Transitional Care CoordinationNCT02087072
Collaborative Home Visits to Reduce Hospital Readmissions and Improve Medication Use During Transitions of Care
An observational study of Transitional Care Coordination and Home Visits, run by Ohio State University at 1 site in United States.
Trial summary
The primary objective is to develop a sustainable practice model emphasizing home visits by a collaborative physician and pharmacist team to decrease unplanned emergency department visits and hospital readmissions at 30 and 90 days for high-risk home bound patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transitional Care Coordination, Home Visits
- What is being tested?
- Collaborative visit with provider and pharmacist
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2014
- Phase
- Observational
- 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
Study population: Patients will be selected from the OSU Healthy at Home program that have been recently discharged from the hospital.
Who may be able to join
- Adult patients discharged from the hospital in the last 7 days and with more than two chronic conditions and significant obstacles to accessing care in an office setting are eligible for study participation
Who cannot join
- Adult patients able to access care in an office setting.
- Adult patients discharged from the hospital greater than 7 days prior to the office visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Division of General Internal Medicine Martha Morehouse
Columbus, Ohio, 43221
About this study
Official title: COLLABORATIVE HOME VISITS TO REDUCE HOSPITAL READMISSIONS AND IMPROVE MEDICATION USE DURING TRANSITIONS OF CARE
The primary objective is to develop a sustainable practice model emphasizing home visits by a collaborative physician and pharmacist team to decrease unplanned emergency department visits and hospital readmissions at 30 and 90 days for high-risk home bound patients. Secondary objectives include (1) tracking the number, type, and severity of adverse drug events (ADE) and potential adverse drug events (pADE) that occur following hospital discharge and (2) resolving any identified ADE and pADE within 7 days of hospital discharge.
Adult patients will be scheduled for a home visit by the Healthy at Home Columbus program at the time of hospital discharge. The home visit will occur within 7 days of hospital discharge and will consist of a complete hospital and medication review by a physician or nurse practitioner and a pharmacist (including all lab tests, imaging studies, medication changes, and proposed plan of care at the time of discharge). The investigators hypothesize these home visits will reduce 30 and 90 days hospital readmission rates and ED visits.
The number of emergency department visits and unplanned hospital readmissions will be tracked at 30 and 90 days following discharge from the hospitalization that led to study enrollment. A comparison cohort of patients discharged in the 12 months prior to study initiation will be used to compare the effectiveness of the home visit program. The number and type of adverse drug events (ADE) and potential adverse drug events (pADE) that occur during transitions of care will also be characterized. All ADE and pADE will be resolved during the initial home visit and will be classified based on severity. All ADE and pADE will be evaluated independently by two pharmacist reviewers; each reviewer will independently assign a severity rating to each ADE and pADE.
- Conditions
- Transitional Care Coordination, Home Visits
- Being tested
- Collaborative visit with provider and pharmacist
- Keywords
- home visits, transitions of care, pharmacist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative visit with provider and pharmacistOther
| Study group | Role | What they receive |
|---|---|---|
| Recently discharged homebound patients | Not described Receives: Other: Collaborative visit with provider and pharmacist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission
Measured: 30 days
Secondary outcomes (1)
Emergency Department Visit
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transitional Care CoordinationStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Health-System Pharmacy Foundation
- Responsible party
- Principal investigator, Stuart Beatty, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087072
- Sponsor's protocol ID
- 2013H0185
- Status last verified
- Sep 2022
- First submitted
- 12 Mar 2014
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLLABORATIVE HOME VISITS TO REDUCE HOSPITAL READMISSIONS AND IMPROVE MEDICATION USE DURING TRANSITIONS OF CARE
- ClinicalTrials.gov ID
- NCT02087072
- Acronym / sponsor ID
- 2013H0185
- Conditions
- Transitional Care Coordination, Home Visits
- Keywords
- home visits, transitions of care, pharmacist
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Society of Health-System Pharmacy Foundation
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Mar 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 primary objective is to develop a sustainable practice model emphasizing home visits by a collaborative physician and pharmacist team to decrease unplanned emergency department visits and hospital readmissions at 30 and 90 days for high-risk home bound patients. Secondary objectives include (1) tracking the number, type, and severity of adverse drug events (ADE) and potential adverse drug events (pADE) that occur following hospital discharge and (2) resolving any identified ADE and pADE within 7 days of hospital discharge.
Adult patients will be scheduled for a home visit by the Healthy at Home Columbus program at the time of hospital discharge. The home visit will occur within 7 days of hospital discharge and will consist of a complete hospital and medication review by a physician or nurse practitioner and a pharmacist (including all lab tests, imaging studies, medication changes, and proposed plan of care at the time of discharge). The investigators hypothesize these home visits will reduce 30 and 90 days hospital readmission rates and ED visits.
The number of emergency department visits and unplanned hospital readmissions will be tracked at 30 and 90 days following discharge from the hospitalization that led to study enrollment. A comparison cohort of patients discharged in the 12 months prior to study initiation will be used to compare the effectiveness of the home visit program. The number and type of adverse drug events (ADE) and potential adverse drug events (pADE) that occur during transitions of care will also be characterized. All ADE and pADE will be resolved during the initial home visit and will be classified based on severity. All ADE and pADE will be evaluated independently by two pharmacist reviewers; each reviewer will independently assign a severity rating to each ADE and pADE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recently discharged homebound patients | – | Other: Collaborative visit with provider and pharmacist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from the OSU Healthy at Home program that have been recently discharged from the hospital.
Key inclusion criteria (1 listed)
- Adult patients discharged from the hospital in the last 7 days and with more than two chronic conditions and significant obstacles to accessing care in an office setting are eligible for study participation
Key exclusion criteria (2 listed)
- Adult patients able to access care in an office setting.
- Adult patients discharged from the hospital greater than 7 days prior to the office visit.
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 |
|---|---|---|
| Collaborative visit with provider and pharmacist | Other | Recently discharged homebound patients |
Primary outcome
Hospital Readmission
Time frame: 30 days
1 secondary outcome
Emergency Department Visit
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transitional Care Coordination and Home Visits, run by Ohio State 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 1 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: withdrawn, as of the sponsor's last update on 30 Sep 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Hospital Readmission (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2022.