Chronic IllnessNCT01107119
Integrated Care Pathways in a Community Setting
A study testing integrated care pathway in people with Chronic Illness, run by Norwegian University of Science and Technology at 7 sites in Norway.
Trial summary
The ambition of this study is to raise the quality of care for old and chronically ill patients by establishing a sustainable, systematic prevention and integrated care model for users of home care services. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Chronic Illness
- What is being tested?
- integrated care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 7 sitesNorway
- Study dates
- Oct 2009to Oct 2012
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Person 70 years or above being discharged from the general hospital
- Will receive home care services within four weeks after being discharges from the hospital.
Who cannot join
- Do not agree or are not able to agree to participate
- Is already involved in other research studies affecting the home care services.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites
Fræna Municpality
Fræna
Molde hospital
Molde
Orkdal Municipality
Orkdal
Sunndal Municiplaity
Sunndal
Surnadal Municipality
Surnadal
St Olav's University hospital
Trondheim, 7006
Trondheim municiplaity
Trondheim
About this study
Official title: Enabling Elderly Patients to Manage Their Own Lives - A Systematic Management Program for Home Care Services.
The ambition of this study is to raise the quality of care for old and chronically ill patients by establishing a sustainable, systematic prevention and integrated care model for users of home care services.
In this cluster randomized study the intervention will be carried through in five municipalities and three general hospitals. The home care units in every municipality will be randomized to either intervention og control units.
Read the detailed description
The primary objective of this study is to develop a functional and integrated care model between primary and secondary health care that will meet the needs both in the city and in smaller rural areas.
The secondary objective of this study is to reduce the need of care at primary and secondary level through a a systematic and integrated follow-up by home care nurses and general practitioners to:
- Enable these patients to manage their health needs more efficiently and independently
- Achieve better collaboration within primary care
- Achieve better collaboration between primary- and secondary health care professionals
- Achieve increased satisfaction and confidence with the health care services by the users and their relatives both for included patients and other patients receiving home care services.
- Promote health and prevent unnecessary decline in health
- Strengthen the patients' ability to manage their daily activities.
- Conditions
- Chronic Illness
- Being tested
- integrated care pathway, usual care
- Keywords
- Frail elderly, Chronic illness, Integrated care model, Clinical pathways, Home care services
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated care pathwayOther
communication and follow-up program for integrated care
usual careOther
| Study group | Role | What they receive |
|---|---|---|
| Integrated care pathway | Experimental | program for
1. communication and information flow aimed at collaboration between hospitals, general practitioners and home care services
2. systematic patient follow-up in home care services by using checklists Receives: Other: integrated care pathway |
| usual care | Active comparator | usual care Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
activities of daily living (ADL)
Individbasert pleie- og omsorgsstatistikk (IPLOS) scale, and Nottingham Extended ADL Scale
Measured: 6 and 12 months
Institutional health care at primary and secondary level
Readmission (30 days)and inpatient hospital stays, number and length of stay (EPJ hospitals) Number and length of stay in municipal nursing homes (EPJ municipals) Days before permanent stay in municipal nursing homes
Measured: 1 year
Secondary outcomes (1)
Achieve better collaboration within primary care and between primary- and secondary health care providers
Extract information on communication from EPJ municipal care and EPJ General practitioners
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, St. Olavs Hospital, Nordmøre and Romsdal Hospital Trust, City of Trondheim, Local authorities of Orkdal, Local authorities of Surnadal, Local authorities of Sunndal, Local authorities of Fræna
- Responsible party
- Sponsor
- Investigators
- Anders Grimsmo, md phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107119
- Sponsor's protocol ID
- 21528
- Status last verified
- Apr 2017
- First submitted
- 18 Apr 2010
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosstad T, Garasen H, Steinsbekk A, Sletvold O, Grimsmo A. Development of a patient-centred care pathway across healthcare providers: a qualitative study. BMC Health Serv Res. 2013 Apr 1;13:121. doi: 10.1186/1472-6963-13-121.
PubMed 23547654Rosstad T, Garasen H, Steinsbekk A, Haland E, Kristoffersen L, Grimsmo A. Implementing a care pathway for elderly patients, a comparative qualitative process evaluation in primary care. BMC Health Serv Res. 2015 Mar 4;15:86. doi: 10.1186/s12913-015-0751-1.
