Self-management to Improve Function Following Amputation
Phase: NA
Conditions: Amputation, Limb Loss
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
 
Protocol # 13-51 
Self-management to Improve Function Following Amputation 
 
Funding Agency: U.S. Department of Veterans Affairs 
Rehabilitation Research and Development (#D1143-R) 
 
Principal Investigator/Study Chair: Aaron P. Turner, Ph.D. 
Co-Principal Investigator: Joseph M. Czerniecki, M.D. 
 
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Abstract 
Lower extremity amputations in the Veterans Administration Health Care System are a 
significant cause of morbidity, mortality, loss of function, and reduced quality of life. Adaptation 
to limb loss is a long-term and complex process. Recent research suggests that patients benefit 
from ongoing partnerships with healthcare providers to help improve overall health and reduce 
disability. One important piece of this partnership is self-management, which is the process 
where a patient adopts an active role in managing the symptoms, treatment, physical and 
psychosocial consequences, and lifestyle changes that are inherent in living with a chronic 
condition, such as an amputation. The primary purpose of this study is to evaluate the 
effectiveness of a 5-week group-based self-management intervention for Veterans with lower 
extremity limb loss (VETPALS). VETPALS is an adaption of an empirically supported self-
management program, PALS (Promoting Amputee Life Skills). The PALS program 
demonstrated improved physical and psychosocial functioning when delivered in community-
based support groups for amputees, but this program has not been adapted for the needs of 
Veterans and implemented in the VA healthcare system.  
 
This study is a two-arm randomized controlled trial (RCT) to determine the efficacy of 
VETPALS. Study staff will screen and enroll Veterans with recent lower extremity limb loss 
within the last 2 years. Each participant will complete a baseline interview and then is 
sequentially placed into a cohort of 6-10 participants; each cohort will be randomized to the 
VETPALS group based self-management program (intervention) or an individual education 
support program (control). Once participants complete the randomized arm and follow-up 
assessments, they are free to participate in the other group. This ensures participants are 
offered both programs and are not deprived of a potentially valuable healthcare service.  
 
All participants will complete outcome interview assessments at baseline, 6 weeks (coinciding 
with the end of the VETPALS or individual program) and 6 months. The assessments evaluate 
the efficacy of the intervention by examining depression, physical function, self-efficacy, patient 
activation, problem solving, quality of life, and positive affect. This study is one of the only 
prospective randomized controlled trials of a behavioral intervention for individuals with limb 
loss. Up to 750  patients will be enrolled in the study across 5 VA sites. The VA Puget Sound 
Health Care System (Seattle, WA) will oversee this study at five VA sites: Seattle, Houston, 
Cleveland, Tampa, and Minneapolis. Target enrollment between the five VA sites is 472 
participants. Additionally, these five VA sites will partner with other VA facilities to enroll 
additional participants in the study who can participate in the study via video telehealth and 
telephone interviews. At the end of the study, we expect that results of the study will be used to 
integrate a self-management intervention into the VA Amputation System of Care.  
 
 

 
 
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List of Abbreviations 
AE 
 
 
Adverse Event  
AUDIT-C 
 
Alcohol Use Disorders Identification Test  
CHQOER 
 
Center for Health Quality, Outcomes, and Economic Research 
COWAT 
 
Controlled Oral Word Association Test  
CPG 
 
 
Chronic Pain Grade questionnaire  
CRF 
 
 
Case Report Form 
DCF 
 
 
Data Clarification Form  
DOD  
 
Department of Defense 
eCRF  
 
Electronic Case Report Form  
EDC 
 
 
Electronic Data Capture  
FCI 
 
 
Functional Comorbidity Index  
JAHVH 
 
James A. Haley Veterans’ Hospital (Tampa, FL)  
LSCVAMC 
 
Louis Stokes Cleveland VA Medical Center (Cleveland, OH)  
MEDVAMC 
 
Michael E. DeBakey VA Medical Center (Houston, TX)  
MFA-SF 
 
Musculoskeletal Function Assessment Short Form  
MSES  
 
Modified Self-Efficacy Scale  
MSPSS 
 
Multidimensional Scale of Perceived Social Support  
MVAHCS 
 
Minneapolis VA Health Care System (Minneapolis, MN) 
OHSU  
 
Oregon Health & Science University  
PALS  
 
Promoting Amputee Life Skills 
PAM 
 
 
Patient Activation Measure  
PANAS 
 
Positive and Negative Affect Schedule  
PANS  
 
Polytrauma Amputation Network Sites  
PAVE  
 
Prevention of Amputations in Veterans Everywhere  
PI/SC  
 
Principal Investigator/Study Chair  

 
 
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PHQ-9  
 
Patient Health Questionnaire Depression Module  
PTCS  
 
Psychosocial Treatment Compliance Scale  
RAC 
 
 
Regional Amputation Centers  
RBANS 
 
Repeatable Battery for the Assessment of Neuropsychological Status 
RCT 
 
 
Randomized Controlled Trial  
SAE 
 
 
Serious Adverse Event  
SPMSQ 
 
Short Portable Mental Status Questionnaire  
SPSI-R 
 
Social Problem-Solving Inventory-Revised  
UAE 
 
 
Unanticipated Adverse Event  
UAP 
 
 
Unanticipated Problem Involving Risks to Participants or Others  
VAPSHCS 
 
VA Puget Sound Health Care System (Seattle, WA) 
VETPALS 
 
Modified intervention of PALS for the Veteran population  
VSSC  
 
VHA Support Service Center 
WAIS-III 
 
Weschler Adult Intelligence Scale – Third Edition  
WHOQOL-BREF 
World Health Organization Quality of Life Scale  
 
 
List of Appendices 
 
Appendix A 
 
Study approach letter, study brochure, recruitment video  
Appendix B 
 
Informed Consent Form, HIPAA Authorization Form 
Appendix C 
 
Telephone script, Screening CRF 
Appendix D 
 
Suicide Risk Reduction Protocol  
Appendix E 
 
Study measures, evaluations, interview questions 
Appendix F 
 
Central IRB forms – SAEs, UAPs, Protocol Deviations 
Appendix G 
 
Protocol Supplement for Multi-Site Studies 

 
 
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Contents 
1.0 
Study Personnel .............................................................................................................. 6 
2.0 
Introduction ....................................................................................................................11 
3.0 
Objectives ......................................................................................................................15 
4.0 
Resources and Personnel ..............................................................................................17 
5.0 
Study Procedures ...........................................................................................................20 
5.1 Study Design ...................................................................................................................20 
5.2 Recruitment Methods.......................................................................................................27 
5.3 Informed Consent Procedures .........................................................................................29 
5.4 Inclusion/Exclusion Criteria ..............................................................................................31 
5.5 Study Evaluations ............................................................................................................32 
5.6 Data Analysis ..................................................................................................................42 
5.7 Withdrawal of Subjects ....................................................................................................44 
6.0 
Reporting ........................................................................................................................45 
7.0 
Privacy and Confidentiality .............................................................................................47 
8.0 
Communication Plan ......................................................................................................50 
9.0 
References .....................................................................................................................52 
 

 
 
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Self-management to Improve Function Following Amputation  
Rehabilitation R&D Project #D1143-R 
1.0 
Study Personnel 
Lead PI/SC and Project Staff at VA Puget Sound Health Care System (Seattle, WA)  
Role 
Title 
Contact Information  
Principal Investigator 
Aaron P. Turner, Ph.D.  
Clinical Psychologist 
 
Associate Professor 
University of Washington 
VA Puget Sound Health Care 
System 
Rehabilitation 
Care 
Service, 
RCS-117 
1660 S. Columbian Way 
Seattle, WA 98108-1532 
 
Aaron.Turner@va.gov 
Office: (206) 277-6134 
Co-Principal Investigator  
Joseph M. Czerniecki, M.D. 
Attending Physician 
 
Professor 
University of Washington 
VA Puget Sound Health Care 
System 
Rehabilitation 
Care 
Service, 
RCS-117 
1660 S. Columbian Way 
Seattle, WA 98108-1532 
 
Joseph.Czerniecki@va.gov 
Office: (206) 277-5188 
Co-Investigator 
Rhonda Williams, Ph.D. 
Clinical Psychologist 
 
Associate Professor 
University of Washington 
VA Puget Sound Health Care 
System 
Rehabilitation 
Care 
Service, 
RCS-117 
1660 S. Columbian Way 
Seattle, WA 98108-1532 
 
Rhonda.Williams@va.gov 
Office: (206) 277-6290 
Co-Investigator 
Stephen T. Wegener, Ph.D. 
Clinical Psychologist 
 
Associate Professor,  
Johns Hopkins University  
Johns 
Hopkins 
School 
of 
Medicine 
600 N. Wolfe St.  
Phipps 174 
Baltimore, MD 21287-0005 
 
swegener@jhmi.edu  
Office: 410-502-2441 
Co-Investigator 
Dawn Ehde, Ph.D. 
Clinical Psychologist 
 
Professor 
University of Washington 
University of Washington, School 
of Medicine 
Harborview Medical Center,  
Box 359612 
325 9th Ave.  
Seattle, WA 98104-2420 
 
ehde@uw.edu  
Office: 206-744-2811 

 
 
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Biostatistician 
David Yanez, Ph.D. 
Associate Professor,  
Biostatistics 
 
Oregon 
Health 
& 
Science 
University 
Department of Public Health and 
Preventative Medicine 
3181 SW Sam Jackson Park 
Road 
Mail Code CB 669 
Portland, OR 97239-3098 
 
yanezn@ohsu.edu 
Office: 503-494-5354 
Program Manager / Consultant  
Daniel C. Norvell, Ph.D. 
Clinical Epidemiologist 
Vice 
President, 
Spectrum 
Research, Inc.  
 
705 S. 9th St., Suite 203 
Tacoma, WA 98405-4622 
 
dan@specri.com 
Office: (253) 722-2210  
Database Manager/Programmer 
Ian Ellis, B.S.  
Clinical Data Manager 
705 S. 9th St., Suite 203 
Tacoma, WA 98405-4622 
 
ian@specri.com 
Office: (253) 722-2210 
Project Coordinator  
Juliana Bondzie, MA 
Research 
Coordinator/Health 
Science Research Specialist 
VA Puget Sound Health Care 
System  
 
1660 S. Columbian Way 
S-151 
Seattle, WA 98108-1532 
 
juliana.bondzie@va.gov 
Office: 253-583-1890 
 
Project Staff at VA Puget Sound Health Care System (Seattle, WA)  
Role 
Title 
Contact Information  
Local site investigator  
Jeffrey T. Heckman, D.O.  
Medical 
Director, 
Regional 
Amputation Center – Seattle  
VA Puget Sound Health Care 
System  
 
1660 S. Columbian Way 
RCS-117 
Seattle, WA 98108-1532  
 
Jeffrey.T.Heckman@va.gov 
Office: (206) 277-3899 
Co-Investigator 
Jennifer K. Bambara, Ph.D.  
Clinical 
Psychologist, 
Rehabilitation Care Service 
 
VA Puget Sound Health Care 
System  
1660 S. Columbian Way 
RCS-117  
Seattle, WA 98108-1532 
 
Jennifer.Bambara@va.gov 
Office: (206) 277-4264 
VETPALS Facilitator  
Ellen Ferris, B.S., PT 
Physical Therapist, Amputation 
Rehabilitation Coordinator   
VA Puget Sound Health Care 
System  
 
1660 S. Columbian Way 
RCS-117 
Seattle, WA 98108-1532 
 
Ellen.Ferris@va.gov  

 
 
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Office: (206) 277-3721 
Site Study Coordinator 
 
Juliana Bondzie, MA 
Research Coordinator/ 
Health 
Science 
Research 
Specialist 
VA Puget Sound Health Care 
System  
 
1660 S. Columbian Way 
S-151 
Seattle, WA 98108-1532 
 
 
juliana.bondzie@va.gov 
Office: 253-583-1890 
 
 
 
 
Project Staff at Louis Stokes Cleveland VA Medical Center (Cleveland, OH) 
Role 
Title 
Contact Information  
Local site investigator  
Clay M. Kelly, M.D. 
Service Chief – PM&R 
 
1F-138 CARES Tower 
Louis 
Stokes 
Cleveland 
VA 
Medical Center 
10701 East Blvd.  
Cleveland, OH 44106 
 
Clay.Kelly@va.gov  
Office: (216) 791-3800 x 1169 
VETPALS Facilitator  
Joseph Boncser, MSPT 
Amputation 
Rehabilitation 
Coordinator 
 
Louis 
Stokes 
Cleveland 
VA 
Medical Center 
10701 East Blvd.  
Cleveland, OH 44106 
 
Joseph.Boncser@va.gov  
Office: (216) 791-3800 x 1170 
Co-Investigator 
VETPALS Facilitator  
Farrah M. Thomas, Psy.D. 
Clinical Psychologist 
 
Louis 
Stokes 
Cleveland 
VA 
Medical Center 
10701 East Blvd.  
Cleveland, OH 44106 
 
Farrah.Thomas@va.gov 
Office: (216) 791-3800 x 5521 
Site Study Coordinator 
Jennifer Graebert, B.S.  
Research Coordinator  
Louis 
Stokes 
Cleveland 
VA 
Medical Center 
10707 East Blvd.  
Cleveland, OH 44106 
 
Jennifer.Graebert@va.gov 
jgraebert@aptcenter.org  
Office: (216) 791-3800 x3063 
 
Project Staff at Michael E. DeBakey VA Medical Center (Houston, TX) 
Role 
Title 
Contact Information  
Local site investigator  
Helene K. Henson, M.D. 
PM&R 
Service 
Chief, 
Rehabilitation Care Line 
Michael E. DeBakey VA Medical 
Center 
2002 Holcombe Blvd.  
RCL-117 Suite 2B-435 
Houston, TX 77030-4211 
 
HENSON.HELENEK@va.gov 
Office: (713) 794-7117 

 
 
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VETPALS Facilitator 
Stacy Flynn, PT, DPT  
Physical Therapist, Amputation 
Rehabilitation Coordinator  
Michael E. DeBakey VA Medical 
Center 
2002 Holcombe Blvd.  
RCL-117 
Houston, TX 77030-4211 
 
Stacy.Flynn@va.gov 
Office: (713) 791-1414 
Site Study Coordinator 
Dallese Jones, M.A.  
Health Science Specialist 
Michael E. DeBakey VA Medical 
Center 
2002 Holcombe Blvd. 
Suite 2B-168 
Houston, TX 77030 
 
Dallese.Jones@va.gov 
Office: (713) 791-1414 x5366 
 
Project Staff at James A. Haley Veterans’ Hospital (Tampa, FL)  
Role 
Title 
Contact Information  
Local site investigator  
Gail A. Latlief, D.O. 
Director, Southeastern Regional 
Amputation Center 
Medical 
Director, 
Amputation 
Specialty Program  
James A. Haley VA Hospital 
1300 Bruce B. Downs Blvd.  
673-151R 
Tampa, FL 33612-4745 
 
Gail.Latlief@va.gov 
Office: (813) 558-3982 
VETPALS Facilitator 
James D. Switzer, BS, PT 
Physical Therapist, Amputation 
Rehabilitation Coordinator 
James A. Haley VA Hospital 
Tampa 
Regional 
Amputation 
Center 
8900 Grand Oak Circle 
Tampa, FL 33637-1022 
 
James.Switzer@va.gov  
Office: (813) 558-3919 
VETPALS Facilitator 
Amy Firestone, PT,DPT, CCCE 
Physical Therapist, PT Training 
Program Director 
 
 
 
 
James 
A. 
Haley Veterans' 
Hospital, PM&RS (117) 
13000 Bruce B. Downs Blvd, 
Tampa, FL 33612 
 
Amy.Firestone@va.gov 
(813)972-2000 ext. 2126  
Study Coordinator  
Nora Arriola, MA 
Research Coordinator 
James A. Haley VA Hospital 
HSR&D/RR&D 
Center 
of 
Innovation 
on 
Disability 
and 
Rehabilitation Research 
8900 Grand Oak Circle (151R) 
Tampa, FL 33637 
 
Nora.Arriola@va.gov 
Office: (813) 558-3951 
 
Site Study Assistant   
Barbara C. Mckenzie, M.A. 
Project Manager, HSR&D/RR&D 
James A. Haley VA Hospital 
HSR&D/RR&D 
Center 
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Center of Excellence 
Innovation 
on 
Disability 
and 
Rehabilitation Research 
8900 Grand Oak Circle (151R) 
Tampa, FL 33637  
 
Barbara.Mckenzie@va.gov 
Office: (813) 558-3914 
 
 
 
 
Project Staff at Minneapolis VA Health Care System (Minneapolis, MN)  
Role 
Title 
Contact Information  
Local site investigator  
Andrew Hansen, PhD 
Director, 
Rehabilitation 
Engineering Research Program 
Research Biomedical Engineer, 
Extended Care & Rehabilitation  
Minneapolis VA Health Care 
System 
One Veterans Drive (151) 
Minneapolis, MN 55417 
 
Andrew.Hansen2@va.gov 
Office: (612) 467-2910 
VETPALS Facilitator 
Grace Wilske, OTR/L 
Occupational 
Therapist, 
Amputation 
Rehabilitation 
Coordinator 
Minneapolis VA Health Care 
System 
One Veterans Drive (4K) 
Minneapolis, MN 55417 
 
Grace.Wilske@va.gov  
Office: (612) 629-7560 
Study Coordinator  
Billie Slater, MAEd 
Research Coordinator 
Minneapolis VA Health Care 
System 
One Veterans Drive (151) 
Minneapolis, MN 55417 
 
Billie.Slater@va.gov 
Office: (612) 629-7830 
 
VETPALS Facilitator   
Stephanie Burcusa, PhD 
Clinical Psychologist, Extended 
Care & Rehabilitation 
Minneapolis VA Health Care 
System 
One Veterans Drive (4K) 
Minneapolis, MN 55417 
 
Stephanie.Burcusa@va.gov 
Office: (612) 467-1793 
 
 
 
 
 
 
 
 
 
2.0 
 

 
 
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3.0 
Introduction 
Scientific Background 
 
Dysvascular lower extremity amputation is a significant health care concern. Lower extremity 
amputations are a significant cause of morbidity, mortality and loss of function. Every year, over 
150,000 individuals undergo amputation related to dysvascular disease or diabetes.
1 Over the period of 1988 to 1996, rates of lower limb amputation in the Unites States 
complicated by these chronic illnesses increased over 27%, 2  and annual Medicare and 
Medicaid costs exceeded 4.3 billion dollars annually.1  In 2005, it was estimated that there were 
over 806,000 individuals living with lower limb loss related to dysvascular disease or diabetes in 
the US, and because of the rising prevalence of diabetes, future increases between the years 
2020 and 2050 are expected to be highest in this group.3  
 
Figure 1 
 
We need to improve the long term 
care 
of 
Veterans 
with 
an 
amputation. Models of chronic 
illness 
are 
well 
suited 
to 
amputation care. Over the last two 
decades, 
there 
has 
been 
increasing recognition that the 
challenges 
posed 
by 
chronic 
illness 
and 
disability 
differ 
substantially from those brought by 
acute illnesses, and that health 
care delivery should be adapted and tailored to these specific longer-term needs. One 
prominent example is the Wagner Model of Chronic Illness Care.4 The Wagner Model proposes 
that for individuals with chronic illness, health care resources and practices should be re-aligned 
so as to focus less on discrete, acute intervention and more on sustainable, long-term 
management.5  The ultimate goal is an ongoing partnership between "informed active patients 
and a prepared proactive team” (Figure 1).4, 6 - 7  Thus, building patients' investment and 
involvement in their own care is an essential component of this process. The specific 
mechanism for doing this is the promotion and facilitation of self- management. This increased 
emphasis upon patient participation is also highly consistent with the Institute of Medicine's 
charge to the US health care system to become more patient and family centered.8   
Self-management has been defined as a dynamic and continuous process9 that encompasses 
the tasks that individuals must undertake to live well with one or more chronic conditions.10 More 
specifically this entails the "ability to manage the symptoms, treatment, physical and 
psychosocial consequences, and lifestyle changes inherent in living with a chronic condition."9   
This last statement includes the important notion that individuals with limb loss have 
opportunities to impact their health in three domains by 1) impacting their primary disease 
process (e.g., properly managing diabetes, hypertension), 2) managing secondary 

 
 
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complications and symptoms (e.g., skin care, pain management, depression), and 3) proactively 
engaging in activities that may or may not be directly related to limb loss, but bolster health, 
well-being and quality of life (e.g., stress management, social support).  
Self-management interventions have been successful in improving outcomes across a broad 
variety of chronic illnesses including arthritis 11 , 12 , 13 , 14  asthma, 15 , 16  diabetes, 17 18 19  and 
hypertension20. They have been effectively utilized to treat depression in individual21 22and 
group-based formats23, and have been implemented as a key component of collaborative care 
for comorbid depression and chronic illness24. They have been shown to reduce health care 
utilization in the form of ER visits, hospital admissions, and bed days of care.15,25  Multiple 
studies have demonstrated that self-management programs are cost effective over the life of an 
illness, and bring noticeable improvements in quality adjusted life years.26,27,28 
Self-management interventions improve outcomes by promoting self-efficacy, patient activation 
and problem solving. Self-efficacy is "the belief in one’s capabilities to organize and execute the 
courses of action required to manage prospective situations."29  In a health care setting, this 
may include such things as monitoring blood sugar, learning transfer techniques, interacting 
with health providers, and reducing stress. This belief is based upon a history of behavior-
specific learning, and can be both taught and improved.30  Existing literature suggests that self-
management programs result in improvements in self-efficacy that can be retained over many 
years.31,14  In turn, self-efficacy is associated with better health maintenance, as well as greater 
physical and psychosocial functioning. For example, among diabetics, greater self-efficacy is 
associated with more frequent blood glucose testing, less frequent skipping of medication and 
binge eating, and closer adherence to an ideal diet.32  Self-efficacy has also been associated 
with lower levels of depression as well as better global health status.25   
Significance of the Proposed Work 
 
In 2008 VA Patient Care Services established a National Amputation System of Care to meet 
the needs of Veterans with limb loss. The stated mission of this program is to enhance the 
environment of care for persons with amputation receiving services in the VA by incorporating 
the latest practice in medical rehabilitation management, rehabilitation therapies, and prosthetic 
componentry. 33   With a series of regional centers, network sites, and clinic teams, the 
amputation system of care is charged with providing services that are comprehensive, holistic, 
and "coordinate lifelong rehabilitation… for service members and veterans as they progress 
from the acute care setting to their home environments."34  One essential component of this 
service is the promotion of a partnership between patients and providers such that new 
amputees receive the knowledge and skills to become active participants in their own long-term 
health care.  
 
The VA Amputation System of Care recognizes the value of self-management in long-term 
amputation care and intends to disseminate self-management interventions. Given the 
demonstrated value of self-management programs, the VA Amputation System of Care is in the 
process of actively establishing self-management groups at RACs (Regional Amputee Centers) 
and PANS (Polytrauma Amputation Network Sites) locations throughout the United States. 
Based upon the initial data reported by members of the current study team, the PALS program 
has been selected as the intervention for national VA dissemination. In fact, in 2011 staff 

 
 
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members at each RAC and PANS location were trained to deliver the original PALS intervention 
in anticipation of the implementation of this program. Nonetheless, very important questions 
remain as to how best to translate the intervention in terms of duration, content, and delivery 
(i.e., partially by video teleconferencing) to achieve maximum benefit in the VA. The proposed 
project is both well poised and well timed to provide meaningful information to inform the 
development of health care practice and policy for Veterans with amputation.  
Limitations of current data and research 
Initial evidence of the effectiveness of self-management following limb loss is promising, but 
limited. Only one published trial to date has examined self-management for amputees. The 
Promoting Amputee Life Skills (PALS) project,35 conducted by members of the current study 
team, designed and implemented an 8-week group-based intervention to improve self-
management following limb loss. The intervention was implemented within a network of existing 
support groups maintained nationally by the Amputee Coalition, a prominent non-profit 
consumer group. The PALS project demonstrated that group-based self-management could 
effectively improve physical and psychosocial functioning following limb loss, and was well 
received by participants. The current proposal builds upon previous research that has 
demonstrated the efficacy of the PALS self-management intervention, but addresses important 
next questions:  1) Is the PALS self-management intervention appropriate for Veterans, 
specifically considering the very high prevalence of diabetes and vascular disease, 2) Can it be 
housed and delivered within a health care system as opposed to existing community support 
groups 3) Will the intervention be more effective for individuals who are new amputees and 4) 
Will a shorter format that also incorporates an option for video teleconferencing retain the 
efficacy of the original PALS intervention? 
Limitations of the initial PALS trial  
Despite the important groundwork laid by the initial PALS trial, the applicability of this 
intervention to the VA Health Care System remains unknown. Several important questions 
remain unanswered: 
1. The original PALS intervention made use of existing community-based support groups. 
PALS was implemented in a network of established support groups maintained by the 
Amputee Coalition, a national consumer organization. Groups were composed of individuals 
who had already expressed an interest in, and dedication to, support group attendance. 
Although this study design had obvious strengths in terms of its ability to capitalize upon 
existing programs, it also had challenges, as the casual settings and strong emphasis upon 
socialization sometimes undermined the ability to cover formal content. As a part of its 
ongoing quality improvement processes, the Amputee Coalition has recommended that 
PALS be implemented in a structured medical setting. The efficacy of PALS in such a 
setting has not been established. This is one of the primary goals of this current study.  
2. The original PALS intervention made use of a heterogeneous patient population that is not 
typical of new amputees within the VA Healthcare System. Original PALS participants 
reported a range of etiologies of limb loss. Roughly one third (37.1%) reported their 

 
 
