Background
Methods/Design
Study overview
Design
Setting
Site and hospital | Description |
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Alabama (AL) Russell Medical Center | Located in Alexander City, AL, 80 bed, not-for-profit, acute care facility serving the needs of east central Alabama. Approximately, 24,827 patients visited the hospital’s emergency room. There are 67 physicians affiliated with the hospital, and the hospital had a total of 3245 admissions. Its physicians performed 835 inpatient and 3264 outpatient surgeries. Russell Medical Center also supports community health education services through health screenings, support groups, childbirth classes, self-help programs, and athletic trainers to multiple sports teams in its service area. |
Mississippi (MS) Highland Community Hospital | Located in Picayune MS, a 60-bed not-for-profit hospital and affiliated clinics provide access to a broad range of quality services, supporting the community and enhancing the level of care for the residents of Picayune and the surrounding areas. There are 100 physicians affiliated with the Highland Community Hospital. Its community outreach includes classes and events in different themes including community education, continuing education, screenings, and support groups. |
South Carolina Aiken Regional Medical Center | Located in Aiken, SC, a 245-bed acute care facility offering a comprehensive range of specialties and services. The medical staff includes over 900 skilled healthcare/support professionals, a medical staff of more than 120 multi-specialty physicians, and a team of 230 volunteers. The center provides nearly 50 specialty services through its acute care facility, behavioral healthcare hospital, and the Cancer Care Institutes of Carolina. Services are provided to residents of Aiken and its surrounding communities. Community outreach in Aiken Regional Medical Center includes classes, seminars, support groups, and information about new services. |
Phase I: developing site specific CAGs and training PC physicians and site coordinators in culturally based tele-consultation intervention and study protocol
Community advisory group (CAG) development and training
Phase II: conducting the RCT
Participants
Recruitment and consent
Randomization and blinding
The Community Tele-pal intervention
Contact # | When | With whom | Method | Purpose |
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#1 Palliative care tele-consult | As soon after randomization as possible | Patient (and family) referring hospitalist and remote palliative clinician Local study coordinator Remote IDT Members | Secure tele-consult Remote IDT review eHR document | 1. Conduct community-developed, culturally based palliative assessment. 2. IDT review (as needed) 3. Develop recommendations and palliative care plan |
#2 Follow-up day 3 | Within 3 days post consult | Patient and (family) Local study coordinator Remote and local clinicians | eHR document Telephone | 1. Provide recommendations and care plan 2. Respond to patient, family and remote team questions 3. Identify community care team and initiate referrals as needed (primary clinician/hospice provider if appropriate). |
#3 Follow-up day 6 | Within 6 days post consult | Patient and family Study coordinator/ Remote palliative care clinician and community care team members | Telephone | 1. Reassess patient and care plan 2. Assess adequacy of discharge plan or home experience 3. Refer to community resources |
Tele-consultation contact #1 (initial consult)
Hospital Name [AUTOPOPULATE, if possible] | |
Date of consult: [AUTOPOPULATE, if possible] | |
Patient Name/DOB/Gender/Race/MR# [AUTOPOPULATE, if possible] | |
Referral Source/Provider: [AUTOPOPULATE, if possible – if considered an “order”] | |
Primary problem/focus of consult: [If possible, havedrop-down listwith these options: • Symptom Management • Support/Coping • Goals of Care/Advance Care Planning • Interdisciplinary referral(s) • Local Resources / Community Care Medical / Other Support Communication • Hospice / Home Services • Other] | |
Secondary problem/focus of consult: [If possible, havedrop-down listwith these options: • Symptom Management • Support/Coping • Goals of Care/Advance Care Planning • Interdisciplinary referral(s) • Local Resources / Community Care Medical / Other Support Communication • Hospice / Home Services • Other] | |
History of Present Illness: | |
Past Medical/Surgical History: [AUTOPOPULATE, if possible] | |
Medications Review and Allergies: [AUTOPOPULATE, if possible] | |
Physical ROS/Cognition/Functional status: | |
Social History/Assessment: | |
Support Systems/Family concerns: | |
Spirituality/Beliefs: | |
Physical Exam-Limited: [AUTOPOPULATE Vital signs, Weight, Inputs/Outputs (including bowel movements) if possible] | |
Lab/Diagnostic studies/Records Review Highlights: [DO NOT AUTOPOPULATE] | |
