Living With Multimorbidity: CO-ORDINATE Program

Not Applicable

Completed

Conditions: Multimorbidity
Quality of Life
Symptom Management

Interventions: Other: Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention

Registration Number: NCT05985044

Lead Sponsor: Johns Hopkins University

Brief Summary: 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.

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention	A patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention

Primary Outcome Measures

Name	Time	Method
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Pain	Baseline, 6-weeks post intervention, 3 months post intervention	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).
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Tiredness	Baseline, 6-weeks post intervention, 3 months post intervention	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).
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Drowsiness	Baseline, 6-weeks post intervention, 3 months post intervention	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).
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Nausea	Baseline, 6-weeks post intervention, 3 months post intervention	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).
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Lack of Appetite	Baseline, 6-weeks post intervention, 3 months post intervention	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).
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Shortness of Breath	Baseline, 6-weeks post intervention, 3 months post intervention	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).
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Depression	Baseline, 6-weeks post intervention, 3 months post intervention	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).
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Anxiety	Baseline, 6-weeks post intervention, 3 months post intervention	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).
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Well-being	Baseline, 6-weeks post intervention, 3 months post intervention	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).
Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Physical	Baseline, 6-weeks post intervention, 3 months post intervention	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.
Quality of Life Assessed by Short Form Survey (SF-36) Score - Physical Functioning	Baseline, 6-weeks post intervention, 3 months post intervention	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.
Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Emotional	Baseline, 6-weeks post intervention, 3 months post intervention	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.
Quality of Life Assessed by Short Form Survey (SF-36) Score - Vitality	Baseline, 6-weeks post intervention, 3 months post intervention	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.
Quality of Life Assessed by Short Form Survey (SF-36) Score - Mental Health	Baseline, 6-weeks post intervention, 3 months post intervention	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.
Quality of Life Assessed by Short Form Survey (SF-36) Score - Social Functioning	Baseline, 6-weeks post intervention, 3 months post intervention	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.
Quality of Life Assessed by Short Form Survey (SF-36) Score - Bodily Pain	Baseline, 6-weeks post intervention, 3 months post intervention	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.
Quality of Life Assessed by Short Form Survey (SF-36) Score - General Health	Baseline, 6-weeks post intervention, 3 months post intervention	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.

Secondary Outcome Measures

Name	Time	Method
Health-care Utilization - Total Healthcare Utilization	3 months before and after entering the program	Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of total healthcare utilization, hospitalizations, emergency visits, and critical care admissions. Higher the numbers higher the healthcare utilization.
Health-care Utilization - Emergency Department (ED) Visit s	3 months before and after entering the program	Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of total healthcare utilization, hospitalizations, emergency visits, and critical care admissions. Higher the numbers higher the healthcare utilization.
Health-care Utilization - Hospitalization	3 months before and after entering the program	Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of total healthcare utilization, hospitalizations, emergency visits, and critical care admissions.. Higher the numbers higher the healthcare utilization.
Health-care Utilization - Critical Care Admission	3 months before and after entering the program	Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of total healthcare utilization, hospitalizations, emergency visits, and critical care admissions. Higher the numbers higher the healthcare utilization.