Clinical trial NCT05095363: Palliative Care Planner (PCplanner)
Official title: The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Keywords: palliative care
advance care planning
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Palliative Care planner (PCplanner) is a mobile app platform that aims to facilitate communication on unmet needs and advance care planning between patients with idiopathic pulmonary fibrosis and their pulmonary clinicians. Participants will be randomized to intervention arm in a 2:1 intervention:control ratio.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called Palliative Care Planner (PCplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their clinicians.

Detailed description: Interstitial lung disease (ILD) affects roughly 6.3 to 76 per 100,000 people of predominantly older adult patients worldwide and is associated with high morbidity and mortality. Patients with such idiopathic pulmonary fibrosis suffer symptom burdens similar to patients with cancer and commonly experience long, costly hospitalizations that often include care in an intensive care unit (ICU). Despite the presence of numerous unmet needs, ILD patients uncommonly receive palliative care because of lack of symptom recognition, supports to provide advanced care planning (ACP) and symptom control, and processes to promote collaboration between primary teams and palliative care specialists to deliver the appropriate level of care. To address this important clinical gap, we propose adapting our existing needs-targeted PCplanner (Palliative Care planner) mobile app platform to the outpatient setting. PCplanner Outpatient will allow patients to report their needs, provide video content to stimulate knowledge of and discussion about more advanced care planning, and assist primary physicians in recognizing the optimal timing of specialist palliative care referral.

Eligibility criteria: Inclusion Criteria:

* Patient has diagnosis of idiopathic pulmonary fibrosis
* Patient has GAP (gender, age, physiology) index score ≥ 4
* Patient is established in interstitial lung disease clinic (i.e., has had at least 1 previous clinic visit)

Exclusion Criteria:

* Patient lacks fluency in English sufficient to complete study surveys
* Patient is already seeing palliative care or enrolled in hospice
* NEST score \<10 at baseline T1

Primary outcomes:
measure: Feasibility of intervention
timeFrame: Up to 16 weeks
measure: Acceptability of intervention
timeFrame: Up to 16 weeks
measure: Completion of intervention
timeFrame: Up to 16 weeks
measure: Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
timeFrame: Baseline to week 8
measure: Documentation of advance care planning in electronic health record
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale
timeFrame: Baseline to week 16
measure: Change in Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: Baseline to week 8
measure: Change in Patient Health Questionnaire-9 (PHQ-9) score
timeFrame: Baseline to week 16
measure: Change in General Anxiety Disorder-7 (GAD-7) score
timeFrame: Baseline to week 8
measure: Change in General Anxiety Disorder-7 (GAD-7) score
timeFrame: Baseline to week 16
measure: Change in Patient Health Questionnaire-10 (PHQ-10) score
timeFrame: Baseline to week 8
measure: Change in Patient Health Questionnaire-10 (PHQ-10) score
timeFrame: Baseline to week 16
measure: Change in EuroQol - 5 Dimension (EQ-5D) score
timeFrame: Baseline to week 8
measure: Change in EuroQol - 5 Dimension (EQ-5D) score
timeFrame: Baseline to week 16
measure: Change in Quality of Life Visual Analogue Scale (QOL VAS)
timeFrame: Baseline to week 8
measure: Change in Quality of Life Visual Analogue Scale (QOL VAS)
timeFrame: Baseline to week 16
measure: Change in Therapeutic Alliance score
timeFrame: Baseline to week 8
measure: Change in Therapeutic Alliance score
timeFrame: Baseline to week 16
Other outcomes:
measure: Number of hospitalizations during study
timeFrame: Up to 16 weeks
measure: Referral to palliative care specialist during study
timeFrame: Up to 16 weeks
measure: Referral to hospice during study
timeFrame: Up to 16 weeks
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Christopher Cox, MD
role: PRINCIPAL_INVESTIGATOR
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