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amputation was due to dysvascular disease or diabetes, one third reported a traumatic 
amputation (39.3%) and the remaining third reported amputation due to cancer, limb 
deficiency, or other cause (23.6%). In contrast, nearly 98% of amputations within the VA are 
due to dysvascular disease or diabetes.36  This observation suggests that the content and 
skills presented in PALS should be tailored more specifically to the needs of Veterans with 
limb loss due to medical comorbidities such as dysvascular disease and diabetes. This 
project aims to maintain much of the original content and structure of PALS, but alter class 
examples, support materials, and peer modeling for VETPALS to more heavily emphasize 
challenges experienced by Veterans with limb loss. 
3. The original PALS intervention enlisted individuals who frequently had experienced limb loss 
several years prior. The median number of years since amputation was 4. Although PALS 
demonstrated that self-management could be introduced at any point in the life of an 
individual living with chronic illness, there is a strong rational for providing education, skills, 
and support early in the process of adapting to amputation. To provide just one example, 
good early knowledge of, and investment in, self-management strategies to promote skin 
care could prevent complications leading to additional amputation. As previously mentioned, 
subgroup analyses of PALS outcomes indicated it was more effective for individuals less 
than 3 years following limb loss and, when asked, most participants in PALS reported it 
should be offered during the first 6 months after amputation as we propose in this project. 
4. The original PALS intervention consisted of 8 consecutive weeks of group attendance and a 
follow-up visit. While this format encouraged the ongoing development of group cohesion, it 
also represented a barrier to participation. Notably, the project defined treatment completers 
as individuals who attended at least 75% of the scheduled sessions. Within the intervention 
condition receiving PALS, only 64.7% achieved this level of compliance. Based upon the 
experience from this previous trial, the proposed VETPALS intervention has altered the 
session structure so that the initial session in which skills are presented is longer, but the 
total number of sessions is reduced to 5. There is good evidence that chronic disease self-
management skills can be effectively taught in 5 weeks.  
5. The original PALS intervention required in person attendance, which also represented a 
barrier to participation. The VA has demonstrated an increasing investment in expanding the 
use of telehealth services to overcome obstacles related to distance and physical limitations, 
as well as costs associated with medical care. In fact, the VA Amputation System of Care is 
specifically mandated to implement and sustain tele-rehabilitation programs "to assure 
consistency of amputation rehabilitation across the VA." 37   The proposed VETPALS 
intervention allows Veterans to participate via video teleconferencing. To date there is no 
evidence of the effectiveness of amputation self-management that utilizes telehealth 
technology to facilitate participation.  
6. The original PALS intervention was more effective for individuals endorsing difficulties with 
an outcome the intervention was designed to address. Individuals who reported depression 
or low self-efficacy at baseline were more likely to experience improvements in physical 
functioning, depression, and self-efficacy as a result of the intervention. Although this finding 

 
 
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is not surprising, and is not a specific limitation of PALS, it raises an important question for 
an intervention that is directed globally at Veterans with limb loss, namely "Do the identified 
outcomes of this intervention actually reflect important challenges faced by Veterans?"   
Despite promising early evidence, the applicability of PALS to the VA remains unknown. 
Specifically, little is known about the efficacy of PALS 1) when implemented in medical 
settings, 2) for Veterans with dysvascular disease and diabetes, 3) who are new amputees, 
4) using a shortened format incorporating video teleconferencing to improve participation. 
The proposed study, using the adapted intervention, VETPALS, addresses these issues and 
represents the next logical step in research on the application of this clinical program to the 
VA.  
4.0 
Objectives 
 
Aim 1: Randomized Controlled Trial – Primary Outcomes  
Determine the impact of a group-based self-management intervention for Veterans with 
limb loss (VETPALS) upon physical and psychosocial functioning 
 
Hypothesis 1a: Individuals randomized to VETPALS will display greater improvements from 
baseline in physical functioning as measured by the Musculoskeletal Function Assessment 
Short Form (MFA-SF) than Veterans in the individual education support (control) condition post-
intervention and at 6-month follow-up. 
 
Hypothesis 1b: Individuals randomized to VETPALS will display greater improvements from 
baseline in psychosocial functioning as measured by the Patient Health Questionnaire 
Depression Module (PHQ-9) than Veterans in the individual education support condition post-
intervention and at 6-month follow-up.  
 
Aim 2: Randomized Controlled Trial – Secondary Outcomes 
Determine the impact of a group-based self-management intervention (VETPALS) upon 
self-efficacy, patient activation, problem solving, quality of life, and positive affect.  
 
Hypothesis 2a-e: Individuals randomized to VETPALS will display greater improvements from 
baseline in self-efficacy, patient activation, problem solving, quality of life and positive affect 
than Veterans in the individual education support condition post-intervention and at 6-month 
follow-up.  
 
Hypothesis 2f: Changes in the intermediate outcomes of self-efficacy, patient activation, and 
problem solving, thought to be core components of effective self-management, will correlate 
strongly with changes in the primary outcomes of physical and psychosocial functioning.  
 
 
Aim 3: Implementation Evaluation 
 
We will evaluate the implementation of the VETPALS intervention into the VA health care 
system by examining 1) actual versus planned participation (recruitment, retention, treatment 
engagement, treatment fidelity), 2)  barriers and facilitators to implementation, and 3) participant 
perceptions of the treatment.  

 
 
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Our evaluation is directly informed by, and reflective of, the RE-AIM framework 38, which 
proposes dimensions for consideration in the translation of research into real-world practice. 
RE-AIM incorporates the following: Reach (participation within intended population and 
characteristics of participants), Efficacy (the impact of an intervention when implemented as 
intended), Adoption (the percentage and representativeness of organizations that will adopt the 
intervention), Implementation (intervention integrity, quality, and consistency), and Maintenance 
(the degree to which intervention impacts are maintained at the individual and organizational 
level). Our particular implementation and strategies questions are tailored primarily to provide 
qualitative information about Reach (by gathering qualitative information about characteristics of 
participants and non-participants using focus groups) and Implementation (via fidelity monitoring 
as well as focused interviews to assess qualitative aspects of intervention integrity). Information 
about Efficacy and Maintenance (at an individual level) will be assessed in Aims 1 and 2. Our 
combined use of survey measures and qualitative, semi-structured interviews is a well-
established methodology in the health services literature,39-40 and several of our questions were 
modeled after the semi-structured interview items provided in Curran et al. (2011). 
To assess actual versus planned intervention participation in the VA context, which reflects the 
RE-AIM dimensions of Reach and Implementation, we will measure several aspects of 
participation (proportion of appropriate population who participates, characteristics of 
participants and non-participants, retention, treatment engagement/adherence, other therapy 
exposures) and implementation (treatment fidelity, leader perceptions of the intervention) on an 
ongoing basis and at the time of treatment completion. Study coordinators will maintain detailed 
logs of all potentially eligible participants, so that reach can be assessed. For participants, group 
leaders will maintain a weekly log documenting attendance and modality of participation (in-
person vs. video teleconference), tardiness or early departures from each session, and whether 
or not homework assignments were completed in the previous week. Additionally, to assess 
overall treatment engagement and adherence, we will have both group leaders complete the 
Psychosocial Treatment Compliance Scale (PTCS) 41  for each participant upon treatment 
completion. The combination of these two data sources (weekly logs and PTCS) will allow us to 
examine differences in participation by delivery modality (in-person vs. video teleconference), 
understand retention, and quantify treatment exposure. 
For participants in both the control and intervention conditions we will also administer a brief 
survey at the end of the intervention that measures utilization of supplementary project 
resources, 
including 
the 
recommended 
websites 
and 
participation 
in 
concurrent 
therapeutic/clinical activities (e.g., therapies, locally available programs such as peer visits, 
utilization of Amputee Coalition resources). This brief survey will also assess several potential 
factors in engagement, including perceived credibility of the treatment and perceived self-
reported engagement in the treatment.  
Treatment fidelity will be computed on an ongoing basis. The overall fidelity of the therapists to 
the treatment will be computed as a percentage of essential treatment elements adhered to out 
of the total number of essential elements (using the checklists). Treatment fidelity will be 

 
 
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reported in the final manuscript submitted for publication. Inter-rater reliability for the fidelity 
checks will also be computed and reported.  
To describe and understand barriers and facilitators to implementation in the VA context and to 
further assess Reach and Implementation dimensions, we will assess for any systematic 
differences in recruitment and retention due to age, gender, ethnicity, geographic distance from 
the medical center, amputation level, or marital status. Additionally, investigator-level study staff 
(Drs. Turner, Williams, Norvell) will conduct structured interviews with the site coordinators and 
each of the VETPALS facilitators in the program at the study conclusion to assess the time 
commitment required to lead each group, the administrative procedures used (i.e., clinic and 
procedure codes, scheduling strategies), and any local clinical or organizational factors that 
facilitated or hindered recruitment, scheduling, retention, or delivery of the intervention. To 
understand better any barriers and facilitators to implementation from the Veteran’s perspective, 
we will conduct 2-4 focus groups in the final year of the study. Participants in the focus groups 
will be non-randomly selected to ensure good representation of participant demographics, 
health status, geographic distribution, and varying levels of intervention engagement and 
attendance. Focus groups will be facilitated by Investigator level staff using guided questions to 
ascertain treatment, psychological, organizational and logistical factors that may have affected 
participation.  
To understand the causal events leading to change and the specific components of the 
intervention that most influenced it, we will solicit feedback from the intervention participants, 
control participants, and leaders via the focus groups described above. All participants, 
including those participating via telehealth, may be invited. We will conduct in-person focus 
groups which may include participants via telehealth. We will also ask all intervention 
participants to complete a questionnaire via pencil-and-paper to formally assess treatment 
satisfaction (the same satisfaction items used in the original PALS study).  
5.0 
Resources and Personnel 
Roles and responsibilities  
The Principal Investigator/Study Chair (Aaron P. Turner, PhD) and Co-Principal (Joseph M. 
Czerniecki, MD), will assume responsibility for all aspects of the conduct of this research study 
and supervise all Seattle-based personnel. They, along with the site PIs, will be responsible for 
training research staff, including the VETPALS facilitators, peer facilitators, and site study 
coordinators. They will also develop the study protocol, operations manual, monitoring plan and 
have oversight on study monitoring and study steering committee meetings.  
Site Principal Investigators (Drs. Heckman, Henson, Kelly, Latlief, and Hansen) are 
responsible for operations, data collection, and data integrity at their sites which involves 
oversight of the site study coordinators and regular meetings to discuss data and operations. 
They are also responsible for training the research staff at their site, including the VETPALS 
facilitator, peer facilitator, and site study coordinator. Site PIs, along with VETPALS facilitators, 

 
 
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will contact the data manager to obtain random assignment for participants. Site Principal 
Investigators may also assist with screening and enrollment as needed at their site.  
Co-Investigators (Rhonda Williams, PhD and Dawn Ehde, PhD) will oversee VETPALS 
facilitator ratings on an ongoing basis to provide corrective feedback to facilitators in real-time 
along with the PI/SC. They will also lead weekly meetings with the study facilitators to provide 
ongoing supervision and discuss delivery of the treatment, including the prevention of facilitator 
drift in the manuals. The Co-Investigators will also assist with tasks as requested by the PI/SC, 
which include but are not limited to: finalizing the study protocol, overseeing progress at all 
sites, developing the operations manual and other study SOPs, monitor treatment fidelity by 
reviewing audio files, running steering committee meetings, and training VETPALS facilitators 
and peer facilitators.  
Co-Investigator Stephen T. Wegener, PhD was a Co-PI for the original PALS program on 
which VETPALS is based. He will assist with tasks as requested by the PI/SC and Co-
Investigators, which include but are not limited to: training VETPALS facilitators and peer 
facilitators, revising the treatment manual/participant workbook, interpretation of statistical 
analysis, and writing manuscripts for publication at the end of the study.  
Co-Investigator and Consultant Dr. Daniel Norvell is responsible for all pre-study tasks and 
training of research staff. This includes oversight of all baseline and follow-up assessments, 
database development for data entry and analysis, and assistance in IRB submission. The VA 
Puget Sound will act as the lead study site and will host an investigators' meeting, which study 
site PIs, coordinators and VETPALS facilitators will attend to receive appropriate pre-study 
training. During this training session, the core investigators will ensure that all study materials 
(surveys, protocol, inclusion/exclusion criteria) are discussed, ensure that the study coordinator 
fully understands the study procedures and SOPs, and that all regulatory documents are 
approved and appropriately filed in regulatory binders. Initial training for VETPALS group 
facilitators will happen at this time and is described in more detail in the next section. He will 
also be a consultant on study operations. He will also monitor subject recruitment and follow-up 
rates at all sites and will monitor all adverse events.  
Dr. Norvell will also oversee the database manager at Spectrum Research and all database 
operations, including but not limited to, data queries, data analysis, data export as requested by 
the PI/SC. He will have primary responsibility for ensuring the safety and secure storage of all 
electronic study data. Dr. Norvell and Spectrum Research will only have access to coded data.  
Site study coordinators are primarily responsible for day to day study operations, which 
include recruiting participants and ensuring that all enrolled participants are adhering to the 
study protocol. These tasks include: ensuring all potential participants are identified through 
screening procedures, appropriately obtaining informed consent and HIPAA authorization, 
maintaining an updated screening and enrollment log, contacting participants regularly to 
schedule and remind them of study visits, and collecting baseline and follow-up data through the 
electronic data capture (EDC) system using an eCRF. The Seattle site study coordinator may 
also conduct study interviews by telephone for other sites in the event a site study coordinator is 

