Care TransitionNCT07661355
Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers
A study testing Patient-Centered Program and Family Caregiver Enhanced Program in people with Care Transition, run by Wake Forest University Health Sciences at 4 sites in United States.
Trial summary
This study investigates better ways to help people after they leave the hospital and how to involve their families in this process. The main goal is to see if adding family support to a patient-centered hospital-to-home intervention helps patients stay safely at home, spend fewer days back in the emergency room or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Care Transition
- What is being tested?
- Patient-Centered Program and Family Caregiver Enhanced Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,560 participants
- Where
- 4 sitesUnited States
- Study dates
- 22 Jul 2026to Nov 2031
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Patient Inclusion Criteria:
- 65 and older
- English and Spanish speaking
- Preadmission location: community dwelling
- Distance from Hospital: Local and Distant (rural) included
- Cognitive impairment, dementia allowed
- Technology Literacy: Flexible from high to low
- EPIC readmission risk score over 12
- Discharged home
Patient Exclusion Criteria:
- Admitted from skilled nursing facility
- Discharged to skilled nursing facility
- Left Against Medical Advice (AMA)
- Planned readmission
- Died during index admission
- Caregiver unwilling to participate
- Admitted to surgical services
Caregiver Inclusion Criteria:
- Adults 18 and older
- English and Spanish speaking
- Providing tangible support to patient
- Distance from Hospital: Local and Distant (rural) included
- Only Mild Cognitive Impairment allowed
- Able to be trained in Video Visit Technology
- Available to support post-discharge
Caregiver Exclusion Criteria:
- Has a greater than a mild cognitive impairment (< 12 on MoCA)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Davie Medical Center
Bermuda Run, North Carolina, 27006
Houston, 508-688-4341, Thomas.Houston@advocatehealth.org
- Recruiting
High Point Medical Center
High Point, North Carolina, 27262
Houston, 508-688-4341, Thomas.Houston@advocatehealth.org
- Recruiting
Atrium Health Wake Forest Baptist Wilkes Medical Center
North Wilkesboro, North Carolina, 28659
Houston, 508-688-4341, Thomas.Houston@advocatehealth.org
- Recruiting
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Houston, 508-688-4341, Thomas.Houston@advocatehealth.org
About this study
This study investigates better ways to help people after they leave the hospital and how to involve their families in this process. The main goal is to see if adding family support to a patient-centered hospital-to-home intervention helps patients stay safely at home, spend fewer days back in the emergency room or going back into the hospital. The study team also wants to see if the family-centered approach helps improve the patient's ability to do everyday activities without feeling overwhelmed. Two approaches are being compared: one focuses just on the patient, and the other includes special strategies to better support families involved too. Family will be involved in assessing what the patient and family needs. The family-focused approach not only emphasizes the experience, health, and safety of the patient but also the experience of the family member caring for the older adult. The study also involves families in education and provides families skills-building experiences that can help with caregiving stress, problem-solving, and communicating with the healthcare team. The approach will help the family member prepare for their loved one's transition home and provide coaching with the goal of reducing the mental, physical and financial burden of providing care at home. To spread the intervention across many states, the study team will be using telephone calls, video calls, and other technologies as families prefer.
Read the detailed description
For all patients, the transition from hospital to home is a vulnerable period, placing them at great risk for adverse events. In a landmark 2003 report on care transitions, investigators found that 19% of patients experience adverse events soon after discharge (many preventable or ameliorable) and 66% experience adverse drug events. Care transitions also impact those around the recently discharged patient - increasing the burden on family members who provide caregiving support. Without communication and engagement in care transitions, family members experience reduced preparedness for their post-discharge caregiving role, increased caregiver burden, social isolation, and reduced mental/physical well-being.
Patient-centered care transitions can be supported through evidence-based interventions. Recent knowledge generated through PCORI's Transitional Care Evidence to Action Network and other research programs has identified remaining evidence gaps. This Phased Large Award for Comparative Effectiveness Research entitled Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers will create new knowledge related to engaging and supporting family caregivers. After optimization in the feasibility phase, briefly, the Phase 2 comparative effectiveness trial will have the following characteristics:
Setting: 20 Acute Care Hospitals across 5 states selected for rural/urban diversity and patient characteristics Sample: Dyads: Older Adults (N = 1,200) discharged to home and their Family Caregivers (N = 1,200)
Comparators:
Comparator A is an active care transition program that includes effective strategies focused on the patient.
