-h period immediately before the procedure, a waiting period of just hours in duration. No studies have been identified in which an intervention was provided from the beginning of the waiting period and throughout the duration of the wait. In order to provide comprehensive health care for this population, we must investigate and implement strategies that effectively treat and manage the psychological elements of emotional stress and anxiety that affect patients throughout the waiting period.
The goal of this study was to decrease anxiety in patients awaiting elective CATH by provision of a psychoeducational nursing intervention at the beginning of the waiting period. The primary outcome was patient anxiety as measured by (1) The State-Trait Anxiety Inventory (STAI) [14] and (2) patient verbal self-rating (VAR) using a 10-point visual analogue scale, where 0 meant ‘no anxiety’ and 10 meant ‘the feeling of being terrified’. Secondary outcomes were general and disease-specific health-related quality of life (HRQL), assessed, respectively, by the Medical Outcomes Study-Short Form 36 (SF-36) [15,16] and the Seattle Angina Questionnaire (SAQ) [17].
Originally, the study focus was simply on anxiety as the outcome of this nursing intervention. However, early in the investigation it became apparent that there was also an opportunity to assess the impact of waiting on patients’ health related quality of life. Therefore, the latter two measures were added to the instrumentation after the first 80 patients had been enrolled.
Methods
Design
This study employed a randomized controlled trial design. Consenting subjects were randomly allocated, using a concealed randomization process, to either an intervention or control group. The intervention group received a nurse-delivered, detailed information/education session within 2 weeks of being placed on the waiting list for elective CATH. The control group patients received the usual care given to patients waiting for elective CATH. Usual care for patients who are waiting for CATH involves no regular contact from any health professional and patients were directed to contact their family physician or cardiologist about any changes in health status during the waiting time.
Baseline measures included completion of the STAI for the anxiety outcome and the SF-36 and SAQ for the HRQL outcomes. Patients completed baseline measurements at entry to the study (the beginning of the waiting period) and at their outpatient, pre-CATH appointment, which occurred approximately one week before their CATH (the end of the waiting period). The patients’ verbal self-rating of anxiety was obtained approximately 2 weeks prior to their scheduled CATH date in an attempt to capture a more accurate measure of anxiety since it is known that anxiety may rise spuriously just before the procedure. This study conforms to the principles of the Declaration of Helsinki [18] and was reviewed and approved by the Research Ethics Board prior to its implementation.
Instrumentation
The STAI is a widely used instrument for measuring anxiety in adults and has been shown to have good psychometric properties. It has been used world-wide in more than 40 languages. The STAI differentiates between the temporary condition of ‘state’ anxiety and the more general and long-standing quality of ‘trait’ anxiety. It has been shown to discriminate between anxiety and depression. The STAI has a total of 40 items; 20 for each of the ‘state’ and ‘trait’ subscales. There is a range of four possible answers to each question.
The SF-36 consists of 36 items representing eight subscales that cover the domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Individual subscale scores as well as two summary scores, called physical composite score (PCS) and mental composite score (MCS), may be computed. The subscales of the SF-36 have been shown to have good internal consistency reliability with Cronbach alphas ranging from 0.76 to 0.88.
The SAQ is a disease-specific self-administered functional status measure for patients with coronary artery disease (CAD). The scale was developed to quantify the physical and emotional effects of CAD. The instrument consists of a 19-item questionnaire with five subscales that measure clinically relevant domains of CAD including physical limitation, angina stability, angina frequency, treatment satisfaction and disease perception. The physical limitation scale measures how daily activities are limited by symptoms of CAD. The anginal stability scale assesses change over time in the frequency of angina at the patient's most strenuous level of activity, while the anginal frequency scale quantifies the number of anginal episodes. The treatment satisfaction scale quantifies satisfaction with the patient's current treatment of angina. The disease perception scale characterizes the patient's perception of the impact of CAD on their HRQL. A subscale score for each of the dimensions is calculated rather than a global quality-of-life score; higher scores indicate better levels of functioning. Adequate reliability and validity of each of the subscales have been reported [19,20].
The VAR is a verbally administered linear anxiety rating on which patients rate their present level of anxiety from 0 to 10. The use of a VAR such as this was demonstrated to have convergent and discriminant validity as well as sensitivity to change due to changing situations [21].