 
 
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unavailable. The site study coordinator will have regular contact with Dr. Norvell and the site PI. 
The site study coordinators remain blind to treatment group.  
The study project coordinator is based at the Seattle site, and is primarily responsible for 
oversight of daily study operations at the five participating sites. The project coordinator also 
has regular contact with Dr. Norvell, the PI (Dr. Turner) and Co-PI (Dr. Czerniecki) to assist in 
study troubleshooting with the site PIs and study coordinators as needed. The study project 
coordinator, with oversight from the PI and Co-PI, is responsible for submitting IRB materials to 
the VA Central IRB, including but not limited to: initial applications, protocol modifications, site 
correspondence, protocol deviations, and SAE reports. The project coordinator, along with Dr. 
Norvell, also monitors the site study coordinators and communicates with investigators to 
ensure efficient day-to-day study operations. The project coordinator will organize monthly 
teleconferences with site PIs and study coordinators to discuss progress, operations, and 
answer group operational questions as they arise.  
Additionally, VAPSHCS project staff will conduct periodic site monitoring and quality assurance 
of each site to ensure that informed consent, training requirements, and adverse event 
monitoring are being routinely performed in strict accordance with the research protocol, 
requirements of the Central IRB, and local VA R&D committees. During the first 6 months of 
enrollment at each site, the project coordinator and/or Drs. Turner and Norvell will conduct a 
virtual internal audit using the regulatory audit template from VAPSHCS. We will encourage 
each site to conduct an internal audit that adheres to their facility audit process to confirm both 
project wide and local facility compliance. We will also work to request a formal R&D audit 
during year 1, if possible, regardless of the local policy at each site.  
VETPALS facilitators are allied health professionals who are responsible for implementing the 
VETPALS intervention group sessions. VETPALS facilitators will be trained by the core group of 
investigators to deliver a modified version of PALS which reflects changes in content, delivery 
modalities (e.g. telehealth, video teleconferencing), and participants (Veterans with dysvascular 
disease/diabetes). VETPALS facilitators will receive training during a two-day group-based 
training that includes didactics, supervised practice, discussion, and home study. Notably, all 
VETPALS facilitators have already received initial training the PALS protocol and have 
advanced Department of Defense (DOD) training and certification in amputation care. VETPALS 
facilitators are primarily responsible for contacting the data manager to randomize a group of 
participants, maintaining an accurate randomization log, and conducting the 5 intervention 
sessions per group of 8±2 participants. The intervention sessions will take place in a private 
conference room with video teleconferencing capabilities at each VA site. All VETPALS 
facilitators will participate in ongoing group supervision as part of fidelity monitoring of the 
intervention, and additional focused instruction will be provided on an individual basis as needed 
when identified during a review of audio-recorded sessions. VETPALS facilitators may assist 
with screening and enrollment at their site.  
VETPALS peer facilitators are Veterans with limb loss. One peer facilitator at each site will be 
identified and trained by the VETPALS facilitator. Substitute or alternate peer facilitators may 
also receive training as needed at each site. The peer facilitator will help co-lead the VETPALS 

 
 
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sessions (as in the original PALS program). The peer mentor will only have study-related 
contact with participants in the context of the class. The peer will not access the medical record, 
or engage in other research-related activities. Thus, the peer mentor will not have access to any 
information about the participant that is not shared directly by the participant during class.  
The biostatistician (David Yanez, PhD) will conduct periodic queries of the database to look for 
any discrepancies or inaccuracies in the data (e.g. missing and nonsensical values) that may 
not have picked up during the electronic data entry process. The biostatistician will primarily be 
responsible for statistical analysis as outlined in the original grant application and study protocol. 
The biostatistician will only have access to coded data.  
6.0 
Study Procedures 
5.1 Study Design 
Study Overview  
All Veterans undergoing lower extremity amputation or receiving post-operative amputee care in 
the VA health care system during a 3 year period of prospective enrollment will be screened for 
study participation at all sites. Research staff at each site will identify potential participants who 
meet study eligibility criteria immediately following amputation surgery. All lower extremity 
amputees meeting study criteria who present to each study site will be invited to participate. All 
patients being considered or who have recently had lower extremity amputations are seen 
during the weekly amputee multidisciplinary rounds at each site. Study site coordinators and site 
PIs designated specifically for this study have established relationships with medical residents, 
fellows, physicians, and staff in various medical specialties (orthopaedics, vascular, podiatry, 
rehab, wound/skin) who have contact with potential participants. These personnel will refer 
patients to the study coordinator for evaluation of eligibility. Coordinators will also screen 
medical records of individuals receiving amputation in the 2 years prior to the start of the study 
to identify additional participants. Clinicians from one of these service lines will then introduce 
the study and the study coordinator to potentially eligible participants. Upon agreement from the 
patient, study site coordinators will approach patients individually and inquire about their interest 
and eligibility in volunteering for this study. Study coordinators will also mail an approach letter 
to patients who do not have an upcoming clinic appointment or who cannot be approached in 
person. Patients can call for more information or to opt-out of the study. Study coordinators will 
call patients who do not respond to the letter to see if they have questions or would like more 
information about the study.  
The site study coordinator will conduct the screening interview, which includes a series of 
questions to confirm eligibility (screening questions), a description of the study, its importance in 
amputee patient care, the responsibilities of participating in the study, and the potential risks 
and benefits of participating. Upon patient agreement, the study coordinator will initiate the 
informed consent process and inform the patient of the timeline for completing the baseline 
questionnaire, and assign the patient a unique study ID.  

 
 
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Once 8±2 participants are enrolled or nearly enrolled at each site, study coordinators will 
schedule appointments to complete the baseline assessment, either in person or by phone. 
Data are collected via electronic Case Report Form (eCRF). Individual or groups of participants 
may attend an in-person appointment with the study coordinator either in a private room in the 
Clinical Research Unit or office, or in the VA library or computer lab. Participants will use 
computers to complete the eCRFs and study coordinators are available to help guide 
participants and answer any questions.  
Enrolled participants are assigned on a rolling basis into successive cohorts of 8±2 individuals 
at each participating site. Each time 8±2 participants are enrolled, that cohort will be randomized 
1:1 to receive either the VETPALS intervention or individual education support program (control 
condition). We will ensure that participants will not have completed a PALS program prior to 
study participation and will not be part of an existing PALS group during their study participation. 
Randomization will occur through an email exchange between the study sites (VETPALS 
facilitator or site PI) and the data manager at Spectrum Research. The data manager will 
maintain a randomization table that is stored locally on a server at Spectrum Research. When a 
cohort is ready for randomization, the facilitator or site PI will send an email to the data manager 
stating that a group of participants is ready for randomization. The email will also include a list of 
study ID numbers but will not contain any information that could identify participants. Within 12-
24 hours of receiving the email, the data manager will verify the list of study IDs in the database 
to ensure all baseline assessments are complete, and then will obtain random assignment by 
accessing the randomization table. The data manager will respond via email to the facilitator or 
site PI with a value of 0 or 1 (0=individual education support program, 1=VETPALS). Both 
parties will retain a copy of the email for reference. The data manager will record the treatment 
assignment for the group in the randomization table, and the facilitator or site PI will record the 
treatment assignment in the randomization log. This method will ensure that treatment allocation 
is concealed during the recruitment of each cohort. A balanced number of groups will be 
randomly assigned to each site based on the projected enrollment at that site, which is a 
common randomization schedule used in group-based interventions. The randomization 
schedule and algorithm will not be shared with local sites to maintain concealment of treatment 
allocation. Additionally, the data manager will record a value of 0 or 1 to each study ID in the 
database which is linked to the study ID assigned at enrollment. Clinical research staff at each 
location (applicable investigators and VETPALS facilitators) will receive the treatment allocation 
and randomization ID in order to proceed with the treatment, intervention or control. Site study 
coordinators who conduct the baseline and follow-up assessments are blind to treatment.  
Additionally, each VA site will partner with another VA site treating Veteran amputee patients. 
Providers at the partner sites (e.g. Seattle partners with Tucson) will introduce the study to 
potentially eligible patients. Providers will give interested patients a study brochure so that 
patients can contact the VA site study coordinator. Patients will be screened via telephone script 
and those interested and eligible in participating will be consented by telephone and mail. 
Coordinators will mail a research study consent form using a USPS tracking number, establish 
telephone contact with the patient to answer questions during the informed consent process, 
and provide a postage-paid envelope for the patient to return the consent form. Patients 
participating in this study at partner sites will participate in the study via telephone assessments 

 
 
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with a site study coordinator. Patients from partner sites who are randomized to the intervention 
group can participate via telehealth (video teleconferencing). Similarly, patients randomized to 
the control group are contacted by telephone and receive post-amputation education materials 
by mail. Providers at the partner sites assist with scheduling the VETPALS classes as usual 
clinical care appointments, but are not involved in interacting with the participant for research 
purposes.  
Cohorts allocated to the intervention will work with the VETPALS facilitator and 5 clinical 
appointments will be created in the participant’s medical record. Participants may receive 
reminder phone calls prior to each scheduled session. As in the original PALS intervention, 
participants will be encouraged to become members of the Amputee Coalition (free of charge) 
which allows access to publications and educational materials. Participants also receive copies 
of some educational materials from the Amputee Coalition, along with a VETPALS participant 
workbook. The VETPALS workbook is a modified version of the original PALS workbook. The 
PALS workbook is publicly available by request through the Amputee Coalition of America. The 
VETPALS workbook has been condensed as the original PALS program was 10 weeks, and 
VETPALS is 5 weeks. The VETPALS intervention occurs over 5 sessions and is co-led by an 
allied health professional (facilitator) and a peer who is an amputee. At all sites, the VETPALS 
facilitator is the Amputation Rehabilitation Coordinator (ARC) of each facility and are licensed 
physical therapists, with advanced DOD training and certification in amputation care. 
Additionally, one of the sites has a second facilitator who is a Clinical Health Psychologist with a 
focus in physical medicine and rehabilitation. Other research staff who are trained in VETPALS 
(e.g. Site PIs, Co-Is) who are trained in the VETPALS intervention may lead sessions in the 
event of a facilitator absence. Upon completion of the study protocol, all Veterans in the 
VETPALS program will be offered the individual education support program.  
Outline of VETPALS intervention classes  
Session 1: 4 hour workshop 
Self-management skills 
-Knowledge of self-management 
-Problem-solving 
-Goal-setting 
-Self-monitoring 
-Skill focus: relaxation, calming mind & body 
Tools for self-management 
-Communication 
-Relaxation 
Session 2: 2 hour class 
Managing Emotions  
-Knowledge of behavioral activation  
-Skills: building resilience and positive mood  

 
 
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Session 3: 2 hour class 
Health and Activity  
-Chronic disease management knowledge  
-Health behaviors  
Session 4: 2 hour class 
Interacting with family & friends 
Session 5: 2 hour class 
Maintenance of self-management behaviors 
-Set goals for the future 
-Maintaining everyday life/health self-management activities 
-Prevention relapse 
 
The cohorts assigned to the individual education support program (control) will be informed of 
their treatment group by research personnel other than the study coordinator. Participants will 
have access to all of the medical and rehabilitation services they would typically receive in the 
normal course of amputation care (e.g. post-surgical follow-up, medical stabilization and wound 
healing, rehab for functional independence, prosthetic fit, gait training). This includes other VA 
Amputation System of Care resources such as caregiver and amputee support group. 
Participants will not receive the VETPALS or original PALS intervention during their time in the 
study. To enhance usual care and encourage study participation, participants in the control 
condition will be systematically contacted by a clinical member of the research team and 
provided with post-amputation education materials. We will use one or more of the following: 
First Step – A Guide for Adapting to Limb Loss and SideStep – A Guide to Preventing and 
Managing Diabetes and Its Complications published by the Amputee Coalition and The Next 
Step – The Rehabilitation Journey After Lower Limb Amputation, a VA/DOD publication. 
Participants will receive a subsequent call confirming receipt of the patient education materials, 
and inquiring about questions associated with the information. Individuals who express an 
interest in additional information will be referred to their amputation care team for appropriate 
follow-up. All contact in the control condition will take place on an individual basis. Upon 
completion of the study protocol, all Veterans in the individual education support program will be 
offered the VETPALS program.  
Participants will complete follow-up assessments with study coordinators in-person or by 
telephone at 6 weeks and 6 months. Study coordinators will screen for any anticipated and 
unanticipated adverse events at scheduled follow-up visits and by telephone contact with 
participants at 3 weeks and 18 weeks. Coordinators will briefly call participants to check-in, do a 
few medical review questions, and give a reminder of the next study appointment. Coordinators 
who cannot reach participants by phone at 3 or 18 weeks for the medical review questions 
should alert another site researcher who can complete the assessment by medical record 
review in CPRS. At the end of the study, coordinators will conduct a final 1-year medical record 
review. Study coordinators do not access the medical record until all follow-ups are complete at 
the end of the study in order remain blind to intervention assignment.  

 
 
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Additional details of the assessments and a study flow sheet can be found in the protocol 
document. Participants will receive reminders via telephone and mail for upcoming study visits 
from the study coordinator. The baseline assessment will take up to 60 minutes to complete and 
follow-up assessments will take up to 30 minutes to complete. Study coordinators remain 
blinded to treatment condition throughout the entire study and will be trained to ensure 
consistent and optimal administration of the assessments, as well as on strategies to remain 
blinded from treatment (e.g. strategies to remind patients not to reveal treatment). 
Randomization  
As described on page 21, this is a two-arm randomized controlled trial. The treatment allocation 
will automatically be matched to the study ID in the online randomization system. Clinical 
research staff at each location (site PIs and VETPALS facilitators) will receive the treatment 
allocation and proceed with study related activities for both conditions. Again, site study 
coordinators who conduct the baseline and follow-up assessments are blind to treatment. 
This online randomization system (maintained by Spectrum Research) will have layers of 
security, including a requirement for a username and password to avoid intentional tampering 
with the treatment allocation, as well as the highest level of encryption of user information and 
storage into a secure SQL-based database. The system will maintain a log of all coordinators or 
study personnel (who have privileges) who have logged in with a time stamp. Data will be 
maintained in such a way that reports can be produced routinely that allow the investigators to 
review the treatment allocations per site. Each Site PI will also maintain a separate 
randomization log and patient selection log by study ID. 

 
 
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Participant Flow Chart  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Potential Risk/Benefit Analysis 
Risks to all participants: This project poses minimal risks to participants. Participants may find 
it inconvenient to schedule and attend appointments for the baseline, 6-week, and 6-month 
study interviews, which take up to one hour to complete. Participants may also feel 
uncomfortable about having the group assignment chosen randomly, but to minimize this risk of 
discomfort, all potential participants are informed that they have access to the other program 
once they complete the program that they are randomized to, including the follow-up 
assessments. The questionnaires also ask sensitive questions about physical and emotional 
health. Participants may be uncomfortable answering some questions. During the consent 
process and before each interview, participants are reminded that they can pass on any 
questions they do not comfortable answering. There is a risk of loss of confidentiality; although 
we make every effort to keep research information safe and secure, no system for protecting 
information can be completely secure. Finally, the study may have risks that are currently 
unforeseeable, but we will contact participants if new findings occur that pose a risk.  
Additional risks to participants in the intervention condition: Participants may find it 
inconvenient to attend the VETPALS intervention sessions as the first session is 4 hours, and 
remaining sessions 2-5 are all 2 hours in length. Participants may also feel shy and/or 
Baseline Assessment  
Weeks 1-5: Individual Education 
Support Program/ Wait List 
Control 
(N = 204) 
Screen New Lower Extremity Amputees 
Accrue in Groups of 8±2 
Week 6: Post-Intervention Assessment  
Week 24: 6- Month Follow-Up Assessment 
Weeks 1 – 5: VETPALS Self-
Management Intervention 
Weekly Group Sessions 
(N=204) 
 
$20 payment  
$20 payment  
$20 payment  
Randomize Group  
Participants offered other intervention 

 
 
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uncomfortable when participating in group discussion and other activities during the intervention 
sessions.  
Risks to participants in the control condition: Participants in the control group may feel 
some discomfort or sadness about being randomized to the control/individual education support 
program. Participants may also feel some discomfort, sadness, or anxiety when reading post-
amputation education materials, or when receiving a phone call from a researcher/clinician to 
confirm receipt of the materials and inquire about further questions. All Veterans in the control 
condition are offered the VETPALS intervention upon completion of the study protocol. This 
ethically ensures that study participation does not deprive Veterans of a potentially valuable 
service.  
Anticipated benefits to society:  
The VETPALS intervention is a potentially valuable health care service. This project is important 
to test the hypothesis that a group-based self-management intervention provides benefits above 
and beyond exposure to usual care and supplemental information alone in the five areas of: 
knowledge, problem solving, self-monitoring, behavioral goal setting, and skill acquisition. This 
study represents one of the only prospective randomized controlled trials of a behavioral 
intervention for individuals with limb loss. At the completion of the study, it is expected that the 
results will be used to inform the integration of self-management interventions into the VA 
Amputation System of Care.  
Anticipated benefits to participants: 
Previous research showed that the original PALS intervention improved physical and 
psychosocial functioning when delivered in existing community-based support groups for 
amputees. Other benefits of PALS include decreased isolation, greater optimism, improved 
knowledge of treatment and coping options, perceived coping ability, and functional social 
support. The PALS intervention was well tolerated in previous studies as indicated by a 90% or 
greater retention rate. VETPALS is an adaption of this empirically-supported self-management 
program. 
Activities to minimize risk: Only the IRB-approved research staff will have access to research 
records. Patients screened for the study will be assigned a unique screening ID code, which will 
be linked to the last initial and full SSN (CPRS medical record). This log will be stored in a 
password-protected Excel file, on a secure VA network drive, in a restricted-access folder, 
behind the VA firewall that only the research staff has access to.  
With respect to privacy and confidentiality, all enrolled participants will be assigned a unique 
study ID. All research data (which does not contain any PHI) will be stored entirely separate 
from research materials that contain PHI, such as a consent form, contact log, and consent 
enrollment log. The crosswalk document, which links the study ID to the patient’s identity, will be 
maintained also in a password-protected Excel file, on a secure VA network drive, in a 
restricted-access folder, behind the VA firewall that only the research staff has access to.  

 
 
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The presence of study related adverse events will be regularly reviewed by the investigator 
team. The occurrence of 5 or more adverse events or 2 or more serious adverse events in 
either condition will trigger a review of the protocols at the time of occurrence. This process will 
serve several purposes. First, it will better accommodate the expected low-base rate of 
problems and allow for the early identification of issues than would a DSMB that met at an 
arbitrary regular interval. 
5.2 Recruitment Methods 
Up to 750  participants across all sites (including partner telehealth sites) will be 
recruited and enrolled in the project. The study has an overall final enrollment goal of 
472. Table 1 below outlines expected enrollment by site and year.  
Year 1 
Year 2 
Year 3 
Year 4 
Site 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Enroll 
Retai
n 
Seattle 
  
2 groups 
4 groups 
4 groups 
2 groups 
  
96 
72 
Cleveland 
  
2 groups 
4 groups 
4 groups 
2 groups 
  
96 
72 
Houston 
  
2 groups 
5 groups 
5 groups 
3 groups 
  
120 
90 
Tampa 
  
  
2 groups 
  
4 groups 
  
4 groups 
2 groups 
  
96 
72 
Minneapolis 
 
 
N/A 
 
4 groups 
 
4 groups 
TBD 
 
64 
48 
Total 
E = 64 
C = 48 
E = 168 
C = 126 
E = 168 
C = 126 
E = 72 
C = 54 
 472 
 354 
Table 1: Projections assume group enrollment rate (E) of N=8±2 and completion rate (C) of N=6 per group. 
Based upon a 50% enrollment rate. 
Based upon a 75% follow-up retention rate. 
 
The recruitment methods employed throughout the study ensure that the study sites can 
capture 100% of the patient population that meets inclusion and exclusion criteria. The 
recruitment plan ensures that we will be able to successfully identify patients in this specialized 
population, and that the only excluded patients are those that are clinically ineligible for this 
study.  
Patient identification and Pre-screening  
VA patients who recently had an amputation or are scheduled for an amputation are identified 
on an ongoing basis using computerized clinic lists from CPRS. Study coordinators may also 
receive alerts from ICD-9 codes and hospital admissions to identify VA patients. Alerts are 
created by CPRS programmers at each study site. The study coordinator screens the medical 
record to identify potentially eligible participants and determine if the patient has an upcoming 
clinic appointment for amputee-related post-operative care. The study coordinator attends clinic 
appointments and asks providers to determine if the patient might be eligible and interested. 
Providers approach patients who may be eligible and interested in the study, and ask if the 
patients would agree to be contacted by the study coordinator. If the patient agrees, the study 
coordinator initiates contact following the clinic appointment, either in person or by telephone. 

 
 
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As part of the initial approach conversation the coordinator may show a short recruitment video. 
The recruitment video is an adaptation of a PALS recruitment video and discusses the 
advantages of a self-management program. The video has been edited to best represent the 
self-management program as it is available to participants in the VetPals study. If the study 
coordinator is unable to attend the clinic appointment, providers can give the patient a brochure 
and a short recruitment video (e.g. CD, DVD, or link to video) with an overview of the study and 
a telephone number to call if interested or for questions. Additionally, the study coordinator may 
mail an approach letter, and when possible, a short recruitment video to potential participants 
who cannot be approached in clinic. Upon receipt of the approach letter, patients can call to opt-
in or opt-out of the study. As stated in the approach letter, we will call patients who did not 
respond to the approach letter within approximately one week to determine interest and 
eligibility. 
 
Study coordinators also screen surgery schedules from orthopaedics, vascular, and podiatry, 
and will screen medical records of anyone scheduled for an eligible surgical procedure. Study 
coordinators will then monitor the patient’s progress and look for an upcoming clinic 
appointment to establish initial contact and determine if the patient is eligible and interested. 
 
Providers from the multi-disciplinary PAVE Program (Prevention of Amputations in Veterans 
Everywhere) also identify potentially eligible patients through inpatient rounds and outpatient 
clinic appointments. The PAVE team includes providers from many service lines (orthopaedics, 
vascular, podiatry, skin/wound, physical therapy, rehabilitation medicine, prosthetics, 
rehabilitation psychology). Study coordinators screen medical records of patients referred by 
providers to determine eligibility and will attend a clinic appointment to establish initial contact, 
or will send an approach letter. Patients who previously agreed to be contacted may be 
contacted by telephone to determine interest and eligibility.  
 
The study team also uses VA administrative data from the VHA Support Service Center (VSSC) 
to identify Veterans who recently had an amputation. VSSC data contains names and last 4 
SSN. Study coordinators use this information to screen potentially eligible patients, and later 
contact the patient via an upcoming clinic appointment for amputee-related post-operative care.  
 
Screening and Recruitment  
Study coordinators initiate phone contact for any provider referrals for patients who do not have 
an upcoming clinic appointment but indicated an interest in the study and agreed to have a 
study coordinator initiate contact by phone. Also, study coordinators initiate phone contact for 
provider referrals from partner telehealth sites. Study coordinators use a phone script to 
introduce the study, verify basic criteria, and if eligible, proceed with the formal screening 
questions.  
 
Study coordinators use a screening case report form (CRF) to verify inclusion and exclusion 
criteria, and obtain basic demographics. The screening CRF also contains the Short Portable 
Mental Status Questionnaire 42 (SPMSQ), a brief test to determine inadequate cognitive or 
language function to consent or participate in the study. The screening CRF may originally be 
completed on a paper CRF, but later entered using an electronic CRF (eCRF), which is linked to 

 
 
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the study screening log and database. Study coordinators then initiate the informed consent 
process for interested and eligible patients.  
 
Recruitment Materials 
Study recruitment is heavily dependent on physician referrals and in-person initial contact 
between the patient and study coordinator. However, the study uses an approach letter, a study 
brochure, and video when in-person contact is not possible. The study brochure, and when 
possible a short recruitment video, are also used when participants may be interested, but not 
necessarily ready for screening and consent. See Appendix A.  
 
Participant Payments  
Enrolled participants are eligible to receive up to $60 for study participation. Payments for the 
study are submitted by the study coordinator using VA Form 10-1078. Payment slips are routed 
through the fiscal office at each institution in order to issue payment by check/mail. Participants 
can request cash payment if an appointment is scheduled in advance for the coordinator to 
obtain necessary signatures on VA Form 10-1078. Cash payments require participants to take a 
payment slip and photo ID to the agent cashier at each VA Medical Center.  
 
Participants are paid according to the payment schedule below. Payments are submitted (if by 
check/mail) or issued (if cash) following the completion of each study visit. If a participant 
withdraws or misses a study visit, they are compensated only for the visit completed.  
 
Baseline: $20 
 
6 week follow-up: $20 
 
6 month follow-up: $20  
Participants are informed during the informed consent process that payments will take up to 8 
weeks to receive a check by mail, and that cash payment on the day of the study is possible but 
may not always be available as it is reliant on advance scheduling and several signatures. 
Study staff will ensure that payments are submitted in a timely manner (within one week of 
participants completing a study visit).  
 
Participants in the intervention group are eligible to receive travel pay for attending intervention 
sessions in accordance with the amount they receive for usual care clinic visits. Participants in 
the intervention group are scheduled to attend five in-person sessions, which are scheduled as 
usual clinical care visits. Participants are compensated travel pay for this usual clinical care visit 
even though the intervention is part of the research study. Participants in the control condition 
may also have usual care clinical visits during the time period when they are participating in this 
study. Any clinical visits associated with the control condition are eligible for travel pay in 
accordance with the Veteran participant’s usual care travel pay amount. It is the responsibility of 
participants to claim travel pay for these visits, not the responsibility of the study staff.  
5.3 Informed Consent Procedures 
 
Waivers  
We have a waiver of informed consent for screening and recruitment purposes so that 
participants can be screened without requiring completion of a full informed consent. The waiver 

 
 
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allows the site study coordinators to identify and approach only potentially eligible patients. 
Patients are identified through clinic lists in CPRS, CPRS alerts, physician referrals, surgery 
schedules, and VA administrative data on amputations obtained through the VHA Service 
Support Center. The CPRS medical record is screened to verify eligibility. The waiver will also 
allow staff to recruit potentially eligible patients. Providers who are part of a multi-disciplinary 
amputee team will approach patients who may be eligible and interested in the study, and ask if 
they can be contacted by study personnel. If the patient agrees, the patient can initiate contact 
with the study team by phone, the study coordinator can call the patient, or the study 
coordinator can speak to the patient after the clinic visit if the coordinator is able to attend the 
clinic appointment. Once the study coordinator confirms eligibility using the screening CRF, the 
informed consent will be obtained prior to any other research procedures. The screening CRF 
takes approximately 5 minutes or less to complete and is conducted in the form of an interview 
by the study coordinator.  
 
