ReadmissionNCT05116644
Prevalence of Factors Contributing to Unplanned Hospital Readmission of Older Medical Patients
An observational study of Readmission, run by University of Aarhus at 1 site in Denmark.
Trial summary
We need to identify the essential factors that are linked to readmission among older medical patients as approximately 20% of all medical patients above the age of 65 are readmitted within 30 days after discharge. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Readmission
- What is being tested?
- NONE - this is a cross-sectional survey design
- How many people
- 165 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Sep 2020to 25 Jun 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Readmitted patients who are eligable for inclusion will be prospectively recruited whilst admitted on a medical ward. There has been no selectioin in the process meaning all eligable patients will be asked to participate except those patients who are discharged soon after the readmission e.g. in the evening or in the weekend.
Who may be able to join
- Aged 65 or above
- Danish citizens
- Discharged from a general medical ward at Horsens Regional Hospital (HRH) AND readmitted to a general medical ward at HRH within 30 days after discharge
- Living in the municipality of Horsens, Hedensted, Odder or Skanderborg
Who cannot join
- Not able to speak and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Factors Contributing to Unplanned Hospital Readmission of Older Medical Patients When Assessed by Patients, Their Significant Others and Healthcare Professionals: a Cross-sectional Survey
We need to identify the essential factors that are linked to readmission among older medical patients as approximately 20% of all medical patients above the age of 65 are readmitted within 30 days after discharge.
The objective of this cross-sectional survey study is to to identify factors and aspects that contribute to unplanned hospital readmissions of older medical patients.
This will be done through a survey where readmitted patients and their relatives and healthcare professionals answer questions about the patients readmission. The survey questions cover following themes: 1) disease, 2) diagnostics, treatment and care, 3) social network, 4) organisation, 5) communication, 6) competences and knowledge, 7) resources and 8) practical aspects. The hypothesis is that the more knowledge we gain on factors that contribute to readmission, the more targeted actions and interventions and thus preventing readmissions.
Read the detailed description
The objective of this cross-sectional survey study to identify unique factors and aspects involved in the process of unplanned hospital readmissions of medical patients aged 65 or above within 30 days of discharge.
To identify these factors following research questions will be examined:
- what are the most prevalent factors that contribute to 30-days readmissions among medical patients above 65 years?
- to what degree do patients, relative and health care professionals agree upon the contributing factors?
- where on the patient pathway between sectors are the contributing factors most prevalent?
Unplanned Readmission is defined as follows:
- The admission occurs between four hours and 30 days after the last admission
- The onset of the admission is acute
- The admission cannot be a result of a referral from another hospital or ward
- The patient cannot have a cancer- or accident diagnosis
- Admission not part of existing treatment regimen, such as intravenous antibiotic treatment, or readmission planned at latest discharge.
Respondents are divided in five groups: patients and their relative, community-based nurses, general practitioners (GP) and hospital-based doctors.
DATA COLLECTION Patients will be prospectively recruited September 2020 to June 2021. All eligible patients will be asked to sign an informed consent for use of individual healthcare data. No formal ethical approval is necessary. Data collection will be performed by the PhD student and project staff.
Data will be collected from two sources; 1) from questionnaires and from 2) CROSS-TRACKS.
Data from questionnaires There is no existing questionnaire that examine factors that contribute to readmissions among medical patients aged 65 or above. Therefore, to evaluate unique dimensions on the same readmission, study-specific questionnaires have been developed to examine the perspectives on the readmission from the patient, relative, community-based nurse (if the patient has home health care), GP, and receiving hospital-based doctor. The development process will be described below.
Development of the questionnaires:
In short, the stepwise process of developing the study-specific questionnaires is described below.
Step 1: to prepare and conduct semi-structured interviews to generate knowledge from the target groups. In total, 25 interviews of one hour were conducted with patients, relatives, GPs, community-based nurses and hospital doctors. These interviews were transcribed and the content was condensed and coded using NVIVO.
Step 2: to gain knowledge from peer reviewed evidence on risk factors and predictors of readmission among older medical patients.
Step 3: the 3 questionnaires were developed. Knowledge gathered from the two preliminary steps were used to create the individual items in the questionnaire. A formative questionnaire model was chosen. Likert scales, open-ended questions, multiple choice and yes/no/don't know were chosen as response formats, developed, and subsequently validated by an expert in questionnaires. The questionnaires were pilot tested twice.
Step 4: the 3 questionnaires were finalized, implemented and pilot tested in a study-specific REDCap database.
The questionnaires to GPs, hospital doctors and community-based nurses are identical. The 3 questionnaires cover following factors that can contribute to unplanned hospital readmissions: 1) disease specific factors, 2) diagnostic specific factors, treatment and care specific factors, 3) social network specific factors, 4) organisation specific factors, 5) communication specific factors, 6) competences and knowledge specific factors, 7) resources specific factors and 8) practical specific factors. The questionnaire to the patients is a short version modified to frail and vulnerable older people. The questionnaire to the relatives is an intermediate version between the questionnaire to the health care professionals and patients. All responders receive a personal link which ensures that the survey only can be answered by this specific person.
