Contact information
Type
Scientific
Primary contact
Miss Jane Arnold
ORCID ID
Contact details
MCRU
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 2220882
j.a.arnold@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
109232
Study information
Scientific title
Acronym
Study hypothesis
Chest pain from suspected heart disease is a common cause for emergency hospital attendance. The Chest Pain Unit (CPU) has been developed to provide rapid and accurate diagnostic assessment for patients with acute chest pain. A recent randomised controlled trial has shown that, compared to routine care, CPU care leads to improved patient quality of life and satisfaction, and reduced hospital admissions.
Hypothesis:
Does provision of a written factsheet to patients suffering an episode of acute chest pain reduce subsequent symptoms of anxiety?
Ethics approval
Added 03/03/2009: Approved by North Sheffield Local Research Ethics Committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute chest pain
Intervention
Chest pain from suspected heart disease is a common cause for emergency hospital attendance. Despite receiving a thorough investigation, many patients report anxiety, poor health and concerns regarding poor communication after their hospital attendance. Written factsheets have been shown to improve communication in the outpatient setting. This study will adapt these factsheets to the emergency setting and formally test them. We will give factsheets to some patients, but not others, and then compare levels of anxiety, health, chest pain symptoms, satisfaction with care, and attempts at lifestyle change. If the factsheets are beneficial for patients, we will recommend their widespread use.
During the initial four months of the evaluation fifteen to twenty semi-structured face-to-face interviews will be undertaken with patients who have recently undergone diagnostic assessment on the CPU. Patients assessed on the CPU will be given the factsheet relevent to their condition following diagnostic evaluation and verbal communication with medical and nursing staff. Appropriate individuals will be identified and invited to participate in the study.
The interview will focus on identifying misunderstandings, inappropriate advice, and potential areas for improvement. Following analysis of the transcripts the factsheets will be adapted to take into account feedback from the interviews and ensure that they are appropriate for use in the emergency setting.
Phase 2: Evaluation of the factsheets
The specific hypotheses outlined in the aims will be tested in a randomised controlled trial. Consecutive patients with acute chest pain who are managed on the CPU will be invited to participate in the trial. Eligible patients will be asked to provide written, informed consent. After providing consent each patient will be randomly allocated to receive either standard verbal advice or verbal advice augmented with the written factsheet.
Follow-up:
One month after attendance all participants will be sent a postal questionnaire consisting of the Hospital Anxiety and Depression Scale (HADS), the SF-36 health-related quality of life survey, the Group Health Association of America (GHAA) Consumer Satisfaction Survey, and a brief questionnaire asking:
1. Severity and duration of any chest pain related symptoms
2. Any attempts at lifestyle change (smoking cessation, dietary change and exercise)
3. Specific questions testing the patients knowledge of their complaint
4. Whether the patient sought information about their complaint from other sources
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The primary outcome will be score on the anxiety scale of the Hospital Anxiety and Depressions Scale (HADS).
Secondary outcome measures
1. HADS depression score
2. 36-item Short Form health survey (SF-36) scores
3. Patient satisfaction
4. Proportion with persistent chest pain at one month
5. Proportion who have attempted/succeeded in smoking cessation
6. Dietary change or increased exercise
7. A 'knowledge score' regarding their complaint
Planned subgroup analyses will compare outcomes for the following subgroups:
1. Patients with a final diagnosis of angina
2. Patients with an uncertain diagnosis
3. Patients with benign (non-cardiac) chest pain
Overall trial start date
15/11/2005
Overall trial end date
14/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
All patients presenting to the Emergency Department with acute chest pain who are subsequently managed on the Chest Pain Unit (CPU) will be eligible for inclusion in the study: phase 1 and 2.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Phase 1: 15 - 20; Phase 2: 350 intervention, 350 control
Participant exclusion criteria
Patients who are unable to read or understand the trial will be excluded.
Recruitment start date
15/11/2005
Recruitment end date
14/11/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MCRU
Sheffield
S1 4DA
United Kingdom
Funders
Funder type
Charity
Funder name
The Health Foundation (UK) - Leading practice through research award scheme (ref: 577/3869)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19246544
Publication citations
-
Results
Arnold J, Goodacre S, Bath P, Price J, Information sheets for patients with acute chest pain: randomised controlled trial., BMJ, 2009, 338, b541.