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

NCT ID: NCT07157982

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2028-03-31

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. Can the COORDINATE Program improve participants' quality of life?

2. 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:

1. A needs assessment to find out what matters most to them

2. A list of helpful questions to ask their care team

3. Goal-setting to support managing their conditions

4. Tracking their symptoms and progress

5. 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.

Conditions

Multimorbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

COORDINATE Program Intervention

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.

Group Type: EXPERIMENTAL

COORDINATE Program

Intervention Type: 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.

Enhanced Usual Care

Participants receive enhanced usual care, including standard discharge teaching, a multimorbidity management toolkit, and follow-up check-ins.

Group Type: OTHER

Enhanced Usual Care

Intervention Type: 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.

Interventions

COORDINATE Program

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.

Intervention Type: BEHAVIORAL

Enhanced Usual Care

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Care Coordination and Symptom Management Program (COORDINATE)

Eligibility Criteria

Inclusion Criteria

1. aged 50 years and older

2. living with two or more chronic health conditions as identified by diagnosis in the electronic health record

3. medically complex patients defined as those admitted to intermediate care units

4. have a working telephone or contact method.

Exclusion Criteria

1. cannot provide informed consent

2. non-English speakers

3. incapacitated or have documented cognitive impairment

4. are in hospice

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binu Koirala, PhD, MGS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Nursing

Locations

Johns Hopkins Health System

Baltimore, Maryland, United States

Countries

United States

Central Contacts

Binu Koirala, PhD, MGS

Role: CONTACT

bkoiral1@jhu.edu

410-614-4718

Facility Contacts

Binu Koirala, PhD, MGS

Role: primary

bkoiral1@jhu.edu

410-614-4718

Other Identifiers

IRB00500267

Identifier Type: -

Identifier Source: org_study_id