Other Cancer
Conditions
Keywords
Cancer Care
Brief summary
In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery. \- It is expected that about 30,000 people will take part in this research study, 29,550 of these patients, the vast majority, will be included only for medical record review.
Detailed description
The purpose of this study is to improve the quality of care provided to millions of older Americans with cancer. The investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may dramatically improve health care delivery. This is pragmatic stepped wedge cluster randomized trial (SW-CRT) of a Comprehensive ACP (Advance Care Planning) Program among older oncology patients. The ACP Program will include training clinicians in communication skills and using video decision aids for participants. \- This study will involve medical record review of 30,000 people age 65 or older with advanced cancer. We will also recruit 450 eligible patients (150 patients from each of our three sites broken down into 75 patients during the control phase and 75 patients during the intervention phase) to conduct a survey for our secondary patient-centered outcomes (confidence, satisfaction with physician communication, patient decisional satisfaction and regret). From among this sub-group we will engage 240 participants (80 from each of our three sites broken down into 40 patients during the control phase and 40 patients during the intervention phase) in an activity to film video declarations of their preferences. During the first year, three pilot sites (one at each health care system) will trial the intervention. The subjects recruited at these pilot sites will not be included in the final analysis. Thus, the main trial will begin during year 2 and continue through year 5 with recruitment of 30,000 subjects for the primary outcome at 30 oncology clinics. The first year pilot will serve to inform the larger roll-out and the intervention may change during the first year based on pilot-clinic experience.
Interventions
OTHERClinician Communication Skills Training
Communication skills training
OTHERAdvance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids
OTHERVideo Declarations (ViDec)
Recording of patient advance care planning videos
Sponsors
Massachusetts General Hospital
Boston Medical Center
Northwell Health
Mayo Clinic
Duke University
National Institute on Aging (NIA)
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for clinics: Clinic eligibility criteria include: * More than one oncologist * Serve a patient population that is at least 30% aged 65 or older * Disease-based oncology clinic Subject Eligibility: (for the in-person surveys): \- Any patient affiliated with one of the study clinics who speaks English and is aged 65 or older with advanced cancer is eligible for participation. Advanced cancer is defined as metastatic disease for solid tumors and recurrent or refractory disease for hematological malignancies. There are no exclusions based on gender, race, or ethnicity.
Exclusion criteria
* Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Advance Care Planning Documentation | 6 months | Any advance directive (e.g., living will, POLST, etc.) and changes of resuscitation orders or any indication in the EHR of a goals-of-care or advance care planning conversation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Palliative Care Consultation | 6 months | Use of palliative care services (consults, outpatient visits) in the EHR |
| Rate of Hospice Use | 6 months | Use of hospice documented in the EHR |
| Number of Participants With CODE Status Limitations | 6 months | Documented choices regarding CPR and mechanical ventilation in the EHR |
| Communication and Decisional Satisfaction | 6 months | (In person survey) patient satisfaction with communication and decision making.The scale range is from 1- Strongly Disagree to 5 - Strongly Disagree. Higher values represent better outcomes. Subscales were combined questions were summed to compute a total score. The lowest possible score is a 9 and the highest possible score is 45. Lower scores indicate lower communication and decisional satisfaction. |
| Decisional Regret | 6 months | (In person survey) patient regret regarding decision making. The response range is 1 - Strongly Disagree to 5 - Strongly agree. Higher numbers represent a worse outcome. Scale questions were summed to compute a total score. The lowest possible score is 2 and the highest possible score is 10. Lower scores indicate less decisional regret. |
| Confidence in Future Care | 6 months | (in person survey) patient confidence that they will receive the right care at the right time by their health system. The scale ranged from 1 Not at all confident to 5 Very confident. Higher values represent a better outcome. |
Countries
United States
Participant flow
Recruitment details
Recruitment was from April, 2020 - November, 2022. Locations: 36 cancer clinics
Pre-assignment details
