Nursing-Driven Primary Palliative Care for Urban-Dwelling African Americans With Chronic Lung Disease

NCT05611125 | Completed

• 2 other identifiers: 083-51020-U32301#22G.350
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

In prior work, this research team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. Researchers will test the TIPC intervention to assess palliative care (PC) support for patients with chronic obstructive pulmonary disease (COPD) among a population of urban-dwelling, African American (AA) persons over the course of 15 months. The aims of this study are to 1) evaluate patient, caregiver, and clinical team perspectives of feasibility and acceptability of the TIPC model with urban-dwelling AAs with advanced COPD, and 2) explore the impact of TIPC intervention on knowledge and completion of advanced care planning (ACP) and on hospice and healthcare utilization patterns in the target population, as well as on additional quality of life (QOL) endpoints, and compare these between individuals participating in the intervention group and control group.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change in Feasibility, Acceptability, Satisfaction regarding TIPC intervention as Assessed by Survey

  Participants in the intervention group will report their experience with the TIPC model via survey questions. Participants will indicate whether or not they strongly disagree, disagree, have no opinion, agree, or strongly agree with a series of statements asking them about their experience with TIPC intervention.

  6 months

Secondary Outcomes (11)

• Change in Knowledge of Advanced Care Planning (ACP)

  3 months

• Change in Knowledge of Advanced Care Planning (ACP)

  6 months

• Change in Disease-Specific Quality of Life as Assessed by the CCQ

  Baseline

• Change in Disease-Specific Quality of Life as Assessed by the CCQ

  3 months

• Change in Disease-Specific Quality of Life as Assessed by the CCQ

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Individuals in the intervention group will undergo a series of two telehealth video visits and a series of survey assessments at baseline, 3, and 6 months.

Other: Telehealth Integrated Primary Care (TIPC)

Control

NO INTERVENTION

Individuals in the control group will continue with their usual standard of care and undergo a series of survey assessments at baseline, 3, and 6 months.

Interventions

Telehealth Integrated Primary Care (TIPC) OTHER

The TIPC model of intervention incorporates video visits across research clinicians and patients' existing care clinicians for more synergized and accessible care provision for a given clinical indication. The first TIPC visit will center around the patient setting care goals for themselves and their caregiver with the help of a palliative care physician. The second TIPC visit will focus on assessing goal attainment and also close the care loop between their existing care team, a research-appointed palliative care team, and their involvement in our study.

Also known as: TIPC

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD Diagnosis
• Age 18 years or older

You may not qualify if:

• Traumatic Brain Injuries
• Incarceration
• Homelessness
• Developmental disorders
• Pregnancy

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Rita & Alex Hillman Foundation: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: November 9, 2022
• Study Start: December 2, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

US (1)