Unplanned readmitted patients will be approached and enrolled in the study within 72 hours after readmission.
Patients who accept to participate in the study, accept data collection through registers, questionnaire and accept data collection from their relatives, GP, community-based nurse and hospital-based doctor.
Data from CORSS-TRACKS Data will be retrieved from CORSS-TRACKS. CORSS-TRACKS data are gathered from different Danish sources and cover; 1) Primary care; Municipality-based electronic care provision record, Danish National Health Service Register, Danish National Database of Reimbursed Prescriptions, Prehospital electronic record, 2) Secondary care; Danish National Patient Registry, Electronic health record, Clinical laboratory information system, 3) Danish Civil Registration System and 4) Danish Register for Evaluation of Marginalization.
CORSS-TRACKS data is merged with data collected from questionnaires to conduct sub-analysis.
ANALYSIS Quantitative analysis
- Descriptive analysis including prevalence
- Cohen's kappa or similar analysis for the level of agreement between responses
Qualitative analysis
- Quantitative content analysis will be used as method to analyze open-ended questions. NVivo will be used when coding the content.
- Conditions
- Readmission
- Being tested
- NONE - this is a cross-sectional survey design
- Keywords
- Readmission, causes of readmission, survey, cross-sectional, older medical patients, multiperspective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NONE - this is a cross-sectional survey designOther
NONE - this is a cross-sectional survey design
| Study group | Role | What they receive |
|---|---|---|
| Included patients | Included patients: 165 Receives: Other: NONE - this is a cross-sectional survey design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of factors contributing to 30-day readmission
Through questionnaire responses, it will be possible to identify factors that contribute to readmission among readmitted older medical patients
Measured: Immediately after each patient has been enrolled in the study
The agreement between patients and significant others and between hospital physicians and GPs
Kappa analysis of the agreement on contributing factors on patient level
Measured: Immediately after each patient has been enrolled in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start14 Sep 2020
- Primary completion25 Jun 2021
- Study completion25 Jun 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 ReadmissionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Enversion, Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Merete Gregersen, PhD, Study chair, Aarhus University, Aarhus Uviversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116644
- Sponsor's protocol ID
- Quest2020
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Other researchers can apply for data sharing
Publications
Rasmussen LF, Grode L, Barat I, Gregersen M. Prevalence of factors contributing to unplanned hospital readmission of older medical patients when assessed by patients, their significant others and healthcare professionals: a cross-sectional survey. Eur Geriatr Med. 2023 Aug;14(4):823-835. doi: 10.1007/s41999-023-00799-6. Epub 2023 May 24.
PubMed 37222865
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Factors Contributing to Unplanned Hospital Readmission of Older Medical Patients When Assessed by Patients, Their Significant Others and Healthcare Professionals: a Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT05116644
- Acronym / sponsor ID
- Quest2020
- Conditions
- Readmission
- Keywords
- Readmission, causes of readmission, survey, cross-sectional, older medical patients, multiperspective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Enversion, Central Denmark Region
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 11 Nov 2021 (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.
We need to identify the essential factors that are linked to readmission among older medical patients as approximately 20% of all medical patients above the age of 65 are readmitted within 30 days after discharge.
The objective of this cross-sectional survey study is to to identify factors and aspects that contribute to unplanned hospital readmissions of older medical patients.
This will be done through a survey where readmitted patients and their relatives and healthcare professionals answer questions about the patients readmission. The survey questions cover following themes: 1) disease, 2) diagnostics, treatment and care, 3) social network, 4) organisation, 5) communication, 6) competences and knowledge, 7) resources and 8) practical aspects. The hypothesis is that the more knowledge we gain on factors that contribute to readmission, the more targeted actions and interventions and thus preventing readmissions.
Detailed description
The objective of this cross-sectional survey study to identify unique factors and aspects involved in the process of unplanned hospital readmissions of medical patients aged 65 or above within 30 days of discharge.
To identify these factors following research questions will be examined:
- what are the most prevalent factors that contribute to 30-days readmissions among medical patients above 65 years?
- to what degree do patients, relative and health care professionals agree upon the contributing factors?
- where on the patient pathway between sectors are the contributing factors most prevalent?
Unplanned Readmission is defined as follows:
- The admission occurs between four hours and 30 days after the last admission
- The onset of the admission is acute
- The admission cannot be a result of a referral from another hospital or ward
- The patient cannot have a cancer- or accident diagnosis
- Admission not part of existing treatment regimen, such as intravenous antibiotic treatment, or readmission planned at latest discharge.
Respondents are divided in five groups: patients and their relative, community-based nurses, general practitioners (GP) and hospital-based doctors.
DATA COLLECTION Patients will be prospectively recruited September 2020 to June 2021. All eligible patients will be asked to sign an informed consent for use of individual healthcare data. No formal ethical approval is necessary. Data collection will be performed by the PhD student and project staff.
Data will be collected from two sources; 1) from questionnaires and from 2) CROSS-TRACKS.