Sample size and feasibility
Based on both the literature review and our pilot study findings, we estimated that approximately 60% of patients are anxious while waiting for elective CATH. Our pilot study data showed a mean anxiety score of 2.7 on a three-point scale, with a standard deviation of 0.54. Studies of the effect of pre-operative educational interventions on anxiety have reported anxiety reductions in the range of 15% as measured by the STAI [22]. Therefore, in order to detect a 15% reduction in anxiety as a result of our intervention, a sample size of 104 subjects per group was required at alpha 0.05 and 90% power. In order to account for a 10% drop-out/loss rate, we enrolled 114 subjects per group for a total sample size of 228.
Subjects
Participants were male and female patients undergoing elective cardiac CATH at Hamilton Health Sciences-General Campus (HHS). Inclusion criteria were: (1) referred for first-time, elective cardiac CATH; (2) anticipated wait of between 6 weeks and 6 months; (3) able to speak and read English and (4) geographically accessible to the hospital. Exclusion criteria were: (1) inability to provide written informed consent; (2) had seen a surgeon for possible open heart surgery; (3) previous cardiac CATH and (4) currently involved in a cardiac rehabilitation program.
Procedures
On a daily basis, the study nurse collected and screened the names of all potential subjects from a centralized referral registry in the Heart Investigation Unit at the HHS. Following assessment of inclusion/exclusion criteria, the study nurse telephoned potential participants to explain the study, obtain verbal consent and to arrange an appointment time within 2 weeks. At that appointment, written consent was obtained and patients completed baseline measures. After completion of all baseline assessments, patients were randomly assigned to either the intervention or control group.
Randomized to control group
Participants in the control group received the usual care provided to patients. The usual procedure is that patients wait to be informed by their cardiologist's office about their CATH date. Once that is known, they attend a pre-CATH outpatient appointment at the hospital, which takes place 1–10 days before the procedure. This group of participants received one phone call 2 weeks before the CATH date asking them to verbally rate their present level of anxiety on a scale of 1–10.
Randomized to intervention group
Participants who were randomly assigned to the intervention group had an immediate, one-hour appointment with a cardiac nurse clinician who had special expertise related to CATH. This visit included question and answer discussions with the nurse, presentation of written material explaining the procedure and the viewing of a video. The nurse also facilitated a discussion of the atherosclerotic disease process, risk factor modification and the patient's current medications. The nurse obtained the patient's medical history and performed a physical assessment.
Two weeks before the CATH date, patients received a phone call asking them to verbally rate their present level of anxiety on a scale of 1–10.
Prior to their scheduled pre-CATH appointments, patients in both groups were sent, by mail, the STAI, the SF-36 and SAQ. They were asked to complete the questionnaires and return them on the day of their pre-CATH appointment. Any questions arising at the pre-CATH appointment with respect to the CATH procedure were addressed for both groups of patients. The control group patients were provided with the written material that the intervention group had received earlier and had the opportunity, if they desired, to view the video at this time.
Statistical analysis
Demographic, medical history and baseline questionnaire data were analyzed for between group differences using, as appropriate, (a) simple descriptive statistics, (b) Chi square or Fisher's exact tests for categorical variables and Student's t-test for continuous variables. Differences detected at baseline between the two groups were handled as covariates in analysis. Questionnaire and outcome data were analyzed using univariate and multivariate repeated measures analysis of variance (RMANOVA). An alpha level of ≤0.05 was considered significant. All numeric data are represented as means±standard deviations unless otherwise specified.
Results
Patients
Patients were recruited from the waiting list for CATH between January 1999 and April 2000. During this period, 1231 patients were referred for CATH. Of those, 895 were ineligible for reasons such as: previous CATH (331), referral outdated (254), language barrier or unable to provide informed consent (261) and unable to contact (49). One hundred and eight patients declined to participate. A total of 228 patients were randomly assigned to one of the two study groups. Nine patients withdrew following baseline intervention and 11 patients had their waiting status changed from elective to urgent. There was one death. Patient flow through the study is outlined in Fig. 1.
00027-6-fig1.png)
Flow of patients through the study.
The intervention and control groups did not differ at baseline for the vast majority of variables (Table 1). Both groups had similar medical histories and sociodemographic characteristics. Both groups comprised roughly 55% males and 45% females. The typical patient in this study was approximately 64 years old, retired and living with a spouse. Additional characteristics of the typical participant were an education level less than grade 12 and an annual income of less than $50000.
