Hospital ReadmissionsNCT04981977
Enhancing the Care Transitions Intervention With Peer Support to Reduce Disparities
A study testing Care Transitions Intervention and Care Transitions Intervention and Peer Support in people with Hospital Readmissions, run by University of South Florida at 1 site in United States.
Trial summary
Unplanned hospital readmissions are extremely costly to patients and our healthcare system. Being readmitted to the hospital also leads to increased risk of health complications for patients including infections and impairments in functioning. Hospital readmissions are particularly common among older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hospital Readmissions
- What is being tested?
- Care Transitions Intervention and Care Transitions Intervention and Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 483 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient participants (N=402) will be included in the study if they:
- Are aged 60+
- Identify as African American or Latino/Hispanic (any race)
- Are being discharged from one of our three hospital partners to home with no planned readmissions
- Have access to a household telephone or cellphone
- Speak English or Spanish
Who cannot join
- Patient participants will be excluded from the study if they:
- Are younger than age 60
- Identify as any race/ethnicity other than African American or Latino/Hispanic
- Are being discharged with a condition that has planned readmission (e.g. transplant patient, chemotherapy etc.)
- Are permanent residents of a skilled nursing facility, receiving hospice service, or are being discharged to a long-term care facility
- Have a comorbid substance use disorder
- Are actively suicidal or homicidal
- Have a comorbid psychotic disorder or organic mental disorder (e.g., dementia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of The Evidence-Based Care Transitions Intervention Enhanced With Peer Support to Reduce Racial Disparities in Hospital Readmissions and Negative Outcomes Post Hospitalization
Unplanned hospital readmissions are extremely costly to patients and our healthcare system. Being readmitted to the hospital also leads to increased risk of health complications for patients including infections and impairments in functioning. Hospital readmissions are particularly common among older adults. Further, racial/ethnic disparities are evident in readmission rates and are the greatest among African American and Latino/Hispanic older adults. Effective, sustainable, and culturally appropriate interventions to improve outcomes, reduce unplanned hospital readmissions, and reduce health disparities are urgently needed. The proposed randomized controlled trial will evaluate the effectiveness of a novel transitional care strategy designed to avoid unplanned hospital readmissions and improve patient health outcomes in a racially/ethnically diverse sample of older adults who have been admitted to the hospital due to a chronic health condition.
Eric Coleman's Care Transitions Intervention (CTI) has been identified as the strategy most successfully implemented and evaluated in multiple settings and systems of care. CTI has been shown to reduce hospital readmissions for non-Hispanic White older adults, however its' effects have not been as strong for minority older adults in some studies and research trials have not recruited a sufficient number of racial/ethnic minorities to examine outcomes by race or ethnicity. Thus, it is unknown whether CTI is effective for racial/ethnic minority older adults who suffer disproportionately high readmission rates. Further, studies of transitions interventions suggest that older adult and racial/ethnic minority patients require additional assistance and support during transitions in care. The researchers hypothesize the addition of peer support will enhance and maximize the benefit of the CTI and increase its' cultural sensitivity and future sustainability.
The proposed 3-arm trial is designed to evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), as compared to usual care (UC), on unplanned all-cause hospital readmissions occurring within 6 months (assessed at 30 days, 90 days and 6 months) and secondary health system (i.e., ED visits) and patient-centered outcomes (i.e., self-efficacy managing chronic disease, quality of life, functional status and mortality) among 402 hospitalized African American and Latino/Hispanic older adults (age 60+) who have a chronic physical illness (e.g., cardiovascular disease, diabetes, COPD) and are being discharged from the hospital back to the community.
Read the detailed description
Unplanned hospital readmissions represent a critical failure of the healthcare system, perpetuate health disparities, and are the single largest driver of excess healthcare costs. For patients, hospital readmission increases risk for complications, infections, and functional impairment. Hospital readmissions are particularly prevalent among older adults. Further, racial/ethnic disparities in readmission rates are profound and are the greatest among African American and Latino/Hispanic older adults. Effective, sustainable and culturally appropriate interventions to improve outcomes, reduce un-planned hospital readmissions, and reduce health disparities are urgently needed. The proposed randomized controlled trial will evaluate the effectiveness of a novel transitional care strategy designed to avert un-planned hospital readmissions and improve patient health outcomes in a high-risk and under studied population of medically hospitalized African American and Latino/Hispanic older adults (age 60+). Transitional care strategies are interventions initiated before hospital discharge with the aim of ensuring the safe and effective transition of patients from the acute hospital setting to home. Of all the transitional care interventions tested, Eric Coleman's Care Transitions Intervention (CTI) has been identified as the strategy most successfully implemented and evaluated in multiple settings and systems of care. CTI is a non-clinical coaching strategy that occurs in the hospital, home, and via telephone for 28 days post-discharge.
CTI has been shown to reduce hospital readmissions for non-Hispanic White older adults, however intervention effects have been mixed for minority older adults and effectiveness trials have not recruited a sufficient number of racial/ethnic minorities to examine race or ethnicity specific outcomes. Thus, it is unclear whether CTI is effective for racial/ethnic minority older adults who suffer disproportionately high readmission rates. Further, studies of transitions interventions suggest that older adult and racial/ethnic minority patients require additional assistance and support during transitions in care. To address this gap, the researchers propose to add peer support (PS) to the CTI to enhance its effectiveness among high-risk populations of racial/ethnic minority older adults. The researchers believe the addition of peer support will enhance and maximize the benefit of the CTI and increase its' cultural sensitivity and future sustainability. The proposed 3-arm trial is designed to evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), as compared to usual care (UC), on all cause unplanned hospital readmissions occurring within 6 months (assessed at 30 days, 90 days and 6 months) and secondary health system (i.e., ED visits) and patient-centered outcomes (i.e., self-efficacy managing chronic disease, quality of life, functional status and mortality) among 402 hospitalized African American and Latino/Hispanic older adults (age 60+) who have a chronic physical illness (e.g., cardiovascular disease, diabetes, COPD) and are being discharged from the hospital back to the community. The researchers will also maximize the uniquely diverse sample to explore potential mediators and moderators of intervention effects. The researchers will further conduct semi-structured interviews with patients (n=48) and caregivers (n=24) to qualitatively examine mechanisms impacting readmission risk and patient-centered outcomes post discharge. The researchers will utilize multi-methods to triangulate and contextualize the findings.
- Conditions
- Hospital Readmissions
- Being tested
- Care Transitions Intervention, Care Transitions Intervention and Peer Support, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Transitions InterventionBehavioural
Also called CTI
CTI is delivered by a trained Care Transitions Coach (Coach) who works closely with patients to ensure a smooth transition from hospital to home following an acute hospitalization. The patient, caregiver, and Coach work together to maximize the involvement of interdisciplinary experts, ensuring that the appropriate professionals are involved, issues are addressed, goals are understood, and the discharge care plan is executed correctly. There are three aspects to CTI; the first is the initial hospital visit, followed by an in-home visit, concluding with telephone follow-up over a 28-day period. During these visits, the Coach focuses on four conceptual areas, referred to as pillars (i.e., Personal Health Record, Medication Management, Red Flags, and Physician Follow up). The Coach ensures the patient understands and utilizes the Personal Health Record to facilitate communication and ensure continuity of care plan across providers and settings.
Care Transitions Intervention and Peer SupportBehavioural
Also called CTI + PS
The PS intervention for this study is based upon the principles of motivational interviewing, which is a person-centered, goal-directed method to enhance intrinsic motivation for change by exploring and resolving ambivalence. A recent meta-analysis found the mean effect size for MI to be significantly larger for racial and ethnic minority samples (0.79 vs. 0.26) as compared to non-Hispanic Whites, highlighting its potential benefit and cultural relevance for minority populations. Patients in this arm of the study will receive the 28-day CTI intervention with a 2-month long Peer Support (PS) intervention provided by trained peer educators (PEs).
