Implementation of a Telehealth Palliative Care Model for Persons With Dementia
Phase: NA
Conditions: Palliative Care, Dementia
Sponsor: University of Maryland, Baltimore

 
Protocol Template, Version 3.0  
 
Clinical Interventional Study 
Protocol Template 
 
 

 
 
Protocol Template, Version 3.0 
 
PREFACE 
The Clinical Intervention Study Protocol Template is a suggested format for clinical trials sponsored 
by the National Institute on Aging (NIA). Investigators are encouraged to use this format, as 
appropriate, when developing protocols for their studies. Large multi-site observational studies will 
also benefit from this protocol template. 
Note that instructions and explanatory text are indicated by italics and should be replaced in your 
protocol with appropriate text.  Section headings and template text formatted in regular type should be 
included in your protocol document as provided in the template. 
The goal of this template is to provide a general format applicable to all single- and multicenter clinical 
intervention trials (e.g., drug, surgery, behavioral, nutritional, device, etc).  
As you can see the version number and date are on the bottom of each page. When making changes to 
an approved and “final” protocol, please provide a summary of the changes, with the date, at the front 
of the protocol. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Protocol Template, Version 3.0 
 
 
FULL PROTOCOL TITLE 
 
Implementation of a Telehealth Palliative Care Model for Persons with Dementia 
 
Study Chairman or Principal Investigator: 
Joan G. Carpenter, PhD, CRNP 
Assistant Professor 
University of Maryland, Baltimore 
Supported by: 
The National Institute on Aging 
 IMPACT Collaboratory FY20_Pilot1_Carpenter 
Study Intervention Provided by:  
N/A 
Sponsor of IND/IDE:  
N/A 
 
Version 1.9 
September 21, 2022
 
 

 
Protocol Template, Version 3.0                                                                                                                                   ii 
 
Table of Contents 
PREFACE ....................................................................................................................................... i 
FULL PROTOCOL TITLE ......................................................................................................... ii 
PRÉCIS .......................................................................................................................................... v 
Study Title ................................................................................................................................... v 
Objectives ................................................................................................................................... v 
Design and Outcomes ................................................................................................................. v 
Interventions and Duration ......................................................................................................... v 
Sample Size and Population ........................................................................................................ v 
STUDY TEAM ROSTER ............................................................................................................ 1 
Principal Investigator:   Joan G. Carpenter, PhD, CRNP ......................................................... 1 
Research Project Manager:  Jasmine A. Newman, B.S. .......................................................... 1 
PARTICIPATING STUDY SITES ............................................................................................. 1 
1 
Study objectives ..................................................................................................................... 2 
1.1 
Primary Objective ............................................................................................................ 2 
1.2 
Secondary Objectives ....................................................................................................... 2 
2 
BACKGROUND AND RATIONALE ................................................................................ 2 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ................................ 2 
2.2 
Study Rationale ................................................................................................................ 2 
3 
STUDY DESIGN ................................................................................................................... 2 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................ 3 
4.1 
Inclusion Criteria .............................................................................................................. 3 
4.2 
Exclusion Criteria ............................................................................................................. 3 
4.3 
Study Enrollment Procedures ........................................................................................... 3 
5 
STUDY INTERVENTIONS ................................................................................................ 4 
5.1 
Interventions, Administration, and Duration .................................................................... 4 
5.2 
Handling of Study Interventions ...................................................................................... 5 
5.3 
Concomitant Interventions ............................................................................................... 5 

 
Protocol Template, Version 3.0                                                                                                                                   iii 
 
5.3.1 
Allowed Interventions ............................................................................................. 5 
5.3.2 
Required Interventions ........................................................................................... 5 
5.3.3 
Prohibited Interventions ........................................................................................ 5 
5.4 
Adherence Assessment ..................................................................................................... 5 
6 
STUDY PROCEDURES ...................................................................................................... 7 
6.1 
Schedule of Evaluation for Intervention .......................................................................... 7 
6.2 
Description of Evaluations for the Intervention ............................................................... 8 
6.2.1 
Screening Evaluation .............................................................................................. 8 
6.2.2 
Enrollment, Baseline, and/or Randomization ...................................................... 8 
6.2.3 
Follow-up Visit(s) Day 20 (± 10 Days) ................................................................... 9 
6.2.4 
Completion/Final Evaluation ................................................................................. 9 
7 
SAFETY ASSESSMENTS ** Note: this project requires safety officer (SO) oversight 
rather than a full DSMB**........................................................................................................... 9 
7.1 
Specification of Safety Parameters .................................................................................. 9 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters ........ 9 
7.3 
Adverse Events and Serious Adverse Events ................................................................. 10 
7.3.1 
Reporting Procedures ........................................................................................... 10 
7.3.2 
Follow-up for Adverse Events .............................................................................. 12 
7.4 
Safety Monitoring .......................................................................................................... 12 
8 
INTERVENTION DISCONTINUATION ....................................................................... 12 
9 
STATISTICAL CONSIDERATIONS .............................................................................. 13 
9.1 
General Design Issues .................................................................................................... 13 
9.2 
Sample Size and Randomization .................................................................................... 13 
9.2.1 
Treatment Assignment Procedures ..................................................................... 13 
9.3 
Interim analyses and Stopping Rules ............................................................................. 13 
9.4 
Outcomes ........................................................................................................................ 13 
9.4.1 
Primary outcome ..................................................................................................... 13 
9.4.2 
Secondary outcomes ............................................................................................... 13 
9.5 
Data Analyses ................................................................................................................. 13 
10 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 14 
10.1 
Data Collection Forms ................................................................................................ 14 
10.2 
Data Management ....................................................................................................... 14 
10.3.1 Training ................................................................................................................. 14 
10.3.2 Metrics ................................................................................................................... 14 

 
Protocol Template, Version 3.0                                                                                                                                   iv 
 
10.3.3 Protocol Deviation ................................................................................................. 14 
10.3.4 Monitoring .............................................................................................................. 14 
11 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 14 
11.1 
Institutional Review Board (IRB) Review ................................................................. 14 
11.2 
Participant Confidentiality .......................................................................................... 15 
11.3 
Study Discontinuation ................................................................................................ 16 
12 Compensation ...................................................................................................................... 16 
13 ETHICAL CONSIDERATIONS ....................................................................................... 16 
14 COMMITTEES .................................................................................................................. 16 
15 PUBLICATION OF RESEARCH FINDINGS ................................................................ 16 
16 REFERENCES .................................................................................................................... 16 
17 SUPPLEMENTS/APPENDICES ...................................................................................... 18 
 
