Cancer, End of Life
Conditions
Keywords
cancer, end of life, patient-centered
Brief summary
The purpose of the LEAPS program is to understand how a trained lay health worker who engages with newly diagnosed patients after a diagnosis of an advanced stage of cancer can help to engage patients in advance care planning, improve patient satisfaction with their decision-making, activation, quality of life, and healthcare resource utilization.
Detailed description
Unite Here Health proposes to implement and evaluate several critical elements to be in alignment with the mission of the organization to provide high value care to their members. The Lay Health Worker Engages, Educates, and Encourages Patients to Share intervention is an innovative program that will strengthen provider-patient relationship and facilitate whole person care about matters important to Unite Here Health members who are diagnosed with cancer and important to support network and family. The project is intended to help establish Goals of Care Plan with appropriate documentation, develop, deploy, and evaluate a model of care for persons with cancer that is intended to improve clinical outcomes and experience of care for individuals. The intervention provides patients with lay health coaches who assist patients and their families in discussing goals of care and engage in shared-decision making. The goal of the project is to demonstrate that there is improved documentation of goals of care, patient experiences, patient activation and quality of life outcomes, and that the program helps to reduce utilization of health care resources at the end of life.
Interventions
BEHAVIORALLay Health Worker Intervention
Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention is provided along with usual care as provided by Unite Here Health and local oncologists.
OTHERUsual Care
Usual care as provided by Unite Here Health and local oncologists
Sponsors
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Newly diagnosed patients with a cancer diagnosis. 2. Patients with any relapse or progressive disease (any cancer diagnosis) as identified by imaging or biopsy and confirmed by physician. 3. The patients must be 18 years or older. 4. Patients must have the capacity to verbally consent.
Exclusion criteria
1. Inability to consent to the study due to lack of capacity as documented by the referring physician. 2. Patients without a newly diagnosed malignancy or patients without relapse of disease. 3. Patients not eligible for Fund benefits. Patients without a newly diagnosed malignancy or patients without relapse of disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey | Change in Quality of Life from Baseline to 4 Months | Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at baseline and 4 months. We will measure the change in quality of life at baseline to 4 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | Proportion of patients who strongly agree that decisions about their health care were theirs to make at 12 months post study enrollment. | The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 12 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. I am satisfied that I am adequately informed about the issues important to my decision) on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group are averaged at 12 months after study enrollment. Results are expressed as a proportion of participants who responded strongly agree at 12 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded strongly agree are reflected from baseline to 12 months. |
| Patient Activation Using the Patient Activation Measure Survey | Change in Patient Activation Measure from baseline to 4 months post enrollment. | Each patient will receive the 13-item Patient Activation Measure (PAM-13) at 4 months after study enrollment. This is a validated measure from Insignia Health. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional not applicable option). Higher scores indicate greater patient activation. For the PAM-13, minimum score is 0 and maximum is 100. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining Behaviors and Pushing Further. Scores for each group will be averaged at 4 months after study enrollment. |
| Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey | Health-related quality of life at 12 months | Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at 12 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General Survey-General survey. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life. |
| Emergency Department Visit (Chart Review) | 4 months after patient enrollment | Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment. |
| Hospitalization Visit (Chart Review) | 4 months after patient enrollment | Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment. |
| Hospitalization Visits (Chart Review) | 12 months after study enrollment | Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment. |
| Advance Directive Documentation (Chart Review) | 4 months after patient enrollment | Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment. |
| Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey | Proportion of patients who strongly agree that decisions about their health care were theirs to make at 4 months post study enrollment. | The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 4 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. I am satisfied that I am adequately informed about the issues important to my decision) on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group were averaged at 4 months after study enrollment. Results are expressed as a proportion of participants who responded strongly agree at 4 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded strongly agree are reflected from baseline to 4 months post-enrollment. |
| Goals of Care Documentation (Chart Review) | 4 months after patient enrollment | Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment. |
| Total Costs of Care | 12 months after patient enrollment | Total Costs of Care will be evaluated by review of claims data from time of enrollment until 12 months post-enrollment |