Comparator B includes all Comparator A active strategies, plus focused family caregiver engagement and support.
Randomization:
1:1 Dyad-level RCT stratified by rural/urban home setting and presence of patient cognitive impairment
Patient-Centered Outcomes Include: Patient remaining safely at home (60-day hospital free days), post-discharge adverse events, patient-reported outcomes (e.g.: role functioning). Also, this study extends beyond prior effectiveness research by assessing family-caregiver-reported outcomes (e.g.: caregiver burden).
- Conditions
- Care Transition
- Being tested
- Patient-Centered Program, Family Caregiver Enhanced Program
- Keywords
- hospitalization, older adults, aging, care transition, mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Centered ProgramOther
Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.
Family Caregiver Enhanced ProgramOther
Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.
| Study group | Role | What they receive |
|---|---|---|
| Patient Focused Strategies | Active comparator | An active care transition program that includes effective strategies focused on the patient. Receives: Other: Patient-Centered Program |
| Patient and Family Focused Strategies | Experimental | An active care transition program that includes effective strategies focused on the patient plus focused family caregiver engagement and support. Receives: Other: Patient-Centered Program; Other: Family Caregiver Enhanced Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-Free Days
The count of days alive and outside acute care hospitals from discharge to day 60. It will be calculated using EHR and Medicare claims data to objectively capture hospital free days elements (i.e.: mortality days, inpatient days, observation stays, and ED visits).
Measured: Day 60
Secondary outcomes (19)
Number of Hospital-Free Days
The count of days alive and outside acute care hospitals from discharge to a specified day. It will be calculated using EHR and Medicare claims data to objectively capture hospital free days elements (i.e.: mortality days, inpatient days, observation stays, and ED visits).
Measured: Day 30, 90, and 180
Number of Patient Readmissions
All-cause, acute care readmissions calculated as both a count and dichotomous using EHR and Medicare claims data.
Measured: Day 30, 60, and 90
Zarit Burden Interview Score
Caregiver burden will be measured using the 12-item Zarit Burden Interview. Scores will range from 0 to 48. Higher scores indicate greater burden.
Measured: Day 60
Zarit Burden Interview Score
Caregiver burden will be measured using the 12-item Zarit Burden Interview. Scores will range from 0 to 48. Higher scores indicate greater burden.
Measured: Day 30, 90, and 180
PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score
Social role function is one's ability to perform usual social roles and activities (e.g.: leisure, family). It will be measured by using the APS-SF8. Each item is scored using a 5-point Likert scale (1=Never, 5=Always). Scores are typically converted to a standardized T-score, with a mean of 50 and a standard deviation of 10.
Measured: Day 60
PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score
Social role function is one's ability to perform usual social roles and activities (e.g.: leisure, family). It will be measured by using the APS-SF8. Each item is scored using a 5-point Likert scale (1=Never, 5=Always). Scores are typically converted to a standardized T-score, with a mean of 50 and a standard deviation of 10.
Measured: Day 30, 90 and 180
Partners at Care Transitions Measure (PACT-M) - Patient Satisfaction Score
Patient satisfaction will be measured using the 9-item PACT-M-1. Scores will range from 9 to 45. Higher scores indicate better perception of the quality of discharge arrangements.
Measured: Day 7
Partners at Care Transitions Measure (PACT-M) - Patient Self-Efficacy Score
Patient self-efficacy will be measured using the 8-item PACT-M-2. Scores will range from 8 to 40. Higher scores indicate a better experience with managing care at home.
Measured: Day 30
Patient Activation Measures Score
Patient activation will be measured using the 13-item Patient Activation Measures. Scores will range from 0 to 100. Higher scores indicate greater knowledge, skills, and confidence for managing their health and health care.
Measured: Day 60
Preparedness for Caregiving Scale Score
Family caregiver preparedness will be measured using the 8-item Preparedness for Caregiving Scale. Scores will range from 0 to 32. Higher scores indicate better preparedness for the caregiving role.