 
 

 
Protocol Template, Version 3.0                                                                                                                                   v 
 
PRÉCIS 
Study Title  
Implementation of a Telehealth Palliative Care Model for Persons with Dementia  
Objectives  
1) 
Assess the reach of the Palliative Care Consultation in Post-Acute Care (PCC-PAC) 
intervention defined as acceptability and appropriateness through a Stakeholder 
Engagement Plan. 
2) 
Assess Treatment Delivery Fidelity defined as a provider adherence to the PCC-PAC 
intervention protocol among 30 persons living with dementia (PLWD) in 1 nursing home 
(NH) with 2 providers. 
3) 
Assess Intervention Implementation Fidelity defined as NH adherence to PCC-PAC 
recommendations among 30 PLWD in 1 NH with 2 providers 
Design and Outcomes   
Single arm pilot clinical trial to assess implementation outcomes of the PCC-PAC among 30 
PLWD age 60 years or older newly admitted to a NH for post-acute care and their care partners.  
Interventions and Duration  
Subjects will receive usual care plus a telehealth palliative care consultation by specialty 
providers who will document their findings in the Electronic Health Record (EHR) and 
communicate their findings and recommendations to the clinical team. 
Sample Size and Population  
10 Stakeholders to meet objective 1 
 
30 PLWD age 60 years or older newly admitted to a NH for post-acute care and their care 
partners to meet objectives 2 and 3. 
 
 

 
Protocol Template, Version 3.0                                                                                                                                   1 
 
STUDY TEAM ROSTER  
Principal Investigator:  
 
Joan G. Carpenter, PhD, CRNP 
655 W. Lombard St., Suite 442A 
Baltimore, MD 21201 
 
 
 
 
 
410-706-2585 
Joan.carpenter@umaryland.edu 
Supervise all aspects of this study’s implementation including 
study start up, regulatory approvals, data collection, data 
management, all analyses, lead the drafting of primary 
manuscripts and conference abstracts. 
Research Project Manager: 
 
Jasmine A. Newman, B.S. 
 
 
 
 
 
655 W. Lombard St., Suite 442A 
Baltimore, MD 21201 
410-706-7819 
Jasmine.newman@umaryland.edu 
 
Manage all aspects of this study’s implementation including 
study start up, regulatory approvals, data collection, data 
management, all analyses, lead the drafting of primary 
manuscripts and conference abstracts. 
 
PARTICIPATING STUDY SITES  
Site: UMB--The PI is engaged in research procedures at UMB including stakeholder engagement plan 
(focus groups and/or semi-structured interviews); assessment of nurse practitioner fidelity; assessment of 
nursing home implementation fidelity 
 
Site: Collingswood Rehabilitation and Healthcare Center-- The telehealth palliative care consults are 
being implemented at this location; the site and staff are not engaged in research procedures. All activities 
at this location are ‘standard care’. 
 
 

 
Protocol Template, Version 3.0                                                                                                                                   2 
 
1 
STUDY OBJECTIVES 
1.1 
Primary Objective 
Grounded in the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) Model, this 
study will assess the implementation outcomes of the provider delivered telehealth Palliative Care 
Consultation in Post-Acute Care (PCC-PAC) intervention for persons living with dementia (PLWD) 
and their care-partners newly admitted to nursing homes (NHs) for post-acute care. 
1.2 
Secondary Objectives 
N/A 
2 
BACKGROUND AND RATIONALE  
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Dementia is the fifth-leading cause of death in older adults1 and the majority of people with 
advanced dementia die in nursing homes (NHs).2 Miller at al reported that 40% of U.S. nursing 
home (NH) residents dying with advanced dementia received post-acute Skilled Nursing Facility 
(SNF) care in the last 90 days of life, and receipt of this care was associated significantly with 
poorer end-of-life (EOL) outcomes, including a higher risk of dying in a hospital, compared to 
decedents with dementia and no SNF care.3 SNF care is a Medicare post-acute rehabilitation service 
delivered in NHs focused on intense rehabilitation and disease-modifying therapies. Regardless of 
life expectancy, use of post-acute SNF care typically precludes access to hospice services.  
Palliative Care (PC) offers an approach to improve care for persons living with dementia (PLWD) 
in SNFs.4,5 It incorporates symptom assessment and management and open communication and 
documentation of patients’/families’ goals of care and treatment preferences.6 
2.2 
Study Rationale 
Research demonstrates that PC consultations are associated with improved health-related quality of 
life and lower symptom burden.7 Specifically, NH residents who receive PC consultations are 
significantly less likely to be hospitalized at the EOL compared with propensity-matched 
controls.8,9 Studies have shown that PC delivered to PLWD increases advance care planning10 
improves patient and care partner satisfaction,11 and reduces costs12 and acute care use.13, 14 
 
The evidence-based Palliative Care Consultation in Post-Acute Care (PCC-PAC) is a multi-
component non-pharmacologic, nurse practitioner provider delivered intervention designed to meet 
the needs of PLWD receiving post-acute care in NHs. Components focus on assessing and 
managing symptoms; conducting and documenting goals of care conversations; and communicating 
needs, recommendations, and treatment preferences to the NH team members and primary care 
providers. PCC-PAC is well suited for telehealth delivery because care for PLWD often involves 
family care partners (e.g., caregivers, surrogate decision makers), many of whom are unable to visit 
inside the facility and thus rely on remote communication with providers. 
3 
STUDY DESIGN 
Embedding complex interventions in NHs is challenging and requires addressing barriers to 
adopting new practices.5,15 Well-established guidelines emphasize the need for conducting carefully 
designed pilot pragmatic studies to address effective implementation (defined as acceptability and 
appropriateness, treatment fidelity, and implementation fidelity).16 
This single arm embedded pragmatic pilot clinical trial will provide data to assess the 
implementation outcomes of the provider delivered telehealth Palliative Care Consultation in Post-

 
Protocol Template, Version 3.0                                                                                                                                   3 
 
