ED Patients With Chronic Medical IllnessesNCT01973296
Implementing an Emergency Department to Home Care Transition Intervention
A study testing ED to home care transition in people with ED Patients With Chronic Medical Illnesses, run by University of Florida at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether a new way of educating/coaching chronically ill patients discharged from the Emergency Room will help them receive post-ER health care and strengthen their links to a regular, personal doctor. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- ED Patients With Chronic Medical Illnesses
- What is being tested?
- ED to home care transition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2013to Dec 2014
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age or older,
- are on Medicare,
- are community dwelling,
- reside within the geographical area defined by specific zip codes (to enable home visits),
- have a working telephone, and
- have at least one of the following conditions documented in their medical record: congestive heart failure, chronic obstructive pulmonary disease, coronary artery disease, diabetes, stroke, pneumonia, medical and surgical back conditions (predominantly spinal stenosis), hip fracture, peripheral vascular disease, cardiac arrhythmias, deep venous thrombosis, pulmonary embolism, peptic ulcer disease or hemorrhage.
- health literacy will be assessed with the 66-item Rapid Estimate of Adult Literacy in Medicine (REALM)(Davis, Crouch et al.)
Who cannot join
- current diagnosis of psychosis,
- active substance abuse related to alcohol or drugs,
- cancer,
- dialysis
- history of organ transplantation,
- have dementia without a live-in caregiver, or
Show all 10Show fewer
- in hospice care,
- reside outside the defined geographical area,
- reside in a skilled nursing facility, or
- assisted living will be excluded
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Health
Gainesville, Florida, 32608
UF Health
Jacksonville, Florida, 32209
About this study
The purpose of this study is to determine whether a new way of educating/coaching chronically ill patients discharged from the Emergency Room will help them receive post-ER health care and strengthen their links to a regular, personal doctor.
Read the detailed description
Emergency Room (ER) patients with limited health literacy who agree to participate in this study will be asked to complete a survey about how they feel about their health care and how easy or hard it is to get health care. Patients will also be asked for some basic information about themselves like their age, race, gender, employment and marital status, their overall health and health conditions. The research team will review the electronic medical record for information about participants' health conditions and how sick the ER nurse thought the patient was when they came to the ER.
Patients who decide to participate in the study will also be randomly assigned, much like the flip of a coin to receive either a new way of educating patients (the Care Transition Intervention) or normal care. This means:
If patients receive the new way of educating, a coach will visit the patient at home one time one or two days after the ER visit to see how the patient is doing. He/she will talk with the patient about following up with a regular, personal doctor and symptoms to look out for. He/she will help the patient understand their medicines and help the patient make a personal health record. The coach will also tell the patient about the Area Agency on Aging, also called Elder Options. If the patient receives normal care, the patient will not receive a visit from the coach or hear about the Area Agency on Aging but will be given discharge instructions from the ER nurse and doctor.
If the patient receives the new way of educating (the Care Transition Intervention), the coach will call the patient at least 3 times after the ER visit. He/she will talk with the patient about the same items listed above. If the patient receives normal care, the coach will not call. The patient has a 1 in 2 chance of receiving the new way of educating and a 1 in 2 chance of receiving normal care.
All patients will be asked to complete a phone survey 31-60 days after their ER visit. This survey will ask the patient about follow up with a regular, personal doctor. The survey will also ask the patient how they feel about their health care and how easy or hard it is to get health care after an ER visit.
Some patients will also be asked if they are willing to give a separate interview. The study doctor will ask about what happened when you were in the ER. She will also ask about how things went after your ER visit. If the coach contacted you, she will ask about this as well. This interview will be audio recorded.
- Being tested
- ED to home care transition, Usual Care
- Keywords
- Health Literacy, Care Transition Intervention, Emergency Department Population, Access to Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED to home care transitionBehavioural
Also called Care Transition Intervention (CTI)
The CTI coach's role is to build self-management capabilities for the patient and caregiver. During each contact, the coach reviews the four components of the CTI: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The coach assists the patient use the PHR to document and maintain vital information and to communicate with providers.
Usual CareOther
Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| ED to home care transition | Experimental | The ED to home care transition intervention is a 4-week program that uses a Area Agency on Aging coach to conduct a home visit and three follow up phone calls to help patients develop the skills needed for self-management and to communicate with healthcare providers. Receives: Behavioral: ED to home care transition |
| Usual Care | Other | Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timely and appropriate outpatient medical follow-up
The purpose of this aim is to determine if the ED to home care transition intervention improves patients' access to timely and appropriate outpatient medical follow-up. Patient response to telephone questionnaire will be used to determine time to physician follow-up and type of physician encounter.
