A randomised controlled trial of an intervention to improve communication with patients suffering acute chest pain
| ISRCTN | ISRCTN85248020 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85248020 |
| Secondary identifying numbers | 109232 |
- Submission date
- 20/10/2005
- Registration date
- 28/11/2005
- Last edited
- 03/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Jane Arnold
Scientific
Scientific
MCRU
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 2220882 |
|---|---|
| j.a.arnold@sheffield.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Added 03/03/2009: Approved by North Sheffield Local Research Ethics Committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/11/2005 |
| Completion date | 14/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Phase 1: 15 - 20; Phase 2: 350 intervention, 350 control |
| Key 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. |
| Key exclusion criteria | Patients who are unable to read or understand the trial will be excluded. |
| Date of first enrolment | 15/11/2005 |
| Date of final enrolment | 14/11/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MCRU
Sheffield
S1 4DA
United Kingdom
S1 4DA
United Kingdom
Sponsor information
The University of Sheffield (UK)
University/education
University/education
New Spring House
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom
"ROR" |
https://ror.org/05krs5044 |
|---|
Funders
Funder type
Charity
The Health Foundation (UK) - Leading practice through research award scheme (ref: 577/3869)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/02/2009 | Yes | No |