Acute Care (PCC-PAC) intervention among 30 persons living with dementia (PLWD) and their care-
partners newly admitted to one nursing homes (NH) for post-acute care. 
To assess acceptability and appropriateness, we will engage approximately 10 stakeholders in a 
stakeholder engagement plan that include (1) PC providers; (2) Social Work (SW) NH champions; 
(3) post-acute care unit nursing staff and providers (including medial directors); (4) NH leadership, 
information technology staff; and (5) a PLWD and their care partners in focus groups and one on one 
semi structured interviews via phone or videoconference. Before, during, and after the study, we will 
invite stakeholders to join 8-10 regularly scheduled meetings to discuss different aspects of the PCC-
PAC intervention and its implementation. Interview guides will be used to structure the meetings. 
Interview guides will be developed in an iterative fashion informed by the previous meetings and 
submitted to the institutional review board prior to being used. Note: a PLWD who receives the 
intervention will not be in the stakeholder engagement plan. 
To assess Treatment Delivery Fidelity defined as providers adherence to the PCC-PAC intervention 
protocol among 30 PLWD in 1 NH with 2 providers. 
To assess Intervention Implementation Fidelity defined as NH adherence to PCC-PAC 
recommendations among 30 PLWD in 1 NH with providers. 
PCC-PAC Intervention Structure: The PC providers conducts the structured PCC-PAC via 
videoconference or telephone. The communication component includes documentation using a 
standardized template that is integrated into the electronic health record (EHR) PointClickCare® and 
direct contact with NH team members and primary care provider. New visits last approximately 45 
minutes and follow up visits 20 minutes. Each PLWD and care partner receives at least 1-2 visits; 
follow up visits depend on their ongoing needs but no longer than 30 days after new visit. 
 
4 
SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 
Inclusion Criteria  
Stakeholders (1) PC providers; (2) Social Work (SW) NH champions; (3) post-acute care unit 
nursing staff and providers (including medical directors); (4) NH leadership, information 
technology staff; and (5) PLWD and their care partner(s). 
 
PLWD: 1) documented dementia diagnosis, 2) admitted for post-acute care; 3) age ≥ 60 years; 
4) if unable to participate in a conversation or lacking capacity to make healthcare decisions 
as determined by the NH staff/providers, a care partner who can act as a surrogate decision 
maker in the PCC-PAC.  
4.2 
Exclusion Criteria  
Stakeholders: PLWD who receives the intervention 
PLWD: All candidates meeting any of the exclusion criteria at baseline will be excluded from 
study participation: 1) planned discharge within 48 hours of screening, 2) currently receiving 
specialty palliative and/or hospice care 
4.3 
Study Enrollment Procedures  
Stakeholders: Stakeholders will be identified by the participating NH leadership. We will invite 
stakeholders by phone or email to join regularly scheduled phone or video conference meetings to 
discuss different aspects of the intervention and its implementation. Using an interview guide we 
will conduct 8-10, 1-hour focus group and/or semi-structured interviews via phone or 
videoconference with different groups of stakeholders to encourage open communication and 

 
Protocol Template, Version 3.0                                                                                                                                   4 
 
identification of challenges and facilitators that are unique to each group. We will conduct the 
stakeholder engagement plan with an alteration (verbal) of standard informed consent.  
 
PLWD screening/recruitment: With IRB and nursing facility approval, we will use a full waiver 
of HIPAA authorization to screen/recruit potential subjects. This pragmatic clinical trial involves 
minimal interaction between the research team and PLWD subjects; the PHI for identifying subject 
eligibility and contacting potential subjects is what is normally collected for usual clinical care by 
nursing facility social workers and consultants (palliative care nurse practitioners). Using the 
Electronic Health Record (EHR), participating sites Information Technology (IT) personnel or 
nursing home staff will identify PLWD over 60 years of age on post-acute care admission to a 
participating NH by an ICD 10 dementia diagnosis. They will generate a roster of potentially 
eligible PLWD which will be automatically delivered to the facility social work (SW) champion via 
secure email 2x/week.  
 
PLWD enrollment: We will request a waiver of consent with an opt-out option to enroll 
partipants.17 This is appropriate for IRB approved minimal risk interventions18 of evidence based 
best practices and is consistent with clinical practice because PLWD or their care partner can opt-
out of a palliative care consultation if it is not desired. In the PLWD and/or the care partner are non-
English speaking, we will make interpreter services available and adhere to the nursing home site’s 
procedures for interpreters. 
We will maintain a deidentified screening log for ineligible candidate and for those who opt-out of 
PC consultation. 
5 
STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
The PC providers conducts the structured PCC-PAC (Table 1) via videoconference or telephone 
with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW 
and PC providers will set up a mutually agreed upon consultation day/time with the PLWD and/or 
care partner, within 5 business days of NH admission and follow up visits will occur no more than 
30 days later (if needed). The PC provider will access the EHR PointClickCare® for clinical data 
and documentation. In keeping with a pragmatic trial, PC providers and NHs will have some 
flexibility implementing the protocol and this will be reviewed during stakeholder interviews. 
Because the trial is pragmatic, we expect the nurse practitioners and nursing home staff may make 
adaptations to tailor the protocol to their local context. All adaptations will be tracked and reported. 
providers and SWs also will provide feedback on the technical quality of the phone or 
videoconference via a technical quality form. 
The potential risks associated with study participation are minimal because the study focuses on 
evidence-based assessment and management tools. Most of the data collected for the study is 
information that is similar to that which is already contained in the medical record. Patients who are 
able to self-report will be queried regarding their pain, function, and mood, but again, this 
information is not outside the realm of what is collected for clinical purposes. 
 