Consent 
Following screening, the study coordinator and patient will set-up a time to meet in person to go 
through the informed consent process and obtain the necessary signatures. The informed 
consent process will take place in a private clinic room, hospital room, room in the Clinical 
Research Unit, or in a quiet area of the hospital to protect the participant’s privacy. The consent 
form clearly states that participation in this study is voluntary, and potential participants can 
decline participation at any time. Potential participants are also informed their participation is 
voluntary during the recruitment process. No attempt will be made to persuade patients who 
decline participation. Potential participants will also be asked if they need some time to consider 
their involvement before providing consent, and they will be given the opportunity to ask any 
and all questions related to the study before consenting. In the event the patient does not have 
an appointment at the VA, or cannot set up an appointment to come to the VA, the study 
coordinator will initiate the informed consent process by telephone/mail. Coordinators will mail a 
consent form using a USPS tracking number, establish telephone contact with the patient to 
answer questions during the informed consent process, and provide a postage-paid envelope 
for the patient to return the consent form. All study sites are Regional Amputation Centers and 
provide amputation-related care for participants from an expansive geographic area. The 
telephone/mail consent process will be used as appropriate to avoid unnecessary travel or 
inconvenience for patients for the consent process. The telephone/mail consent process will 
also be used in the event a participant is screened in person but requires additional time to 
consider study participation.  
 
The study coordinators at each site will conduct the informed consent process, rather than the 
study PI/LSI, so that the participants do not feel obligated to participate. Alternatively, in the 
event the study coordinator is not available to obtain informed consent, another IRB-approved 
investigator designated by the PI/LSI may obtain consent. Finally, we will tell all potential 
participates that their decision about participation will not affect their clinical care in any way. 
See Appendix B.  
 

 
 
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The PI/SC and LSIs are responsible for training all applicable study staff at participating sites 
how to conduct the informed consent process. The PI/SC will hold pre-study training conference 
calls, which will cover the informed consent process. LSIs are also ensuring that site study 
coordinators receive additional training as necessary. Additionally, study staff will participate in 
ongoing monthly conference calls to discuss recruitment, enrollment, and retention and the 
consent process will be reviewed during these monthly meetings. Prior to the start of 
recruitment, Seattle will host a kick-off meeting for LSIs, VETPALS facilitators, and study 
coordinators. The consent process will be reviewed and practiced during this meeting.  
Site coordinators will use the following guidelines for the consent process by telephone/mail. 
This guidance was provided by the Research Compliance Officer at the lead study site, 
VAPSHCS.  
1. For studies that allow for consent to be obtained over the telephone, study staff will mail 
the Veteran, at the last known residential mailing address, a copy of the following 
documents:  
Informed Consent Form 
HIPAA Authorization Form  
VA Form 10-3203  
Note: Mail the above forms with a stamped, returned, addressed, VA envelope. It is 
helpful to add stickers or highlighting to indicate where to sign and date.  
2. The study coordinator (SC) will call the Veteran to verify the receipt of the forms. 
3. The SC will determine if there is sufficient time to explain and review the study details 
and forms received. If not, the SC will make a telephone call appointment to consent the 
Veteran.  
4. The SC consents the Veteran to the study.  
5. The SC will explain the study details to the Veteran and what it means for the Veteran to 
consent to participate in the study. 
6. The SC will ensure the Veteran has plenty of time to consider study participation and a 
chance to talk it over with family and friends, if necessary.  
7. The SC will direct the Veteran to sign and date all the forms where indicated.  
8. The SC will advise the Veteran to mail the signed, dated and completed forms back to 
the study team in the VA envelope that was provided.  
9. A member of the study team will call the Veteran to verify receipt of the forms. 
10. The SC will sign and date all the forms. 
11. The SC will mail a copy of all the forms to the Veteran or the Veteran will receive the 
signed copy if he/she has an upcoming appointment.  
5.4 Inclusion/Exclusion Criteria 
Inclusion criteria are intended to allow maximum inclusion of the majority of Veterans 
undergoing any new lower extremity amputation within 2 years prior to study enrollment. At the 
same time, it will allow for shared experience of managing the medical comorbidities that 
contributed to limb loss. Allowing multiple levels of amputation, as well as revisions, creates a 
study population that approximates the case mix of the VA Amputation System of Care and 
improves the generalizability of findings. 
Inclusion criteria: 
1. Ages 18 and older. 

 
 
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2. Transfemoral (above-knee), transtibial (below-knee), knee disarticulation (through-knee), 
Syme’s/ankle disarticulation (through-ankle), and transmetatarsal amputation (through-
foot, includes Chopart amputation and Lisfranc amputation) due to dysvascular 
disease/diabetes. Can include a revision of an amputation. Revision amputation is a soft 
tissue revision with bone shortening at the same or higher level.  
3. Participant has a contact address and phone number so that s/he can be reached during 
the course of the study*. 
4. Enrolled within 2 years of amputation. 
5. Speak and comprehend English.  
*We will ask a participant who do not meet eligibility criteria because of inclusion criteria item 3 if s/he will have one in 
the near future, and if yes, permission to contact them again that time. This allows the participant to be included, if 
interested and eligible, at a later date.  
 
Exclusion criteria are intended to screen out a small number of individuals who would likely not 
benefit from participation in a group-based psychosocial intervention. Similar criteria are 
routinely used in the course of clinical care outside of the context of research study, and as a 
result are not thought to pose a significant threat to generalizability. 
Exclusion criteria:  
1. Inadequate cognitive or language function to consent or participate defined by ≥ 6 errors 
on the SPMSQ or diagnosis of dementia or Alzheimer’s disease.  
2. Active substance use disorder identified by chart review and initial screening. Note: No 
personnel involved in the study may identify, directly or indirectly, any individual patient 
or subject in any report of such research or otherwise disclose patient or subject 
identifies in any manner. 
3. Major uncontrolled psychiatric illness (bipolar disorder, psychosis, severe suicidality) 
identified by chart review and confirmed as necessary by discussion with current 
providers.  
4. Spinal cord injury 
5.5 Study Evaluations    
 
Screening 
Study coordinators will collect screening information in the form of an interview. After discussing 
the study in person, or using the telephone script to introduce the study to patients recruited by 
telephone, interested patients will be asked to answer some screening questions. Patients will 
be asked to complete the SPMSQ, which is a brief test to determine inadequate cognitive or 
language function to consent or participate in the study. This is a 10 item questionnaire where a 
score of 5/10 or more is required to participate in the study. The screen also confirms eligibility 
by a series of inclusion/exclusion criteria, collects basic demographic information (age, gender, 
race, ethnicity, primary or telehealth site participant, and approximate driving distance from the 
study site), and documents informed consent for eligible patients who decide to participate in 
the study. Study coordinators may answer record screening answers initially on a paper CRF, 
but all screening CRF data will be transferred to the study database using the eCRF. Study 

 
 
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coordinators may also initially use the eCRF during the screening process if a computer is 
available or patients are being screened by phone. See Appendix C.  
Baseline 
All participants complete a baseline assessment that includes a medical record review, clinical 
interview, and administration of primary and secondary outcome measures and covariates. Site 
study coordinators conduct interviews with participants in person or by telephone, whichever is 
most convenient for the participant. In person interviews take place in a private hospital or clinic 
room, private room in the Clinical Research Unit, VA hospital library, or VA hospital computer 
lab. In person interviews may occur individually or in a small group of other study participants. 
To protect confidentiality and privacy, participants will be seated at separate computers and 
coordinators will conduct brief cognitive testing with participants individually in a separate room. 
If the interview is by phone, the study coordinator will ask the participant questions and answers 
will be marked using an eCRF that is linked to the study database. If the interview is in person, 
participants can sit at a private computer and respond to questions. The study coordinator is 
available to answer questions or conduct the interview if the patient does not wish to use the 
computer. All data are collected using EDC (no paper baseline CRFs) on VA approved and 
secure laptop and desktop computers. The baseline assessment takes up to one hour to 
complete. 
 
During the clinical interview, the site study coordinator will collect medical information including 
amputation date (translated to time in days since original amputation), location, type (initial or 
revision), and level (e.g. transmetatarsal, transtibial, transfemoral). Although this information 
was verified and collected during screening, more detailed information, including time (in days) 
since original date of surgery, is recorded during the baseline assessment.  
 
During the baseline medical record review we will use the Functional Comorbidity Index (FCI), 
amputation level, previous amputations, and contralateral limb assessment questions. Data will 
be recorded on eCRFs. A list of the measures used at baseline and follow-up are found in the 
assessment measures section and in Table 2. 
Randomization 
Participants will be randomized to a treatment group (group-based program/intervention vs. 
individual education program/control) following completion of the baseline assessment (see 5.1 
Study Design). The site study coordinators will be naïve to treatment allocation throughout all of 
the assessments to minimize potential bias of the outcomes.  
Group based self-management program (VETPALS Intervention)  
Participants randomized to the intervention group will be asked to complete a checklist about 
their use of supplementary class resources, a checklist about their satisfaction with the classes, 
and selected participants will be invited to participate in a focus group to respond to and discuss 
implementation variables. The site PIs and VETPALS facilitator have primary responsibility in 
overseeing data collection on paper forms. Data will be entered into the central study database 
by the site PIs and/or VETPALS facilitator via eCRF. In the event a participant doesn’t receive 

 
 
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any necessary materials during class sessions, a facilitator will mail materials to the participant 
and will include a return postage-paid addressed envelope if needed. Participants randomized 
to the intervention group are offered the other program at the end of their 6-month follow-up 
assessment. Study coordinators will record (yes/no) patients who elect to participate in the 
individual program and will refer patients to the facilitator who will discuss the other program and 
scheduling in more detail.  
We will use a digital voice recorder to audio-record the VETPALS sessions. The purpose of 
audio-recording the VETPALS sessions is to monitor treatment fidelity, assess feedback, and 
ensure protocol adherence. Each participating site will consult with the local R&D office to 
ensure that the digital audio-recorder meets local VA guidelines, and all recorders will use FIPS 
140-2 validated encryption. Sites will use the device(s) listed in the local site Central IRB 
applications.  
Individual education support program (Control)  
Participants randomized to the control group will not have any additional assessments or 
evaluations to complete. In the event a participant doesn’t receive any necessary materials 
during the individual education support program, a facilitator will mail materials to the participant 
and will include a return postage-paid addressed envelope if needed. Participants in the control 
group are offered the VETPALS intervention classes at the end of their 6-month follow-up 
assessment. Study coordinators will record (yes/no) patients who elect to participate in the 
intervention classes and will refer patients to the facilitator who will discuss the other program 
and scheduling in more detail.  
Patients who are randomized but unable to begin VETPALS or the Individual Education 
Support Program  
In the event a participant is randomized but cannot begin participating in the assigned 
intervention, the participant will be given several options. There may be unexpected 
circumstances (e.g. personal or family illness, change in job status, personal situation) that may 
prevent a participant from starting the assigned intervention with their cohort as originally 
planned. VETPALS facilitators will discuss options with the participant.   
1. The participant can be included in the same randomized intervention at a later date. The 
facilitator will wait for the next cohort that is assigned the same intervention and will 
contact participants to determine if they can participate with the next cohort.  
2. If the participant agrees to be included in the next cohort, the facilitator will notify the 
study coordinator of this change so the study coordinator can include the participant in 
all subsequent follow-up assessments. The facilitator will only share the participant’s 
study ID number so the coordinator remains blinded to treatment.  
3. Participants may be asked to complete a second baseline assessment with the study 
coordinator. This will be assessed on an individual participant basis and site 
investigators and the PI will use their discretion when deciding if a second baseline 
should be completed. Collecting the baseline data again prior to starting the intervention 

 
 
