Piloting 'mPal,' a Multilevel Strategy for Palliative Care Implementation

Study Overview
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Brief Summary
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The purpose of this study is to assess the feasibility and acceptability of mPal, a multilevel implementation strategy to improve palliative care use among advanced stage lung cancer patients receiving cancer treatment.

Detailed Description
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In this study, 60 advanced stage lung cancer patients will be randomized to mPal's patient-level component or usual care. Oncology providers will receive the mPal intervention. mPal is designed to help oncology providers integrate outpatient palliative care (non-hospice palliative care; NHPC) into routine clinical practice through: 1) electronic health record enhancements; 2) patient education and preparation for NHPC discussions when patients are in clinic to see their oncology providers; and 3) provider education about NHPC. This study will examine the feasibility and acceptability of mPal and gather preliminary data on potential outcomes for a future effectiveness trial.

Official Title
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Piloting 'mPal,' a Multilevel Implementation Strategy to Integrate Non-hospice Palliative Care Into Advanced Stage Lung Cancer Treatment

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: mPal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: new or recurrent AJCC stage IIIb-IV non-small cell lung cancer or extensive stage small cell lung cancer ECOG performance status 0-3/Karnofsky 40-100 at least three weeks into active oncologic treatment (chemotherapy, immunotherapy, chemo-immunotherapy) Exclusion Criteria: unstable brain metastases Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate Receiving palliative care Unable to speak and read English

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mPal intervention<br>Participants in this group will receive the mPal intervention. mPal's patient content includes a multi-component web-based tool with the following: (1) a brief educational video that seeks to educate patients about palliative care; (2) and assessment of palliative care knowledge; (3) assessment of palliative care needs; and (4) an assessment of whether patients would like to meet with palliative care or discuss palliative care and their palliative care needs with their oncology provider. mPal's provider content (not randomized) will include education. System-level modifications will also be made to the electronic health record to facilitate palliative care discussions and referrals. | Behavioral: mPal<br>* mPal's patient content includes a multi-component web-based tool with the following: (1) a brief educational video that seeks to educate patients about palliative care; (2) and assessment of palliative care knowledge; (3) assessment of palliative care needs; and (4) an assessment of whether patients would like to meet with palliative care or discuss palliative care and their palliative care needs with their oncology provider. The provider-level component includes provider education on palliative care. The system-level component includes electronic health record modifications to facilitate palliative care discussions and referrals.<br>|
| No Intervention: Standard of care<br>Participants in this group will receive standard of care (applies to patients only). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of enrollment: Proportion of eligible and approached patients who agree to participate | Proportion of eligible and approached patients who agree to participate | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient palliative care referrals | Proportion of patients in each arm who receive a referral to palliative care within 1-month and 3-months post-intervention | up to 3-months post-intervention | 
| Acceptability of intervention | 4-item acceptability of intervention measure (AIM); items responded to on a 5-point Likert-type scale with higher scores indicating greater acceptability. | up to 2 weeks post-intervention viewing | 
| Change in palliative care attitudes | Palliative Care Attitudes Scale; 9-items responded to on a Likert-type scale with higher scores indicating more favorable attitudes and motivation towards palliative care | Baseline, up to 2-months post intervention | 
| Feasibility of intervention | 4-item feasibility of intervention measure (FIM); items responded to on a 5-point Likert-type scale with higher scores indicating higher feasibility. | up to 2 weeks post-intervention viewing | 
| Change in palliative care knowledge | Health Information National Trends Survey Palliative Care Knowledge and Perceptions Questionnaire; 10-items responded to on a Likert-type scale. Items are examined individually | Baseline, up to 2-months post-intervention | 
| Feasibility of retention | Proportion of patients who complete baseline and follow-up questionnaire | up to 2-months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care