Table 1. Telehealth PCC-PAC Encounter Protocol  
Steps 
Actions/Content 
Materials 
1. Gather 
Information 
- Discuss progress since admission with facility social work 
champion (e.g. improvement, stabilization, decline)  
- Elicit patient/family/staff input  
 Electronic Health Record 
(EHR) PC note template 
 Video/tele conference 
2. Patient 
Assessment 
- Examine patient assisted by facility social work champion 
(subjective, objective assessments)  
- Conduct a comprehensive pain and symptom assessment  
 EHR PC note template 
 Primary team notes 
 Video/tele conference 

 
Protocol Template, Version 3.0                                                                                                                                   5 
 
3. Goals of Care 
Conversation 
- Determine illness understanding/ treatment expectations  
- Discuss initial transition planning after post-acute care  
- Elicit goals; explore preferences for type and site of care 
 Advance care planning 
education 
 Communication 
scripts/guides 
 EHR PC note template 
 Video/tele conference  
4. Document  
 
- Symptom assessment/management 
 
- Propose treatment plan, ensure patient/family agreement 
 Symptom management 
protocols 
 EHR PC note template 
5. Communicate 
- Communicate findings and recommendations to nursing 
and medical staff; determine agreement 
- Determine if additional visit or meeting is needed  
 Preferred communication 
with primary care provider 
and staff 
 EHR PC note template 
6. Follow up 
- Decide based on continued need for symptom assessment 
and management and ongoing goals of care discussions 
EHR PC note template for 
follow up 
 
5.2 
Handling of Study Interventions  
A standardized treatment manual will guide the general approach for the providers and SWs 
delivering the intervention. 
5.3 
Concomitant Interventions 
5.3.1 
Allowed Interventions 
All 
5.3.2 
Required Interventions  
None 
5.3.3 
 Prohibited Interventions 
None 
5.4 
Adherence Assessment  
We will assess Treatment Delivery Fidelity to the 6 steps and corresponding content of the PCC-
PAC encounter protocol (Table 1) on a 20% random sample of (n=3 per provider) by direct 
observation or an audio recording (with the provider and PLWD/care partners permission). The PI 
will conduct monthly (or more often as needed) calls with the providers who will present cases and 
discuss telehealth PCC-PAC encounter protocol issues or adaptations.  
We will evaluate Intervention Implementation Fidelity, defined as evidence of collaboration 
between the PC provider and NH team members and primary care providers using a standardized 
chart audit tool. We will review the EHR PCC-PAC encounter note template and subsequent 
treatment/therapy orders and plan of care changes, and therapies actually administered in the 
medical administration record and treatment administration record to assess whether the PCC-PAC 
was accurately ‘received’ by the participant. Table 2 captures the ‘mechanisms’ of the intervention.  
We will use outcomes of the treatment delivery and intervention implementation fidelity 
evaluations to provide additional context for stakeholder interviews and learn about adoption, 
acceptability, and provider/SW or facility adaptation of the intervention. 
Table 2. Intervention implementation fidelity monitoring protocol 

 
Protocol Template, Version 3.0                                                                                                                                   6 
 
*no relevant recommendations; IDT- interdisciplinary team; ADs= Advance Directives 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Component 
Complete 
Partial 
None 
N/A
* 
Notes  
Goals of care: 
  
  
  
  
1. Recommend IDT meeting to discuss concerns 
  
  
  
  
2. Complete IDT meeting  
 
 
 
 
3. Recommend portable life sustaining treatment form 
or ADs 
  
 
 
 
4. Complete portable life sustaining treatment form or 
ADs 
 
 
 
 
5. Other (list):  
 
 
 
 
Symptom management: 
  
  
  
  
1. Recommended medications for symptoms are 
ordered 
  
  
  
  
2. Recommended medications for symptoms are 
administered 
  
  
  
  
3. Other (list):  
 
 
 
 
Recommended Referrals completed: 
  
  
  
  
1.  Hospice 
  
  
  
  
2.  Spiritual care 
  
  
  
  
3. Other (list):  
 
 
 
 

 
Protocol Template, Version 3.0                                                                                                                                   7 
 
6 
STUDY PROCEDURES 
6.1 
Schedule of Evaluation for Intervention 
 
Assessment 
Screening: Visit 
(Day -14 to  
Day  -1) 
Baseline, 
Enrollment 
 (Day 0) 
Treatment 
Visit 1  
Day 5 (±2 
Days) 
Follow-up 
Visits) by 
Day 20 (± 10 
Days) 
Post-
completion 
Demographics 
X 
  
  
 
 
Inclusion/Exclusion Criteria  
 X 
 
  
  
 
Enrollment 
  
X 
  
  
 
Adverse Events  
  
 
X 
X 
 
Treatment Delivery Fidelity  
 
 
X 
 
 
Intervention Implementation 
Fidelity 
 
 
 
 
X 

 
Protocol Template, Version 3.0                                                                                                                                   8 
 
6.2 
Description of Evaluations for the Intervention 
6.2.1 Screening Evaluation 
Screening  
PLWD: Using the Electronic Health Record (EHR), participating sites Information Technology 
(IT) personnel to identify PLWD over 60 years of age on post-acute care admission to a 
participating NH by an ICD 10 dementia diagnosis. They will generate a roster of potentially 
eligible PLWD. SWs will review the roster of potentially eligible PLWD with the PC provider 2 
times/week, including decision-making capacity, ability to participate in a goals of care 
discussion, and presence of care partner who can act as an LAR/surrogate if needed. The SW also 
will facilitate scheduling the PCC-PAC with the PLWD and/or care partner and supply additional 
clinical information if needed.  
Consent Procedure 
PLWD: We will seek a waiver of traditional informed consent for this study. A waiver of consent 
is permitted under 45 CFR provided the study meets the following requirements:  
• 
The research involves no more than minimal risk to subjects; 
• 
The waiver or alteration will not adversely affect the rights and welfare of subjects; 
• 
The research could not practicably be carried out without the waiver or alteration; 
• 
When appropriate, the subjects will be provided with additional pertinent information 
after participation 
We will seek approval from the Institutional Review Board to conduct this pragmatic trial with a 
waiver of informed consent based on the following NIH Common Rule criteria: (1) palliative care 
consultation is standard of care and a low risk intervention; (2) the waiver will not adversely 
affect the rights and welfare of the subjects; hospice/palliative care and telehealth consults are 
already being offered in this site and this trial seeks to increase the opportunity for PLWD and 
their surrogates to benefit from telehealth palliative care consultation, while not restricting choice 
to forego it because it is not offered (3) The research cannot be practicably conducted without a 
waiver of the requirement for informed consent; the trial will evaluate system-level 
implementation of an evidence-based intervention; requiring prospective informed consent would 
introduce important selection biases greatly reducing the knowledge generated; and (4) to the 
extent possible, the subjects will be provided with pertinent information after participating in the 
trial. 
Baseline Assessments (Self- Reported) 
• 
Sex 
• 
Race 
• 
Ethnicity 
6.2.2 
Enrollment, Baseline, and/or Randomization 
Enrollment 
PLWD: Despite seeking a waiver of consent, subjects still retain full autonomy over their 
healthcare decisions, including whether to participate in the telehealth palliative care consult. 
Subjects remain free to refuse the palliative care consultation and/or any care or therapies offered 
as a result of said consultation. 

