MultimorbidityNCT07157982
Living With Multimorbidity: Care Coordination and Symptom Management Program (COORDINATE)
A study testing COORDINATE Program in people with Multimorbidity, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a new care program, called the COORDINATE Program, can help older adults with two or more chronic health conditions. These individuals are being discharged from special hospital units called Intermediate Care Units (IMCUs), which care for people who are very sick but… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- COORDINATE Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to Mar 2028
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 50 years and older
- living with two or more chronic health conditions as identified by diagnosis in the electronic health record
- medically complex patients defined as those admitted to intermediate care units
- have a working telephone or contact method.
Who cannot join
- cannot provide informed consent
- non-English speakers
- incapacitated or have documented cognitive impairment
- are in hospice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Johns Hopkins Health System
Baltimore, Maryland, 21205
About this study
The goal of this clinical trial is to learn if a new care program, called the COORDINATE Program, can help older adults with two or more chronic health conditions. These individuals are being discharged from special hospital units called Intermediate Care Units (IMCUs), which care for people who are very sick but don't need intensive care.
The main questions this study wants to answer are:
Read more
- Can the COORDINATE Program improve participants' quality of life?
- Can the program reduce emergency visits, intensive care admissions, and rehospitalizations?
Researchers will compare the COORDINATE Program to the enhanced usual care with extra support to see if it works better. Participants will receive either the COORDINATE Program or enhanced usual care. They will also complete surveys at three different time points: before starting the intervention, at 3 months, and at 12 months.
For those in the COORDINATE Program group, a trained nurse will guide them through:
- A needs assessment to find out what matters most to them
- A list of helpful questions to ask their care team
- Goal-setting to support managing their conditions
- Tracking their symptoms and progress
- Attend a discharge visit and have 5 follow-up phone or video calls over 3 months
Participants in both groups will be compensated for completing the surveys. The study hopes to improve how care is given to older adults with complex health needs and reduce unnecessary hospital visits.
Read the detailed description
This study is a single-blind, two-arm randomized controlled trial (RCT) conducted at Johns Hopkins Health System IMCUs to pilot test the Care Coordination and Symptom Management (COORDINATE) Program, a multicomponent care coordination and symptom management program. The participants will be randomized 1:1 into either the COORDINATE intervention group or the enhanced usual care group. Follow-up assessments will occur at 3 and 12 months post-discharge.
Intervention Participants in the COORDINATE group will receive a structured, nurse-led intervention beginning after randomization and extending through 3 months post-discharge. The program consists of: Needs Assessment, Question Prompt List, Goals of Care Discussion, and Symptom Assessment and Tracking.
Enhanced Usual Care Participants in the enhanced usual care group receive enhanced usual care, which includes standard discharge teaching and follow-up planning by hospital staff. In addition, they are provided with a multimorbidity management toolkit developed during the co-design phase, covering communication strategies, care coordination, and resource access. A nurse also conducts discharge check-ins and follow-up calls, but without the structured components of the COORDINATE program.
- Conditions
- Multimorbidity
- Being tested
- COORDINATE Program, Enhanced Usual Care
- Keywords
- Continuity of Patient Care, Hospital to Home Transition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COORDINATE ProgramBehavioural
Also called Care Coordination and Symptom Management Program (COORDINATE)
The COORDINATE Program is a nurse-led, multicomponent intervention designed to support older adults with multiple chronic conditions during their transition from hospital to home. The intervention is delivered over a 3-month period and includes the following components:
- Discharge Planning Visit: Conducted in person or via video, this session includes a needs assessment and shared decision-making conversation to identify participants' values and preferences.
- Question Prompt List: A tailored list of questions is provided to help participants engage more effectively with their care team.
- Goal Setting: Participants work with a nurse to identify short-term goals and action steps related to their health and care needs.
- Symptom Monitoring: Participants track symptoms weekly using a symptom checklist to support ongoing management and communication with providers.
