Living With Multimorbidity: CO-ORDINATE Program

Quality of Life Clinical Trial

Official title:

Living With Multimorbidity: Symptom Management Across the Illness Trajectory

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05985044
• Other study ID #: IRB00244792
• Secondary ID: P30NR018093
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 22, 2022
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: May 2024
• Est. primary completion date: February 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multimorbidity
• Quality of Life
• Symptom Management

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).

Locations

Country	Name	City	State
United States	Johns Hopkins School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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