 
Protocol Template, Version 3.0                                                                                                                                   9 
 
PLWD subjects will be informed by the provider/SW that they are receiving a clinical evaluation 
via telehealth to discuss goals of care, symptoms, and any unmet needs associated with their 
illness. 
Baseline Assessments (from Electronic medical record) 
• 
Age 
• 
Sex 
• 
Race 
• 
Ethnicity 
• 
Marital Status 
• 
Diagnoses & Co-morbidities 
• 
Brief Inventory of Mental Status 
• 
Relationship of LAR/surrogate to subject 
• 
Palliative Care Consult Notes 
• 
Subsequent medical orders 
Randomization 
N/A 
6.2.3 
Follow-up Visit(s) Day 20 (± 10 Days)  
§ 
Adverse Events 
§ 
Palliative Care Consult Notes 
§ 
Subsequent medical orders 
§ 
Hospitalizations 
6.2.4 
Completion/Final Evaluation 
N/A 
7 
SAFETY ASSESSMENTS ** NOTE: THIS PROJECT REQUIRES SAFETY OFFICER 
(SO) OVERSIGHT RATHER THAN A FULL DSMB** 
7.1 
Specification of Safety Parameters 
The Principal Investigator (PI) will be responsible for ensuring participants’ safety on a daily basis. 
In addition, the NIA-appointed SO will oversee all data and safety monitoring activities for this 
study. This SO will act in an advisory capacity to the NIA Director to monitor participant safety, to 
evaluate the progress of the study, and to review procedures for maintaining the confidentiality of 
data, the quality of data collection, management, and analyses. Advarra IRB will conduct the 
ethical review required for the protection of human subjects.   
Refer to the NIA IMPACT Collaboratory Omnibus DSMB Charter for details. 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters 
Safety reports will be provided directly to the SO and NIA PO by the study team at the intervals 
described below. The SO will report on the status of pilot studies they are overseeing at the NIA 
IMPACT Collaboratory DSMB meetings.  

 
Protocol Template, Version 3.0                                                                                                                                   10 
 
For the pilot study, the frequency of DSM will proceed as follows: 1. Prior to the start of participant 
enrollment and data collection, the pilot study PI must submit a DSMP for approval by the SO 
and/or the NIA PO; 2. Four to six months after the initiation of participant enrollment and/or data 
collection, the pilot study PI must submit a DSM report to the SO. This interim report will be 
reviewed by the SO to determine whether there are any human subjects or data safety concerns; and 
3. At the end of the pilot study, the PI must submit a final DSM report to the SO. 
The content of the data and safety monitoring report will include: study status, subject descriptive 
demographics, any safety findings, actions taken, and plans to abate any potential risks identified 
during the course of the study. 
7.3 
Adverse Events and Serious Adverse Events  
Adverse Event (AE): AE is any untoward or unfavorable medical occurrence in a human study 
participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), 
symptom, or disease, temporally associated with the participants’ involvement in the research, 
whether or not considered related to participation in the research.  
• 
PLWD experiences inadequate symptom management or side effects from a therapy that is 
recommended by the PCC-PAC  
Serious Adverse Event (SAE): SAEs consist of any adverse event that results in death; is life 
threatening or places the participant at immediate risk of death from the event as it occurred; 
requires or prolongs hospitalization; causes persistent or significant disability or incapacity; results 
in congenital anomalies or birth defects; is another condition which investigators judge to represent 
significant hazards 
Because this proposal involves an evidence-based palliative care intervention provided by specialty 
trained Nurse Practitioners, no serious adverse events are expected to occur. However, the following 
may occur in persons with serious illness: 
 
• 
Death, Hospitalization, Change in clinical status 
7.3.1 
Reporting Procedures 
Because this study involves minimal interaction between the research team and subjects, AEs and 
SAEs will most likely be identified through conversations with and reporting by clinical staff 
(providers & SWs) who provide direct care to enrolled subjects. Regular, monthly meetings with 
clinical staff will include dedicated questions to elicit whether any possible AEs or SAEs may 
have occurred.  
 
AEs and SAE’s will be recorded by the PI, research assistant immediately and the research team 
will conduct an analysis and determination of 1) whether or not the adverse event occurred, 2) the 
seriousness of the adverse event, 3) likelihood that the adverse event is associated with the 
intervention/study procedures; and 4) if necessary, preparation of report to the IRB and other 
entities. 
 
Event 
Action 
Participant experiences inadequate 
symptom management or side 
effects from a therapy that is 
recommended by the PCC-PAC 
Primary care team will be advised to make therapeutic 
adjustments.  
Study team staff member completes alert form and 
provides to project manager and PI. A determination 
will be made by the person reporting the event, the PI 

 
Protocol Template, Version 3.0                                                                                                                                   11 
 
and the study team jointly as to the extent to which the 
event is a consequence of the intervention.  
Study team staff member monitors series of events.  
Death 
Hospitalization 
Change in clinical status 
Study team staff member completes alert form and 
provides to project manager and PI. 
A determination will be made by the person reporting 
the event and the PI jointly as to the extent to which the 
event is a consequence of the intervention.  
Monitor series of events in both groups to determine if 
rate is higher in the either group 
 
 
• 
All adverse events that are both serious (SAE) and unexpected (i.e., have not been previously 
reported for the study’s intervention) will be reported to the IMPACT Collaboratory Regulatory 
and Data Team Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. 
Partha Bhattacharya), and the IMPACT Collaboratory SO (Dr. Madhuri Reddy) within 48 hours 
of the study’s knowledge of SAE.  
• 
The summary of all other SAEs will be reported to IMPACT Collaboratory Regulatory and Data 
Team Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. Partha 
Bhattacharya), and the IMPACT Collaboratory SO (Dr. Madhuri Reddy) quarterly, unless 
otherwise requested by the SO. 
• 
All deaths will be reported to IMPACT Collaboratory Regulatory and Data Team Leader (Julie 
Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. Partha Bhattacharya), and the 
IMPACT Collaboratory SO (Dr. Madhuri Reddy) within 24 hours of study’s knowledge of death.  
• 
AEs will be reported per IRB policies and also to IMPACT Collaboratory Regulatory and Data 
Team Leader (Julie Lima PhD), Advarra IRB, NIA IMPACT Collaboratory PO (Dr. Partha 
Bhattacharya), and the SO (Dr. Madhuri Reddy) at minimum every 6 months, or at a frequency 
requested by NIA and/or by the SO. 
Severity  
• 
Mild: Awareness of signs or symptoms, but easily tolerated and are of minor irritant type 
causing no loss of time from normal activities. Symptoms do not require therapy or a medical 
evaluation; signs and symptoms are transient. 
• 
Moderate: Events introduce a low level of inconvenience or concern to the participant 
and may interfere with daily activities, but are usually improved by simple therapeutic measures; 
moderate experiences may cause some interference with functioning 
• 
Severe:  Events interrupt the participant’s normal daily activities and generally require 
systemic drug therapy or other treatment; they are usually incapacitating 
Relatedness   
• 
Definitely Related:  The adverse event is clearly related to the investigational 
agent/procedure – i.e. an event that follows a reasonable temporal sequence from administration 
of the study intervention, follows a known or expected response pattern to the suspected 

 
Protocol Template, Version 3.0                                                                                                                                   12 
 
intervention, that is confirmed by improvement on stopping and reappearance of the event on 
repeated exposure and that could not be reasonably explained by the known characteristics of the 
subject’s clinical state. 
• 
Possibly Related:  An adverse event that follows a reasonable temporal sequence from 
administration of the study intervention follows a known or expected response pattern to the 
suspected intervention, but that could readily have been produced by a number of other factors. 
• 
Not Related:  The adverse event is clearly not related to the investigational 
agent/procedure - i.e. another cause of the event is most plausible; and/or a clinically plausible 
temporal sequence is inconsistent with the onset of the event and the study intervention and/or a 
causal relationship is considered biologically implausible. 
7.3.2 
Follow-up for Adverse Events 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the 
attention of study personnel during conversations with providers/SWs. 
All AEs not meeting the criteria for SAEs will be captured on the appropriate form. Information 
to be collected includes event description, time of onset, qualified medical professional’s 
assessment of severity, relationship to (assessed only by those with the training and authority to 
make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on 
study will be documented appropriately regardless of relationship. All AEs will be followed to 
adequate resolution. 
Any medical condition that is present at the time that the participant is screened will be 
considered as baseline and not reported as an AE.  
A study team member will record all reportable events with start dates occurring any time after 
study enrollment is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day 
of study participation.  Events will be followed for outcome information until resolution or 
stabilization. 
7.4 
Safety Monitoring 
An NIA IMPACT safety officer will oversee study safety monitoring. The Principal Investigator 
will be responsible for ensuring participants’ safety on a daily basis. In addition, the NIA-
appointed SO will oversee all data and safety monitoring activities for this study. This SO will act 
in an advisory capacity to the NIA Director to monitor participant safety, to evaluate the progress 
of the study, and to review procedures for maintaining the confidentiality of data, the quality of 
data collection, management, and analyses. Advarra IRB will conduct the ethical review required 
for the protection of human subjects.   
8 
INTERVENTION DISCONTINUATION  
Subjects remain free to refuse the palliative care consultation and/or any care or therapies offered 
as a result of said consultation.  Subjects may withdraw voluntarily from participation in the study 
at any time and for any reason. Participants should continue to be followed for 30 days, with their 
permission, even if the study intervention is discontinued.  
If subject discontinued is due to an AE or SAE, every effort will be made to undertake protocol-
specified safety follow-up procedures. If voluntary withdrawal occurs, the subject will be given 
appropriate care under medical supervision until the symptoms of any AE resolve or the subject’s 
condition becomes stable. 

 
Protocol Template, Version 3.0                                                                                                                                   13 
 
9 
STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
N/A 
9.2 
Sample Size and Randomization 
As this is a pilot clinical trial, the primary objective is to study the implementation outcomes to 
inform refinement of the intervention and modifications for a large-scale effectiveness trial. We 
anticipate 8-10 stakeholders will be required to achieve an understanding of the acceptability and 
appropriateness of the telehealth PCC-PAC and 30 PLWD to assess intervention fidelity and NH 
adoption of the telehealth PCC-PAC. 
 
9.2.1 
Treatment Assignment Procedures 
All PLWD subjects will be assigned to the intervention. 
9.3 
Interim analyses and Stopping Rules 
An interim analysis is not planned. 
9.4 
Outcomes  
9.4.1 
Primary outcome   
Implementation outcomes: acceptability, appropriateness, intervention fidelity, and NH 
adoption of the telehealth PCC-PAC 
 
Clinical outcome:  
 
Number of hospitalization(s) 
9.4.2 
Secondary outcomes   
N/A 
9.5 
Data Analyses 
Stakeholder Engagement: Interviews will be audiotaped and transcribed verbatim and managed and 
analyzed using NVivo 12.0. We will conduct initial descriptive data coding guided by directed 
content analysis techniques to describe the perceived most and least effective components of the 
intervention, barriers to implementation, and factors that facilitated the uptake, acceptance 
(adoption), and any adaptations of the intervention. We will then reorganize and condense coded 
data to compare similarities and differences and identify overarching categories. Categories will be 
grouped by their properties to develop themes. The study team will meet weekly during analysis to 
discuss codes, categories, and initial themes. The team will maintain a comprehensive audit trail, 
including methodological and analytic memos throughout the project. 
PLWD: Intervention Implementation Fidelity (collaboration and implementation of findings from 
the PCC-PAC): Participating sites IT will provide deidentified reports to the study staff including 
each participants PCC-PAC notes and accompanying medical and treatment orders in the EHR. We 

 
Protocol Template, Version 3.0                                                                                                                                   14 
 
will quantitatively evaluate treatment delivery and treatment receipt using 90% adherence as a 
benchmark of success. Hospitalizations will be quantified for each participant 
10 
DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms 
The project manager or research assistant will collect clinical and demographic variables for 
eligible subjects from the EHR. 
10.2 Data Management  
Study data will be entered and managed using NVivo 12.0 and REDCap (http://www.project-
redcap.org) which is a secure, web-based application. The University of Maryland is a member of 
the REDCap consortium and this application is freely available to consortium members. REDCap 
provides: 1) an intuitive interface for data entry (with data validation); 2) audit trails for tracking data 
entry and changes; 3) automated export procedures for seamless data downloads to common 
statistical packages, 4) procedures for importing data from external sources; and 5) advanced 
features, such as branching logic and calculated fields.  
 