This is a stepped-wedge, cluster randomized trial where clinics were randomized at various steps to move from a control period to the intervention periods. A total of 13,800 unique participants from 29 clinics were enrolled in the study. Participants could have contributed data multiple times during any step of the study.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm Patients with cancer being seen at the 30 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Clinician Communication Skills Training: Communication skills training
Advance Care Planning (ACP) Decisions Videos Decisions Aids: ACP Decisions video decision aids
Video Declarations (ViDec): Recording of patient advance care planning videos | 15,754 |
| Usual Care Arm Patients who were not exposed to any intervention | 13,603 |
| Total | 29,357 |
Baseline characteristics
| Characteristic | Intervention Arm | Usual Care Arm | Total |
|---|---|---|---|
| Age, Continuous | 74.4 Years STANDARD_DEVIATION 6.6 | 74.6 Years STANDARD_DEVIATION 6.7 | 74.5 Years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 454 Participants | 392 Participants | 846 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14750 Participants | 12,801 Participants | 27551 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 550 Participants | 410 Participants | 960 Participants |
| Language English | 15096 Participants | 13067 Participants | 28163 Participants |
| Language Other | 554 Participants | 490 Participants | 1044 Participants |
| Language Unknown | 104 Participants | 46 Participants | 150 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 35 Participants | 27 Participants | 62 Participants |
| Race (NIH/OMB) Asian | 556 Participants | 479 Participants | 1035 Participants |
| Race (NIH/OMB) Black or African American | 1978 Participants | 1455 Participants | 3433 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 10 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1347 Participants | 1188 Participants | 2535 Participants |
| Race (NIH/OMB) White | 11830 Participants | 10441 Participants | 22271 Participants |
| Sex: Female, Male Female | 7284 Participants | 6729 Participants | 14013 Participants |
| Sex: Female, Male Male | 8470 Participants | 6874 Participants | 15344 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5,702 | 0 / 5,702 | 0 / 5,702 | 3,958 / 5,702 |
| other Total, other adverse events | 0 / 5,702 | 0 / 5,702 | 0 / 5,702 | 0 / 5,702 |
| serious Total, serious adverse events | 0 / 5,702 | 0 / 5,702 | 0 / 5,702 | 0 / 5,702 |
Outcome results
Primary
Number of Participants With Advance Care Planning Documentation
Any advance directive (e.g., living will, POLST, etc.) and changes of resuscitation orders or any indication in the EHR of a goals-of-care or advance care planning conversation
Time frame: 6 months
Population: The primary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Number of Participants With Advance Care Planning Documentation | Step 3 | 1047 Participants |
| Intervention Arm | Number of Participants With Advance Care Planning Documentation | Step 4 | 1698 Participants |
| Intervention Arm | Number of Participants With Advance Care Planning Documentation | Baseline | 0 Participants |
| Intervention Arm | Number of Participants With Advance Care Planning Documentation | Step 1 | 349 Participants |
| Intervention Arm | Number of Participants With Advance Care Planning Documentation | Step 2 | 886 Participants |
| Usual Care Arm | Number of Participants With Advance Care Planning Documentation | Step 2 | 511 Participants |
| Usual Care Arm | Number of Participants With Advance Care Planning Documentation | Step 1 | 901 Participants |
| Usual Care Arm | Number of Participants With Advance Care Planning Documentation | Step 4 | 0 Participants |
| Usual Care Arm | Number of Participants With Advance Care Planning Documentation | Step 3 | 259 Participants |
| Usual Care Arm | Number of Participants With Advance Care Planning Documentation | Baseline | 1163 Participants |
p-value: <0.0595% CI: [2.8, 10.8]binomial regression with identity link
Secondary
Communication and Decisional Satisfaction
(In person survey) patient satisfaction with communication and decision making.The scale range is from 1- Strongly Disagree to 5 - Strongly Disagree. Higher values represent better outcomes. Subscales were combined questions were summed to compute a total score. The lowest possible score is a 9 and the highest possible score is 45. Lower scores indicate lower communication and decisional satisfaction.
Time frame: 6 months
Population: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | Communication and Decisional Satisfaction | 44 units on a scale |
| Usual Care Arm | Communication and Decisional Satisfaction | 44 units on a scale |
Secondary
Confidence in Future Care
(in person survey) patient confidence that they will receive the right care at the right time by their health system. The scale ranged from 1 Not at all confident to 5 Very confident. Higher values represent a better outcome.
