Patient ReadmissionNCT03066492
Evaluation of a Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization in Low Income Adults
A study testing Northwestern Follow Up Care Coordination and Federally Qualified Health Center in people with Patient Readmission, run by Northwestern University at 1 site in United States.
Trial summary
This randomized controlled trial examines the effects of a transitional care clinic for high-risk patients at an academic medical center who had no trusted medical home. The trial will provide the first reliable evaluation of the Northwestern Transitional Care Clinic / Follow Up Clinic's (NFC) impact on re-admissions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Readmission
- What is being tested?
- Northwestern Follow Up Care Coordination and Federally Qualified Health Center
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 654 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2015to 1 May 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients eligible for Northwestern Transitional Follow Up care post-discharge from Northwestern Memorial Hospital
- Adults (18 years of age or older)
- Patients referred by an Northwestern Memorial Hospital care provider for discharge coordination by the Northwestern Transitional Follow Up Clinic
Who cannot join
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant Women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Evaluation of a Novel Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization Among Low Income Adults
This randomized controlled trial examines the effects of a transitional care clinic for high-risk patients at an academic medical center who had no trusted medical home. The trial will provide the first reliable evaluation of the Northwestern Transitional Care Clinic / Follow Up Clinic's (NFC) impact on re-admissions, care coordination, and costs. This research will allow us to assess the value of the NFC and similar models of care for providing a more coordinated care approach that results in better treatment outcomes for urban poor populations.
It is hypothesized that NFC patients will have fewer 90-day re-hospitalizations and are more likely to have a usual source of primary care 6 months after discharge.
Read the detailed description
The Northwestern Transitional Care Follow-up Clinic (NFC) was established in 2012 to improve the coordination of care for these patients following inpatient or Emergency Department discharge from Northwestern Memorial Hospital. Since 2012, the NFC has constructed an integrated team care approach, logging about 2000 post-discharge encounters with Medicaid or patients without insurance. The NFC model has evolved over the past 2 years in response to a need to address mental as well as physical health needs and to interface with community resources to address social determinants of health that might otherwise lead to frequent re-admission. By working with clinical partners and public payers like Medicaid and County Care, the NFC has also worked to transition patients to accessible primary care medical homes that will provide behavioral, physical, and preventive care. The current study will provide the first reliable evaluation of the clinic's impact on re-admissions, care coordination, and costs. This research will allow us to assess the value of the NFC and similar models of care for providing a more coordinated care approach that results in better treatment outcomes for urban poor populations.
- Conditions
- Patient Readmission
- Being tested
- Northwestern Follow Up Care Coordination, Federally Qualified Health Center
- Keywords
- Tertiary Care Center, Patient Readmission, Health Services Research, Hospital Readmissions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Northwestern Follow Up Care CoordinationOther
Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at the Northwestern Transitional Care Follow Up Clinic.
Federally Qualified Health CenterOther
Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at a nearby Federally Qualified Health Center.
| Study group | Role | What they receive |
|---|---|---|
| Federally Qualified Health Center | Active comparator | Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at a nearby Federally Qualified Health Center. Receives: Other: Federally Qualified Health Center |
| Northwestern Follow Up Care Coordination | Experimental | Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at the Northwestern Transitional Care Follow Up Clinic. Receives: Other: Northwestern Follow Up Care Coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-Day Re-hospitalization or Death
90-day re-hospitalization (Emergency Department and/or inpatient admission) or death
Measured: 90 days
Secondary outcomes (6)
Usual Source of Primary Care
Patient report of being seen in a usual source of primary medical care 6 months after discharge
Measured: 6 months
30-Day Re-hospitalization or Death
90-day re-hospitalization (Emergency Department and/or inpatient admission) or death
Measured: 30 days
180-Day Re-hospitalization or Death
180-day re-hospitalization (Emergency Department and/or inpatient admission) or death
Measured: 180 days
365-Day Re-hospitalization or Death
365-day re-hospitalization (Emergency Department and/or inpatient admission) or death
Measured: 365 days
Health Advocate Effect
This evaluation will determine if being offered support of a novel care team member known as a "health advocate" (a form of care navigator who will assist patients to overcome social determinants of readmission) is more likely to prevent hospital readmission than receiving the standard Northwestern Transitional Follow Up Care team intervention alone.
Measured: 12 months
Intervention Cost
This is an evaluation of the incremental costs to implement and sustain standard Northwestern Transitional Follow Up team care, as well as the enhanced standard + health advocate personnel model
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start2 Sep 2015
- Primary completion1 May 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient ReadmissionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 654 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Responsible party
- Principal investigator, Ronald Ackermann, Northwestern University
- Investigators
- Ronald T Ackermann, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066492
- Sponsor's protocol ID
- STU00200259
- Status last verified
- Jun 2019
- First submitted
- 22 Feb 2017
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liss DT, Ackermann RT, Cooper A, Finch EA, Hurt C, Lancki N, Rogers A, Sheth A, Teter C, Schaeffer C. Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial. J Gen Intern Med. 2019 Sep;34(9):1758-1765. doi: 10.1007/s11606-019-05078-4. Epub 2019 May 29.