10.3 Quality Assurance  
10.3.1 Training 
To maximize quality control, the study team will be trained in all data collection and entry 
procedures. A designated team member will monitor data collection by checking completed 
data fields.  
Quality Control Committee  
N/A 
10.3.2 Metrics 
We will utilize double-data entry methods on a 10% random sample, with checks for 
discordant errors, and as data are entered into the REDCap system. 
10.3.3 Protocol Deviation 
Protocol deviations will be captured, documented, and reviewed by a member of the 
study team during interaction with providers and SWs. The PI will monitor deviations 
and the team will review each deviation for its root cause and assess whether a 
modification to the protocol is needed. Of note: PCC-PAC Intervention protocol 
adaptations will be tracked using a standard form. 
10.3.4 Monitoring 
The PI will monitor protocol compliance and data quality monthly with the study team. 
11 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review 
This protocol and any subsequent modifications will be reviewed and approved by the Advarra 
IRB who is responsible for oversight of the study.  

 
Protocol Template, Version 3.0                                                                                                                                   15 
 
Consent Procedure 
Stakeholders: will provide verbal consent for participating in focus groups or semi-structured 
interviews using a script. The stakeholder who is a PLWD will be read the script for verbal 
consent to participate in the focus groups/semi structured interviews. The PLWD will then be 
asked what they understand about the purpose, the procedures, and the ability to refuse 
participation in the focus groups/semi structured interview at any time. 
PLWD: We will seek a waiver of traditional informed consent for this study. A waiver of consent 
is permitted under 45 CFR provided the study meets the following requirements:  
• 
The research involves no more than minimal risk to subjects; 
• 
The waiver or alteration will not adversely affect the rights and welfare of subjects; 
• 
The research could not practicably be carried out without the waiver or alteration; 
• 
When appropriate, the subjects will be provided with additional pertinent information 
after participation 
We will seek approval from the Institutional Review Board to conduct this pragmatic trial with a 
waiver of informed consent based on the following NIH Common Rule criteria: (1) palliative care 
consultation is standard of care and a low risk intervention; (2) the waiver will not adversely 
affect the rights and welfare of the subjects; hospice/palliative care and telehealth consults are 
already being offered in this site and this trial seeks to increase the opportunity for PLWD and 
their surrogates to benefit from telehealth palliative care consultation, while not restricting choice 
to forego it because it is not offered (3) The research cannot be practicably conducted without a 
waiver of the requirement for informed consent; the trial will evaluate system-level 
implementation of an evidence-based intervention; requiring prospective informed consent would 
introduce important selection biases greatly reducing the knowledge generated; and (4) to the 
extent possible, the subjects will be provided with pertinent information after participating in the 
trial. 
PLWD subjects will be informed by the provider/SW that they are receiving a clinical evaluation 
via teleheath to discuss goals of care, symptoms, and any unmet needs associated with their 
illness. As this is a pragmatic clinical trial and the PCC-PAC is being integrated into the routine 
and usual care delivery of PLWD, the SW will use the same approach they use for other usual 
care delivery activities in the facility that address goals of care, symptoms, and unmet needs. Any 
of which the PLWD/surrogate decision maker will be informed that they can decline at any time.   
INSERT HIPAA 
11.2 Participant Confidentiality  
We will keep all data confidential in accordance with state and federal laws. Data will not 
be linked to participant identifying name in the study database. Any data, specimens, forms, 
reports, or audio recordings, and other records that leave the site will be identified only by 
a participant identification number (Participant ID, PID) and stored in secure computer 
files and locked filing cabinets to maintain confidentiality. All computer entry and 
networking programs will be done using PIDs only. Information will not be released 
without written permission of the participant, except as necessary for monitoring by IRB, 
the FDA, the NIA, and the OHRP. The study team will destroy the records at the earliest 
opportunity following data analysis and study completion. 

 
Protocol Template, Version 3.0                                                                                                                                   16 
 
11.3 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or other 
government agencies as part of their duties to ensure that research participants are protected. 
 
12 COMPENSATION 
Stakeholder subjects will be compensated $50 per focus group or semi-structured 
interview that they participate in after providing verbal consent for a total of 8-10 focus 
group or semi-structured interviews over one year.  
Subjects will be paid following each completed visit or at the end of their participation in 
the research study, whichever they prefer. 
13 ETHICAL CONSIDERATIONS 
The guiding ethical principles being followed by the study include the NIH Common Rule. 20 
14 
COMMITTEES 
N/A 
15 
PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and procedures developed by 
the NIA IMPACT Collaboratory.  Any presentation, abstract, or manuscript will be made available 
for review by the sponsor and the NIA prior to submission. 
16 
REFERENCES 
1. 
Alzheimer's Association. 2019 Alzheimer's disease facts and figures. 
https://www.alz.org/alzheimers-dementia/facts-figures. Published 2020. Accessed May 20, 2020. 
2. 
Mitchell SL, Teno JM, Miller SC, Mor V. A national study of the location of death for older 
persons with dementia. J Am Geriatr Soc. 2005;53(2):299-305. 
3. 
Miller SC, Lima JC, Looze J, Mitchell SL. Dying in U.S. nursing homes with advanced 
dementia: how does health care use differ for residents with, versus without, end-of-life 
Medicare skilled nursing facility care? J Palliat Med. 2012;15(1):43-50. 
4. 
Carpenter J, Lam, K., Ritter, A., Ersek, M.,. A systematic review of nursing home palliative care 
interventions: Characteristics and outcomes. Journal of American Medical Directors Association. 
2020;21(5):583-596. 
5. 
Ersek M, Carpenter JG. Geriatric palliative care in long-term care settings with a focus on 
nursing homes. J Palliat Med. 2013;16(10):1180-1187. 
6. 
National Consensus Project for Quality Palliative Care. Clinical Practice Guidelines for Quality 
Palliative Care. 2018. 
7. 
Kavalieratos D, Corbelli J, Zhang D, et al. Association Between Palliative Care and Patient and 
Caregiver Outcomes: A Systematic Review and Meta-analysis. JAMA. 2016;316(20):2104-
2114. 
8. 
Miller SC, Dahal R, Lima JC, et al. Palliative Care Consultations in Nursing Homes and End-of-
Life Hospitalizations. J Pain Symptom Manage. 2016;52(6):878-883. 
9. 
Miller SC, Lima JC, Intrator O, Martin E, Bull J, Hanson LC. Palliative Care Consultations in 
Nursing Homes and Reductions in Acute Care Use and Potentially Burdensome End-of-Life 
Transitions. J Am Geriatr Soc. 2016;64(11):2280-2287. 

