A randomised controlled trial to measure the effect of chest pain unit care upon anxiety, depression, and health-related quality of life [ISRCTN85078221]

Acute chest pain is a common reason for emergency hospital attendance and admission. Patients with chest pain that remains undiagnosed after clinical assessment, ECG and chest radiograph pose a particular problem. They carry a low, but important risk of an acute coronary syndrome [1]. The potentially life-threatening nature of this diagnosis means that a cautious approach is often taken, with many patients being admitted to hospital for observation and investigation [2]. Yet most patients with undifferentiated chest pain do not have a coronary syndrome, whereas anxiety and psychological morbidity are common [3–5] and appear to be associated with impaired quality of life [6]. It is possible that anxiety could be influenced by the investigation and management of chest pain. If this is so, then decision analysis modelling suggests that the potential health gains that could be achieved by reducing anxiety and improving quality of life among the majority of patients who do not have an acute coronary syndrome substantially outweigh the potential health gains from detecting and treating acute coronary syndromes [7].

The chest pain unit (CPU) was developed to provide rapid and accurate diagnosis for patients presenting with acute undifferentiated chest pain [8]. Patients receive up to six hours of observation and biochemical testing followed by an exercise treadmill test. If these tests are positive then they are admitted to hospital with a clear diagnosis, if negative they are discharged home. Evaluation of CPU care has focussed upon cardiac events, process measures and economic measures [9]. There is some evidence that CPU care is associated with improved diagnostic certainty [10] and patient satisfaction [11], but no data to compare psychological morbidity and quality of life after CPU and routine care, despite substantial data to suggest that this is an important problem for patients [3–5, 12–14].

The ESCAPE (effectiveness and safety of chest pain evaluation to prevent emergency admission) trial was a randomised controlled trial and economic evaluation of CPU versus routine care that showed that CPU care was associated with reduced hospital admission [15], improved health utility [15] and improved patient satisfaction [16], and was likely to be considered cost-effective [15]. This paper reports quality of life and psychological measures from the ESCAPE trial. We aimed to measure the effect of CPU care upon anxiety, depression, and health related quality of life, and to determine whether CPU care reduced subsequent symptoms of chest pain.

The Northern General Hospital Emergency Department provides adult emergency care to the 530,000 population of Sheffield, United Kingdom. In 1999 a CPU was established in the emergency department, staffed by three specialist chest pain nurses, and able to accommodate up to six patients with acute undifferentiated pain. Patients were selected using validated clinical predictors and received two to six hours of observation and biochemical cardiac testing, followed by, where appropriate, an exercise treadmill test. Full details of the CPU protocol have been published [17]. Routine care, prior to development of the CPU, consisted of assessment by a doctor who had access to biochemical cardiac tests, but not observation facilities or exercise treadmill testing.

From 5^th February 2001 to 5^th May 2002 the CPU was subject to a cluster randomised controlled trial. Days of the week (N = 442) were randomised to CPU or routine care in equal numbers. All patients attending with acute chest pain were screened for eligibility in the trial. Patients were excluded if they had ECG changes diagnostic for an acute coronary syndrome, clinically obvious unstable angina, co-morbidity or alternative pathology requiring hospital admission (e.g. suspected pulmonary embolus), negligible risk of acute coronary syndrome (e.g. age less than 25 years), or if they were unable to consent to participation. Written, informed consent was requested and patients who agreed to participate were followed up in a review clinic at two days, and by postal questionnaire at one month. The study protocol was approved by the North Sheffield Research Ethics Committee. Full details of the ESCAPE trial have been published [15].

Health related quality of life was measured using the SF-36 questionnaire [18]. Anxiety and depression were measured using the Hospital Anxiety Depression Scale (HADS) [19]. Both are widely used, validated, self-completed questionnaires. Both were administered at two days and one month. At two days patients were handed the questionnaires in the review clinic and asked to complete it in their own time and return it to the Medical Care Research Unit. No reminder was sent to non-responders to this questionnaire. Further questionnaires were mailed at one month with one re-mailing for non-responders.