| Total Costs of Care End of Life | Last 30 days of life up to 12 months from patient enrollment | Total Costs of Care during the last 30 days of life will be evaluated by review of claims data from the 30 days preceding death for those patients who become deceased within 12 months of study enrollment. |
| Palliative Care Use (Chart Review) | 4 months after patient enrollment | Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment. |
| Hospice Use (Chart Review) | 4 months after patient enrollment | Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment. |
| Survival (Chart Review) | 4 months after patient enrollment | Survival rate for patients will be abstracted by electronic medical record chart review at 4 months after enrollment. |
| Physician Orders for Life Sustaining Treatment (Chart Review) | 4 months after patient enrollment | Physician Orders for Life Sustaining Treatment (POLST) documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Control Group The control group arm participants receive usual care. | 80 |
| Lay Health Worker Intervention Group Patients randomized into the intervention are assigned a lay health worker who will contact the patient to begin the intervention, and also receive usual care. | 80 |
| Total | 160 |
Baseline characteristics
| Characteristic | Usual Care Control Group | Total | Lay Health Worker Intervention Group |
|---|---|---|---|
| Age, Continuous | 58 years | 58 years | 58 years |
| Anatomic site of cancer diagnosis Breast | 22 Participants | 37 Participants | 15 Participants |
| Anatomic site of cancer diagnosis Gastrointestinal | 16 Participants | 30 Participants | 14 Participants |
| Anatomic site of cancer diagnosis Genitourinary | 10 Participants | 19 Participants | 9 Participants |
| Anatomic site of cancer diagnosis Head and Neck | 2 Participants | 7 Participants | 5 Participants |
| Anatomic site of cancer diagnosis Lung | 10 Participants | 21 Participants | 11 Participants |
| Anatomic site of cancer diagnosis Malignant hematologic | 7 Participants | 18 Participants | 11 Participants |
| Anatomic site of cancer diagnosis Other (skin, soft tissue, brain) | 8 Participants | 15 Participants | 7 Participants |
| Anatomic site of cancer diagnosis Ovarian | 5 Participants | 13 Participants | 8 Participants |
| Annual household income < $25,000 | 10 Participants | 24 Participants | 14 Participants |
| Annual household income ≥ $25,000 to $34,999.00 | 50 Participants | 103 Participants | 53 Participants |
| Annual household income ≥ $35,000 to $49,999.00 | 20 Participants | 33 Participants | 13 Participants |
| City Atlantic City, NJ | 53 Participants | 108 Participants | 55 Participants |
| City Chicago, IL | 27 Participants | 52 Participants | 25 Participants |
| Education Level 2-year college or Bachelor degree | 4 Participants | 6 Participants | 2 Participants |
| Education Level High school | 15 Participants | 25 Participants | 10 Participants |
| Education Level Less than high school | 61 Participants | 129 Participants | 68 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 47 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants | 113 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 31 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 44 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 38 Participants | 82 Participants | 44 Participants |
| Region of Enrollment United States | 80 Participants | 160 Participants | 80 Participants |
| Sex/Gender, Customized Female | 42 Participants | 83 Participants | 41 Participants |
| Sex/Gender, Customized Male | 37 Participants | 75 Participants | 38 Participants |
| Sex/Gender, Customized Non-binary | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 80 | 23 / 80 |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
Primary
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at baseline and 4 months. We will measure the change in quality of life at baseline to 4 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.
Time frame: Change in Quality of Life from Baseline to 4 Months
Population: Participants who completed the survey at each respective time point are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care Control Group | Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey | Baseline | 74.1 score on a scale | Standard Deviation 16.5 |
| Usual Care Control Group | Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey | Month 4 | 70.3 score on a scale | Standard Deviation 16.8 |
| Lay Health Worker Intervention Group | Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey | Baseline | 73.5 score on a scale | Standard Deviation 15.8 |
| Lay Health Worker Intervention Group | Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey | Month 4 | 80.7 score on a scale | Standard Deviation 16.4 |
p-value: <0.00195% CI: [7.27, 14.58]Type III F test
Secondary
Advance Directive Documentation (Chart Review)
Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Advance Directive Documentation (Chart Review) | 55 Participants |
| Lay Health Worker Intervention Group | Advance Directive Documentation (Chart Review) | 72 Participants |
Secondary
Advance Directive Documentation (Chart Review)
Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Time frame: 4 months after patient enrollment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care Control Group | Advance Directive Documentation (Chart Review) | Baseline | 1 Participants |
| Usual Care Control Group | Advance Directive Documentation (Chart Review) | 4 Months | 15 Participants |
| Lay Health Worker Intervention Group | Advance Directive Documentation (Chart Review) | Baseline | 0 Participants |
| Lay Health Worker Intervention Group | Advance Directive Documentation (Chart Review) | 4 Months | 46 Participants |
Secondary
Emergency Department Visit (Chart Review)
Emergency Department Use will be abstracted by electronic medical record chart review for each patient who is deceased within 12 months of enrollment, looking at their ER visits during the last 30 days of life.
