Condition category
Mental and Behavioural Disorders
Date applied
13/11/2013
Date assigned
29/11/2013
Last edited
29/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Jose Ignacio Emparanza

ORCID ID

Contact details

Pº Doctor Beguiristain 107-115
San Sebastian-Donostia
20014
Spain

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 measures

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

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

Sponsor information

Organisation

Donostia University Hospital (Hospital Universitario Donostia) (Spain)

Sponsor details

Pº Doctor Beguiristain 107-115
San Sebastian-Donostia
20014
Spain

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes