Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05116644 |
| Other study ID # |
Quest2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 14, 2020 |
| Est. completion date |
June 25, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
University of Aarhus |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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:
1. what are the most prevalent factors that contribute to 30-days readmissions among
medical patients above 65 years?
2. to what degree do patients, relative and health care professionals agree upon the
contributing factors?
3. 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.
