Communication management: a trial comparing two strategies for information communication to patients

ISRCTN ISRCTN01508870
DOI https://doi.org/10.1186/ISRCTN01508870
Secondary identifying numbers 05/2013
Submission date
13/11/2013
Registration date
29/11/2013
Last edited
29/11/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Jose Ignacio Emparanza
Scientific

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

Study information

Study designRandomized controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleA prospective randomized controlled clinical trial comparing two strategies for information communication to patients
Study objectivesThe 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(s)Clinical Research Ethics Committee of Guipuzcoa Health Area, 22/05/2013
Health condition(s) or problem(s) studiedEmotional distress
InterventionControl 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 typeOther
Primary outcome measure1. 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 measuresPerceived communication quality measured by a questionnaire, communication assessment tool. Quantitative variable will be measured at the end of the study.
Overall study start date29/11/2013
Completion date29/11/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsGiven the absence of similar studies we will estimate the sample size after we have collected 30 patients (15 per group).
Key inclusion criteriaPatients, male and female aged over 18 years admitted to Donostia University Hospital chronic patient service.
Key exclusion criteria1. Already included in another trial
2. Patients with moderate or severe dementia
Date of first enrolment29/11/2013
Date of final enrolment29/11/2014

Locations

Countries of recruitment

  • Spain

Study participating centre

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

Sponsor information

Donostia University Hospital (Hospital Universitario Donostia) (Spain)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/04fkwzm96

Funders

Funder type

Hospital/treatment centre

Donostia University Hospital (Hospital Universitario Donostia) (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan