NCT04628728

Brief Summary

Health literacy describes one's capability to understand and implement health information in daily practice. Hospital referral letters remain a main information tool for patients as well as physicians with information about therapeutic measures done during hospital stay as well as recommendations on drug intake, further therapies or diagnostics to be done after hospital discharge. With increasing medical knowledge, hospital referral letters have become more difficult to understand for patients and stakeholders alike. The aim of this study is to develop a patient-friendly referral letter that is easier to understand while transporting the same amount of information for patients as well as stakeholders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
982

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

November 4, 2020

Last Update Submit

March 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of the study is the comprehension of medical content.

    The comprehension of medical content is assessed with a questionnaire-based survey encompassing specific questions inquiring the understanding of medical information delivered in the referral letters. All questions are answered based on a Likert-scale. Improvement of comprehension will be measured via comparison of the results between the two groups.

    1 day (single measurement by means of questionnaire)

Secondary Outcomes (2)

  • Subjective satisfaction with the referral letter

    1 day (single measurement by means of questionnaire)

  • Influence of demographic parameters on the understanding of medical content

    1 day (single measurement by means of questionnaire)

Study Arms (2)

Current referral letters

One letter will be chosen from the selection of current referral letters (of average quality according to the results of the study mentioned above). Any data that would allow identification of the respective patient (i.e. name, date of birth, social insurance number, address) will be anonymised (not blackened in order not to disturb fluent reading).

Other: Survey based on questionnaire (self-designed)

New referral letters

The other one will be a corrected version of the first letter according to the ELGA (Elektronische Gesundheitsakte) requirements and the identified needs of patients and stakeholders (see Previous Work 1).

Other: Survey based on questionnaire (self-designed)

Interventions

Participants are handed a questionnaire to asses comprehension of medical content provided in the referral letters.

Current referral lettersNew referral letters

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1000

You may qualify if:

  • Patients of any department of the University Hospital Graz at the time of hospital discharge, or during waiting hours at the outpatient department (since those patients can be regarded as not critically ill and in a mental and physical state that will allow them to fill out a questionnaire).
  • Physicians of any department of the University Hospital Graz and outside of the hospital, irrespective of their specialisation
  • Nursing staff of any department of the University Hospital Graz and outside of the hospital, irrespective of the additional training
  • Students of the Medical University of Graz, irrespective of the field of study

You may not qualify if:

  • Patients who are critically ill and/or mentally or physically obviously not capable to partake in the survey
  • Participants who are unwilling to partake, i.e. did not fill out the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Graz

Graz, Styria, 8036, Austria

Location

Related Publications (1)

  • Schwarz CM, Hoffmann M, Smolle C, Borenich A, Furst S, Tuca AC, Holl AK, Gugatschka M, Grogger V, Kamolz LP, Sendlhofer G. Patient-centered discharge summaries to support safety and individual health literacy: a double-blind randomized controlled trial in Austria. BMC Health Serv Res. 2024 Jul 9;24(1):789. doi: 10.1186/s12913-024-11183-w.

MeSH Terms

Conditions

Patient Acceptance of Health CareMedication AdherenceInformation Seeking Behavior

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorPatient ComplianceCommunication

Study Officials

  • Christian Smolle, Dr.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 13, 2020

Study Start

July 15, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations