Living With Multimorbidity: CO-ORDINATE Program

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05985044
Collaborator
National Institute of Nursing Research (NINR) (NIH)
25
1
1
16.3
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention
N/A

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;

  1. 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Living With Multimorbidity: Symptom Management Across the Illness Trajectory
Actual Study Start Date :
Nov 22, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

A patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) 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).

Outcome Measures

Primary Outcome Measures

  1. Change in Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score [Baseline, 6 weeks, and after completion of intervention up to 3 months]

    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. Change in Quality of Life assessed by Short Form Survey (SF-36) score [Baseline, 6 weeks, and after completion of intervention up to 3 months]

    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

  1. Change in Health-care utilization [Baseline, 6 weeks, and after completion of intervention up to 3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins School of Nursing Baltimore Maryland United States 21205

Sponsors and Collaborators

  • Johns Hopkins University
  • National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Binu Koirala, PhD, Johns Hopkins School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT05985044
Other Study ID Numbers:
  • IRB00244792
  • P30NR018093
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 14, 2023