Discharge PlanningNCT02318680
Follow Home Visits After Discharge
A study testing Review of follow home visits after discharge from Nykøbing Falster Hospital in people with Discharge Planning and Readmission, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The study aims to assess whether a follow home visit after discharge of frail elderly patients from Nykøbing Falster Hospital reduces the risk of readmission within 180 days. Staff from the hospital ward identifies patients fulfilling the inclusion criteria and refers the patients to two project nurses at the hospital… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Discharge Planning, Readmission, Hospital
- What is being tested?
- Review of follow home visits after discharge from Nykøbing Falster Hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 545 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jan 2015
- Phase
- Interventional
- 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
Who may be able to join
- Discharge from the Medical Department, Geriatric Department B, Emergency Department, Surgical Department or Department of Orthopedic Surgery at Nykøbing Falster Hospital.
- Address in Guldborgsund, Lolland or Vordingborg municipalities.
- Minimum 3 out of the following 9 criteria must be met:
- The patient's behavior raises suspicion of cognitive disorders, including dementia, which affects how the patient masters his daily life.
- The patient has an abuse of medication, drugs and / or alcohol, which affects how the patient masters his daily life.
- The patient has a psychiatric disorder that affects how the patient masters his daily life.
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- The patient has a strained - or no - social network.
- The patient has a significantly lower level of functioning compared to prior to admission.
- The patient uses 6 or more different types of drugs at the time of discharge.
- The patient has, within the preceding 6 months, had at least one acute hospital contact beyond the current.
- The patient has a fall-history where the cause is not yet determined.
- There are suspicion of housing conditions that hamper the patient in his daily activities.
Who cannot join
- Patients who do not want to participate or cannot give informed consent. Discharge between 4 pm and 8 am Monday-Friday and discharge on weekends. Patients with planned readmission. Former participant in the study. Patients who needs terminal care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow Home Visits by Hospital and Municipality After Discharge of Frail Elderly Patients From Nykøbing Falster Hospital - a Randomized Controlled Trial
The study aims to assess whether a follow home visit after discharge of frail elderly patients from Nykøbing Falster Hospital reduces the risk of readmission within 180 days.
Staff from the hospital ward identifies patients fulfilling the inclusion criteria and refers the patients to two project nurses at the hospital (follow home team). One of the project nurses gets the informed consent from the patient, or in case of a patient who is not able to give informed consent, from the family and general practitioner. The patient is then randomized to intervention (follow home visit after discharge) or control.
In the intervention group, the hospital project nurse and the patient meets with the municipal nurse in the patient's home on the same day the patient is being discharged from the hospital. During this visit the discharge from the hospital and the actual functioning of the patient in his own surroundings is reviewed, using a structured assessment.
Read the detailed description
The study consists of two parts: First, the project nurse reviews the patients hospitalization and discharge together with the nurse from the ward. Next, the patient is discharged from the hospital and is driven by the project nurse from the hospital to the patient's home where they meet the nurse from the municipality. Together with the patient the two nurses review:
- Cognitive skills
- Medicine
- Nutrition
- Mobility
- Level of functioning
- Future appointments in the health care sector
All patients in the project - both patients in the intervention group and patients in the control group - will receive treatment and care equivalent to normal applicable quality standards with discharge from the hospital.
It is expected that the study will demonstrate a reduction of hospital readmissions within 180 days in the intervention group with 14 % (with a power of 90% and a significance level of 5%). There will be a need for 200 patients in both the control and intervention group, ie 400 patients in total.
- Conditions
- Discharge Planning, Readmission, Hospital, Frail Elderly Patients
- Being tested
- Review of follow home visits after discharge from Nykøbing Falster Hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Review of follow home visits after discharge from Nykøbing Falster HospitalOther
The intervention is follow home visits which is randomized and is an intervention that is assigned by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Review of follow home visits after discharge from Nykøbing Falster Hospital Receives: Other: Review of follow home visits after discharge from Nykøbing Falster Hospital |
| Control | No intervention | Standard health care and discharge services |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who are readmitted
Measured: 180 days
Secondary outcomes (6)
Total use of municipal services (nursing, practical help, personal care)
Measured: 180 days
The number of contacts with general practitioner
Measured: 180 days
Time to readmission
Measured: 180 days
Total number of readmissions
Measured: 180 days
Total number of days of readmission
Measured: 180 days
Death
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionJan 2015
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 Discharge PlanningStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Zealand, Nykøbing Falster County Hospital, Guldborgsund Municipality, Lolland Municipality, Vordingborg Municipality
- Responsible party
- Sponsor
- Investigators
- Maurice Antoine Lembeck, MD, Study director, Region Zealand, Nykøbing Falster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318680
- Sponsor's protocol ID
- SJ-329
- Status last verified
- Jan 2015
- First submitted
- 11 Dec 2014
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lembeck MA, Thygesen LC, Sorensen BD, Rasmussen LL, Holm EA. Effect of single follow-up home visit on readmission in a group of frail elderly patients - a Danish randomized clinical trial. BMC Health Serv Res. 2019 Oct 25;19(1):751. doi: 10.1186/s12913-019-4528-9.
