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Table 2 Measures and outcomes

From: A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

Outcome Instrument(s) Time Point Target Description
Aim 1 Outcome (Implementation Outcome, Patient Level)
ENABLE Uptake ENABLE Nurse Coach Contact Log (patients and caregivers) Months 1-15 Coordinator or Nurse Coach This contact log documents the delivery of each ENABLE session.
Aim 2 Outcome (Service Outcome, Practice Level)
Overall Program Implementation ENABLE GOI Baseline, 6, 12 months Coordinator and Nurse Coach (other staff may attend call) The ENABLE General Organizational Index (GOI) is conducted via a phone interview with the Coordinator and Nurse Coach (other staff may attend call) to assess factors that influence institutional implementation and fidelity to an evidence-based practice. It covers 12 domains and is scored on a Likert scale. Qualitative analysis will also be conducted [38,39,40].
Additional Implementation Outcomes
ENABLE Program Implementation ENABLE RE-AIM Self-Assessment Tool Baseline, 6, 12 months Coordinator and Nurse Coach The ENABLE RE-AIM Self Assessment Tool (Reach, Efficiency, Adoption, Implementation, and Maintenance) was developed in our prior work to collect reach, adoption, implementation, and maintenance [23, 24, 38]. Reach is defined as the number of enrolled participants divided by the number of eligible participants. Efficacy will be measured by patient and caregiver quality of life and mood outcomes (see Explanatory Aim 1 measures). Adoption will be measured by calculating the number of oncology physicians who refer patients divided by those who have the opportunity to refer patients to the study. Implementation is captured in the study’s primary outcome, ENABLE uptake. Maintenance will be measured by the presence of the ENABLE program 6 months after the completion of the VLC or TA implementation strategy in the ENABLE Sustainment Survey. The ENABLE Nurse Coach and/or coordinator will complete the online ENABLE RE-AIM Self-Assessment tool at baseline, 6 months (± 8 weeks), and 1 year (± 8 weeks).
Perceptions of Early Palliative Care Provider Perceptions of Early Palliative Care Survey Baseline, 15 months Oncologist and Nurse Coach The survey asks about attitudes about palliative care, feelings about palliative care specialists, comfort with an preferences for providing early concurrent oncology palliative care, and description of early concurrent palliative care provided in the practice cluster [38, 41]. Responses are on a Likert scale.
VLC and TA Process Outcomes
Program Participation and Engagement (VLC or TA) VLC Practice Participation and Engagement; TA Practice Participation and Engagement Months 1-15 Study team (VLC lead, TA lead) The VLC and TA Participation and Engagement forms assess the extent to which the sites participate in the assigned strategy (VLC or TA). The forms share commonalities, but are distinct to reflect the different methods of communicating with practice clusters. The site’s level of participation in the session is scored on a Likert scale with an additional free text entry. A higher score indicates better participation and engagement.
Fidelity (VLC or TA) VLC Fidelity; TA Fidelity Months 1-15 Study team (VLC lead, TA lead) The instrument measures fidelity and adherence to key features of the VLC and TA study arms respectively. The forms will be completed after each session. The instrument for the VLC and TA study arm are distinct. The study team will audit 10% of sessions by reviewing the recording and verifying key components being discussed during sessions.
ENABLE Process Measures
Palliative Care Assessment Palliative Care Assessment Checklist Baseline Nurse Coach This form documents each of the key components of the palliative care assessment that are completed.
Additional ENABLE Contacts ENABLE Additional Contacts Log (patients and caregivers) Months 1-15 Coordinator and Nurse Coach This instrument tracks other patient and caregiver contacts or activities as part of the ENABLE program. The ENABLE Nurse Coach will document non-session contacts and activities each week (i.e., time spent doing ENABLE related study tasks other than delivering the sessions) and enter them into REDCap. The coordinator will also document the time to complete recruitment and enrollment procedures in the log on REDCap every 2 weeks.
Fidelity to Palliative Care Assessment Palliative Care Assessment Adjudication Checklist Baseline, months 4-6 Nurse Coach An ENABLE expert will review four of each practice cluster’s palliative care assessments to ensure completion and correct documentation. At each practice cluster, we will request the clinical note in the medical record associated with the palliative care assessment for the first two patients enrolled and then a random sample of two additional patients. Study personnel will review the note and compare it to the Palliative Care Assessment Checklist. Adequate fidelity will be demonstrated by ≥85% of the components identified on the Palliative Care Assessment Checklist.
