Palliative Care Planner (PCplanner)

NCT05095363 | Completed

• 1 other identifier: Pro00108264
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Keywords

palliative care; advance care planning

Outcome Measures

Primary Outcomes (5)

• Feasibility of intervention

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

  Up to 16 weeks

• Acceptability of intervention

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

  Up to 16 weeks

• Completion of intervention

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

  Up to 16 weeks

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

  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.

  Baseline to week 8

• Documentation of advance care planning in electronic health record

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

  Up to 16 weeks

Secondary Outcomes (13)

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

  Baseline to week 16

• Change in Patient Health Questionnaire-9 (PHQ-9) score

  Baseline to week 8

• Change in Patient Health Questionnaire-9 (PHQ-9) score

  Baseline to week 16

• Change in General Anxiety Disorder-7 (GAD-7) score

  Baseline to week 8

• Change in General Anxiety Disorder-7 (GAD-7) score

  Baseline to week 16

Other Outcomes (3)

• Number of hospitalizations during study

  Up to 16 weeks

• Referral to palliative care specialist during study

  Up to 16 weeks

• Referral to hospice during study

  Up to 16 weeks

Study Arms (2)

PCplanner mobile app platform

EXPERIMENTAL

Participants who are randomized to the intervention arm will complete surveys at 3 timepoints and will be given resources on advance care planning via PCplanner, the mobile app platform. They will receive a telephone call by the study team about a week after enrollment to answer any questions about the resources provided. If needs and questions are not resolved quickly after the clinic visit, then another layer of patient support with a telephone call by a palliative care specialist will be provided to the participant to help develop potential management plans.

Behavioral: PCplanner

Usual Care

NO INTERVENTION

Participants who are randomized to the usual care arm will complete surveys at 3 timepoints and receive usual care by pulmonary clinician.

Interventions

PCplanner BEHAVIORAL

A mobile app platform that will display participant survey results to clinicians to facilitate communication on specific needs as well as provide resources on advance care planning to participants.

PCplanner mobile app platform

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (11)

• Olson A, Hartmann N, Patnaik P, Wallace L, Schlenker-Herceg R, Nasser M, Richeldi L, Hoffmann-Vold AM, Cottin V. Estimation of the Prevalence of Progressive Fibrosing Interstitial Lung Diseases: Systematic Literature Review and Data from a Physician Survey. Adv Ther. 2021 Feb;38(2):854-867. doi: 10.1007/s12325-020-01578-6. Epub 2020 Dec 14.

  PMID: 33315170 BACKGROUND

• Moens K, Higginson IJ, Harding R; EURO IMPACT. Are there differences in the prevalence of palliative care-related problems in people living with advanced cancer and eight non-cancer conditions? A systematic review. J Pain Symptom Manage. 2014 Oct;48(4):660-77. doi: 10.1016/j.jpainsymman.2013.11.009. Epub 2014 May 5.

  PMID: 24801658 BACKGROUND

• Gore JM, Brophy CJ, Greenstone MA. How well do we care for patients with end stage chronic obstructive pulmonary disease (COPD)? A comparison of palliative care and quality of life in COPD and lung cancer. Thorax. 2000 Dec;55(12):1000-6. doi: 10.1136/thorax.55.12.1000.

  PMID: 11083884 BACKGROUND

• Au DH, Udris EM, Fihn SD, McDonell MB, Curtis JR. Differences in health care utilization at the end of life among patients with chronic obstructive pulmonary disease and patients with lung cancer. Arch Intern Med. 2006 Feb 13;166(3):326-31. doi: 10.1001/archinte.166.3.326.

  PMID: 16476873 BACKGROUND

• Bausewein C, Booth S, Gysels M, Kuhnbach R, Haberland B, Higginson IJ. Understanding breathlessness: cross-sectional comparison of symptom burden and palliative care needs in chronic obstructive pulmonary disease and cancer. J Palliat Med. 2010 Sep;13(9):1109-18. doi: 10.1089/jpm.2010.0068.

  PMID: 20836635 BACKGROUND

• Bajwah S, Higginson IJ, Ross JR, Wells AU, Birring SS, Patel A, Riley J. Specialist palliative care is more than drugs: a retrospective study of ILD patients. Lung. 2012 Apr;190(2):215-20. doi: 10.1007/s00408-011-9355-7. Epub 2012 Jan 5.

  PMID: 22218887 BACKGROUND

• Rabow MW, Dibble SL, Pantilat SZ, McPhee SJ. The comprehensive care team: a controlled trial of outpatient palliative medicine consultation. Arch Intern Med. 2004 Jan 12;164(1):83-91. doi: 10.1001/archinte.164.1.83.

  PMID: 14718327 BACKGROUND

• Higginson IJ, Bausewein C, Reilly CC, Gao W, Gysels M, Dzingina M, McCrone P, Booth S, Jolley CJ, Moxham J. An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: a randomised controlled trial. Lancet Respir Med. 2014 Dec;2(12):979-87. doi: 10.1016/S2213-2600(14)70226-7. Epub 2014 Oct 29.

  PMID: 25465642 BACKGROUND

• Ley B, Ryerson CJ, Vittinghoff E, Ryu JH, Tomassetti S, Lee JS, Poletti V, Buccioli M, Elicker BM, Jones KD, King TE Jr, Collard HR. A multidimensional index and staging system for idiopathic pulmonary fibrosis. Ann Intern Med. 2012 May 15;156(10):684-91. doi: 10.7326/0003-4819-156-10-201205150-00004.

  PMID: 22586007 BACKGROUND

• Ryerson CJ, Vittinghoff E, Ley B, Lee JS, Mooney JJ, Jones KD, Elicker BM, Wolters PJ, Koth LL, King TE Jr, Collard HR. Predicting survival across chronic interstitial lung disease: the ILD-GAP model. Chest. 2014 Apr;145(4):723-728. doi: 10.1378/chest.13-1474.

  PMID: 24114524 BACKGROUND

• Gu J, Wang P, Chow SC, Dempsey K, Bermejo S, Swaminathan A, Soskis A, Fried J, Kloefkorn C, Jones C, Cox CE. An App Platform-Facilitated Collaborative Palliative Care Intervention for Outpatients With Interstitial Lung Disease: A Pilot Randomized Trial. Am J Hosp Palliat Care. 2025 Jul;42(7):653-660. doi: 10.1177/10499091241275966. Epub 2024 Aug 19.

  PMID: 39158903 DERIVED

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis

Study Officials

• Christopher Cox, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 27, 2021
• Study Start: March 16, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)