PubMed 31144279Ackermann RT, Liss DT, French DD, Cooper AJ, Aikman C, Schaeffer C. Randomized Trial Evaluating Health System Expenditures with Transitional Care Services for Adults with No Usual Source of Care at Discharge. J Gen Intern Med. 2022 Nov;37(15):3832-3838. doi: 10.1007/s11606-022-07473-w. Epub 2022 Mar 9.
PubMed 35266127
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization Among Low Income Adults
- ClinicalTrials.gov ID
- NCT03066492
- Acronym / sponsor ID
- STU00200259
- Conditions
- Patient Readmission
- Keywords
- Tertiary Care Center, Patient Readmission, Health Services Research, Hospital Readmissions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 654 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Northwestern Memorial Hospital
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 28 Feb 2017 (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.
This randomized controlled trial examines the effects of a transitional care clinic for high-risk patients at an academic medical center who had no trusted medical home. The trial will provide the first reliable evaluation of the Northwestern Transitional Care Clinic / Follow Up Clinic's (NFC) impact on re-admissions, care coordination, and costs. This research will allow us to assess the value of the NFC and similar models of care for providing a more coordinated care approach that results in better treatment outcomes for urban poor populations.
It is hypothesized that NFC patients will have fewer 90-day re-hospitalizations and are more likely to have a usual source of primary care 6 months after discharge.
Detailed description
The Northwestern Transitional Care Follow-up Clinic (NFC) was established in 2012 to improve the coordination of care for these patients following inpatient or Emergency Department discharge from Northwestern Memorial Hospital. Since 2012, the NFC has constructed an integrated team care approach, logging about 2000 post-discharge encounters with Medicaid or patients without insurance. The NFC model has evolved over the past 2 years in response to a need to address mental as well as physical health needs and to interface with community resources to address social determinants of health that might otherwise lead to frequent re-admission. By working with clinical partners and public payers like Medicaid and County Care, the NFC has also worked to transition patients to accessible primary care medical homes that will provide behavioral, physical, and preventive care. The current study will provide the first reliable evaluation of the clinic's impact on re-admissions, care coordination, and costs. This research will allow us to assess the value of the NFC and similar models of care for providing a more coordinated care approach that results in better treatment outcomes for urban poor populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Federally Qualified Health Center | Active comparator | Other: Federally Qualified Health CenterEach patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at a nearby Federally Qualified Health Center. |
| Northwestern Follow Up Care Coordination | Experimental | Other: Northwestern Follow Up Care CoordinationEach patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at the Northwestern Transitional Care Follow Up Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients eligible for Northwestern Transitional Follow Up care post-discharge from Northwestern Memorial Hospital
- Adults (18 years of age or older)
- Patients referred by an Northwestern Memorial Hospital care provider for discharge coordination by the Northwestern Transitional Follow Up Clinic
Key exclusion criteria (3 listed)
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant Women
- Prisoners
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 |
|---|---|---|
| Northwestern Follow Up Care CoordinationEach patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at the Northwestern Transitional Care Follow Up Clinic. | Other | Northwestern Follow Up Care Coordination |
| Federally Qualified Health CenterEach patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at a nearby Federally Qualified Health Center. | Other | Federally Qualified Health Center |
Primary outcome
90-Day Re-hospitalization or Death
Time frame: 90 days
90-day re-hospitalization (Emergency Department and/or inpatient admission) or death
6 secondary outcomes
Usual Source of Primary Care
Time frame: 6 months
30-Day Re-hospitalization or Death
Time frame: 30 days
180-Day Re-hospitalization or Death
Time frame: 180 days
365-Day Re-hospitalization or Death
Time frame: 365 days
Health Advocate Effect
Time frame: 12 months
Intervention Cost
Time frame: 12 months
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 Jun 2019.
- Results publication: PubMed 31144279Liss DT, Ackermann RT, Cooper A, Finch EA, Hurt C, Lancki N, Rogers A, Sheth A, Teter C, Schaeffer C. Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial. J Gen Intern Med. 2019 Sep;34(9):1758-1765. doi: 10.1007/s11606-019-05078-4. Epub 2019 May 29.
- Derived from this study: PubMed 35266127Ackermann RT, Liss DT, French DD, Cooper AJ, Aikman C, Schaeffer C. Randomized Trial Evaluating Health System Expenditures with Transitional Care Services for Adults with No Usual Source of Care at Discharge. J Gen Intern Med. 2022 Nov;37(15):3832-3838. doi: 10.1007/s11606-022-07473-w. Epub 2022 Mar 9.
- Individual participant dataSharing planned: No
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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.
Ronald T Ackermann, MD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Northwestern Follow Up Care Coordination and Federally Qualified Health Center in people with Patient Readmission, run by Northwestern University 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 3 inclusion and 3 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 Jun 2019. 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?
90-Day Re-hospitalization or Death (time frame: 90 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 NCT03066492, which also lists 2 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 25 Jun 2019.