Baseline characteristics
Baseline characteristics
Since measurement of HRQL was added after the first 80 subjects had been enrolled, those data are presented on 148 subjects. Subjects before and after the addition of these questionnaires differed only on having a history of angina (P=0.046).
The mean waiting time for cardiac CATH was 13.4±7.2 weeks and there was no difference in waiting time between the intervention and control groups (P=0.509). There was a significant main effect for time in State Anxiety (P=0.028) where both groups demonstrated higher levels of anxiety at the pre-CATH visit compared to baseline (Fig. 2). There was a significant difference (P=0.002) between the intervention (4.0±2.7) and control (5.2±3.0) groups in self-reported anxiety on the VAR (Fig. 3
00027-6-fig2.png)
Changes in state anxiety over time. ∗Main effect for time (P=0.028).
00027-6-fig3.png)
Effect of early education on self reported anxiety at 2-weeks prior to CATH. ∗Significant difference between groups (P=0.002).
There were no significant differences between the two groups at baseline for any of the eight sub-scales of the SF-36 or the five sub-scales of the SAQ. There was a significant main effect for time in the SF-36 sub-scales of physical functioning (P=0.003), role emotional (P=0.022), bodily pain (P=0.007), general health (P=0.007) and social functioning (P=0.002) as well as a trend towards significance in the physical composite score (PCS) of the SF-36 (P=0.06).
There was an additional, significant main effect for time in four of the five subscales of the SAQ (Table 2) but no significant group×time interaction was detected. At the time of the pre-CATH appointment, patients’ reports of exertional capacity (P<0.0001), anginal stability (P=0.05), treatment satisfaction (P≤0.0001) and disease perception (P=0.008) were all significantly worse, compared to baseline, and this was consistent across both groups.
Health related quality of life
Health related quality of life
(Mean±SD)
main effect for time; P=0.005.
main effect for time; P=0.022.
main effect for time; P=0.002.
main effect for time; P≤0.0001.
main effect for time; P=0.046.
main effect for time; P≤0.0001.
main effect for time; P=0.008.
This study described the impact of a waiting period prior to elective CATH on patients’ anxiety and HRQL. In addition, the findings revealed that early education, provided by a specialist nurse, had a significant effect on patients’ reported anxiety during the wait. Overall, the findings demonstrate that the waiting period prior to elective CATH does appear to have a negative impact on perceived anxiety and HRQL and that a simple intervention, provided at the beginning of the waiting period, can positively affect the experience of waiting.
Patients in this study appeared to be representative of the typical patient waiting for elective CATH in Ontario, Canada. Natarajan et al. [23] studied over 8000 patients who were referred for CATH, of which 4725 were outpatients, as in this study. The mean age of outpatients in the larger study was 63.3 years and 66.2% were males. These characteristics are consistent with those of the patients in this study. Outpatients in the study by Natarajan et al. waited for approximately 8.5 weeks, on average, for CATH. However, their study included urgent and semi-urgent patients within the outpatient category whereas our study only included patients considered to be elective. Elective outpatients wait the longest of all for their tests and procedures.
Perceived anxiety on the waiting list for CATH increased over the average waiting time of 13.4 weeks in both groups of patients. This finding is consistent with those of Bengston et al. [2], who reported that longer delays produced significantly more nervous reactions, including anxiety and sleeplessness. However, they did not differentiate between waiting for CATH and waiting for revascularisation. Though we found no significant difference in anxiety between groups when measured by the STAI immediately prior to the CATH, there was a significant difference between them when using a verbal anxiety rating two weeks before their scheduled test date. Patients who were in the intervention group gave verbal anxiety ratings that were significantly lower than those in the usual care group. Recently, Benotsch et al. [21] examined measures of anxiety assessment in medical patients and provided evidence of validity for verbally administered (0–10) anxiety rating scales. They also showed that a score of 5 on the VAR was roughly equivalent to a score of 49 on the STAI (the mean STAI score of patients diagnosed with anxiety disorders). Therefore, patients in our usual care group, who had a mean VAR of 5.2±3.0, had a very high level of anxiety two weeks before their CATH. Patients who received the early education intervention had a 23% reduction in perceived anxiety. This is consistent with Hathaway's [24] meta-analysis of 68 studies related to the effect of pre-operative teaching on post-operative outcomes. In general, patients who received pre-operative teaching had post-operative outcomes that were 20% more favorable.