Usual CareOther
Also called UC
The researchers will follow a control group of patients who meet study inclusion criteria. These older adults will participate in the traditional discharge case-management offered by the hospital where they were admitted and discharged. UC at our three partner hospitals consists of: (1) routine inpatient nurse intake that includes screening about housing, substance abuse, and functional status; (2) medication reconciliation performed by treating practitioners; (3) discharge patient education provided by inpatient nurses; (4) a list of resources for safety-net clinics and community-based services; and (5) for patients with severe chronic illness (e.g. heart failure) there may be a planned home visit by a nurse practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Care Transitions Intervention | Experimental | Patient participants in this arm will receive the Care Transition Intervention. Receives: Behavioral: Care Transitions Intervention |
| Care Transition Intervention and Peer Support | Experimental | Patient participants in this arm will receive the Care Transition Intervention. Receives: Behavioral: Care Transitions Intervention and Peer Support |
| Usual Care | Other | Patient participants in this arm will receive the usual discharge/transition care provided by the hospital. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned All-Cause Hospital Readmissions
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned all-cause hospital readmissions using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).
Measured: 30 days
Unplanned All-Cause Hospital Readmissions
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned all-cause hospital readmissions using data from the Florida Health Information Exchange (HI
Measured: Three months
Unplanned All-Cause Hospital Readmissions
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned all-cause hospital readmissions using data from the Florida Health Information Exchange (HI
Measured: Six months
Related Secondary Health-System Visits (i.e., ED Visits)
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned related secondary health-system visits using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).
Measured: 30 days
Related Secondary Health-System Visits (i.e., ED Visits)
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned related secondary health-system visits using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).
Measured: Three months
Related Secondary Health-System Visits (i.e., ED Visits)
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned related secondary health-system visits using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).
Measured: Six months
Secondary outcomes (22)
Demographic Questionnaire
All participants be asked a series of demographic questions, which include self-reported: race, ethnicity, gender, education, employment status, health insurance status, immigration status marital status, exposure to violence, number of children, and self-rated health.
Measured: At time of enrollment/Baseline
Care Transitions Measure (CTM-3)
The Care Transitions Measure (CTM-3) assesses the extent to which essential care was performed by hospital staff when planning to discharge a patient from the hospital and engage them in posthospital self-care activities (Antchkova et al., 2014). The 3-item CTM accounts for 88% of variance in the original 15-item CTM score (Parry et al., 2008).
Measured: 30 days
Care Transitions Measure (CTM-3)
The Care Transitions Measure (CTM-3) assesses the extent to which essential care was performed by hospital staff when planning to discharge a patient from the hospital and engage them in posthospital self-care activities (Antchkova et al., 2014). The 3-item CTM accounts for 88% of variance in the original 15-item CTM score (Parry et al., 2008).
Measured: Three months
Care Transitions Measure (CTM-3)
The Care Transitions Measure (CTM-3) assesses the extent to which essential care was performed by hospital staff when planning to discharge a patient from the hospital and engage them in posthospital self-care activities (Antchkova et al., 2014). The 3-item CTM accounts for 88% of variance in the original 15-item CTM score (Parry et al., 2008).
Measured: Six months
Self-Efficacy (SES-6)
The SES-6 is a 6-item scale that was developed for the Chronic Disease Self-Management Study that assess for emotional functioning, role function, symptom control, and communication with physicians (Lorig et al., 2001).
Measured: Baseline
Self-Efficacy (SES-6)
The SES-6 is a 6-item scale that was developed for the Chronic Disease Self-Management Study that assess for emotional functioning, role function, symptom control, and communication with physicians (Lorig et al., 2001).
Measured: 30
Self-Efficacy (SES-6)
The SES-6 is a 6-item scale that was developed for the Chronic Disease Self-Management Study that assess for emotional functioning, role function, symptom control, and communication with physicians (Lorig et al., 2001).
Measured: Three months
Self-Efficacy (SES-6)
The SES-6 is a 6-item scale that was developed for the Chronic Disease Self-Management Study that assess for emotional functioning, role function, symptom control, and communication with physicians (Lorig et al., 2001).
Measured: Six months
Medical Outcomes Study Short Form (MOS SF-36)
The RAND MOS SF-36 was adapted from the SF-36 for use in an observational study that measured differences in the practicing styles of physicians and patient outcomes. It assesses for 8 health concepts: (1) physical functioning; (2) bodily pain; (3) limitations in physical activity due to health challenges; (4) limitations in social activities due to due to physical or emotional challenges; (5) general health perceptions; (6) energy and fatigue (vitality); (7) emotional well-being; and (8) social functioning (Ware \& Sherbourne, 1992).