Enhanced Usual CareBehavioural
Participants in this arm will receive enhanced usual care, which includes standard discharge instructions, scheduled check-ins, and a resource toolkit with educational materials. The content includes guidance on symptom management, advance care planning, and available community resources. Participants will receive follow-up reminders and wellness checks but will not receive the structured, nurse-led intervention provided in the COORDINATE Program.
| Study group | Role | What they receive |
|---|---|---|
| COORDINATE Program Intervention | Experimental | Participants receive the nurse-led COORDINATE Program, a nurse-led structured intervention focused on transitional care, including a discharge planning visit (pre-discharge and/or within 48 hours of discharge) and follow-ups at 1 week, 4 weeks, 6 weeks, and 3 months. Receives: Behavioral: COORDINATE Program |
| Enhanced Usual Care | Other | Participants receive enhanced usual care, including standard discharge teaching, a multimorbidity management toolkit, and follow-up check-ins. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Health-related Quality of Life as Measured by the EuroQoL at 3 months
Health-related quality of life will be assessed using the EuroQoL, a widely used questionnaire that helps measure a person's overall health and quality of life. It asks about five key areas: 1) Mobility, 2) Self-care, 3) Usual daily activities, 4) Pain or discomfort, and 5) Anxiety or depression. It also includes a rating scale (0 to 100) where people mark their overall health, 0 means the worst health you can imagine, and 100 means the best.
Measured: Baseline and 3 months post-discharge
Change from Baseline in Quality of Life as Measured by the EuroQoL at 12 Months
Health-related quality of life will be assessed using the EuroQoL, a widely used questionnaire that helps measure a person's overall health and quality of life. It asks about five key areas: 1) Mobility, 2) Self-care, 3) Usual daily activities, 4) Pain or discomfort, and 5) Anxiety or depression. It also includes a rating scale (0 to 100) where people mark their overall health, 0 means the worst health you can imagine, and 100 means the best.
Measured: Baseline and 12 months post-discharge
Secondary outcomes (6)
Difference in Number of Emergency Department Visits from Discharge to 3 Months Between the COORDINATE Program and Enhanced Usual Care
Emergency department (ED) visits will be tracked from hospital discharge through 3 months. Data will be collected from electronic health records and participant reports to evaluate differences between the COORDINATE Program and enhanced usual care.
Measured: Immediately hospital discharge to 3 months post-discharge
Difference in Number of Emergency Department Visits from Discharge to 12 Months Between the COORDINATE Program and Enhanced Usual Care
Emergency department (ED) visits will be tracked from hospital discharge through 12 months. Data will be collected from electronic health records and participant reports to evaluate differences between the COORDINATE Program and enhanced usual care.
Measured: Immediately hospital discharge to 12 months post-discharge
Difference in Number of Critical Care Admissions from Discharge to 3 Months Between the COORDINATE Program and Enhanced Usual Care
Critical care admissions, including ICU stays, will be measured from the time of discharge to 3 months post-discharge. This outcome will be used to assess whether the COORDINATE Program reduces the frequency of critical care admissions compared to enhanced usual care.
Measured: Immediately hospital discharge to 3 months post-discharge
Difference in Number of Critical Care Admissions from Discharge to 12 Months Between the COORDINATE Program and Enhanced Usual Care
Critical care admissions, including ICU stays, will be measured from the time of discharge to 12 months post-discharge. This outcome will be used to assess whether the COORDINATE Program reduces the frequency of critical care admissions compared to enhanced usual care.
Measured: Immediately hospital discharge to 12 months post-discharge
Difference in Number of All-Cause Rehospitalizations from Discharge to 3 Months Between the COORDINATE Program and Enhanced Usual Care
All-cause rehospitalizations will be recorded for each participant from discharge to 3 months. Data will be used to assess the impact of the COORDINATE Program on reducing readmission rates.
