Health Care UtilizationNCT04628728
Possibilities and Measures to Improve Health Literacy
An observational study of Health Care Utilization and Medication Compliance, run by Medical University of Graz at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Health Care Utilization, Medication Compliance, Information Seeking Behavior
- What is being tested?
- Survey based on questionnaire (self-designed)
- How many people
- 982 participants
- Where
- 1 siteAustria
- Study dates
- 15 Jul 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1000
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
During the last decades healthcare systems had to face new challenges in patient care: Along with increasing life expectancy and better treatment options for many diseases also the amount of chronically ill elderly patients increased. Much is expected of this particular patient group regarding self-management and comprehension of their medical condition. However, also younger patients or parents can be overstrained with self-care demands. Recent research among the US population showed that poor health literacy is associated with more frequent healthcare utilization and expenditures, showing that poor health literacy also has impact on the healthcare system itself.
In this respect, adequate patient information is crucial. With every hospital visit - after hospitalisation or in the outpatient clinic - patients usually receive a referral letter which ideally describes the present symptoms or illness, the treatment carried out and steps the patient should take by herself/himself in the near or distant future. In reality these notes are often written in medical language that is difficult or impossible to understand for lays and usually contain information that is intended rather for communication between physicians or therapists. However, it is difficult to find a middle course that provides patients with adequate information while at the same time not losing informational content of immediate relevance for all professions involved in patient care.
Despite great efforts of all departments of the University Hospital Graz and all Styrian (KAGES) hospitals, adequate referral letters that also suffice the demands of stakeholders such as general practitioners, remains an issue needing further attention. Up to now, there has been no referral letter that provides both medical information for professionals as well as information that addresses the patient directly and is adapted to the respective medical knowledge.
Aim and Hypothesis The aim of this study is to develop and test an improved referral letter within the KAGES-wide project "Entlassungsdokumentation NEU"
- Being tested
- Survey based on questionnaire (self-designed)
- Medical subject headings
- Patient Acceptance of Health Care, Medication Adherence, Information Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey based on questionnaire (self-designed)Other
Participants are handed a questionnaire to asses comprehension of medical content provided in the referral letters.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Survey based on questionnaire (self-designed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (single measurement by means of questionnaire)
Secondary outcomes (2)
Subjective satisfaction with the referral letter
Subjective satisfaction 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.
Measured: 1 day (single measurement by means of questionnaire)
Influence of demographic parameters on the understanding of medical content
The demographic parameters include age, gender, level of education and profession. The impact of demographic parameters will be measured by setting the survey results of both study groups into relation with age, gender, level of education or profession.
Measured: 1 day (single measurement by means of questionnaire)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start15 Jul 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 982 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Smolle, Dr., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628728
- Sponsor's protocol ID
- EK_NR_31-366 ex 18/19
- Status last verified
- Mar 2023
- First submitted
- 4 Nov 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38982360
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possibilities and Measures to Improve Health Literacy
- ClinicalTrials.gov ID
- NCT04628728
- Acronym / sponsor ID
- EK_NR_31-366 ex 18/19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 982 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the last decades healthcare systems had to face new challenges in patient care: Along with increasing life expectancy and better treatment options for many diseases also the amount of chronically ill elderly patients increased. Much is expected of this particular patient group regarding self-management and comprehension of their medical condition. However, also younger patients or parents can be overstrained with self-care demands. Recent research among the US population showed that poor health literacy is associated with more frequent healthcare utilization and expenditures, showing that poor health literacy also has impact on the healthcare system itself.
In this respect, adequate patient information is crucial. With every hospital visit - after hospitalisation or in the outpatient clinic - patients usually receive a referral letter which ideally describes the present symptoms or illness, the treatment carried out and steps the patient should take by herself/himself in the near or distant future. In reality these notes are often written in medical language that is difficult or impossible to understand for lays and usually contain information that is intended rather for communication between physicians or therapists. However, it is difficult to find a middle course that provides patients with adequate information while at the same time not losing informational content of immediate relevance for all professions involved in patient care.
Despite great efforts of all departments of the University Hospital Graz and all Styrian (KAGES) hospitals, adequate referral letters that also suffice the demands of stakeholders such as general practitioners, remains an issue needing further attention. Up to now, there has been no referral letter that provides both medical information for professionals as well as information that addresses the patient directly and is adapted to the respective medical knowledge.
Aim and Hypothesis The aim of this study is to develop and test an improved referral letter within the KAGES-wide project "Entlassungsdokumentation NEU"
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current referral letters | – | Other: Survey based on questionnaire (self-designed)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). |
| New referral letters | – | Other: Survey based on questionnaire (self-designed)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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1000
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey based on questionnaire (self-designed)Participants are handed a questionnaire to asses comprehension of medical content provided in the referral letters. | Other | Current referral letters, New referral letters |
Primary outcome
The primary endpoint of the study is the comprehension of medical content.
Time frame: 1 day (single measurement by means of questionnaire)
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.
2 secondary outcomes
Subjective satisfaction with the referral letter
Time frame: 1 day (single measurement by means of questionnaire)
Influence of demographic parameters on the understanding of medical content
Time frame: 1 day (single measurement by means of questionnaire)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 38982360Schwarz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Smolle, Dr. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Care Utilization and Medication Compliance, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is the comprehension of medical content. (time frame: 1 day (single measurement by means of questionnaire)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04628728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.