Measured: Baseline
Medical Outcomes Study Short Form (MOS SF-36)
The RAND MOS SF-36 was adapted from the SF-36 for use in an observational study that measured differences in the practicing styles of physicians and patient outcomes. It assesses for 8 health concepts: (1) physical functioning; (2) bodily pain; (3) limitations in physical activity due to health challenges; (4) limitations in social activities due to due to physical or emotional challenges; (5) general health perceptions; (6) energy and fatigue (vitality); (7) emotional well-being; and (8) social functioning (Ware \& Sherbourne, 1992).
Measured: 30 days
Medical Outcomes Study Short Form (MOS SF-36)
The RAND MOS SF-36 was adapted from the SF-36 for use in an observational study that measured differences in the practicing styles of physicians and patient outcomes. It assesses for 8 health concepts: (1) physical functioning; (2) bodily pain; (3) limitations in physical activity due to health challenges; (4) limitations in social activities due to due to physical or emotional challenges; (5) general health perceptions; (6) energy and fatigue (vitality); (7) emotional well-being; and (8) social functioning (Ware \& Sherbourne, 1992).
Measured: Three months
Medical Outcomes Study Short Form (MOS SF-36)
The RAND MOS SF-36 was adapted from the SF-36 for use in an observational study that measured differences in the practicing styles of physicians and patient outcomes. It assesses for 8 health concepts: (1) physical functioning; (2) bodily pain; (3) limitations in physical activity due to health challenges; (4) limitations in social activities due to due to physical or emotional challenges; (5) general health perceptions; (6) energy and fatigue (vitality); (7) emotional well-being; and (8) social functioning (Ware \& Sherbourne, 1992).
Measured: Six months
Quality of Life (WHOQOL-BRIEF)
The WHOQOL-BREF is a 26-item self-report questionnaire that addresses 4 QOL domains: (1) social relationships (3 items); (2) psychological health (6 items); (3) physical health (7 items); and (4) environment (8 items). Two other general health and QOL items are also included.
Measured: Baseline
Quality of Life (WHOQOL-BRIEF)
The WHOQOL-BREF is a 26-item self-report questionnaire that addresses 4 QOL domains: (1) social relationships (3 items); (2) psychological health (6 items); (3) physical health (7 items); and (4) environment (8 items). Two other general health and QOL items are also included.
Measured: 30 days
Quality of Life (WHOQOL-BRIEF)
The WHOQOL-BREF is a 26-item self-report questionnaire that addresses 4 QOL domains: (1) social relationships (3 items); (2) psychological health (6 items); (3) physical health (7 items); and (4) environment (8 items). Two other general health and QOL items are also included.
Measured: Three months
Quality of Life (WHOQOL-BRIEF)
The WHOQOL-BREF is a 26-item self-report questionnaire that addresses 4 QOL domains: (1) social relationships (3 items); (2) psychological health (6 items); (3) physical health (7 items); and (4) environment (8 items). Two other general health and QOL items are also included.
Measured: Six months
Medication Management (MedMaleDE)
The Medication Management Instrument for Deficiencies in the Elderly (MedMalDE), assesses for three domains: (1) what the person knows about their medications; (2) whether a person knows how to take their medications; and (3) whether the person knows how to get their medications.
Measured: Baseline
Medication Management (MedMaleDE)
The Medication Management Instrument for Deficiencies in the Elderly (MedMalDE), assesses for three domains: (1) what the person knows about their medications; (2) whether a person knows how to take their medications; and (3) whether the person knows how to get their medications.
Measured: 30 days
Medication Management (MedMaleDE)
The Medication Management Instrument for Deficiencies in the Elderly (MedMalDE), assesses for three domains: (1) what the person knows about their medications; (2) whether a person knows how to take their medications; and (3) whether the person knows how to get their medications.
