Continuity of Patient CareNCT00244491
The Care Transitions Intervention
A study testing Care Transitions Intervention in people with Continuity of Patient Care, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This intervention tests whether encouraging older patients and their caregivers to assert a more active role in their care transitions could improve clinical outcomes. Patients are supported by a nurse transition coach and specific tools, including a Personal Health Record. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Continuity of Patient Care
- What is being tested?
- Care Transitions Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Aug 2003
- 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
- To be eligible for this study, patients from the participating delivery system had to: 1) be age 65 years or older, 2) be admitted to one of the participating delivery system's contract hospitals during the study period for a non-psychiatrically-related condition, 3) be community-dwelling (i.e., not from a long-term care facility), 4) reside within a predefined geographic radius of the hospital (thereby making a home visit feasible), 5) have a working telephone, 6) be English-speaking, 7) show no documentation of dementia in the medical record, 8) have no plans to enter hospice, 9) not be participating in another research protocol, and 10) have documented in their medical record at least one of 11 diagnoses, including stroke, congestive heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, diabetes, spinal stenosis, hip fracture, peripheral vascular disease, deep venous thrombosis, or pulmonary embolism.
Who cannot join
- Those who did not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Denver, Colorado, 80262
About this study
This intervention tests whether encouraging older patients and their caregivers to assert a more active role in their care transitions could improve clinical outcomes. Patients are supported by a nurse transition coach and specific tools, including a Personal Health Record.
Read the detailed description
See above.
- Conditions
- Continuity of Patient Care
- Being tested
- Care Transitions Intervention
- Keywords
- care transitions, geriatric, care coordination, self-management, chronic illness, patient-centered care
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Transitions InterventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization rate at 30, 90 and 180 days after index hospitalization.
Secondary outcomes (1)
Rehospitalization rate at 30, 90 and 180 days after index hospitalization. Rehospitalization for the same condition as the index hospital stay, at 30, 90 and 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2005 (estimated)
- Study startSep 2002
- Study completionAug 2003
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 Continuity of Patient CareStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,400 participants
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- The John A. Hartford Foundation
- Responsible party
- Sponsor
- Investigators
- Eric A. Coleman, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244491
- Sponsor's protocol ID
- 00-1036
- Status last verified
- Aug 2015
- First submitted
- 24 Oct 2005
- Last updated
- 13 Aug 2015
- Results posted
- No
Publications
Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.
PubMed 17000937
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Care Transitions Intervention
- ClinicalTrials.gov ID
- NCT00244491
- Acronym / sponsor ID
- 00-1036
- Conditions
- Continuity of Patient Care
- Keywords
- care transitions, geriatric, care coordination, self-management, chronic illness, patient-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- The John A. Hartford Foundation
- Study start
- Sep 2002
- Study completion
- Aug 2003
- First posted
- 26 Oct 2005 (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.
This intervention tests whether encouraging older patients and their caregivers to assert a more active role in their care transitions could improve clinical outcomes. Patients are supported by a nurse transition coach and specific tools, including a Personal Health Record.
Detailed description
See above.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- To be eligible for this study, patients from the participating delivery system had to: 1) be age 65 years or older, 2) be admitted to one of the participating delivery system's contract hospitals during the study period for a non-psychiatrically-related condition, 3) be community-dwelling (i.e., not from a long-term care facility), 4) reside within a predefined geographic radius of the hospital (thereby making a home visit feasible), 5) have a working telephone, 6) be English-speaking, 7) show no documentation of dementia in the medical record, 8) have no plans to enter hospice, 9) not be participating in another research protocol, and 10) have documented in their medical record at least one of 11 diagnoses, including stroke, congestive heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, diabetes, spinal stenosis, hip fracture, peripheral vascular disease, deep venous thrombosis, or pulmonary embolism.
Key exclusion criteria (1 listed)
- Those who did not meet the inclusion criteria.
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 |
|---|---|---|
| Care Transitions Intervention | Behavioural | – |
Primary outcome
Rehospitalization rate at 30, 90 and 180 days after index hospitalization.
1 secondary outcome
Rehospitalization rate at 30, 90 and 180 days after index hospitalization. Rehospitalization for the same condition as the index hospital stay, at 30, 90 and 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 13 Aug 2015.
- Results publication: PubMed 17000937Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.
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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.
Eric A. Coleman, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Transitions Intervention in people with Continuity of Patient Care, run by University of Colorado, Denver at 1 site in United States.
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 1 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 13 Aug 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 United States. 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?
Rehospitalization rate at 30, 90 and 180 days after index hospitalization.. 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 NCT00244491, 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 13 Aug 2015.