Clinical trial NCT05985044: Living With Multimorbidity: CO-ORDINATE Program
Official title: Living With Multimorbidity: Symptom Management Across the Illness Trajectory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity
Quality of Life
Symptom Management
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-08-14
Enrollment: 27
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Pain
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Tiredness
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Drowsiness
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Nausea
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Lack of Appetite
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Shortness of Breath
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Depression
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Anxiety
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Well-being
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Quality of Life Assessed by Short Form Survey (SF-36) Score - Physical Functioning
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Physical
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Emotional
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Quality of Life Assessed by Short Form Survey (SF-36) Score - Vitality
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Quality of Life Assessed by Short Form Survey (SF-36) Score - Mental Health
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Quality of Life Assessed by Short Form Survey (SF-36) Score - Social Functioning
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Quality of Life Assessed by Short Form Survey (SF-36) Score - Bodily Pain
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
measure: Quality of Life Assessed by Short Form Survey (SF-36) Score - General Health
timeFrame: Baseline, 6-weeks post intervention, 3 months post intervention
Secondary outcomes:
measure: Health-care Utilization - Total Healthcare Utilization
timeFrame: 3 months before and after entering the program
measure: Health-care Utilization - Emergency Department (ED) Visit s
timeFrame: 3 months before and after entering the program
measure: Health-care Utilization - Hospitalization
timeFrame: 3 months before and after entering the program
measure: Health-care Utilization - Critical Care Admission
timeFrame: 3 months before and after entering the program
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Binu Koirala, PhD
role: PRINCIPAL_INVESTIGATOR
References: