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Clinical Trials/NCT05095363
NCT05095363
Completed
Not Applicable

The Palliative Care Planner (PCplanner) for Outpatients Pilot Trial

Duke University1 site in 1 country43 target enrollmentMarch 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Interstitial Lung Disease
Sponsor
Duke University
Enrollment
43
Locations
1
Primary Endpoint
Acceptability of intervention
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 16, 2022
End Date
March 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Acceptability of intervention

Time Frame: Up to 16 weeks

Number of participants who stated they were satisfied with the intervention as measured by patient survey.

Documentation of advance care planning in electronic health record

Time Frame: Up to 16 weeks

Includes all or any of the following: code status, healthcare power of attorney, advance directive

Feasibility of intervention

Time Frame: Up to 16 weeks

Number of participants who stated intervention was easy to use as measured by patient survey.

Completion of intervention

Time Frame: Up to 16 weeks

Number of participants who completed all three surveys and intervention telephone visits.

Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale

Time Frame: Baseline to week 8

Scale ranges from 0 to 130 with lower score indicates less unmet needs and higher score indicates more unmet needs on issues such as communication, symptoms, social support, and financial stress.

Secondary Outcomes

  • Change in Needs; Existential concerns; Symptoms; and Therapeutic interaction (NEST) scale(Baseline to week 16)
  • Change in General Anxiety Disorder-7 (GAD-7) score(Baseline to week 16)
  • Change in Patient Health Questionnaire-9 (PHQ-9) score(Baseline to week 16)
  • Change in Quality of Life Visual Analogue Scale (QOL VAS)(Baseline to week 16)
  • Change in Patient Health Questionnaire-10 (PHQ-10) score(Baseline to week 16)
  • Change in Therapeutic Alliance score(Baseline to week 16)
  • Change in EuroQol - 5 Dimension (EQ-5D) score(Baseline to week 16)

Study Sites (1)

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