Measured: 31-60 days after Emergency Department (ED) visit
Secondary outcomes (1)
Patient activation measure (PAM) level
The purpose of this aim is to determine if the ED to home care transition intervention improves patients' self management skills as assessed by increased PAM scores.
Measured: 31-60 days following ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ED Patients With Chronic Medical IllnessesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Emergency Medicine Foundation
- Responsible party
- Sponsor
- Investigators
- Donna L Carden, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973296
- Sponsor's protocol ID
- 201200390
- Status last verified
- Jan 2015
- First submitted
- 15 Oct 2013
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Emergency Department to Home Care Transition Intervention
- ClinicalTrials.gov ID
- NCT01973296
- Acronym / sponsor ID
- 201200390
- Keywords
- Health Literacy, Care Transition Intervention, Emergency Department Population, Access to Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Emergency Medicine Foundation
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Oct 2013 (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 purpose of this study is to determine whether a new way of educating/coaching chronically ill patients discharged from the Emergency Room will help them receive post-ER health care and strengthen their links to a regular, personal doctor.
Detailed description
Emergency Room (ER) patients with limited health literacy who agree to participate in this study will be asked to complete a survey about how they feel about their health care and how easy or hard it is to get health care. Patients will also be asked for some basic information about themselves like their age, race, gender, employment and marital status, their overall health and health conditions. The research team will review the electronic medical record for information about participants' health conditions and how sick the ER nurse thought the patient was when they came to the ER.
Patients who decide to participate in the study will also be randomly assigned, much like the flip of a coin to receive either a new way of educating patients (the Care Transition Intervention) or normal care. This means:
If patients receive the new way of educating, a coach will visit the patient at home one time one or two days after the ER visit to see how the patient is doing. He/she will talk with the patient about following up with a regular, personal doctor and symptoms to look out for. He/she will help the patient understand their medicines and help the patient make a personal health record. The coach will also tell the patient about the Area Agency on Aging, also called Elder Options. If the patient receives normal care, the patient will not receive a visit from the coach or hear about the Area Agency on Aging but will be given discharge instructions from the ER nurse and doctor.
If the patient receives the new way of educating (the Care Transition Intervention), the coach will call the patient at least 3 times after the ER visit. He/she will talk with the patient about the same items listed above. If the patient receives normal care, the coach will not call. The patient has a 1 in 2 chance of receiving the new way of educating and a 1 in 2 chance of receiving normal care.
All patients will be asked to complete a phone survey 31-60 days after their ER visit. This survey will ask the patient about follow up with a regular, personal doctor. The survey will also ask the patient how they feel about their health care and how easy or hard it is to get health care after an ER visit.
Some patients will also be asked if they are willing to give a separate interview. The study doctor will ask about what happened when you were in the ER. She will also ask about how things went after your ER visit. If the coach contacted you, she will ask about this as well. This interview will be audio recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED to home care transition | Experimental | Behavioral: ED to home care transitionThe ED to home care transition intervention is a 4-week program that uses a Area Agency on Aging coach to conduct a home visit and three follow up phone calls to help patients develop the skills needed for self-management and to communicate with healthcare providers. |
| Usual Care | Other | Other: Usual CarePatients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 60 years of age or older,
- are on Medicare,
- are community dwelling,
- reside within the geographical area defined by specific zip codes (to enable home visits),
- have a working telephone, and
Key exclusion criteria (10 listed)
- current diagnosis of psychosis,
- active substance abuse related to alcohol or drugs,
- cancer,
- dialysis
- history of organ transplantation,
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 |
|---|---|---|
| ED to home care transitionAlso: Care Transition Intervention (CTI)The CTI coach's role is to build self-management capabilities for the patient and caregiver. During each contact, the coach reviews the four components of the CTI: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The coach assists the patient use the PHR to document and maintain vital information and to communicate with providers. | Behavioural | ED to home care transition |
| Usual CarePatients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care. | Other | Usual Care |
Primary outcome
Timely and appropriate outpatient medical follow-up
Time frame: 31-60 days after Emergency Department (ED) visit
The purpose of this aim is to determine if the ED to home care transition intervention improves patients' access to timely and appropriate outpatient medical follow-up. Patient response to telephone questionnaire will be used to determine time to physician follow-up and type of physician encounter.
1 secondary outcome
Patient activation measure (PAM) level
Time frame: 31-60 days following ED visit
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 26 Jan 2015.
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.
Donna L Carden, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED to home care transition in people with ED Patients With Chronic Medical Illnesses, run by University of Florida at 2 sites 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 7 inclusion and 10 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 26 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 2 sites 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?
Timely and appropriate outpatient medical follow-up (time frame: 31-60 days after Emergency Department (ED) visit). 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 26 Jan 2015.