Measured: Three months
Medication Management (MedMaleDE)
The Medication Management Instrument for Deficiencies in the Elderly (MedMalDE), assesses for three domains: (1) what the person knows about their medications; (2) whether a person knows how to take their medications; and (3) whether the person knows how to get their medications.
Measured: Six months
Satisfaction Survey
Patient participants will complete a brief satisfaction survey at their last follow-up assessment to learn more about their experience participating in this research project and to learn about why they chose to participate in this research project.
Measured: Six months
Caregiver Qualitative Interview
A random selection of patient participants will participate in a one-hour interview with a study GRA at the end of the project. The focus of the interview is to learn more about their experience participating in this project, and to get their perspective on how it has benefited/or not benefited them.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start19 May 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital ReadmissionsStudies of the same condition, open and under way.
- More trials run by University of South 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Tampa General Hospital, Lakeland Regional Health Medical Center, AdventHealth
- Responsible party
- Sponsor
- Investigators
- Amber M Gum, Phd, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981977
- Sponsor's protocol ID
- STUDY002687
- Other IDs
- AD-2019C1-16066
- Status last verified
- Feb 2025
- First submitted
- 19 Jul 2021
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of The Evidence-Based Care Transitions Intervention Enhanced With Peer Support to Reduce Racial Disparities in Hospital Readmissions and Negative Outcomes Post Hospitalization
- ClinicalTrials.gov ID
- NCT04981977
- Acronym / sponsor ID
- STUDY002687
- Conditions
- Hospital Readmissions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 483 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Tampa General Hospital, Lakeland Regional Health Medical Center, AdventHealth
- Study start
- 19 May 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 29 Jul 2021 (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.
Unplanned hospital readmissions are extremely costly to patients and our healthcare system. Being readmitted to the hospital also leads to increased risk of health complications for patients including infections and impairments in functioning. Hospital readmissions are particularly common among older adults. Further, racial/ethnic disparities are evident in readmission rates and are the greatest among African American and Latino/Hispanic older adults. Effective, sustainable, and culturally appropriate interventions to improve outcomes, reduce unplanned hospital readmissions, and reduce health disparities are urgently needed. The proposed randomized controlled trial will evaluate the effectiveness of a novel transitional care strategy designed to avoid unplanned hospital readmissions and improve patient health outcomes in a racially/ethnically diverse sample of older adults who have been admitted to the hospital due to a chronic health condition.
Eric Coleman's Care Transitions Intervention (CTI) has been identified as the strategy most successfully implemented and evaluated in multiple settings and systems of care. CTI has been shown to reduce hospital readmissions for non-Hispanic White older adults, however its' effects have not been as strong for minority older adults in some studies and research trials have not recruited a sufficient number of racial/ethnic minorities to examine outcomes by race or ethnicity. Thus, it is unknown whether CTI is effective for racial/ethnic minority older adults who suffer disproportionately high readmission rates. Further, studies of transitions interventions suggest that older adult and racial/ethnic minority patients require additional assistance and support during transitions in care. The researchers hypothesize the addition of peer support will enhance and maximize the benefit of the CTI and increase its' cultural sensitivity and future sustainability.
The proposed 3-arm trial is designed to evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), as compared to usual care (UC), on unplanned all-cause hospital readmissions occurring within 6 months (assessed at 30 days, 90 days and 6 months) and secondary health system (i.e., ED visits) and patient-centered outcomes (i.e., self-efficacy managing chronic disease, quality of life, functional status and mortality) among 402 hospitalized African American and Latino/Hispanic older adults (age 60+) who have a chronic physical illness (e.g., cardiovascular disease, diabetes, COPD) and are being discharged from the hospital back to the community.