PubMed 31653219
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow Home Visits by Hospital and Municipality After Discharge of Frail Elderly Patients From Nykøbing Falster Hospital - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02318680
- Acronym / sponsor ID
- SJ-329
- Conditions
- Discharge Planning, Readmission, Hospital, Frail Elderly Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Region Zealand, Nykøbing Falster County Hospital, Guldborgsund Municipality, Lolland Municipality, Vordingborg Municipality
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 17 Dec 2014 (estimated)
- 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.
The study aims to assess whether a follow home visit after discharge of frail elderly patients from Nykøbing Falster Hospital reduces the risk of readmission within 180 days.
Staff from the hospital ward identifies patients fulfilling the inclusion criteria and refers the patients to two project nurses at the hospital (follow home team). One of the project nurses gets the informed consent from the patient, or in case of a patient who is not able to give informed consent, from the family and general practitioner. The patient is then randomized to intervention (follow home visit after discharge) or control.
In the intervention group, the hospital project nurse and the patient meets with the municipal nurse in the patient's home on the same day the patient is being discharged from the hospital. During this visit the discharge from the hospital and the actual functioning of the patient in his own surroundings is reviewed, using a structured assessment.
Detailed description
The study consists of two parts: First, the project nurse reviews the patients hospitalization and discharge together with the nurse from the ward. Next, the patient is discharged from the hospital and is driven by the project nurse from the hospital to the patient's home where they meet the nurse from the municipality. Together with the patient the two nurses review:
- Cognitive skills
- Medicine
- Nutrition
- Mobility
- Level of functioning
- Future appointments in the health care sector
All patients in the project - both patients in the intervention group and patients in the control group - will receive treatment and care equivalent to normal applicable quality standards with discharge from the hospital.
It is expected that the study will demonstrate a reduction of hospital readmissions within 180 days in the intervention group with 14 % (with a power of 90% and a significance level of 5%). There will be a need for 200 patients in both the control and intervention group, ie 400 patients in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Review of follow home visits after discharge from Nykøbing Falster HospitalReview of follow home visits after discharge from Nykøbing Falster Hospital |
| Control | No intervention | –Standard health care and discharge services |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Discharge from the Medical Department, Geriatric Department B, Emergency Department, Surgical Department or Department of Orthopedic Surgery at Nykøbing Falster Hospital.
- Address in Guldborgsund, Lolland or Vordingborg municipalities.
- The patient's behavior raises suspicion of cognitive disorders, including dementia, which affects how the patient masters his daily life.
- The patient has an abuse of medication, drugs and / or alcohol, which affects how the patient masters his daily life.
- The patient has a psychiatric disorder that affects how the patient masters his daily life.
Key exclusion criteria (1 listed)
- Patients who do not want to participate or cannot give informed consent. Discharge between 4 pm and 8 am Monday-Friday and discharge on weekends. Patients with planned readmission. Former participant in the study. Patients who needs terminal care.
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 |
|---|---|---|
| Review of follow home visits after discharge from Nykøbing Falster HospitalThe intervention is follow home visits which is randomized and is an intervention that is assigned by the investigator. | Other | Intervention |
Primary outcome
The proportion of patients who are readmitted
Time frame: 180 days
6 secondary outcomes
Total use of municipal services (nursing, practical help, personal care)
Time frame: 180 days
The number of contacts with general practitioner
Time frame: 180 days
Time to readmission
Time frame: 180 days
Total number of readmissions
Time frame: 180 days
Total number of days of readmission
Time frame: 180 days
Death
Time frame: 180 days
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 12 Jan 2015.
- Derived from this study: PubMed 31653219Lembeck MA, Thygesen LC, Sorensen BD, Rasmussen LL, Holm EA. Effect of single follow-up home visit on readmission in a group of frail elderly patients - a Danish randomized clinical trial. BMC Health Serv Res. 2019 Oct 25;19(1):751. doi: 10.1186/s12913-019-4528-9.
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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.
Maurice Antoine Lembeck, MD study director
Region Zealand, Nykøbing Falster Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Review of follow home visits after discharge from Nykøbing Falster Hospital in people with Discharge Planning and Readmission, run by Zealand University Hospital 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 12 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 12 Jan 2015. 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?
The proportion of patients who are readmitted (time frame: 180 days). 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 NCT02318680, 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 12 Jan 2015.