Trial Outcomes & Findings for Lay Health Worker Engage, Educate, and Encourage Patients to Share (NCT NCT03699748)

Lay Health Worker Engage, Educate, and Encourage Patients to Share

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.

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.

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.

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.

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.

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 Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

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.

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

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.

Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Advance Directive documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after 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.

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.

Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Goals of Care documentation for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after 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 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 for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Palliative Care Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

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.

Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 4 months after enrollment.

Hospice Use for each patient will be abstracted by electronic medical record chart review for each patient at 12 months after enrollment.

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.

Survival rate for patients will be abstracted by electronic medical record chart review at 4 months after enrollment.

Survival rate for patients will be abstracted by electronic medical record chart review at 12 months after enrollment.

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.