Measured: Immediately hospital discharge to 3 months post-discharge
Difference in Number of All-Cause Rehospitalizations from Discharge to 12 Months Between the COORDINATE Program and Enhanced Usual Care
All-cause rehospitalizations will be recorded for each participant from discharge to 12 months. Data will be used to assess the impact of the COORDINATE Program on reducing readmission rates.
Measured: Immediately hospital discharge to 12 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start27 Jul 2026
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binu Koirala, PhD, MGS, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157982
- Sponsor's protocol ID
- IRB00500267
- Status last verified
- Jul 2026
- First submitted
- 28 Aug 2025
- Last updated
- 29 Jul 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Multimorbidity: Care Coordination and Symptom Management Program (COORDINATE)
- ClinicalTrials.gov ID
- NCT07157982
- Acronym / sponsor ID
- IRB00500267
- Conditions
- Multimorbidity
- Keywords
- Continuity of Patient Care, Hospital to Home Transition
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Sep 2025 (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.
The goal of this clinical trial is to learn if a new care program, called the COORDINATE Program, can help older adults with two or more chronic health conditions. These individuals are being discharged from special hospital units called Intermediate Care Units (IMCUs), which care for people who are very sick but don't need intensive care.
The main questions this study wants to answer are:
- Can the COORDINATE Program improve participants' quality of life?
- Can the program reduce emergency visits, intensive care admissions, and rehospitalizations?
Researchers will compare the COORDINATE Program to the enhanced usual care with extra support to see if it works better. Participants will receive either the COORDINATE Program or enhanced usual care. They will also complete surveys at three different time points: before starting the intervention, at 3 months, and at 12 months.
For those in the COORDINATE Program group, a trained nurse will guide them through:
- A needs assessment to find out what matters most to them
- A list of helpful questions to ask their care team
- Goal-setting to support managing their conditions
- Tracking their symptoms and progress
- Attend a discharge visit and have 5 follow-up phone or video calls over 3 months
Participants in both groups will be compensated for completing the surveys. The study hopes to improve how care is given to older adults with complex health needs and reduce unnecessary hospital visits.
Detailed description
This study is a single-blind, two-arm randomized controlled trial (RCT) conducted at Johns Hopkins Health System IMCUs to pilot test the Care Coordination and Symptom Management (COORDINATE) Program, a multicomponent care coordination and symptom management program. The participants will be randomized 1:1 into either the COORDINATE intervention group or the enhanced usual care group. Follow-up assessments will occur at 3 and 12 months post-discharge.
Intervention Participants in the COORDINATE group will receive a structured, nurse-led intervention beginning after randomization and extending through 3 months post-discharge. The program consists of: Needs Assessment, Question Prompt List, Goals of Care Discussion, and Symptom Assessment and Tracking.
Enhanced Usual Care Participants in the enhanced usual care group receive enhanced usual care, which includes standard discharge teaching and follow-up planning by hospital staff. In addition, they are provided with a multimorbidity management toolkit developed during the co-design phase, covering communication strategies, care coordination, and resource access. A nurse also conducts discharge check-ins and follow-up calls, but without the structured components of the COORDINATE program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COORDINATE Program Intervention | Experimental | Behavioral: COORDINATE ProgramParticipants receive the nurse-led COORDINATE Program, a nurse-led structured intervention focused on transitional care, including a discharge planning visit (pre-discharge and/or within 48 hours of discharge) and follow-ups at 1 week, 4 weeks, 6 weeks, and 3 months. |
| Enhanced Usual Care | Other | Behavioral: Enhanced Usual CareParticipants receive enhanced usual care, including standard discharge teaching, a multimorbidity management toolkit, and follow-up check-ins. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 50 years and older
- living with two or more chronic health conditions as identified by diagnosis in the electronic health record
- medically complex patients defined as those admitted to intermediate care units
- have a working telephone or contact method.