Palliative Performance Scale: [if possible, have table below displayedANDdrop-down with choices: • 100% = Ambulation: Full; Activity & Evidence of Disease: Normal activity & work, No evidence of disease; Self-Care: Full; Intake: Normal; Conscious Level: Full • 90% = Ambulation: Full; Activity & Evidence of Disease: Normal activity & work, Some evidence of disease; Self-Care: Full; Intake: Normal; Conscious Level: Full • 80% = Ambulation: Full; Activity & Evidence of Disease: Normal activity with Effort, Some evidence of disease; Self-Care: Full; Intake: Normal or reduced; Conscious Level: Full • 70% = Ambulation: Reduced; Activity & Evidence of Disease: Unable Normal Job/Work, Significant disease; Self-Care: Full; Intake: Normal or reduced; Conscious Level: Full • 60% = Ambulation: Reduced; Activity & Evidence of Disease: Unable hobby/house work, Significant disease; Self-Care: Occasional assistance necessary; Intake: Normal or reduced; Conscious Level: Full or Confusion • 50% = Ambulation: Mainly Sit/Lie; Activity & Evidence of Disease: Unable to do any work, Extensive disease; Self-Care: Considerable assistance required; Intake: Normal or reduced; Conscious Level: Full or Confusion • 40% = Ambulation: Mainly in Bed; Activity & Evidence of Disease: Unable to do most activity, Extensive disease; Self-Care: Mainly assistance; Intake: Normal or reduced; Conscious Level: Full or Drowsy +/− Confusion • 30% = Ambulation: Totally Bed Bound; Activity & Evidence of Disease: Unable to do any activity, Extensive disease; Self-Care: Total Care; Intake: Normal or reduced; Conscious Level: Full or Drowsy +/− Confusion • 20% = Ambulation: Totally Bed Bound; Activity & Evidence of Disease: Unable to do any activity, Extensive disease; Self-Care: Total Care; Intake: Minimal to sips; Conscious Level: Full or Drowsy +/− Confusion • 10% = Ambulation: Totally Bed Bound; Activity & Evidence of Disease: Unable to do any activity, Extensive disease; Self-Care: Total Care; Intake: Mouth care only; Conscious Level: Drowsy or Coma +/− Confusion • 0% = Death | |
Goals of Care / Advance Care Planning Assessment: | |
Global Assessment Statement: | |
Recommendations/Plan: A. Symptom Management B. Support / Coping C. Goals of Care / Advance Care Planning (inc. AD, Proxy, DNR, POLST, etc.) D. Interdisciplinary Referrals (PT, OT, Spiritual, Counselor, Social Work, etc.) E. Local Resources / Community Care Medical / Other Support / Communication F. Hospice / Home Services G. Other | |
Transition/Discharge Plans (if known): |
African American | White |
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Distrust is ever present. Recognize and respect. Work to establish trust. | |
White coat, tele-health: Wear white coat | |
Tele-health: Acknowledge not same as face to face | |
Address patient/family | |
By last name or title ONLY | |
1. Introduce self, then invite patient/family to introduce self, hospital staff and CRC last | |
Rapport building | |
Get to know patient, begin establishing rapport | |
Take additional time to get to know family | |
Learn specifics about family and talk about it | |
Discuss something local | |
Family care/social history | |
Recognize that family will be there for patient and care for them at home. Start with that assumption. | |
Illness understanding/prognosis discussion | |
1. Ask patient/family if want to know prognosis; | 1. Sensitively determine if patient/family want to know about prognosis. |
2. Never be blunt. | 2. Honor their decision (i.e., if do not want to know, do not discuss and vice versa). |
3. Never tell patient they are dying. | 3. Be a part of their journey. |
4. If family asks prognosis, never give date or time, only range. | |
5. Explain what’s happening in the body very simply (no medical terms). | |
6. Offer opportunity for patient and family to ask questions. If family does not understand, explain in different way | |
7. If patient/family is religious, physician can say, “I can see that you are a spiritual person, we are doing the best that we can and it’s in God’s hands.” | |
8. Always say: it’s in God’s hands/God decides. If physician not comfortable saying, “God”, say, “it’s in the hands of a higher power.” | |
9. If physician is comfortable, ask if you can pray with the patient/family. | |
Medications/symptoms | |
1. Explain why pain meds needed, especially morphine dosing | |
2. If concern about lack of consciousness raised, explain balance between pain free and being asleep/unconscious | |
3. If concern about morphine dose change, explain flexible dosing | |
4. If concern about addiction is raised, explain addiction not problem | |
5. If fear of overdosing is raised (with potential to enhance death), address concern and ease fear. | |
6. Explain simply; no medical language. | |
Goals of care, treatment preferences and ACP | |
May be confused between: AD, DNR, Power of Atty. | |
Recognize: Care instructions given verbally to family | 1. Ask if they have any documents of wishes. |
1. If patient cannot communicate: Ask if shared instructions w family (and who) | 2. Ask if have been asked to complete documents. Clarify if questions |
2. Ask family what care patient wanted | 3. If has document, ask: What does it specify? Have they changed? Has hospital followed them? |
4. If no AD, ask if know what care pt. wanted | |
5. If not AD, ask if want to complete one. | |
Role of religion and church | |
Recognize importance of pastors, especially in discussing prognosis. Invite pastor to next meeting if discussing prognosis. | |
Recognize importance of religion, source of comfort, knowledge, a guide for all things | Recognize church members are a source of support. If support needed, ask if a church member can assist; ask name of church member and discuss how they can provide support. |
Financial vulnerability | |
Recognize may experience substantial financial difficulties, with harsh/challenging realities | |
Death and dying | |
Recognize death is not discussed in church. Approach possibility of death with caution. | |
Hospice | |
1. Never say ‘hospice’ and do not raise it UNLESS the patient/caregiver raises it or expresses concern about burden of care OR asks about hospice. | 1. Assess how patient and family feel about hospice but do not use the word, “hospice.” Use “home health.” |