Time frame: Last 30 days of life up to 12 months from patient enrollment
Population: Sample of 21 participants in the control group and 23 participants in the intervention group who died within 12 months of study enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Emergency Department Visit (Chart Review) | 3 Emergency Department Visits |
| Lay Health Worker Intervention Group | Emergency Department Visit (Chart Review) | 1 Emergency Department Visits |
Secondary
Emergency Department Visit (Chart Review)
Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Emergency Department Visit (Chart Review) | 24 Emergency Department Visits |
| Lay Health Worker Intervention Group | Emergency Department Visit (Chart Review) | 27 Emergency Department Visits |
Secondary
Emergency Department Visit (Chart Review)
Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Time frame: 4 months after patient enrollment
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Emergency Department Visit (Chart Review) | 15 Emergency Department Visits |
| Lay Health Worker Intervention Group | Emergency Department Visit (Chart Review) | 12 Emergency Department Visits |
Secondary
Goals of Care Documentation (Chart Review)
Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Time frame: 4 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Goals of Care Documentation (Chart Review) | 10 Participants |
| Lay Health Worker Intervention Group | Goals of Care Documentation (Chart Review) | 44 Participants |
Secondary
Goals of Care Documentation (Chart Review)
Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Goals of Care Documentation (Chart Review) | 23 Participants |
| Lay Health Worker Intervention Group | Goals of Care Documentation (Chart Review) | 71 Participants |
Secondary
Hospice Use (Chart Review)
Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Time frame: 4 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Hospice Use (Chart Review) | 2 Participants |
| Lay Health Worker Intervention Group | Hospice Use (Chart Review) | 8 Participants |
Secondary
Hospice Use (Chart Review)
Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Hospice Use (Chart Review) | 6 Participants |
| Lay Health Worker Intervention Group | Hospice Use (Chart Review) | 16 Participants |
Secondary
Hospice Use (Chart Review)
Hospice Use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their hospice use during the last 30 days of life.
Time frame: last 30 days of life
Population: sample of 21 participants in the control group and 23 participants in the intervention group who died within 12 months of study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Hospice Use (Chart Review) | 6 Participants |
| Lay Health Worker Intervention Group | Hospice Use (Chart Review) | 16 Participants |
Secondary
Hospitalization Visit (Chart Review)
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Time frame: 4 months after patient enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Hospitalization Visit (Chart Review) | 16 Hospital Visits |
| Lay Health Worker Intervention Group | Hospitalization Visit (Chart Review) | 32 Hospital Visits |
Secondary
Hospitalization Visits (Chart Review)
Hospitalization use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their hospital visits during the last 30 days of life.
Time frame: last 30 days of life
Population: sample of 21 participants in the control group and 23 participants in the intervention group who died within 12 months of study enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Hospitalization Visits (Chart Review) | 3 Hospital Visits |
| Lay Health Worker Intervention Group | Hospitalization Visits (Chart Review) | 6 Hospital Visits |
Secondary
Hospitalization Visits (Chart Review)
Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time frame: 12 months after study enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Hospitalization Visits (Chart Review) | 50 Hospital Visits |
| Lay Health Worker Intervention Group | Hospitalization Visits (Chart Review) | 33 Hospital Visits |
Secondary
Palliative Care Use (Chart Review)
Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Time frame: 4 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Palliative Care Use (Chart Review) | 5 Participants |
| Lay Health Worker Intervention Group | Palliative Care Use (Chart Review) | 25 Participants |
Secondary
Palliative Care Use (Chart Review)
Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Palliative Care Use (Chart Review) | 13 Participants |
| Lay Health Worker Intervention Group | Palliative Care Use (Chart Review) | 33 Participants |
Secondary
Palliative Care Use (Chart Review)
Palliative Care Use will be abstracted by electronic medical record chart review for each patient who is deceased within12 months of enrollment, looking at their palliative care usage during the last 30 days of life.
Time frame: last 30 days of life
Population: sample of 21 participants in the control group and 23 participants in the intervention group who died within 12 months of study enrollment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Palliative Care Use (Chart Review) | 6 Participants |
| Lay Health Worker Intervention Group | Palliative Care Use (Chart Review) | 16 Participants |
Secondary
Patient Activation Using the Patient Activation Measure Survey
Each patient will receive the 13-item Patient Activation Measure (PAM-13) at 12 months after study enrollment. This is a validated measure from Insignia Health. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional not applicable option). Higher scores indicate greater patient activation. For the PAM-13, minimum score is 0 and maximum is 100 (highest level of activation). Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining Behaviors and Pushing Further. Scores for each group will be averaged 12 months after study enrollment.
Time frame: Change in Patient Activation Measure from baseline to 12 months post-enrollment.
Population: Missingness was only observed due to death among 21 (26.3%) participants in the control group and 23 (28.8%) participants in the intervention group who had died prior to this 12-month assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control Group | Patient Activation Using the Patient Activation Measure Survey | 57.6 score on a scale | Standard Deviation 10.8 |
| Lay Health Worker Intervention Group | Patient Activation Using the Patient Activation Measure Survey | 77.7 score on a scale | Standard Deviation 11.2 |
Secondary
Patient Activation Using the Patient Activation Measure Survey
Each patient will receive the 13-item Patient Activation Measure (PAM-13) at 4 months after study enrollment. This is a validated measure from Insignia Health. Each item is rated on 4-point scale (1 strongly disagree to 4 strongly agree, with additional not applicable option). Higher scores indicate greater patient activation. For the PAM-13, minimum score is 0 and maximum is 100. Raw scores are converted into activation levels per the scoring guidelines by Insignia Health for: level 1 Disengaged and Overwhelmed, level 2 Becoming Aware but Still Struggling, level 3 Taking Action and Gaining Control, level 4 Maintaining Behaviors and Pushing Further. Scores for each group will be averaged at 4 months after study enrollment.
Time frame: Change in Patient Activation Measure from baseline to 4 months post enrollment.
Population: Missingness was only observed due to death among 6 (7.5%) participants in the control group and 9 (11.3%) participants in the intervention group who had died prior to the 4-month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care Control Group | Patient Activation Using the Patient Activation Measure Survey | Baseline | 53.5 score on a scale | Standard Deviation 10.3 |
| Usual Care Control Group | Patient Activation Using the Patient Activation Measure Survey | 4 Months | 53.3 score on a scale | Standard Deviation 10.1 |
| Lay Health Worker Intervention Group | Patient Activation Using the Patient Activation Measure Survey | Baseline | 53.4 score on a scale | Standard Deviation 9.8 |
| Lay Health Worker Intervention Group | Patient Activation Using the Patient Activation Measure Survey | 4 Months | 65.9 score on a scale | Standard Deviation 14.7 |
Secondary
Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey
Each patient will receive a quality of life survey (Functional Assessment of Cancer Therapy - General Survey) at 12 months. Scores for quality of life will be assessed using the Functional Assessment of Cancer Therapy - General Survey-General survey. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. Each question is a 5-point likert scale item. Scores range from 0-108. The higher the score, the better the quality of life.
Time frame: Health-related quality of life at 12 months
Population: Participants who completed the survey at 12 months are included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Control Group | Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey | 73.3 score on a scale | Standard Deviation 15.6 |
| Lay Health Worker Intervention Group | Patient Quality of Life Using the Functional Assessment of Cancer Therapy - General Survey | 84.4 score on a scale | Standard Deviation 16.5 |
p-value: 0.00195% CI: [7.09, 15]Type III F-test
Secondary
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
The validated Satisfaction with Decision (SWD) Survey was administered to all participants at baseline. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. I am satisfied that I am adequately informed about the issues important to my decision) on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Results are expressed as a proportion of participants who responded strongly agree at Baseline on the Satisfaction with Decision scale, which measured ratings of decision-making.
Time frame: Proportion of patients who strongly agreed the decisions about their health care were theirs to make at baseline (study enrollment).
Population: 79 (98.8%) participants in the control group and 80 (100%) participants in the intervention group completed this survey at time of enrollment in the study (baseline).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | 41 Participants |
| Lay Health Worker Intervention Group | Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | 38 Participants |
Secondary
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey
The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 12 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. I am satisfied that I am adequately informed about the issues important to my decision) on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group are averaged at 12 months after study enrollment. Results are expressed as a proportion of participants who responded strongly agree at 12 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded strongly agree are reflected from baseline to 12 months.
Time frame: Proportion of patients who strongly agree that decisions about their health care were theirs to make at 12 months post study enrollment.
Population: A total of 59 participants (73.8%) in the control group and 56 (70.0%) in the intervention group completed this survey question at 12-months post study enrollment; 21 (26.3%) participants in the control group and 23 (28.8%) participants in the intervention group had died at the time of the 12-month assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | 16 Participants |
| Lay Health Worker Intervention Group | Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey | 48 Participants |
Secondary
Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey
The validated Satisfaction with Decision (SWD) Survey was administered to all participants at 4 months after study enrollment. The SWD is a 6-item questionnaire, where respondents rate their agreement with 6 statements (e.g. I am satisfied that I am adequately informed about the issues important to my decision) on a likert-type scale. Answer options were (1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree. Responses to each item were averaged to give a score of 0 to 5 where 0 indicated lowest satisfaction and 5 indicated most satisfied with decision making. Scores for each group were averaged at 4 months after study enrollment. Results are expressed as a proportion of participants who responded strongly agree at 4 months post-enrollment on the SWD scale, which measured ratings of decision-making. Changes in the proportion of participants who responded strongly agree are reflected from baseline to 4 months post-enrollment.
Time frame: Proportion of patients who strongly agree that decisions about their health care were theirs to make at 4 months post study enrollment.
Population: At 4 Months, 74 (92.5%) in the control group and 71 (88.8%) in the intervention group completed this survey and 6 (7.5%) participants in the control group and 9 (11.3%) participants in the intervention group had died by the time of this assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey | 23 Participants |
| Lay Health Worker Intervention Group | Patient Satisfaction With Decision-Making Using the Satisfaction With Decision (SWD) Survey | 64 Participants |
Secondary
Physician Orders for Life Sustaining Treatment (Chart Review)
Physician Orders for Life Sustaining Treatment (POLST) documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.
Time frame: 4 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Physician Orders for Life Sustaining Treatment (Chart Review) | 5 Participants |
| Lay Health Worker Intervention Group | Physician Orders for Life Sustaining Treatment (Chart Review) | 25 Participants |
Secondary
Physician Orders for Life Sustaining Treatment (Chart Review)
Physician Orders for Life Sustaining Treatment (POLST) documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care Control Group | Physician Orders for Life Sustaining Treatment (Chart Review) | 13 Participants |
| Lay Health Worker Intervention Group | Physician Orders for Life Sustaining Treatment (Chart Review) | 33 Participants |
Secondary
Survival (Chart Review)
Survival rate for patients will be abstracted by electronic medical record chart review at 4 months after enrollment.
Time frame: 4 months after patient enrollment
Secondary
Survival (Chart Review)
Survival rate for patients will be abstracted by electronic medical record chart review at 12 months after enrollment.
Time frame: 12 months after patient enrollment
Secondary
Total Costs of Care
Total Costs of Care will be evaluated by review of claims data from time of enrollment until 12 months post-enrollment
Time frame: 12 months after patient enrollment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care Control Group | Total Costs of Care | 153,980.60 US Dollars |
| Lay Health Worker Intervention Group | Total Costs of Care | 72,585.06 US Dollars |
Secondary
Total Costs of Care End of Life
Total Costs of Care during the last 30 days of life will be evaluated by review of claims data from the 30 days preceding death for those patients who become deceased within 12 months of study enrollment.
Time frame: Last 30 days of life up to 12 months from patient enrollment
Population: sample of 21 participants in the control group and 23 participants in the intervention group who died within 12 months of study enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Total Costs of Care End of Life | 6,211 US Dollars |
| Lay Health Worker Intervention Group | Total Costs of Care End of Life | 5,471 US Dollars |