ENABLE Sustainment ENABLE Sustainment Survey Month 21 Oncologist and Nurse Coach (may be completed by other staff) This 9-item instrument measures the presence/sustainment of the ENABLE program 6 months (± 4 weeks) after completion of the 15-month implementation strategy (VLC or TA). Example questions include the number of trained ENABLE Nurse Coaches, number of patient and caregiver participants, ENABLE components currently offered, and any adaptations that have been made to the ENABLE program. Other staff members (e.g., coordinator, Primary Affiliate PI, CCDR Lead) may also complete the survey.
Exploratory Aim 1 Outcome (Patient Outcomes)
Patient Mood HADS Baseline, 12, 24 weeks Patient The Hospital Anxiety and Depression Scale (HADS) instrument assesses mood, including anxiety and depression. Seven questions rate the depression subscale and 7 questions rate the anxiety subscale. Each item has a 4-point scale, ranging from 0 to 3 with possible scores ranging from 0-21 for each subscale. Scoring for each sub-scale is as follows: 0-7 Normal, 8-10 Borderline abnormal, and 11-21 Abnormal [42,43,44,45,46].
Patient Quality of Life FACIT-PAL Baseline, 12, 24 weeks Patient The FACIT-Pal consists of the FACT-G (Functional Assessment of Cancer Therapy-General), a general measure of quality of life, and the palliative care subscale (Pal), which assesses issues specifically relevant to palliative care [37, 47,48,49]. The FACT-G is a 27-item questionnaire that provides a total score as well as four subscale scores: physical, social/family, emotional, and functional wellbeing. The FACIT-Pal includes 19 additional concerns relevant for persons at the end of life. The total score is the sum of the FACT-G plus the FACIT-Pal subscale [50].
Additional Patient Outcomes
Patient Global Health PROMIS Global Health Baseline, 12, 24 weeks Patient The 10-item measure uses Likert-scale response options for each item, ranging from 1 (always) to 5 (never). This instrument produces 2 scores: physical health and mental health score [51,52,53,54].
Symptom burden MDASI Baseline, 12, 24 weeks Patient The MD Anderson Symptom Inventory (MDASI) is a 19-item measure that assesses symptom severity experienced by patients with cancer and the symptom-related interference with daily living [55, 56]. The MDASI uses a 0-10 severity scale for 13 items, with 0 being symptom “not present” and 10 being “the worst you can imagine,” and an interference 0-10 response scale for 6 items ranging from 0 being “did not interfere” to 10 being “interfered completely”.
Demographic and Clinical Characteristics Demographics Form Baseline Patient Patients will be asked to report their education level, marital status, whom they live with, employment status, age, gender, ethnicity, race, employment status, diagnosis, insurance status, annual household income, urban vs. rural living location, religious preference, presence of a living companion, prior and current smoking status and usage, prior and current alcohol consumption.
Exploratory Aim 1 Outcome (Caregiver Outcomes)
Caregiver Mood HADS Baseline, 12, 24 weeks Caregiver See description under Patient Outcomes.
Caregiver Quality of Life PROMIS Global Health Baseline, 12, 24 weeks Caregiver See description under Patient Outcomes.
Caregiver burden MBCB Baseline, 12, 24 weeks Caregiver The Montgomery Borgatta Caregiver Burden (MBCB) Scale is a 14-item instrument assesses caregiver burden and the impacts on the caregiver’s life [57,58,59]. Each item uses a Likert-type scale response option, ranging from 1 (“A lot less”) to 5 (“A lot more”).
Positive Aspects of Caregiving Positive Aspects of Caregiver Baseline, 12, 24 weeks Caregiver The Positive Aspects of Caregiver is a 9-item instrument that assesses positive aspects of caregiving, including the extent to which the caregiver feels: useful, good about him/herself, needed, appreciated, important, strong and confident, appreciates life, more positive attitude toward life, and strengthened relationships with others. Each item is rated on a 5-point ordinal scale ranging from 1 (disagree a lot) to 5 (agree a lot) [60].
Preparedness for Caregiving Preparedness for Caregiving Scale Baseline, 12, 24 weeks Caregiver The Preparedness for Caregiving Scale is a self-rated instrument that consists of 8-items that asks caregivers about their perceived preparedness for multiple domains of caregiving, such as providing physical care, providing emotional support, setting up in-home support services, and dealing with the stress of caregiving [61, 62]. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared) [63]. There is also a question with a free text response.
Demographics Demographic Form Baseline Caregiver Caregivers will also be asked to report education level, marital status, whom they live with, employment status, age, gender, ethnicity, race, employment status, insurance status, annual household income, urban vs. rural living location, religious preference, relationship to patient participant, if the patient participants lives with them, average number of days per week they help take care of the patient, and average hours per day helping the patient participant.