Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07157982

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Multimorbidity

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Health System

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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:

  • 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.

Other names: Care Coordination and Symptom Management Program (COORDINATE)

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 5, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.