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

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Johns Hopkins University

Status

Begins enrollment this month

Conditions

Multimorbidity

Treatments

Behavioral: COORDINATE Program
Behavioral: Enhanced Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT07157982
IRB00500267

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

10 participants in 2 patient groups

COORDINATE Program Intervention
Experimental group
Description:
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.
Treatment:
Behavioral: COORDINATE Program
Enhanced Usual Care
Other group
Description:
Participants receive enhanced usual care, including standard discharge teaching, a multimorbidity management toolkit, and follow-up check-ins.
Treatment:
Behavioral: Enhanced Usual Care

Trial contacts and locations

1

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Central trial contact

Binu Koirala, PhD, MGS

Data sourced from clinicaltrials.gov

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