Other authors have reported positive effects on anxiety when interventions were provided immediately preceding the CATH [12,24,26]. However, no other authors have investigated the effect of anxiety reduction strategies over the duration of the waiting period with an experimental design. Thus, we have extended the work of others with regard to the effect of educational nursing interventions for patients who are awaiting invasive investigations such as CATH.
It was not surprising to see the disappearance of a between-group difference over the time from verbal assessment of anxiety (2 weeks prior to CATH) to the end of the waiting period (just before CATH). It is well documented that anxiety may take a sudden rise on the day of, or just before, a cardiac CATH [25]. Therefore, had we only measured anxiety immediately prior to the test, we may have missed an important possible effect of the nursing intervention.
When anxiety levels were compared between men and women, no significant sex differences were found. These findings are not consistent with those of Heikkila et al. [27], who found that mean anxiety levels in women were higher than in men and that changes in anxiety level over time were similar between sexes. An important difference is that Heikkila et al. [27] assessed anxiety levels on the day of angiography and excluded elective outpatients.
Overall, HRQL deteriorated over time in this study. According to the SF-36, the generic measure, both groups experienced a decline in HRQL in the following domains: physical functioning, role-emotional, bodily pain, general health and social functioning. With respect to the disease-specific measure, the SAQ, quality of life deteriorated in exertional capacity, angina stability, treatment satisfaction and disease perception. These findings are consistent with those of Dougherty [28] who, using the SAQ, reported deterioration in overall cardiac-HRQL in patients with stable angina pectoris over time. A decrease in exertional capacity, coupled with a decrease in the stability of angina, may have had an impact on satisfaction with treatment. The lack of association between group assignment and HRQL over time suggests that early education was not sufficient to have an effect on patients’ HRQL as the waiting time progressed. Since the focus of the psychoeducational session was on understanding angina, reducing fears about symptoms and what to expect in the CATH procedure, it is possible that this intervention assisted patients in dealing with their anxiety about the test but this did not extend to the concepts that are measured by HRQL instruments. An intervention aimed specifically at assisting patients to deal with functional abilities in everyday tasks and management of angina may have resulted in an effect on HRQL.
Limitations
Baseline data on subjects who were approached and refused to participate (n=108) were not collected in this study. Sufficient data should be collected on the characteristics of those who decline to participate to determine selection differences [29]. Thus, these results may not accurately represent the actual HRQL and psychological risk of waiting for elective CATH, but rather, only for those who agreed to participate.
In this study, a possible selection-maturation bias may have been operational. It is possible that decreased HRQL or increased anxiety over the waiting period may have been attributed to the length/nature of the waiting period when in fact it may be due to biological and/or psychological processes (decreased angina, fatigue, boredom) that occur within participants over time. Selection bias may have affected internal validity in this study since patients’ motivation to participate may have been related to their perception that the research would improve their overall care. Some of the findings may have been confounded by the Hawthorne effect [30]. Finally, it may be a limitation that this study was conducted only with English-speaking participants; this may limit the generalizability of the findings.
It is possible that this study may not have had sufficient statistical power to detect between—group differences in HRQL as a result of the intervention. Though we anticipated having a sufficient sample size to detect such an effect, it is possible that the magnitude of the effect of early education alone was not of the same order as that associated with our earlier findings related to a multidimensional intervention of longer duration [31].
Conclusion
While the morbidity and mortality associated with waiting for elective CATH for approximately 3 months was found to be low, waiting does have an important impact on patients’ HRQL and perceived anxiety. An educational intervention provided at the beginning of the waiting period may have a positive impact on patients’ anxiety, however, interventions to improve HRQL need to be explored further. Emotional support, in the form of verbal contact with patients while they await CATH at home, may be indicated for future investigation.
The findings of this study support a more holistic waiting list management strategy that includes timely identification of individuals at risk, measurement of HRQL to inform patient management, and interventions that provide physical and psychosocial support for patients in the queue for elective CATH. Findings from this research have implications for patients waiting for other cardiac health services such as diagnostic testing, consultation with cardiologists, waiting for coronary artery by-pass graft surgery or percutaneous transluminal coronary angiography/angioplasty. Since waiting lists are common in many countries with socialized health care systems, the potential applicability of these findings is widespread.
Footnotes
Acknowledgements
This research was performed at the Hamilton Health Sciences in consultation with Dr Arthur in the School of Nursing at McMaster University.