A brief additional questionnaire was sent at one month that was designed specifically for the study. This predominantly asked questions about health service use for the economic evaluation, but also asked participants whether they had suffered any further chest pain. If they responded that they had, they were asked to score the severity of the chest pain on a 100 mm visual analogue scale. A further question asked whether the patient had taken time off work since their hospital attendance.

The sample size estimate of 988 was based upon the primary outcome measure, the proportion of patients admitted to hospital. Assuming a response rate of 65% to the questionnaires, this sample size would provide 80% power to detect an effect size of 0.25 for these outcomes (alpha = 0.05). Using standard deviations derived from a two-week pilot study, this effect size equates to 1.1 points on the HADS anxiety or depression scores, 11.5 points of the SF-36 physical or emotional role dimensions, and 6 points on the other SF-36 dimensions. Data was analysed using Stata statistical software (version 8.0). Multi-level random effects modelling was used with day of week as a random effect to adjust for clustering by day of week. For the principal analysis no adjustment for confounding was made. For secondary analysis age, gender and past history of coronary heart disease were included as covariates (determined a priori to be important potential confounders), along with any variable that showed significant (p < 0.05) baseline imbalance between the study groups.

Table 5 shows the summary HADS data at two days and one month. CPU care was associated with lower depression scores at both two days and one month. An early significant reduction in anxiety associated with CPU care was no longer significant at one month. HADS data is also summarised in the Figure 1, categorised according to severity of anxiety and depression. Scores of zero to seven are normal, eight to ten are mild, eleven to fourteen are moderate, and fifteen to twenty-one are severe. Most participants had normal levels of depression, but only half reported normal levels of anxiety. CPU care was associated with increased prevalence of normal levels of anxiety at two days (53.4% vs 45.1%; p = 0.028) but not at one month (56.7% vs 50.8%; p = 0.129), and increased prevalence of normal levels of depression at two days (81.8% vs 72.9%; p = 0.005) and one month (80.4% vs 73.2%; p = 0.029).

	N (% completed)	CPU care	Routine care	Difference	95% CI	P-value	ρ
				Unadjusted
				Adjusted
Anxiety- two days	702 (97.9%)	7.73	8.62	0.89	0.21 to 1.56	0.01	0
				0.75	0.09 to 1.41	0.027
Depression-two days	701 (97.8%)	4.30	5.23	0.93	0.34 to 1.51	0.002	0
				0.84	0.26 to 1.42	0.005
Anxiety-one month	645 (95.0%)	7.29	7.77	0.48	-0.26 to 1.23	0.203	0
				0.58	-0.15 to 1.31	0.117
Depression-one month	644 (94.8%)	4.42	5.43	1.00	0.36 to 1.66	0.002	0
				1.02	0.37 to 1.66	0.002

Upper row shows unadjusted analysis (primary analysis) Lower row shows adjusted analysis (secondary analysis) ρ = Intraclass correlation coefficient

At one-month follow-up, 143 out of 318 participants (45.0%) receiving CPU care reported having further pain, compared to 168 out of 314 (53.5%) receiving routine care (unadjusted OR for further pain if receiving CPU care = 0.71, 95% CI 0.52 to 0.97, p = 0.032; adjusted OR = 0.65, 95% CI 0.10 to 0.76, p = 0.010). For those reporting further pain, the mean score on a 100 mm visual analogue pain score was 36.5 mm among those receiving CPU care and 43.0 mm among those receiving routine care (unadjusted difference = 6.5 mm, 95% CI 2.2 to 10.8, p = 0.003; adjusted difference= 6.8 mm, 95% CI 2.2 to 11.5, p = 0.004). Thus, at one month, CPU care was associated with a reduction in the incidence and severity of subsequent chest pain.

One month after hospital attendance, 49 out of 315 participants receiving CPU care (15.6%) reported that they had taken time off work, compared to 58 out of 316 receiving routine care (18.4%). The unadjusted odds ratio for taking time off work after receiving CPU care was 0.82 (95% CI 0.54 to 1.24, p = 0.35; adjusted OR 0.79 (95% CI 0.59 to 1.22, p = 0.287).

CPU care for patients attending hospital with acute, undifferentiated chest pain is associated with reduced initial anxiety, reduced depression over the following month, and improvements in most dimensions of quality of life. Further research is required to establish how this effect is achieved.