Plain English Summary
Background and study aims
In health care, no less than in other aspects of life, we live in an age in which technology can give us almost immediate access to an overwhelming amount of information. But communication involves more than access to information. It comprises the transmission of information, thoughts and feelings, so that it is perceived and understood satisfactorily.
The aim of this study is to compare two strategies for information communication to patients.
Who can participate?
Men and women admitted to Donostia University Hospital chronic patient service.
What does the study involve?
Over the period of one year participants will be invited to participate in this study and they will be randomly allocated to one of the two strategies.
The first strategy is the current communication in Donostia University Hospital
The second strategy is based on the existence of a nurse communication manager. This nurse manager is responsible for reconciling the transmission of information between doctors and patients on admission and discharge. The schedule of the nurse manager will be from 8:00 to 15:00.
At the end of the study we will compare the emotional distress, the number of contradictory messages detected and the perceived communication quality measured by a questionnaire between the two strategies.
What are the possible benefits and risk of participating?
Participants will benefit from better disease information and possibly a reduction in emotional distress.
Participation in this study does not involve any additional risk.
Where is the study run from?
The study will run from Donostia University Hospital (Spain).
When is study starting and how long is expected to run for?
The study is expected to start at the end of November 2013. Participants will be enrolled for a period of one year.
Who is funding the study?
Donostia University Hospital (Spain)
Who is the main contact?
Dr Jose Ignacio Emparanza
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05/2013
Study information
Scientific title
A prospective randomized controlled clinical trial comparing two strategies for information communication to patients
Acronym
Study hypothesis
The existence of an information manger that standardizes the information transmission (change of service, discharged home) will decrease emotional distress or discomfort and improve communication quality perceived by the patient.
Ethics approval
Clinical Research Ethics Committee of Guipuzcoa Health Area, 22/05/2013
Study design
Randomized controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Emotional distress
Intervention
Control group: this group will be subject to the current communication strategy in Donostia University Hospital.
Experimental group: this strategy is based on the existence of a nurse communication manager. This nurse manager is responsible for reconciling the transmission of information between doctors and patients on admission and discharge. The schedule of the nurse manager will be from 8:00 to 15:00. For reconciliation to be as homogeneous as possible between the various nurse managers there will be a written document to follow.
Intervention lasted till discharge.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Emotional distress measured by the distress thermometer. Quantitative variable is measured at entry and exit from the study.
2. Number of contradictory messages detected. Quantitative variable will be collected daily by the communication manager. They will be identified by comparing the clinical record information with the information the patient has.
Secondary outcome measures
Perceived communication quality measured by a questionnaire, communication assessment tool. Quantitative variable will be measured at the end of the study.
Overall trial start date
29/11/2013
Overall trial end date
29/11/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients, male and female aged over 18 years admitted to Donostia University Hospital chronic patient service.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Given the absence of similar studies we will estimate the sample size after we have collected 30 patients (15 per group).
Participant exclusion criteria
1. Already included in another trial
2. Patients with moderate or severe dementia
Recruitment start date
29/11/2013
Recruitment end date
29/11/2014
Locations
Countries of recruitment
Spain
Trial participating centre
Pº Doctor Beguiristain 107-115
San Sebastian-Donostia
20014
Spain
Funders
Funder type
Hospital/treatment centre
Funder name
Donostia University Hospital (Hospital Universitario Donostia) (Spain)
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
Basic results (scientific)
Publication list