Detailed description
Unplanned hospital readmissions represent a critical failure of the healthcare system, perpetuate health disparities, and are the single largest driver of excess healthcare costs. For patients, hospital readmission increases risk for complications, infections, and functional impairment. Hospital readmissions are particularly prevalent among older adults. Further, racial/ethnic disparities in readmission rates are profound and are the greatest among African American and Latino/Hispanic older adults. Effective, sustainable and culturally appropriate interventions to improve outcomes, reduce un-planned hospital readmissions, and reduce health disparities are urgently needed. The proposed randomized controlled trial will evaluate the effectiveness of a novel transitional care strategy designed to avert un-planned hospital readmissions and improve patient health outcomes in a high-risk and under studied population of medically hospitalized African American and Latino/Hispanic older adults (age 60+). Transitional care strategies are interventions initiated before hospital discharge with the aim of ensuring the safe and effective transition of patients from the acute hospital setting to home. Of all the transitional care interventions tested, Eric Coleman's Care Transitions Intervention (CTI) has been identified as the strategy most successfully implemented and evaluated in multiple settings and systems of care. CTI is a non-clinical coaching strategy that occurs in the hospital, home, and via telephone for 28 days post-discharge.
CTI has been shown to reduce hospital readmissions for non-Hispanic White older adults, however intervention effects have been mixed for minority older adults and effectiveness trials have not recruited a sufficient number of racial/ethnic minorities to examine race or ethnicity specific outcomes. Thus, it is unclear whether CTI is effective for racial/ethnic minority older adults who suffer disproportionately high readmission rates. Further, studies of transitions interventions suggest that older adult and racial/ethnic minority patients require additional assistance and support during transitions in care. To address this gap, the researchers propose to add peer support (PS) to the CTI to enhance its effectiveness among high-risk populations of racial/ethnic minority older adults. The researchers believe the addition of peer support will enhance and maximize the benefit of the CTI and increase its' cultural sensitivity and future sustainability. The proposed 3-arm trial is designed to evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), as compared to usual care (UC), on all cause unplanned hospital readmissions occurring within 6 months (assessed at 30 days, 90 days and 6 months) and secondary health system (i.e., ED visits) and patient-centered outcomes (i.e., self-efficacy managing chronic disease, quality of life, functional status and mortality) among 402 hospitalized African American and Latino/Hispanic older adults (age 60+) who have a chronic physical illness (e.g., cardiovascular disease, diabetes, COPD) and are being discharged from the hospital back to the community. The researchers will also maximize the uniquely diverse sample to explore potential mediators and moderators of intervention effects. The researchers will further conduct semi-structured interviews with patients (n=48) and caregivers (n=24) to qualitatively examine mechanisms impacting readmission risk and patient-centered outcomes post discharge. The researchers will utilize multi-methods to triangulate and contextualize the findings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Care Transitions Intervention | Experimental | Behavioral: Care Transitions InterventionPatient participants in this arm will receive the Care Transition Intervention. |
| Care Transition Intervention and Peer Support | Experimental | Behavioral: Care Transitions Intervention and Peer SupportPatient participants in this arm will receive the Care Transition Intervention. |
| Usual Care | Other | Other: Usual CarePatient participants in this arm will receive the usual discharge/transition care provided by the hospital. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are aged 60+
- Identify as African American or Latino/Hispanic (any race)
- Are being discharged from one of our three hospital partners to home with no planned readmissions
- Have access to a household telephone or cellphone
- Speak English or Spanish
Key exclusion criteria (8 listed)
- Are younger than age 60
- Identify as any race/ethnicity other than African American or Latino/Hispanic
- Are being discharged with a condition that has planned readmission (e.g. transplant patient, chemotherapy etc.)