Time frame: 6 months
Population: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Confidence in Future Care | Unknown | 15 Participants |
| Intervention Arm | Confidence in Future Care | None to little confidence | 4 Participants |
| Intervention Arm | Confidence in Future Care | Somewhat confident | 13 Participants |
| Intervention Arm | Confidence in Future Care | Fairly confident | 27 Participants |
| Intervention Arm | Confidence in Future Care | Very Confident | 137 Participants |
| Usual Care Arm | Confidence in Future Care | Very Confident | 90 Participants |
| Usual Care Arm | Confidence in Future Care | Unknown | 5 Participants |
| Usual Care Arm | Confidence in Future Care | Fairly confident | 15 Participants |
| Usual Care Arm | Confidence in Future Care | None to little confidence | 4 Participants |
| Usual Care Arm | Confidence in Future Care | Somewhat confident | 8 Participants |
Secondary
Decisional Regret
(In person survey) patient regret regarding decision making. The response range is 1 - Strongly Disagree to 5 - Strongly agree. Higher numbers represent a worse outcome. Scale questions were summed to compute a total score. The lowest possible score is 2 and the highest possible score is 10. Lower scores indicate less decisional regret.
Time frame: 6 months
Population: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Arm | Decisional Regret | 2 units on a scale |
| Usual Care Arm | Decisional Regret | 2 units on a scale |
Secondary
Number of Participants With CODE Status Limitations
Documented choices regarding CPR and mechanical ventilation in the EHR
Time frame: 6 months
Population: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Number of Participants With CODE Status Limitations | Step 1 | 58 Participants |
| Intervention Arm | Number of Participants With CODE Status Limitations | Step 3 | 280 Participants |
| Intervention Arm | Number of Participants With CODE Status Limitations | Step 2 | 155 Participants |
| Intervention Arm | Number of Participants With CODE Status Limitations | Step 4 | 354 Participants |
| Intervention Arm | Number of Participants With CODE Status Limitations | Baseline | 0 Participants |
| Usual Care Arm | Number of Participants With CODE Status Limitations | Step 4 | 0 Participants |
| Usual Care Arm | Number of Participants With CODE Status Limitations | Baseline | 303 Participants |
| Usual Care Arm | Number of Participants With CODE Status Limitations | Step 1 | 205 Participants |
| Usual Care Arm | Number of Participants With CODE Status Limitations | Step 2 | 142 Participants |
| Usual Care Arm | Number of Participants With CODE Status Limitations | Step 3 | 74 Participants |
p-value: <0.0595% CI: [-0.7, 0.6]binomial regression with identity link
Secondary
Rate of Hospice Use
Use of hospice documented in the EHR
Time frame: 6 months
Population: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Rate of Hospice Use | Step 1 | 50 Participants |
| Intervention Arm | Rate of Hospice Use | Step 3 | 350 Participants |
| Intervention Arm | Rate of Hospice Use | Step 2 | 260 Participants |
| Intervention Arm | Rate of Hospice Use | Step 4 | 468 Participants |
| Intervention Arm | Rate of Hospice Use | Baseline | 0 Participants |
| Usual Care Arm | Rate of Hospice Use | Step 4 | 0 Participants |
| Usual Care Arm | Rate of Hospice Use | Baseline | 491 Participants |
| Usual Care Arm | Rate of Hospice Use | Step 1 | 348 Participants |
| Usual Care Arm | Rate of Hospice Use | Step 2 | 202 Participants |
| Usual Care Arm | Rate of Hospice Use | Step 3 | 108 Participants |
p-value: <0.0595% CI: [-0.4, 1]binomial regression with identity link
Secondary
Rate of Palliative Care Consultation
Use of palliative care services (consults, outpatient visits) in the EHR
Time frame: 6 months
Population: The secondary outcome measure was assessed at the participant level (all eligible patients) and not at the unit level.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Arm | Rate of Palliative Care Consultation | Step 4 | 648 Participants |
| Intervention Arm | Rate of Palliative Care Consultation | Baseline | 0 Participants |
| Intervention Arm | Rate of Palliative Care Consultation | Step 3 | 443 Participants |
| Intervention Arm | Rate of Palliative Care Consultation | Step 1 | 102 Participants |
| Intervention Arm | Rate of Palliative Care Consultation | Step 2 | 324 Participants |
| Usual Care Arm | Rate of Palliative Care Consultation | Step 4 | 0 Participants |
| Usual Care Arm | Rate of Palliative Care Consultation | Step 2 | 253 Participants |
| Usual Care Arm | Rate of Palliative Care Consultation | Step 3 | 128 Participants |
| Usual Care Arm | Rate of Palliative Care Consultation | Baseline | 531 Participants |
| Usual Care Arm | Rate of Palliative Care Consultation | Step 1 | 375 Participants |
p-value: <0.0595% CI: [-0.5, 1.9]binomial regression with identity link