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ensures that the research data reflects the most current responses. Participants who 
complete a second baseline will receive $20 for their time and participation.  
Periodic medical record review  
Site study coordinators will conduct a brief medical review at scheduled assessments (baseline, 
6 weeks, and 6 months) and at 3 weeks, 18 weeks, and 1 year. Site study coordinators will call 
participants by telephone at these intervals to do a brief medical screening to capture all 
anticipated and unanticipated adverse events. Site study coordinators will alert another site 
researcher to complete the assessment via medical record review for participants who cannot 
be contacted by phone. This ensures the study coordinator will remain blind to treatment 
assignment. At the end of the study, coordinators will conduct a final 1-year medical record 
review. Site study coordinators will record any anticipated adverse events, including 
complications such as stump non-healing, revision amputation, contralateral amputation, and 
mortality. For individuals who undergo a revision or new amputation, we will calculate the time in 
days since the qualifying event (original amputation). See 6.0 Reporting for a list of all 
anticipated AEs. Periodic medical record review allows study coordinators to also check for any 
UAE or SAEs. All data are collected on an eCRF using the EDC system.  
Complications and anticipated AEs include stump non-healing, revision to same or higher level, 
contralateral amputation, and mortality. These will be monitored and collected during the 
subjects' hospital stay and after discharge by systematically reviewing the subject’s medical 
record at designated intervals and during formal follow-up interviews at 6 weeks and 6 months.  
Follow-up  
All participants will complete follow-up assessments at approximately 6 weeks after 
randomization (coinciding with the end of the intervention sessions) and at 6 months. Similar to 
the baseline assessment, site study coordinators conduct follow-up interviews in-person or by 
phone, whichever is most convenient for the participant. All follow-up data are collected using 
EDC on VA approved and secure laptop and desktop computers and assessments take up to 
30 minutes to complete. A list of the measures used at baseline and follow-up are found in the 
assessment measures section and in Table 2.  
Temporary changes: Baseline, periodic medical record review, and follow-up  
In the event a site study coordinator is unavailable (e.g. planned absence) the site study 
coordinator and/or project coordinator from the lead site (VA Puget Sound Health Care System, 
Seattle, WA) may conduct baseline, medical record review, and follow-up assessments by 
telephone. Site study staff will inform participants of this temporary change by mailing or hand 
delivering a letter that explains the site study coordinator’s absence. Participant study ID 
number, name, and phone number will be shared with the Seattle site study coordinator and/or 
project coordinator. Local site staff will contact Seattle staff by telephone or PKI-encrypted email 
to share this information. All information from other sites will be stored in accordance with this 
study protocol. See section 7.0 Privacy and Confidentiality for more details.  
Participant Assessment Measures 

 
 
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All data are collected using EDC. Measures are displayed on a computer screen and site study 
coordinators and/or participants respond using VA approved and secure computers and 
responses are automatically placed in the study database. There are no paper CRFs for 
baseline and follow-up assessments as all questionnaires are displayed on eCRFs. In the event 
of a technical problem, data will be recorded on paper CRFs and transferred to an eCRF. The 
coordinator will use a secure shredding bin to discard the paper CRF the eCRF is complete. A 
description of each measure used is below, followed by Table 2, which displays a summary of 
the baseline and follow-up assessments.  
 
Primary Outcomes 
Physical functioning will be measured using the Musculoskeletal Function Assessment Short 
Form (MFA-SF). The MFA-SF is a 46-item questionnaire designed to measure functional status 
across a broad range of musculoskeletal disorders. Participants are asked to rate difficulties 
associated with daily activities ranging from "not at all difficult" to "unable to do," as well as the 
frequency of problems, ranging from "none of the time" to "all of the time."   Responses are 
combined into a single physical functioning score. Twelve of the items constitute a separate 
subscale examining how much individuals are bothered by their limitations. This scale will also 
be computed, but is not the primary outcome. The MFA-SF has been utilized extensively in 
research,43 and has established validity, reliability.44  
Psychosocial functioning will be evaluated by examining depression using the Patient Health 
Questionnaire Depression Module (PHQ-9). The PHQ-9 is a brief self-report screening 
instrument designed to identify depressive symptoms consistent with criteria of the Diagnostic 
and Statistical Manual for Mental Disorders, 4th Edition.45,46  The module instructs participants 
to rate the degree to which they experienced each of 9 symptoms of depression over the last 2 
weeks, ranging from 0 = “not at all” to 3 = “nearly every day”. The PHQ-9 has shown utility in 
estimating the level of depressive severity in medical patients using the sum of scores on each 
of the 9 items.47  The PHQ-9 has been utilized extensively in research and has established 
validity and reliability.45   
The last item on the PHQ asks “Over the last 2 weeks, how often have you been bothered by 
any of the following problems?...Thoughts that you would be better off dead, or of hurting 
yourself in some way?”. Responses range from 0-3 where 0 (not at all), 1 (several days), 2 
(more than half the days), 3 (nearly every day). For participants who respond >0, the study 
coordinator will refer to the Suicide Risk Reduction Protocol (Appendix D). This plan reflects the 
importance of activating hospital procedures for suicide assessment and prevention.  
Secondary Outcomes 
Quality of Life will be measured using the brief form of the World Health Organization Quality of 
Life Scale (WHOQOL-BREF). The WHOQOL-BREF is composed of 26 items examining the 
domains of physical health, psychological health, social relationships, and environment. 
WHOQOL-BREF has demonstrated discriminant validity, content validity, internal consistency 

 
 
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and test-retest reliability. 48 and has been utilized extensively in medical, rehabilitation and 
general population settings.49  In this study, we will focus on the two global items, "How would 
you rate your quality of life?" with response items ranging from "very poor" to "very good" and 
"How satisfied are you with your health?" with responses ranging from "very dissatisfied" to 
"very satisfied."   
Positive Affect will be measured using the Positive and Negative Affect Schedule (PANAS).50  
The PANAS consists of adjectives rated from 1 (very slightly/not at all) to 5 (extremely) that 
measure positive feelings such as joy, pleasure and negative feelings such as anxiety or 
sadness. For the current study, only the 10-item positive affect scale will be utilized. The 
PANAS has good internal consistency, reliability, and construct validity established in large 
normative samples.51  
Intermediate Outcomes 
Self-Efficacy for managing limb loss will be measured using the modified Self-Efficacy scale 
(MSES). The MSES is a 22-item questionnaire designed to measure patients' perceived self-
efficacy to cope with the consequences of chronic disease with 3 subscales: self-efficacy for 
pain management, self-efficacy for coping with symptoms, and self-efficacy for physical 
function.52  Each item is presented as a question (e.g. How certain are you that you can keep 
your amputation from interfering with the things you want to do?). Respondents rate each belief 
on a 10 point Likert-type scale. Items are summed to produce a total score. Psychometric 
properties have been established.  
Patient Activation will be measured by the Patient Activation Measure (PAM). The PAM is a 13-
item survey tool designed to assess a person’s engagement in care, confidence in the ability to 
understand and act upon health challenges, commitment to making needed lifestyle changes, 
and efforts to sustain those changes over time.53  Response options for the 13 PAM questions 
use a Likert-type agreement scale with 4 response options. The options are strongly disagree 
(1), disagree, agree (3), strongly agree (4), and N/A. The raw score is calculated by adding all 
the responses to the 13 questions. The measure has shown good internal consistency and 
validity in both convenience and large national probability samples.54  
Problem Solving will be measured using the 10-item version of the Social Problem-Solving 
Inventory-Revised (SPSI-R).55 This scale assesses two adaptive problem-solving dimensions 
(positive problem orientation and rational problem-solving) and three dysfunctional dimensions 
(negative problem orientation, impulsive/careless style, and avoidance style).55 Items on the 
SPSI-R are rated on a five-point Likert-type scale (0, not at all true of me, to 4, extremely true of 
me) and summed to produce a single total score from 0-40. The SPSI-R has good internal 
consistency, construct validity, and has been used to assess problem solving in a broad range 
of populations.56  
Potential Covariates 
The following variables have been established in the literature as correlates of one or both of 
our primary outcomes. They will be collected primarily to demonstrate the comparability at 

 
 
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baseline of the intervention and control conditions. In instances where randomization does not 
achieve comparability, outcome analyses will include them as covariates. 
Comorbidity will be assessed primarily using the Functional Comorbidty Index (FCI).57  The FCI 
is an 18-item list of diagnoses, each of which is given 1 point if present. The final score of the 
FCI is the sum of the items. The FCI was designed with physical function as the outcome of 
interest.57 It has been found to have both content and criterion validity. We will also collect a 
limited number of pre-operative co-morbidity factors and concomitant diseases particularly 
relevant to amputation outcome (e.g., currently on dialysis - yes/no) from patient interview. 
Pain will be measured using questions from the Chronic Pain Grade (CPG) questionnaire.58  
Participants will be asked to report the intensity and the interference of overall pain as well as 
pain in each of four different body regions. Response options range from 0 to 10. This 
assessment of pain location, intensity and impact conforms to established guidelines.59  The 
CPG itself was designed for interview-based studies due to its relatively simple and brief format. 
The instrument has good internal consistency and reliability.58   
Complications include stump non-healing, revision to same or higher level, contralateral 
amputation, and mortality. These will be monitored and collected during the subjects' hospital 
stay and after discharge by systematically reviewing the subject’s medical record every three 
months as well as during formal follow-up interview at 6 months. 
Social support will be assessed using the Multidimensional Scale of Perceived Social Support 
(MSPSS), 60 a 12-item self-report measure of perceived social support from three specific 
sources: family, friends, and significant other. For each item, participants are asked to rate their 
degree of agreement on a 7-point Likert scale. Possible total scores range from 12 to 84, with 
higher scores indicating greater perceived social support. Items primarily reflect perceived 
availability of emotional, informational, companionship and affection support. Internal 
consistencies of the subscales and total scale are all excellent, and the scales have 
demonstrated strong test-retest stability over two- to three-month intervals.60  
Cognitive functioning will be evaluated using three brief tests from several well established 
neuropsychological instruments including: (1) The List Learning and List Recall Subscales of the 
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); (2) the 
Controlled Oral Word Association Test (COWAT); and (3) the Digit Span subtest of the 
Weschler Adult Intelligence Scale – 3rd Edition (WAIS-III). All of the selected instruments have 
sound psychometric properties and extensive data are available on their reliability, validity, and 
population norms.61  The RBANS is a brief cognitive screening tool designed to balance the 
need for an instrument that is sufficiently sensitive to detect mild to moderate cognitive deficits, 
but also able to differentiate lower levels of cognitive performance without pronounced floor 
effects. It was specifically designed for use with older adults and for individuals in medical 
settings. The WAIS-III is the industry “gold standard” intelligence test. We propose to use only a 
single subtest, Digit Span, which includes two parts: Digits Forward and Digits Backwards. Both 
are tests of attention and working memory. Finally, the COWAT is a test of phonemic verbal 
fluency. It reflects abilities in a number of areas, including executive functioning. The norms for 
these neuropsychological tests are based on protocols that are designed to ensure 

 
 
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standardized administration. Site coordinators will be provided with written instruction scripts 
and trained by an experienced psychologist with extensive experience in neuropsychological 
testing to ensure optimal administration.  
Alcohol use will be measured with the Alcohol Use Disorders Identification Test (AUDIT-C). This 
three-item measure queries individuals about the quantity and frequency of use as well as binge 
drinking episodes and has been extensively validated as a screening tool for identifying use 
disorders in medical populations.62   
Smoking status will be assessed by three standard questions addressing quantity, frequency, 
and recency of smoking established by the Center for Health Quality, Outcomes, and Economic 
Research (CHQOER) for the VA administered as part of a large health survey of Veteran health 
behaviors.  
Internal Study Evaluations/Process Measures  
Treatment engagement and adherence will be assessed using the Psychosocial Treatment 
Compliance Scale (PTCS).41 The PTCS is a 17-item, therapist-rated scale of compliance and 
perceived treatment engagement with psychosocial interventions. Although initially designed for 
individuals with serious mental illness, the items have broader applicability to other populations. 
The scale is comprised of two subscales (participation and attendance). Sample items 
(paraphrased) include “was able to remember the contents/skills taught in previous sessions”, 
“was attentive in treatment”. The scale has excellent internal consistency and construct 
validity.41  
Actual versus planned intervention participation in the VA context will be assessed by the 
screening log and screening data of all potentially eligible participants. VETPALS facilitators will 
maintain a weekly log documenting attendance and modality of participation (in-person or 
telehealth), tardiness or early departures from each session, and completion of homework 
assignments. These two methods, along with the PTCS, will allow investigators to examine 
differences in participation by delivery modality, understand retention, and quantify treatment 
exposure.  
Use of supplementary resources will be assessed for both the intervention and control 
conditions by administering a brief survey coinciding with the end of the intervention sessions. 
The survey measures the use of supplementary project resources, including the recommended 
websites and participation in concurrent therapeutic/clinical activities (e.g. therapies, locally 
available programs such as peer visits, Amputee Support Group, and Amputee Coalition 
resources). This brief survey also will assess several potential factors in engagement, including 
perceived credibility of the treatment and perceived self-reported engagement in the treatment. 
We will formally assess treatment satisfaction using a pencil and paper satisfaction measure 
used in the original PALS program. The VETPALS facilitator will not directly administer or collect 
the satisfaction measure. The Veteran peer amputee or another designee will collect all paper 
copies and place them in a sealed envelope. The facilitator will deliver these to the PI or Co-PI 
at the Seattle site either by hand delivery, secure and traceable mail (e.g. UPS), or scanning 

 
 
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PDF copies and uploading to a secure SharePoint. The PI and Co-PI are responsible for 
reviewing these questionnaires and entering data into the database.   
To describe and understand barriers and facilitators to implementation of VETPALS in the VA, 
Investigator study staff (Drs. Turner, Williams, Norvell) will conduct structured interviews with 
the site study coordinators, VETPALS facilitators, and peer facilitators at the study conclusion. 
These interviews will assess the time commitment required to lead each group, the 
administrative procedures used, and any local clinical or organizational factors that facilitated or 
hindered recruitment, scheduling, retention, or delivery of the intervention.  
Focus Groups 
To better understand any barriers and facilitators to implementation from the Veteran’s 
perspective, we will conduct 2-4 focus groups in the final year of the study (additional details in 
3.0 Objectives). Focus groups will be facilitated by Investigator-level study staff using guided 
questions to ascertain treatment, psychological, and organizational and logistical factors that 
may have affected participation.  
Staff Research Interviews  
To better understand any barriers and facilitators to implementation from the research staff 
perspective, we will conduct individual interviews with site study coordinators and VETPALS 
facilitators. Investigator-level study staff (Drs. Turner, Williams, and Norvell) will conduct 
structured interviews with these staff to assess time commitment required to lead each group, 
administrative procedures used, and any local clinical or organizational factors that facilitated or 
hindered recruitment, scheduling, retention, or delivery of the educational programs.  

