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Completed

NCT Number: NCT05985044

Living With Multimorbidity: CO-ORDINATE Program

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.

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Key information

Conditions

Multimorbidity Quality of Life Symptom Management

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

About this study

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

  • Symptom Burden
  • Quality of Life

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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).

Primary outcomes

  1. Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Pain

    Time frame: 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).

  2. Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Tiredness

    Time frame: 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).

  3. Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Drowsiness

    Time frame: 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).

  4. Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Nausea

    Time frame: 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).

  5. Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Lack of Appetite

    Time frame: 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).

  6. Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Shortness of Breath

    Time frame: 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).

  7. Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Depression

    Time frame: 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).

  8. Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Anxiety

    Time frame: 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).

  9. Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Well-being

    Time frame: 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).

  10. Quality of Life Assessed by Short Form Survey (SF-36) Score - Physical Functioning

    Time frame: 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.

  11. Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Physical

    Time frame: 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.

  12. Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Emotional

    Time frame: 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.

  13. Quality of Life Assessed by Short Form Survey (SF-36) Score - Vitality

    Time frame: 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.

  14. Quality of Life Assessed by Short Form Survey (SF-36) Score - Mental Health

    Time frame: 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.

  15. Quality of Life Assessed by Short Form Survey (SF-36) Score - Social Functioning

    Time frame: 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.

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

    Time frame: 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.

  17. Quality of Life Assessed by Short Form Survey (SF-36) Score - General Health

    Time frame: 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 outcomes

  1. Health-care Utilization - Total Healthcare Utilization

    Time frame: 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.

  2. Health-care Utilization - Emergency Department (ED) Visit s

    Time frame: 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.

  3. Health-care Utilization - Hospitalization

    Time frame: 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.

  4. Health-care Utilization - Critical Care Admission

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Living With Multimorbidity: Symptom Management Across the Illness Trajectory

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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