 
Protocol Template, Version 3.0                                                                                                                                   17 
 
10. Hanson LC, Carey TS, Caprio AJ, et al. Improving decision-making for feeding options in 
advanced dementia: a randomized, controlled trial. J Am Geriatr Soc. 2011;59(11):2009-2016. 
11. Holley AP, Gorawara-Bhat R, Dale W, Hemmerich J, Cox-Hayley D. Palliative Access Through 
Care at Home: experiences with an urban, geriatric home palliative care program. J Am Geriatr 
Soc. 2009;57(10):1925-1931. 
12. Araw M, Kozikowski A, Sison C, et al. Does a palliative care consult decrease the cost of caring 
for hospitalized patients with dementia? Palliative and Supportive Care. 2015;13(6):1535-1540. 
13. Miller SC, Lima JC, Intrator O, Martin E, Bull J, Hanson LC. Specialty Palliative Care 
Consultations for Nursing Home Residents With Dementia. J Pain Symptom Manage. 
2017;54(1):9-16 e15. 
14. Comart J, Mahler A, Schreiber R, Rockett C, Jones RN, Morris JN. Palliative care for long-term 
care residents: effect on clinical outcomes. Gerontologist. 2013;53(5):874-880. 
15. Dzewaltowski DA, Glasgow RE, Klesges LM, Estabrooks PA, Brock E. RE-AIM: evidence-
based standards and a Web resource to improve translation of research into practice. Ann Behav 
Med. 2004;28(2):75-80. 
16. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion 
interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322-1327. 
17. Kim SY, Miller FG. Waivers and Alterations to Consent in Pragmatic Clinical Trials: 
Respecting the Principle of Respect for Persons. Irb. 2016;38(1):1-5. 
 
18. Office for Human Research Protections. January 31, 2008 SACHRP letter to HHS Secretary: 
Recommendations related to waiver of informed consent and interpretation of “minimal risk”. 
U.S. Department of Health & Human Services;2008. 
 
19. Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 
2005;15(9):1277-1288. 
 
20. Federal Policy for the Protection of Human Subjects ('Common Rule'). [Accessed on January 23, 
2021, at http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html.] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol Template, Version 3.0                                                                                                                                   18 
 
 
 
17 
SUPPLEMENTS/APPENDICES 
Appendix I. Technical Quality Form  
 
Phone/Video-call technical quality form 
Type of Call:    
Zoom  
WebEx  
Skype  
FaceTime  
Phone  
 
Other: ______________ 
If the phone/video call did not take place, please indicate the reason: 
subject didn't answer the call 
connection could not be established 
other, please indicate: ______________________ 
1) Did you at the central site experience any difficulties with: 
Sound?  
Yes  
No 
If Yes, please check one of the following in regard to the frequency of the experienced 
difficulty: 
Once 
A few times (2-3) 
A lot (more than 3 times) 
Visit was terminated due to this 
Picture?  
Yes  
No 
If Yes, please check one of the following in regard to the frequency of the experienced 
difficulty: 
Once 
A few times (2-3) 
A lot (more than 3 times) 
Visit was terminated due to this? 
Other?  
 
Yes  
No 
If Yes, please specify:__________________________________ 
2) Did the patient/caregiver at seem to experience any difficulties with: 
Sound?  
Yes  
No 
If Yes, please check one of the following in regard to the frequency of the experienced 
difficulty: 
Once 
A few times (2-3) 
A lot (more than 3 times) 
Visit was terminated due to this 
Picture?  
Yes  
No 
If Yes, please check one of the following in regard to the frequency of the experienced 
difficulty: 
Once 
A few times (2-3) 
A lot (more than 3 times) 
Visit was terminated due to this 
Other?  
 
Yes  
No 
If Yes, please specify:__________________________________ 
4) Would the conversation have been significantly better if it had been performed in person? 
 
Yes 
 
No  
 
Don’t know 

 
Protocol Template, Version 3.0                                                                                                                                   19 
 
5) Were there questions that you didn’t ask today because of the phone/video that you would have 
asked in person? 
Yes 
 
No  
 
Don’t know 
If Yes, please specify:________________________________________ 
6) Did the patient/caregiver seem worried, concerned or generally in a bad mood today at the 
beginning of the video call? 
Yes 
 
No  
 
Don’t know 
7) Overall, how would you rate the technical quality of today's phone/video call? 
Excellent 
 
Good  
Acceptable 
 
 Poor   
 
Unacceptable 
8) Overall, how useful would you rate today's phone/video call for delivering the palliative care 
consult? 
Very Useful  
 
Useful  
Neutral  
 
 
Not Useful 
 
Interferes with the Consult 
9) Please record any other thoughts or observations: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Protocol Template, Version 3.0                                                                                                                                   20 
 
 
 
 
 
Appendix II. Adaptation Tracking Form 
 
Date 
 
 
 
 
 
Description 
 
 
 
 
 
Reason 
 
 
 
 
 
By Whom? 
 
 
 
 
 
What is modified? 
 
 
 
 
 
At what level of delivery? 
 
 
 
 
 
Nature of modification (e.g., 
tailoring, refining) 
 
 
 
 
 
When during the project was 
the adaptation made? 
 
 
 
 
 
Why: purpose of the 
adaptation? 
 
 
 
 
 
Impact: short term results 
 
 
 
 
 
Notes