Trial Outcomes & Findings for Predictive Analytics and Behavioral Nudges to Improve Palliative Care in Advanced Cancer (NCT NCT05590962)

Last Updated: 2025-02-06

Results Overview

Completed palliative care visit within 3 months among high-risk patients with stage III and IV lung and non-colorectal GI malignancies

Recruitment status

COMPLETED

Study phase

Target enrollment

562 participants

Primary outcome timeframe

3 months

Results posted on

2025-02-06

Participant Flow

Unit of analysis: clinical practices

Participant milestones

Participant milestones
Measure	Control Patients in practices randomized to control arm	Intervention Patients in practices randomized to intervention
Overall Study STARTED	266 8	296 7
Overall Study COMPLETED	266 8	296 7
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictive Analytics and Behavioral Nudges to Improve Palliative Care in Advanced Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=266 Participants Patients in practices randomized to control arm	Intervention n=296 Participants Patients in practices randomized to intervention	Total n=562 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 9.7 • n=5 Participants	67.9 years STANDARD_DEVIATION 10.4 • n=7 Participants	68.5 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	128 Participants n=5 Participants	146 Participants n=7 Participants	274 Participants n=5 Participants
Sex: Female, Male Male	138 Participants n=5 Participants	150 Participants n=7 Participants	288 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	215 Participants n=5 Participants	232 Participants n=7 Participants	447 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	30 Participants n=5 Participants	37 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown/Unspecified	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Malignancy Lung	202 Participants n=5 Participants	231 Participants n=7 Participants	433 Participants n=5 Participants
Malignancy Non-colorectal GI	64 Participants n=5 Participants	65 Participants n=7 Participants	129 Participants n=5 Participants
Stage Stage III	93 Participants n=5 Participants	90 Participants n=7 Participants	183 Participants n=5 Participants
Stage Stage IV	173 Participants n=5 Participants	206 Participants n=7 Participants	379 Participants n=5 Participants
Risk Score	3.18 scores on a scale STANDARD_DEVIATION 2.56 • n=5 Participants	3.03 scores on a scale STANDARD_DEVIATION 2.81 • n=7 Participants	3.1 scores on a scale STANDARD_DEVIATION 2.0 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Unadjusted rates of completed PC visits

Completed palliative care visit within 3 months among high-risk patients with stage III and IV lung and non-colorectal GI malignancies

Outcome measures

Outcome measures
Measure	Control n=266 Participants Patients in practices randomized to control arm	Intervention n=296 Participants Patients in practices randomized to intervention
Number of Study Participants Who Have Completed a Palliative Care Visit Within 3 Months of Enrollment	22 participants	130 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: ≤3 days before death

≤3 days before death

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 14 days of death

Within 14 days of death

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 weeks

Feeling Heard \& Understood Quality Measure is a 4-question survey completed by patients using a 5-point Likert scale including Completely true (1); Very true (2); Somewhat true. (3); A little bit true. (4) Not at all true. (5)

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 weeks

Functional Assessment of Chronic Illness Therapy-Palliative (FACIT-Pal) 14 is a 14-question survey completed by patients using a 5-point Likert scale ranging from Not at all (0); A little bit (1); Some-what (2); Quite a bit (3); and Very much (4)

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 87 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 92 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ravi Parikh

University of Pennsylvania

Phone: 3524224285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place