Living With Multimorbidity: CO-ORDINATE Program

Living With Multimorbidity: Symptom Management Across the Illness Trajectory

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05985044

Enrollment

Registered

2023-08-14

Start date

2022-11-16

Completion date

2024-05-30

Last updated

2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multimorbidity, Quality of Life, Symptom Management

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

Interventions

OTHERCare 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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 - 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 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 - 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.

Secondary

Measure	Time frame	Description
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.
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.

Countries

United States

Participant flow

Recruitment details

The participant was approached and recruited in the Intermediate Care Unit (IMCU) of an academic teaching hospital while the participants are in-patient before discharge. The recruitment of eligible participant took approximately 9 months from November 16, 2022 to August 2, 2023.

Pre-assignment details

Out of the 27 participants who signed the informed consent, 25 completed the baseline survey and received the intervention. Two participants did not complete the baseline data collection and could not be reached after signing the consent form.

Participants by arm

Arm	Count
Intervention The participants received the Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention, which includes the following four components: i) needs assessment, ii) question prompt list, iii) goals discussion, and iv) symptom assessment and tracking. The intervention comprises one in-person pre-discharge visit by the study team and four follow-up telephone calls conducted at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge.	25
Total	25

Arm

Count

Intervention

The participants received the Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention, which includes the following four components: i) needs assessment, ii) question prompt list, iii) goals discussion, and iv) symptom assessment and tracking. The intervention comprises one in-person pre-discharge visit by the study team and four follow-up telephone calls conducted at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	6
Overall Study	Incapacitation	3
Overall Study	Lost to Follow-up	4
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Intervention
Age, Continuous	67 years STANDARD_DEVIATION 7
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Quality of Life - General health	49.58 units on a scale STANDARD_DEVIATION 22.07
Quality of Life - Mental Health	65 units on a scale STANDARD_DEVIATION 26.49
Quality of Life - Physical functioning	43.33 units on a scale STANDARD_DEVIATION 30.31
Quality of Life -Role Emotional	48.61 units on a scale STANDARD_DEVIATION 46.08
Quality of Life - Role Physical	27.08 units on a scale STANDARD_DEVIATION 36.05
Quality of Life - Social Functioning	51.04 units on a scale STANDARD_DEVIATION 35.72
Quality of Life - Vitality	42.08 units on a scale STANDARD_DEVIATION 22.89
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	18 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	6 Participants
Region of Enrollment United States	25 Participants
Sex: Female, Male Female	12 Participants
Sex: Female, Male Male	13 Participants
Symptom burden - Anxiety	2.3 units on a scale STANDARD_DEVIATION 2.97
Symptom burden - Depression	1.78 units on a scale STANDARD_DEVIATION 3.19
Symptom burden - Drowsiness	2.48 units on a scale STANDARD_DEVIATION 2.76
Symptom burden - Lack of appetite	1.02 units on a scale STANDARD_DEVIATION 2.19
Symptom burden - Nausea	1.52 units on a scale STANDARD_DEVIATION 2.87
Symptom burden - Pain	4.34 units on a scale STANDARD_DEVIATION 3.63
Symptom burden - Shortness of breath	2.16 units on a scale STANDARD_DEVIATION 2.76
Symptom burden - Tiredness	3.64 units on a scale STANDARD_DEVIATION 2.89
Symptom burden - Well-being	4.48 units on a scale STANDARD_DEVIATION 3.27

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	6 / 25
other Total, other adverse events	0 / 25
serious Total, serious adverse events	0 / 25

Outcome results

Primary

Quality of Life Assessed by Short Form Survey (SF-36) Score - Bodily Pain

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.