The online version of this article (doi:10.1186/1471-2261-14-138) contains supplementary material, which is available to authorized users.
The authors declare that they have no competing interests.
KH coordinated the study, drafted and finalised the manuscript. KC planned and performed the statistical analysis and helped draft and finalise the manuscript. BCM summarised the health economic data and helped draft the manuscript. PE, AM and WC participated in the design of the study, development of the interventions and commented on drafts of the manuscript. AM was Principal Investigator at the study site. WC helped design the data collection tools. GF conceived of the study, designed the study, was Chief Investigator and grant holder, developed the interventions and participated in the design of data collection tools and helped to draft the manuscript. All authors read and approved the final manuscript.
Most people referred to rapid access chest pain clinics have non-cardiac chest pain, and in those diagnosed with stable coronary heart disease, guidance recommends that first-line treatment is usually medication rather than revascularisation. Consequently, many patients are not reassured they have the correct diagnosis or treatment. A previous trial reported that, in people with non-cardiac chest pain, a brief discussion with a health psychologist before the tests about the meaning of potential results led to people being significantly more reassured. The aim of this pilot was to test study procedures and inform sample size for a future multi-centre trial and to gain initial estimates of effectiveness of the discussion intervention.
This was a two-arm pilot randomised controlled trial in outpatient rapid access chest pain clinic in 120 people undergoing investigation for new onset, non-urgent chest pain. Eligible participants were randomised to receive either: a discussion about the meaning and implication of test results, delivered by a nurse before tests in clinic, plus a pre-test pamphlet covering the same information (Discussion arm) or the pre-test pamphlet alone (Pamphlet arm). Main outcome measures were recruitment rate and feasibility for a future multi-centre trial, with an estimate of reassurance in the groups at month 1 and 6 using a 5-item patient-reported scale.
Two hundred and seventy people attended rapid access chest pain clinic during recruitment and 120/270 participants (44%) were randomised, 60 to each arm. There was no evidence of a difference between the Discussion and Pamphlet arms in the mean reassurance score at month 1 (34.2 vs 33.7) or at month 6 (35.3 vs 35.9). Patient-reported chest pain and use of heart medications were also similar between the two arms.
A larger trial of the discussion intervention in the UK would not be warranted. Patients reported high levels of reassurance which were similar in patients receiving the discussion with a nurse and in those receiving a pamphlet alone.
Current Controlled Trials ISRCTN60618114 (assigned 27.05.2011).
Additional file 1: Pretest pamphlet. All patients in the study received this pre-test pamphlet (A5, 4 pages) at the start of their RACPC appointment. (PDF 469 KB)
Additional file 2: Responses to 5 reassurance questions.doc. Plots of patients’ responses to the five questions (Questions 1 to 5) in the reassurance questionnaire at baseline (Questions 1 and 2 only), post-clinic, month 1 and month 6. Answers on a 0–10 scale. (DOCX 65 KB)
Additional file 3: Chest pain diary data. Table presenting patient-reported chest pain in a 7-day period at month 1 and month 6, collected from chest pain diaries. (DOCX 15 KB)
Additional file 4: Secondary outcome data_HADS_BIPQ_SAQ-UK_Guys and St Thomas. Three tables: (i) Change from baseline, at month 1 and month 6, for HADS, BIPQ and SAQ-UK; (ii) Individual item scores from the Brief Illness Perception Questionnaire at baseline, month 1 and month 6 and (iii) Guys and St Thomas’ chest pain score at baseline, month 1 and month 6. (DOCX 27 KB)
Additional file 5: Reassurance Question 3. Patients’ response to Question 3 of the Reassurance Questionnaire (How reassured were you by the test?) for those categorised as “reassured” and “not reassured” according to the method of Petrie et al., 2007. (DOCX 15 KB)
Additional file 6: NCCP subgroup results. Proportion of patients reassured and reassurance score at month 1 and month 6 for NCCP patients only. (DOCX 13 KB)
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- An intervention to reassure patients about test results in rapid access chest pain clinic: a pilot randomised controlled trial
Belen Corbacho Martin
- BioMed Central
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