PubMed 25888898Rosstad T, Salvesen O, Steinsbekk A, Grimsmo A, Sletvold O, Garasen H. Generic care pathway for elderly patients in need of home care services after discharge from hospital: a cluster randomised controlled trial. BMC Health Serv Res. 2017 Apr 17;17(1):275. doi: 10.1186/s12913-017-2206-3.
PubMed 28412943
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Elderly Patients to Manage Their Own Lives - A Systematic Management Program for Home Care Services.
- ClinicalTrials.gov ID
- NCT01107119
- Acronym / sponsor ID
- 21528
- Conditions
- Chronic Illness
- Keywords
- Frail elderly, Chronic illness, Integrated care model, Clinical pathways, Home care services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The Research Council of Norway, St. Olavs Hospital, Nordmøre and Romsdal Hospital Trust, City of Trondheim, Local authorities of Orkdal, Local authorities of Surnadal, Local authorities of Sunndal, Local authorities of Fræna
- Study start
- Oct 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Apr 2010 (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 ambition of this study is to raise the quality of care for old and chronically ill patients by establishing a sustainable, systematic prevention and integrated care model for users of home care services.
In this cluster randomized study the intervention will be carried through in five municipalities and three general hospitals. The home care units in every municipality will be randomized to either intervention og control units.
Detailed description
The primary objective of this study is to develop a functional and integrated care model between primary and secondary health care that will meet the needs both in the city and in smaller rural areas.
The secondary objective of this study is to reduce the need of care at primary and secondary level through a a systematic and integrated follow-up by home care nurses and general practitioners to:
- Enable these patients to manage their health needs more efficiently and independently
- Achieve better collaboration within primary care
- Achieve better collaboration between primary- and secondary health care professionals
- Achieve increased satisfaction and confidence with the health care services by the users and their relatives both for included patients and other patients receiving home care services.
- Promote health and prevent unnecessary decline in health
- Strengthen the patients' ability to manage their daily activities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated care pathway | Experimental | Other: integrated care pathwayprogram for 1. communication and information flow aimed at collaboration between hospitals, general practitioners and home care services 2. systematic patient follow-up in home care services by using checklists |
| usual care | Active comparator | Other: usual careusual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Person 70 years or above being discharged from the general hospital
- Will receive home care services within four weeks after being discharges from the hospital.
Key exclusion criteria (2 listed)
- Do not agree or are not able to agree to participate
- Is already involved in other research studies affecting the home care services.
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 |
|---|---|---|
| integrated care pathwaycommunication and follow-up program for integrated care | Other | Integrated care pathway |
| usual care | Other | usual care |
Primary outcome
activities of daily living (ADL)
Time frame: 6 and 12 months
Individbasert pleie- og omsorgsstatistikk (IPLOS) scale, and Nottingham Extended ADL Scale
Institutional health care at primary and secondary level
Time frame: 1 year
Readmission (30 days)and inpatient hospital stays, number and length of stay (EPJ hospitals) Number and length of stay in municipal nursing homes (EPJ municipals) Days before permanent stay in municipal nursing homes
1 secondary outcome
Achieve better collaboration within primary care and between primary- and secondary health care providers
Time frame: 1 year
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 20 Apr 2017.
- Background: PubMed 23547654Rosstad T, Garasen H, Steinsbekk A, Sletvold O, Grimsmo A. Development of a patient-centred care pathway across healthcare providers: a qualitative study. BMC Health Serv Res. 2013 Apr 1;13:121. doi: 10.1186/1472-6963-13-121.
- Results publication: PubMed 25888898Rosstad T, Garasen H, Steinsbekk A, Haland E, Kristoffersen L, Grimsmo A. Implementing a care pathway for elderly patients, a comparative qualitative process evaluation in primary care. BMC Health Serv Res. 2015 Mar 4;15:86. doi: 10.1186/s12913-015-0751-1.
- Results publication: PubMed 28412943Rosstad T, Salvesen O, Steinsbekk A, Grimsmo A, Sletvold O, Garasen H. Generic care pathway for elderly patients in need of home care services after discharge from hospital: a cluster randomised controlled trial. BMC Health Serv Res. 2017 Apr 17;17(1):275. doi: 10.1186/s12913-017-2206-3.
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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.
Anders Grimsmo, md phd principal investigator
Norwegian University of Science and Technology
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated care pathway in people with Chronic Illness, run by Norwegian University of Science and Technology at 7 sites in Norway.
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 2 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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. 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?
activities of daily living (ADL) (time frame: 6 and 12 months). 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 NCT01107119, which also lists 3 linked publications.
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 20 Apr 2017.