Living With Multimorbidity: CO-ORDINATE Program

Living With Multimorbidity: Symptom Management Across the Illness Trajectory

Multimorbidity is common and is the coexistence of two or more chronic conditions in the same individual. People with multimorbidity suffer from a high symptom burden, directly affecting quality of life (QOL). Hospitalization can be a window of opportunity to initiate interventions to promote recovery and resilience and enhance QOL. However, interventions targeting the symptom trajectory and burden of patients with multimorbidity are lacking. Thus, the investigators envisage a nurse-led pre-discharge intervention augmented by telephone support, focusing on care coordination and symptom management. This approach is anticipated to help reduce symptom burden and improve QOL.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Multimorbidity; Symptom Management
• Intervention / Treatment: Other: Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention

Detailed Description

Aim 1: Describe the symptom trajectory and burden from the perspectives of patients, family caregivers, and health professionals and collectively develop a symptom management toolkit; and

Aim 2: Refine and pilot test the nurse-driven symptom management toolkit/intervention to decrease the symptom burden and increase the QOL of critically ill adults with multimorbidity.

Interventional study (Aim 2):

The study aims to test the feasibility of the Care cOORDInatioN and sympTom managEment (COORDINATE) intervention developed from Aim 1 using an experienced-based co-design methodology. A single-arm feasibility study will be implemented with assumptions on the effectiveness of the COORDINATE intervention on outcomes such as symptom burden and quality of life will be evaluated.

Sample and Setting:

Individuals aged 55 years and older, living with two or more chronic health conditions, and willing to provide informed consent will be included in the study. The exclusion criteria include if participants cannot speak English or have a documented cognitive impairment that would prevent participation. Patients will be approached in the Intermediate Care Unit (IMCU) of an academic teaching hospital while the participants are in-patient before discharge.

Intervention Components and Timing:

The intervention consists of four components- i) needs assessment; ii) question prompt list; iii) goals discussion and; iv) symptom assessment and tracking. The intervention will start with the enrolment of a patient living with multimorbidity. The intervention consists of one in-person pre-discharge visit by the study team and four follow-up telephone calls (at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge).

Primary Outcomes

1. Symptom Burden
2. Quality of Life

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English speakers who are planned for discharge from Johns Hopkins Hospital (JHH) IMCU
• Who meet the criteria for being admitted to IMCU and planned discharge with multimorbidity as defined by two or more chronic conditions.

Exclusion Criteria:

• Who can not provide informed consent or have documented cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; A patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention

Other: Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention; The intervention consists of the following four components: i) needs assessment; ii) question prompt list; iii) goals discussion and; iv) symptom assessment and tracking. The intervention will start with the enrolment of a patient living with multimorbidity. The intervention consists of one in-person pre-discharge visit by the study team and four follow-up telephone calls (at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score	The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).	Baseline, 6 weeks, and after completion of intervention up to 3 months
Change in Quality of Life assessed by Short Form Survey (SF-36) score	Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.	Baseline, 6 weeks, and after completion of intervention up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health-care utilization	Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of hospitalizations, emergency visits and critical care admissions. Higher the numbers higher the healthcare utilization.	Baseline, 6 weeks, and after completion of intervention up to 3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Binu Koirala, PhD, Johns Hopkins School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2022
• Primary Completion (Actual): February 11, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB00244792; P30NR018093 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No