2. Ask which family members are helping to take care of patient (and how). If it is the kind of care home hospice provides, explain that this is the type of care that home health provides. | 2. Whatever their response, acknowledge and respect their feelings/attitudes. |
3. Ask if there are any specific concerns (e.g. cleaning a port, bathing a patient with an open wound) about the family providing care, and discuss until all concerns are alleviated. | 3. If open to it, talk about this is a helpful way to take care of the family at home. |
4. Emphasize that home health NOT there to take over; the family is in charge. | 4. Make sure to emphasize that this is an offer of help and assistance. |
5. If open to it, talk about how this is a helpful way to take care of the family at home. | |
6. Ask if have any concerns about this kind of home help. Address concerns | |
7. Acknowledge and respect their feelings/attitudes. | |
8. If patient/family wants home health/hospice, ask if want you to make referral. | |
9. Stress that all decisions are up to the patient/family. You’re there only to help. | |
Nursing homes | |
1. If patient in nursing home, or family/patient raises issue, discuss nursing home referral. Do not raise if they do not | 1. If patient is in nursing home, help family deal with guilt |
2. If loved one is going to nursing home, provide support to family. |
Tele-consultation contact #2 (day 3 follow-up; approximately 48–72 h after first contact)
Tele-consultation contact #3 (day 6 follow-up; via videoconference if patient is in hospital, via phone if discharged)
Usual care
Outcome measures
Data collection
Domain | Specific measurement | Description of measure | Schedule | |
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Primary aim | ||||
Patient | Symptom burden | Edmonton Symptom Assessment Scale (ESAS) | Symptom intensity using visual analog (9 items) | Baseline, day 7, day 30 |
Secondary aims | ||||
Patient | QOL | PROMIS Global Health-10 | Evaluates physical, social, and emotional health in healthy and chronically ill adults (10 items) | Baseline, day 7, day 30 |
Satisfaction | Feeling Heard and Understood | Self-report quality measures for palliative care settings on Likert scale (1 item) | Baseline, day 7, day 30 | |
Resource use | Patient resource use (hospital readmissions, # of hospital days, # of ICU days etc.) | Day 30 | ||
Caregiver | QOL | PROMIS Global Health-10 | Evaluates physical, social, and emotional health in healthy and chronically ill adults (10 items) | Baseline, day 7, day 30 |
Satisfaction | FamCare | Family satisfaction with availability of care, physical, and psychosocial care, information giving (20 items) | Baseline, day 7, day 30 | |
Caregiver burden | Montgomery Borgatta Caregiver Burden Scale (MBCB) | Subscales objective, subjective, demand burden (14 items) | Baseline, day 7, day 30 | |
Exploratory aim | ||||
Patient | Symptom burden | Edmonton Symptom Assessment Scale (ESAS) | Symptom intensity using visual analog (9 items) | Day 7 |
Caregiver | Caregiver burden | Montgomery Borgatta Caregiver Burden Scale (MBCB) | Subscales objective, subjective, demand burden (14 items) | Day 7 |
Caregiver | Bereavement | Caregiver Evaluation of Quality of End-of-Life (CEQUEL) | 13 items | 2–3 months |
Bereavement | Core Bereavement Items (CBI) | Subscales/Item (7 items) | 2–3 months |
Statistical analysis plan
Sample size and power considerations
Community Tele-pal intervention fidelity monitoring
Usual care monitoring
Ethical aspects
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Emotional distress: talking about their illness and symptoms may cause emotional distress for patients or care partners. Patient may get tired while answering the questions with the study coordinator. If a patient gets too tired, we can come back later in the day. Sometimes people feel embarrassed or uncomfortable when being asked questions so patients/care partners can refuse to answer any question. Upon participant report of emotional distress, data collection can be paused and resumed at a later date. The study coordinators will follow-up to ensure the participant feels supported and this distress will be reported to the palliative care clinician or inpatient support services if necessary.
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Loss of confidentially: There is a chance that people not associated with the study will see patient/care partner's answers to questionnaires. Therefore, any identifying information will be removed from study documents. Data will be kept in locked files in the study research offices at UAB with study ID numbers. All data will be housed in a secure, password-protected database at UAB.
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Burden versus benefits: There is a risk related to being placed into a group by chance (i.e., randomization). Patients in the usual care group may not have the same benefits as patients in the intervention group during their inpatient stay. However, both groups may receive outpatient palliative services from a local home hospice organization if they are available and deemed appropriate by the clinicians and patient/family. Because this trial is being conducted in a facility that lacks palliative care services, there are no inpatient palliative care services available to usual care patients. However, to the extent they wish to receive palliative care from an external hospice agency after hospital discharge, that will be determined by the hospitalist and the patients/family. There are also no scheduled intervention palliative care contacts after contact #3; however, as for the usual care group, palliative care services from home hospice agencies may be instituted.