Measured: Day 7
Caregiver Self-Efficacy Scale Score
Family caregiver self-efficacy will be measured using the 8-item Caregiver Self-Efficacy Scale. Scores will range from 8 to 80. Higher scores indicate higher self-efficacy.
Measured: Day 30
Caregiver Activation Measures Score
Patient activation will be measured using the 13-item Caregiver Activation Measures. Scores will range from 0 to 100. Higher scores indicate greater knowledge, skills, and confidence for managing their health and health care.
Measured: Day 60
Visit Completion Rate
Number of patients that completed follow-up visit
Measured: Day 14 and 30
Time to First Outpatient Follow-up
Number of days between discharge and first outpatient follow-up visit
Measured: Day 14 and 30
Rate of Access to Community Services - Patient
Number of patients that had screening and intervention assessment for unmet social needs.
Measured: Day 30 and 60
Rate of Access to Community Services - Caregiver
Number of caregivers that had screening and intervention assessment for unmet social needs
Measured: Day 30 and 60
Partners at Care Transitions Measures - Adverse Events Score
Adverse events will be measured using the 7-item Partners at Care Transitions Measures. Scores will range from 7 to 30. Higher scores indicate greater care problems and more adverse events post discharge.
Measured: Day 7 and 30
Mortality Rate
Count of days to date of patient death
Measured: Day 60 and 180
Montreal Cognitive Assessment 5-minute Protocol Score
Cognitive function (attention, orientation, language, memory, and executive function) will be measured using the Montreal Cognitive Assessment 5-min protocol. Scores will range from 0 to 30. Higher scores indicate better cognitive function.
Measured: Day 0, 60, and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start22 Jul 2026
- Primary completionNov 2031 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care TransitionStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Thomas Houston, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661355
- Sponsor's protocol ID
- IRB00145199
- Other IDs
- PLACER-2025C1-43844
- Status last verified
- May 2026
- First submitted
- 16 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT07661355
- Acronym / sponsor ID
- IRB00145199
- Conditions
- Care Transition
- Keywords
- hospitalization, older adults, aging, care transition, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,560 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 22 Jun 2026 (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 study investigates better ways to help people after they leave the hospital and how to involve their families in this process. The main goal is to see if adding family support to a patient-centered hospital-to-home intervention helps patients stay safely at home, spend fewer days back in the emergency room or going back into the hospital. The study team also wants to see if the family-centered approach helps improve the patient's ability to do everyday activities without feeling overwhelmed. Two approaches are being compared: one focuses just on the patient, and the other includes special strategies to better support families involved too. Family will be involved in assessing what the patient and family needs. The family-focused approach not only emphasizes the experience, health, and safety of the patient but also the experience of the family member caring for the older adult. The study also involves families in education and provides families skills-building experiences that can help with caregiving stress, problem-solving, and communicating with the healthcare team. The approach will help the family member prepare for their loved one's transition home and provide coaching with the goal of reducing the mental, physical and financial burden of providing care at home. To spread the intervention across many states, the study team will be using telephone calls, video calls, and other technologies as families prefer.
Detailed description
For all patients, the transition from hospital to home is a vulnerable period, placing them at great risk for adverse events. In a landmark 2003 report on care transitions, investigators found that 19% of patients experience adverse events soon after discharge (many preventable or ameliorable) and 66% experience adverse drug events. Care transitions also impact those around the recently discharged patient - increasing the burden on family members who provide caregiving support. Without communication and engagement in care transitions, family members experience reduced preparedness for their post-discharge caregiving role, increased caregiver burden, social isolation, and reduced mental/physical well-being.
Patient-centered care transitions can be supported through evidence-based interventions. Recent knowledge generated through PCORI's Transitional Care Evidence to Action Network and other research programs has identified remaining evidence gaps. This Phased Large Award for Comparative Effectiveness Research entitled Comparing Two Acute Care Transition Programs for Older Adults and Their Family Caregivers will create new knowledge related to engaging and supporting family caregivers. After optimization in the feasibility phase, briefly, the Phase 2 comparative effectiveness trial will have the following characteristics:
Setting: 20 Acute Care Hospitals across 5 states selected for rural/urban diversity and patient characteristics Sample: Dyads: Older Adults (N = 1,200) discharged to home and their Family Caregivers (N = 1,200)
Comparators:
Comparator A is an active care transition program that includes effective strategies focused on the patient.
