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Enrolling by invitation NCT07157982

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

No phase Interventional Multimorbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: COORDINATE Program, Enhanced Usual Care.
Who it may be relevant to
Registry conditions: Multimorbidity. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral 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 tailore
  • 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.

Primary outcome measures

  • 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]
  • Change from Baseline in Quality of Life as Measured by the EuroQoL at 12 Months [Time frame: Baseline and 12 months post-discharge]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Johns Hopkins Health System — Baltimore

Identifiers

NCT: NCT07157982 · IRB00500267

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