Condition category
Signs and Symptoms
Date applied
20/10/2005
Date assigned
28/11/2005
Last edited
03/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 patient’s 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

Sponsor information

Organisation

The University of Sheffield (UK)

Sponsor details

New Spring House
231 Glossop Road
Sheffield
S10 2GW
United Kingdom

Sponsor type

University/education

Website

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

  1. Results

    Arnold J, Goodacre S, Bath P, Price J, Information sheets for patients with acute chest pain: randomised controlled trial., BMJ, 2009, 338, b541.

Additional files

Editorial Notes