Living With Multimorbidity: Care Coordination and Symptom Management Program (COORDINATE)

NCT07157982 | Not Yet Recruiting DMC

• 1 other identifier: IRB00500267
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 don't need intensive care. The main questions this study wants to answer are:

1. 1.Can the COORDINATE Program improve participants' quality of life?
2. 2.Can the program reduce emergency visits, intensive care admissions, and rehospitalizations?
3. 3.A needs assessment to find out what matters most to them
4. 4.A list of helpful questions to ask their care team
5. 5.Goal-setting to support managing their conditions
6. 6.Tracking their symptoms and progress
7. 7.Attend a discharge visit and have 5 follow-up phone or video calls over 3 months

Conditions

Multimorbidity

Keywords

Continuity of Patient Care; Hospital to Home Transition

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  Immediately hospital discharge to 3 months post-discharge

Study Arms (2)

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.

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.

Behavioral: Enhanced Usual Care

Interventions

COORDINATE Program BEHAVIORAL

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.

Also known as: Care Coordination and Symptom Management Program (COORDINATE)

COORDINATE Program Intervention

Enhanced Usual Care BEHAVIORAL

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• cannot provide informed consent
• non-English speakers
• incapacitated or have documented cognitive impairment
• are in hospice

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Health System

Baltimore, Maryland, 21205, United States

Location

Study Officials

• Binu Koirala, PhD, MGS

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binu Koirala, PhD, MGS

CONTACT

410-614-4718; bkoiral1@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)