Data from questionnaires There is no existing questionnaire that examine factors that contribute to readmissions among medical patients aged 65 or above. Therefore, to evaluate unique dimensions on the same readmission, study-specific questionnaires have been developed to examine the perspectives on the readmission from the patient, relative, community-based nurse (if the patient has home health care), GP, and receiving hospital-based doctor. The development process will be described below.
Development of the questionnaires:
In short, the stepwise process of developing the study-specific questionnaires is described below.
Step 1: to prepare and conduct semi-structured interviews to generate knowledge from the target groups. In total, 25 interviews of one hour were conducted with patients, relatives, GPs, community-based nurses and hospital doctors. These interviews were transcribed and the content was condensed and coded using NVIVO.
Step 2: to gain knowledge from peer reviewed evidence on risk factors and predictors of readmission among older medical patients.
Step 3: the 3 questionnaires were developed. Knowledge gathered from the two preliminary steps were used to create the individual items in the questionnaire. A formative questionnaire model was chosen. Likert scales, open-ended questions, multiple choice and yes/no/don't know were chosen as response formats, developed, and subsequently validated by an expert in questionnaires. The questionnaires were pilot tested twice.
Step 4: the 3 questionnaires were finalized, implemented and pilot tested in a study-specific REDCap database.
The questionnaires to GPs, hospital doctors and community-based nurses are identical. The 3 questionnaires cover following factors that can contribute to unplanned hospital readmissions: 1) disease specific factors, 2) diagnostic specific factors, treatment and care specific factors, 3) social network specific factors, 4) organisation specific factors, 5) communication specific factors, 6) competences and knowledge specific factors, 7) resources specific factors and 8) practical specific factors. The questionnaire to the patients is a short version modified to frail and vulnerable older people. The questionnaire to the relatives is an intermediate version between the questionnaire to the health care professionals and patients. All responders receive a personal link which ensures that the survey only can be answered by this specific person.
Unplanned readmitted patients will be approached and enrolled in the study within 72 hours after readmission.
Patients who accept to participate in the study, accept data collection through registers, questionnaire and accept data collection from their relatives, GP, community-based nurse and hospital-based doctor.
Data from CORSS-TRACKS Data will be retrieved from CORSS-TRACKS. CORSS-TRACKS data are gathered from different Danish sources and cover; 1) Primary care; Municipality-based electronic care provision record, Danish National Health Service Register, Danish National Database of Reimbursed Prescriptions, Prehospital electronic record, 2) Secondary care; Danish National Patient Registry, Electronic health record, Clinical laboratory information system, 3) Danish Civil Registration System and 4) Danish Register for Evaluation of Marginalization.
CORSS-TRACKS data is merged with data collected from questionnaires to conduct sub-analysis.
ANALYSIS Quantitative analysis
- Descriptive analysis including prevalence
- Cohen's kappa or similar analysis for the level of agreement between responses
Qualitative analysis
- Quantitative content analysis will be used as method to analyze open-ended questions. NVivo will be used when coding the content.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | Other: NONE - this is a cross-sectional survey designIncluded patients: 165 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Readmitted patients who are eligable for inclusion will be prospectively recruited whilst admitted on a medical ward. There has been no selectioin in the process meaning all eligable patients will be asked to participate except those patients who are discharged soon after the readmission e.g. in the evening or in the weekend.
Key inclusion criteria (4 listed)
- Aged 65 or above
- Danish citizens
- Discharged from a general medical ward at Horsens Regional Hospital (HRH) AND readmitted to a general medical ward at HRH within 30 days after discharge
- Living in the municipality of Horsens, Hedensted, Odder or Skanderborg
Key exclusion criteria (1 listed)
- Not able to speak and understand Danish
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 |
|---|---|---|
| NONE - this is a cross-sectional survey designNONE - this is a cross-sectional survey design | Other | Included patients |
Primary outcome
Prevalence of factors contributing to 30-day readmission
Time frame: Immediately after each patient has been enrolled in the study
Through questionnaire responses, it will be possible to identify factors that contribute to readmission among readmitted older medical patients
The agreement between patients and significant others and between hospital physicians and GPs
Time frame: Immediately after each patient has been enrolled in the study
Kappa analysis of the agreement on contributing factors on patient level
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 25 Sep 2023.
- Derived from this study: PubMed 37222865Rasmussen LF, Grode L, Barat I, Gregersen M. Prevalence of factors contributing to unplanned hospital readmission of older medical patients when assessed by patients, their significant others and healthcare professionals: a cross-sectional survey. Eur Geriatr Med. 2023 Aug;14(4):823-835. doi: 10.1007/s41999-023-00799-6. Epub 2023 May 24.
- Individual participant dataSharing planned: Undecided. Other researchers can apply for data sharing
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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.
Merete Gregersen, PhD study chair
Aarhus University, Aarhus Uviversity Hospital
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 Readmission, run by University of Aarhus at 1 site in Denmark.
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 1 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 25 Sep 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 Denmark. 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?
Prevalence of factors contributing to 30-day readmission (time frame: Immediately after each patient has been enrolled in the study). The study lists 2 primary outcomes in all. 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 NCT05116644, 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 25 Sep 2023.