Patient-caregiver Communication Intervention for Prognostic Understanding

Change in prognostic understanding is assessed at baseline and post-intervention with two items on prognostic understanding: (1) Terminal illness acknowledgement with the item How would you describe your current health status? Answer choices include: 1) Relatively healthy, 2) relatively healthy but terminally ill, 3) seriously ill but not terminally ill, and 4) seriously ill and terminally ill, and (5) I don't know\]. Responses 2 and 4 are coded as accurate and responses 1, 3, and 5 are coded as inaccurate. (2) Life-expectancy \[Months, Years, and I don't know\]. Months are coded as accurate and years and I don't know are coded as inaccurate. Each variable is coded as 0=inaccurate or 1=accurate, for a total summary score range of 0 to 2. Differences between baseline and post-intervention assessments are calculated (possible range, -2 to +2) to determine changes in prognostic understanding.

Time frame: Baseline, post-intervention (within 30 days)

Population: The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up and did not have post-intervention data.

Caregiver burden will be assessed with the Zarit Burden Interview (ZBI), a reliable and valid 22-item measure of caregiver burden used in intervention studies of cancer caregivers. Response options are on a 5-point Likert-type scale (0 = never to 4=nearly always). Scores can range from 0 to 88, with higher scores indicating higher levels of burden. Change in caregiver burden will be assessed at baseline and post-intervention.

Time frame: Baseline, post-intervention (within 30 days)

Population: There are n=0 patients for this measure because this outcome variable was only assessed among caregivers. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up and did not have post-intervention data.

Change in caregiver engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to caregivers. Response options include: yes=1, no=0. Individual scores can range from 0 to 4, with higher scores indicating more decisions have been made. Change scores can range from -4 to +4.

Time frame: Baseline, follow-up (3 months)

Population: There are n=0 patients for this measure because this outcome variable was only assessed among caregivers. The number of caregivers analyzed (n=7) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study, n=3 were lost to follow up and did not have post-intervention data, and n=1 did not provide data for this outcome.

Change in caregiver engagement in advance care planning will be assessed with a companion measure in the final phases of validation by Van Scoy and Sudore. This measure adapts the Advance Care Planning Engagement Survey to apply to caregivers. Response options include: yes=1, no=0. Individual scores can range from 0 to 4, with higher scores indicating more decisions have been made. Change scores can range from -4 to +4.

Time frame: Baseline, post-intervention (within 30 days)

Population: There are n=0 patients for this measure because this outcome variable was only assessed among caregivers. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up and did not have post-intervention data.

Communication quality will be assessed with the 5-item Family Communication subscale of the Cancer Communication Assessment Tool for Patients and Families, a valid measure in cancer patients and caregivers. Response options are on a 5-point Likert-type scale (1 = strongly disagree to 5= strongly agree). Scores can range from 5 to 25, with higher scores indicating worse communication quality. Change in communication quality will be assessed at baseline and post-intervention.

Time frame: Baseline, post-intervention (within 30 days)

Population: The original CCAT scale is scored on a scale from 1 to 6, but this data had a 1 to 5 response scale. The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up.

Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., Have you already decided who you want your medical decision maker to be? Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.

Time frame: Baseline, follow-up (3 months)

Population: There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=7) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study, n=3 patients were lost to follow up and did not have post-intervention data, and n=1 patient did not provide data for this measure.

Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Decision Maker (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around advance care planning (e.g., Have you already decided who you want your medical decision maker to be? Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning. Change scores can range from -4 to +4.

Time frame: Baseline, post-intervention (within 30 days)

Population: There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data.

Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., Have you already decided whether or not certain health situations would make your life not worth living? Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.

Time frame: Baseline, follow-up (3 months)

Population: There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=7) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study, n=3 patients were lost to follow up and did not have post-intervention data, and n=1 patient did not provide data for this measure.

Change in patient engagement in advance care planning will be assessed in patients using the reliable and valid Quality of Life (four items) subscale of the Advance Care Planning Engagement Survey: Action Measures. Response options include: yes=1, no=0. Questions include those asking about whether patients have engaged in a decision around quality of life in advance care planning (e.g., Have you already decided whether or not certain health situations would make your life not worth living? Individual scores can range from 0 to 4, with higher scores indicating that more decisions have been made around advance care planning as it pertains to quality of life. Change scores can range from -4 to +4.

Time frame: Baseline, post-intervention (within 30 days)

Population: There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data.

Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), a valid and reliable 14-item, Likert-type self-report measure of mood disturbance commonly used with cancer patients. The HADS contains two seven-item subscales: 1) anxiety and 2) depressive symptoms. Each item on this scale is rated on a 4-point scale (0 to 3), and all items are summed to create a HADS total score. Total scores can range from 0 to 42, with higher numbers indicating higher levels of distress. Change in psychological distress will be assessed at baseline and post-intervention.

Time frame: Baseline, post-intervention (within 30 days)

Population: The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data. The number of caregivers analyzed (n=8) was less than the total caregivers enrolled (n=14) because n=3 caregivers withdrew from the study and n=3 were lost to follow up and did not have post-intervention data.

Completion of advance directives will be assessed by asking patients whether they completed a do-not-resuscitate order, a living will, and/or identified a health care proxy; data will be verified through the patient's electronic health record. Change in these numbers will be assessed at baseline and post-intervention. Scores are computed by summing together the total number of advance directives completed. Scores can range from 0 to 3, with higher scores indicating increases in completion of advance directives. Change scores can range from -3 to +3.

Time frame: Baseline, post-intervention (within 30 days)

Population: There are n=0 caregivers for this measure because this outcome variable was only assessed among patients. The number of patients analyzed (n=9) was less than the total patients enrolled (n=14) because n=3 patients withdrew from the study and n=2 patients were lost to follow up and did not have post-intervention data.