- Are permanent residents of a skilled nursing facility, receiving hospice service, or are being discharged to a long-term care facility
- Have a comorbid substance use disorder
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 InterventionAlso: CTICTI is delivered by a trained Care Transitions Coach (Coach) who works closely with patients to ensure a smooth transition from hospital to home following an acute hospitalization. The patient, caregiver, and Coach work together to maximize the involvement of interdisciplinary experts, ensuring that the appropriate professionals are involved, issues are addressed, goals are understood, and the discharge care plan is executed correctly. There are three aspects to CTI; the first is the initial hospital visit, followed by an in-home visit, concluding with telephone follow-up over a 28-day period. During these visits, the Coach focuses on four conceptual areas, referred to as pillars (i.e., Personal Health Record, Medication Management, Red Flags, and Physician Follow up). The Coach ensures the patient understands and utilizes the Personal Health Record to facilitate communication and ensure continuity of care plan across providers and settings. | Behavioural | Care Transitions Intervention |
| Care Transitions Intervention and Peer SupportAlso: CTI + PSThe PS intervention for this study is based upon the principles of motivational interviewing, which is a person-centered, goal-directed method to enhance intrinsic motivation for change by exploring and resolving ambivalence. A recent meta-analysis found the mean effect size for MI to be significantly larger for racial and ethnic minority samples (0.79 vs. 0.26) as compared to non-Hispanic Whites, highlighting its potential benefit and cultural relevance for minority populations. Patients in this arm of the study will receive the 28-day CTI intervention with a 2-month long Peer Support (PS) intervention provided by trained peer educators (PEs). | Behavioural | Care Transition Intervention and Peer Support |
| Usual CareAlso: UCThe researchers will follow a control group of patients who meet study inclusion criteria. These older adults will participate in the traditional discharge case-management offered by the hospital where they were admitted and discharged. UC at our three partner hospitals consists of: (1) routine inpatient nurse intake that includes screening about housing, substance abuse, and functional status; (2) medication reconciliation performed by treating practitioners; (3) discharge patient education provided by inpatient nurses; (4) a list of resources for safety-net clinics and community-based services; and (5) for patients with severe chronic illness (e.g. heart failure) there may be a planned home visit by a nurse practitioner. | Other | Usual Care |
Primary outcome
Unplanned All-Cause Hospital Readmissions
Time frame: 30 days
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned all-cause hospital readmissions using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).
Unplanned All-Cause Hospital Readmissions
Time frame: Three months
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned all-cause hospital readmissions using data from the Florida Health Information Exchange (HI
Unplanned All-Cause Hospital Readmissions
Time frame: Six months
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned all-cause hospital readmissions using data from the Florida Health Information Exchange (HI
Related Secondary Health-System Visits (i.e., ED Visits)
Time frame: 30 days
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned related secondary health-system visits using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).
Related Secondary Health-System Visits (i.e., ED Visits)
Time frame: Three months
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned related secondary health-system visits using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).
Related Secondary Health-System Visits (i.e., ED Visits)
Time frame: Six months
The researchers will evaluate the Care Transitions Intervention (CTI) and CTI + Peer Support (PS), compared to usual care (UC), on the primary outcome of unplanned related secondary health-system visits using data from the Florida Health Information Exchange (HIE) Services Electronic Notification System (ENS).
22 secondary outcomes
Demographic Questionnaire
Time frame: At time of enrollment/Baseline
Care Transitions Measure (CTM-3)
Time frame: 30 days
Care Transitions Measure (CTM-3)
Time frame: Three months
Care Transitions Measure (CTM-3)
Time frame: Six months
Self-Efficacy (SES-6)
Time frame: Baseline
Self-Efficacy (SES-6)
Time frame: 30
Self-Efficacy (SES-6)
Time frame: Three months
Self-Efficacy (SES-6)
Time frame: Six months
Medical Outcomes Study Short Form (MOS SF-36)
Time frame: Baseline
Medical Outcomes Study Short Form (MOS SF-36)
Time frame: 30 days
Medical Outcomes Study Short Form (MOS SF-36)
Time frame: Three months
Medical Outcomes Study Short Form (MOS SF-36)
Time frame: Six months
Quality of Life (WHOQOL-BRIEF)
Time frame: Baseline
Quality of Life (WHOQOL-BRIEF)
Time frame: 30 days
Quality of Life (WHOQOL-BRIEF)
Time frame: Three months
Quality of Life (WHOQOL-BRIEF)
Time frame: Six months
Medication Management (MedMaleDE)
Time frame: Baseline
Medication Management (MedMaleDE)
Time frame: 30 days
Medication Management (MedMaleDE)
Time frame: Three months
Medication Management (MedMaleDE)
Time frame: Six months
Satisfaction Survey
Time frame: Six months
Caregiver Qualitative Interview
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Amber M Gum, Phd principal investigator
University of South Florida
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 and Care Transitions Intervention and Peer Support in people with Hospital Readmissions, run by University of South Florida 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 6 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Unplanned All-Cause Hospital Readmissions (time frame: 30 days). The study lists 6 primary outcomes in all. 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 7 Feb 2025.