Key exclusion criteria (4 listed)
- cannot provide informed consent
- non-English speakers
- incapacitated or have documented cognitive impairment
- are in hospice
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 |
|---|---|---|
| COORDINATE ProgramAlso: Care Coordination and Symptom Management Program (COORDINATE)The COORDINATE Program is a nurse-led, multicomponent intervention designed to support older adults with multiple chronic conditions during their transition from hospital to home. The intervention is delivered over a 3-month period and includes the following components: 1. Discharge Planning Visit: Conducted in person or via video, this session includes a needs assessment and shared decision-making conversation to identify participants' values and preferences. 2. Question Prompt List: A tailored list of questions is provided to help participants engage more effectively with their care team. 3. Goal Setting: Participants work with a nurse to identify short-term goals and action steps related to their health and care needs. 4. Symptom Monitoring: Participants track symptoms weekly using a symptom checklist to support ongoing management and communication with providers. | Behavioural | COORDINATE Program Intervention |
| Enhanced Usual CareParticipants in this arm will receive enhanced usual care, which includes standard discharge instructions, scheduled check-ins, and a resource toolkit with educational materials. The content includes guidance on symptom management, advance care planning, and available community resources. Participants will receive follow-up reminders and wellness checks but will not receive the structured, nurse-led intervention provided in the COORDINATE Program. | Behavioural | Enhanced Usual Care |
Primary outcome
Change from Baseline in Health-related Quality of Life as Measured by the EuroQoL at 3 months
Time frame: Baseline and 3 months post-discharge
Health-related quality of life will be assessed using the EuroQoL, a widely used questionnaire that helps measure a person's overall health and quality of life. It asks about five key areas: 1) Mobility, 2) Self-care, 3) Usual daily activities, 4) Pain or discomfort, and 5) Anxiety or depression. It also includes a rating scale (0 to 100) where people mark their overall health, 0 means the worst health you can imagine, and 100 means the best.
Change from Baseline in Quality of Life as Measured by the EuroQoL at 12 Months
Time frame: Baseline and 12 months post-discharge
Health-related quality of life will be assessed using the EuroQoL, a widely used questionnaire that helps measure a person's overall health and quality of life. It asks about five key areas: 1) Mobility, 2) Self-care, 3) Usual daily activities, 4) Pain or discomfort, and 5) Anxiety or depression. It also includes a rating scale (0 to 100) where people mark their overall health, 0 means the worst health you can imagine, and 100 means the best.
6 secondary outcomes
Difference in Number of Emergency Department Visits from Discharge to 3 Months Between the COORDINATE Program and Enhanced Usual Care
Time frame: Immediately hospital discharge to 3 months post-discharge
Difference in Number of Emergency Department Visits from Discharge to 12 Months Between the COORDINATE Program and Enhanced Usual Care
Time frame: Immediately hospital discharge to 12 months post-discharge
Difference in Number of Critical Care Admissions from Discharge to 3 Months Between the COORDINATE Program and Enhanced Usual Care
Time frame: Immediately hospital discharge to 3 months post-discharge
Difference in Number of Critical Care Admissions from Discharge to 12 Months Between the COORDINATE Program and Enhanced Usual Care
Time frame: Immediately hospital discharge to 12 months post-discharge
Difference in Number of All-Cause Rehospitalizations from Discharge to 3 Months Between the COORDINATE Program and Enhanced Usual Care
Time frame: Immediately hospital discharge to 3 months post-discharge
Difference in Number of All-Cause Rehospitalizations from Discharge to 12 Months Between the COORDINATE Program and Enhanced Usual Care
Time frame: Immediately hospital discharge to 12 months post-discharge
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 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Binu Koirala, PhD, MGS principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COORDINATE Program in people with Multimorbidity, run by Johns Hopkins 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 29 Jul 2026. 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?
Change from Baseline in Health-related Quality of Life as Measured by the EuroQoL at 3 months (time frame: Baseline and 3 months post-discharge). The study lists 2 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 29 Jul 2026.