Comparator B includes all Comparator A active strategies, plus focused family caregiver engagement and support.
Randomization:
1:1 Dyad-level RCT stratified by rural/urban home setting and presence of patient cognitive impairment
Patient-Centered Outcomes Include: Patient remaining safely at home (60-day hospital free days), post-discharge adverse events, patient-reported outcomes (e.g.: role functioning). Also, this study extends beyond prior effectiveness research by assessing family-caregiver-reported outcomes (e.g.: caregiver burden).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Focused Strategies | Active comparator | Other: Patient-Centered ProgramAn active care transition program that includes effective strategies focused on the patient. |
| Patient and Family Focused Strategies | Experimental | Other: Patient-Centered Program, Other: Family Caregiver Enhanced ProgramAn active care transition program that includes effective strategies focused on the patient plus focused family caregiver engagement and support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Patient-Centered ProgramEffective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments. | Other | Patient Focused Strategies, Patient and Family Focused Strategies |
| Family Caregiver Enhanced ProgramCaregiver strategies such as a family caregiver needs assessment, structured education, and skill building. | Other | Patient and Family Focused Strategies |
Primary outcome
Hospital-Free Days
Time frame: Day 60
The count of days alive and outside acute care hospitals from discharge to day 60. It will be calculated using EHR and Medicare claims data to objectively capture hospital free days elements (i.e.: mortality days, inpatient days, observation stays, and ED visits).
19 secondary outcomes
Number of Hospital-Free Days
Time frame: Day 30, 90, and 180
Number of Patient Readmissions
Time frame: Day 30, 60, and 90
Zarit Burden Interview Score
Time frame: Day 60
Zarit Burden Interview Score
Time frame: Day 30, 90, and 180
PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score
Time frame: Day 60
PROMIS Ability to Participate in Social Roles and Activities 8-item short form (APS-SF8) Score
Time frame: Day 30, 90 and 180
Partners at Care Transitions Measure (PACT-M) - Patient Satisfaction Score
Time frame: Day 7
Partners at Care Transitions Measure (PACT-M) - Patient Self-Efficacy Score
Time frame: Day 30
Patient Activation Measures Score
Time frame: Day 60
Preparedness for Caregiving Scale Score
Time frame: Day 7
Caregiver Self-Efficacy Scale Score
Time frame: Day 30
Caregiver Activation Measures Score
Time frame: Day 60
Visit Completion Rate
Time frame: Day 14 and 30
Time to First Outpatient Follow-up
Time frame: Day 14 and 30
Rate of Access to Community Services - Patient
Time frame: Day 30 and 60
Rate of Access to Community Services - Caregiver
Time frame: Day 30 and 60
Partners at Care Transitions Measures - Adverse Events Score
Time frame: Day 7 and 30
Mortality Rate
Time frame: Day 60 and 180
Montreal Cognitive Assessment 5-minute Protocol Score
Time frame: Day 0, 60, and 180
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 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Care Transition
Active, not recruiting
Aim 3: Pilot Study of a Serious Game to Promote Transition Readiness Skills
Serious Games, Transition-age Youth
Not yet recruiting
Optimizing Care Transitions in CHD
Congenital Heart Disease (CHD), Mentorship
Recruiting
Wichitasowin: Indigenous Patient Navigator for Young Adults Study
Chronic Diseases in Adolescence
Enrolling by invitation
Attitudes, Experience and Adaptation to Family Presence in the ICU
ICU Staff Attitudes Toward Family Presence, ICU Staff Experience of Family Presence
Recruiting
COordiNated CommuNication, Education, and Care Transitions After Acute Kidney Injury (CONNECT-AKI)
Acute Kidney Injury, Acute Kidney Injury (AKI)
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.
Thomas Houston, MD principal investigator
Wake Forest University Health Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Centered Program and Family Caregiver Enhanced Program in people with Care Transition, run by Wake Forest University Health Sciences at 4 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?
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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Contact Michiyah Kimber (336-716-5719, michiyah.kimber@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-Free Days (time frame: Day 60). 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 21 Sep 2026.