 
 
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Table 2: Assessment Timeline  
See Appendix E for a copy of all measures and interview questions. 
 
 
 
Measure 
 
Screeni
ng 
 
 
Baseline 
 
Treatment 
Completion 
 
Month 6 
Follow-Up 
Screening 
 
 
 
 
 
     Mental Status 
SPMSQ 
X 
 
 
 
Primary Outcomes 
 
 
 
 
 
     Physical Functioning 
MFA-SF 
 
X 
X 
X 
     Psychosocial Functioning 
PHQ-9 
 
X 
X 
X 
Secondary Outcomes 
 
 
 
 
 
     Quality of Life 
WHQOL-BREF 
 
X 
X 
X 
     Positive Affect 
 
PANAS 
 
X 
X 
X 
Intermediate Outcomes 
 
 
 
 
 
     Self-Efficacy 
MSES 
 
X 
X 
X 
     Patient Activation 
PAMS 
 
X 
X 
X 
     Problem Solving 
SPSI-R 
 
X 
X 
X 
     SM Stages of Change 
SOC 
 
X 
X 
X 
     Prosthesis Use 
Prosthesis Use 
 
X 
X 
X 
Potential Covariates 
 
 
 
 
 
     Memory 
RBANS 
 
X 
 
 
     Fluency/Executive Function 
COWAT 
 
X 
 
 
     Attention 
Digit Span 
 
X 
 
 
     Comorbidity 
FCI 
 
X 
 
 
     Pain 
CPG 
 
X 
X 
X 
     Complications 
Chart Review 
 
X 
X 
X 
     Social Support 
MSPSS 
 
X 
X 
X 
     Alcohol Use 
AUDIT-C 
 
X 
X 
X 
     Smoking Status  
CHQOER Ques. 
 
X 
X 
X  
Implementation Variables 
 
 
 
 
 
 
     Treatment Engagement* 
PTCS 
 
 
X 
 
     Treatment Fidelity* 
 
Audio Recording 
Review 
 
Ongoing 
 
 
     Use of Supplementary  
     Resources 
Checklist 
 
 
X 
 
     Satisfaction 
Checklist 
 
 
X 
 
     Implementation Barriers 
     (Facilitator)* 
Focus Group 
 
 
 
Project 
Completion 
     Implementation Barriers 
    (Participant) 
Focus Group 
 
 
Subsample 
 
* Completed by Study Staff 
 

 
 
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5.6 Data Analysis  
Data analysis will be performed by the study biostatistician (Dr. David Yanez) and consultant 
(Dr. Daniel Norvell) with input from investigator-level study staff (Drs. Turner, Czerniecki, 
Williams, site PIs). Data analysis will occur at Spectrum Research, Inc. (Tacoma, WA), the 
University of Washington (Seattle, WA), and Oregon Health & Science University (Portland, 
OR). Data that is off-site at Spectrum Research, University of Washington, and OHSU for 
analysis will be coded and will not contain any HIPAA identifiers. See 7.0 Privacy and 
Confidentiality for additional details on data analysis and storage at these locations.  
Descriptive Statistics 
We will produce descriptive statistics for the recruitment and retention of participants, as well as 
the frequency of session participation in the intervention group. We will also produce descriptive 
statistics of patient demographic characteristics, covariates, and outcome measures. For 
categorical variables, proportions and frequency counts will be calculated. For continuous 
variables, means, standard deviations, medians, minimum and maximum will be computed. 
Missing, extreme, and variable distributions will be explored. Missing values patterns will be 
analyzed.  
Statistical analysis of the primary aims  
For hypotheses 1a and 1b, we will use Generalized Estimating Equations (GEE) linear 
regression to investigate mean change over time in MFA-SF. We will model the mean MFA-SF 
change over time as the outcome, using contrasts D = MFA-SF[Post Intervention] – MFA-
SF[baseline] and D = MFA-SF[6 months] – MFA-SF[baseline], versus a treatment indicator, T. 
The treatment indicator assigns patients T=1 if they receive the VETPALS intervention and T=0 
if they receive enhanced usual care. The GEE model will account for intra-cohort level 
correlation among patients’ measurements. The GEE model will provide valid statistical 
inference if the correlation or variance structure is mis-specified. It does not require normality of 
model errors. Since the focus of the investigation is to estimate within-patient changes (over 
time) and the outcome are intra-patient level differences, repeated measures correlation is 
appropriately accounted for in the model variance estimates. Similarly, we will model the mean 
PHQ-9 change over time as the outcome, using contrasts D = PHQ-9[Post Intervention] – PHQ-
9[baseline] and D = PHQ-9[6 months] – PHQ-9[baseline], versus a treatment indicator, T. The 
primary analysis will be an as-randomized efficacy assessment comparing the self-management 
intervention and individual education groups for improvements in depression and physical 
functioning. The follow-up assessments of participants who do not complete all self-
management sessions in the intervention condition will still be included with those who complete 
the expected course of treatment. This type of analysis provides a more conservative and 
ecologically valid estimation of treatment effect because it retains all participants and does not 
screen out individuals who do not tolerate the intervention. Effect size estimates will be 
obtained. We will assess the randomization assignment by comparing patient-level 
characteristics (e.g., age, gender, and amputation level) by the treatment indicator and adjust 
our models with appropriate covariates as necessary. 
For hypotheses 2a-e, similar to above, we will fit a GEE model to investigate differences in 
mean changes in each outcome variable (VAR). We will model the mean change over time as 
the outcome, using contrasts  = VAR[Post Intervention] – VAR[baseline] and  = VAR[6 months] – 
VAR[baseline], versus a treatment indicator, T. The treatment indicator assigns patients T=1 if 

 
 
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they receive VETPALS and T=0 if they receive individual education support. The primary 
analysis will again be a randomized efficacy assessment comparing the self-management 
intervention and control groups for improvements in self-efficacy, patient activation, and problem 
solving. The follow-up assessments of participants who do not complete all self-management 
sessions in the intervention condition will still be included with those who complete the expected 
course of treatment. This type of analysis provides a more conservative and ecologically valid 
estimation of treatment effect because it retains all participants and does not screen out 
individuals who do not tolerate the intervention. Primary analyses will examine changes 
between baseline and 6-month follow-up scores on outcome measures by treatment group, but 
we will also examine changes in outcome immediately following the intervention. Effect size 
estimates will be obtained. Models will be adjusted for covariates as necessary. 
  
For hypothesis 2f, we will produce mean change scores,  = VAR[6 months] – VAR[baseline], for 
each outcome measure. We will utilize Pearson product moment correlations to establish 
associations between changes in our intermediate outcomes and changes in our primary 
outcomes. This series of analyses is both secondary and exploratory, and is intended to 
produce preliminary data for a future explanatory model hypothesizing that improvements in 
self-efficacy, patient activation, and problem solving represent causal mechanisms of self-
management intervention that in turn produce improvements in physical and psychosocial 
outcomes.  
Sample Size Justification  
Enrollment: Between our 5sites, we anticipate enrolling approximately 157 subjects per year of 
recruitment based on previous numbers from the National VA Registry and our already 
established record of enrollment and follow-up in previous amputation studies conducted by the 
same core group of investigators. This is a conservative estimate as the inclusion/exclusion 
criteria for this proposal are more lenient than in our previous studies examining individuals with 
their first, unilateral amputation. Nonetheless we cautiously project enrollment at 55% of286 , or 
157 participants per year. Over the course of 3 years, we expect to accrue 472 enrollees.  
Retention: The original PALS self-management study maintained a greater than 90% retention 
rate. Even assuming a more conservative 75% retention rate for the proposed study, 
118participants per year would be expected to participate and successfully reach their final 
follow-up. Over the course of 3 years, we expect to retain 354 enrollees. In sum, our sample 
size estimates are grounded in the specific experience of our team enrolling actual Veterans 
with limb loss at VA facilities and reflect conservative estimates of recruitment and retention. 
This is done out of an abundance of caution and we expect that actual rates of recruitment and 
retention are likely to be higher.  
Each primary site intends to recruit one additional secondary site to partner with each primary 
site (e.g. Seattle partners with Tucson VA). Enrollment, retention, and power analysis sections 
do not reflect these anticipated partners and do not require them. The purpose of including 
additional sites is to extend the recruitment and generalizability of the project aims to integrate 
VETPALS into the VA Amputation System of Care.  
Statistical Power 
Power estimates are based upon the sample size projections provided in Table 1 below (also in 
5.2 Recruitment Methods). Effect size estimates were obtained using the estimates provided in 
the original PALS study. We anticipated an enrollment of N=51 cohorts in total for the study and 

 
 
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between 6-10 patients per cohort. The treatments, VETPALS and individual education, will be 
evenly and randomly assigned by cohort. We project between 300 to 500 total patients 
participating in this study. We investigated changes in each outcome by first computing intra-
patient change and accounting for possible intra-cohort level correlation. We assume the 
baseline and six-month values for the outcomes are highly correlated, with Pearson correlation 
between 0.6 and 0.8, and the correlation among the change values within a cohort to be 
modestly correlated, with an intra-class correlation between 0.01 and 0.10. To estimate 
statistical power to detect the anticipated effect sizes at these proposed sample sizes and 
correlations, we conducted a series of Monte Carlo simulations based on the analytic framework 
outlined above. Each of the power calculations were based on 1,000 simulated datasets. Power 
was computed empirically as the proportion of Wald tests (from correlated data regression 
estimates from the simulated datasets) that correctly rejected the null hypothesis of no effect, at 
a five percent alpha level (Type I error rate). 
The results indicate that for the modest effect sizes provided, low levels of intra-cohort 
correlation (ICC) and modest Pearson correlation levels between baseline and six-month 
measurements (rho), we will have adequate power to detect differences between the study 
conditions. To provide two examples, given these conditions we will have power of greater than 
.8 to detect differences in the primary outcome physical functioning (MFA-SF) (and the 
additional outcome self-efficacy (MSES).  
Anticipated Enrollment 
Table 1 (page 25) indicates anticipated enrollment across all 5 sites throughout the 4-year study 
period. Projections assume a group enrollment rate of 8±2 participants and completion rate of 6 
participants per group. We estimate a 50% enrollment rate and expect a 75% retention rate.  
5.7 Withdrawal of Subjects 
Participants are systematically notified that they are free to withdraw from the study at any time. 
No special provisions for withdrawal are necessary. Participants are free to retain other usual 
amputation-related care without interruption. As this study examines the feasibility of a self-
management intervention in the VA Amputation System of Care, it is highly unusual that a 
participant would be withdrawn from the research without consent. The study is interested in 
tracking withdraws and citing reasons for withdrawal. Investigator-initiated withdrawals will be 
evaluated and discussed by site PIs and the lead PI/SC and/or Co-PI. The PI/SC and/or site PI 
may also suspend enrollment of an individual participant if it is determined it was not in his/her 
best interest to continue, or it was not in the best interest of the intervention group (e.g. 
participant was consistently combative and argumentative in group). All reasons for investigator 
initiated withdrawals will be documented in the notes section of the eCRF.  
 
 
 

 
 
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7.0 
Reporting  
 
6.1 Adverse Events 
Definitions 
An Adverse Event (AE) is defined as any unfavorable and unintended diagnosis, sign 
(including an abnormal laboratory finding), symptom, or disease temporarily associated with the 
study intervention, which may or may not be related to the intervention. AEs include any new 
events not present during the pre-intervention period or events that were present during the pre-
intervention period but have increased in severity.  
Anticipated AEs are those that might reasonably be expected to occur in this population with 
significant medical comorbidity and can include, but are not necessarily limited to, re-
hospitalization, revision amputation, conversion to higher-level amputation, contralateral limb 
amputation, pain, stroke, myocardial infarction, deep venous thrombosis, dialysis, superficial or 
deep infection, and death. Each site will maintain a log of all anticipated AEs, including those 
captured on eCRFs through medical record review.  
An unanticipated adverse event (UAE) is an adverse event that is not expected to occur in 
this population with significant medical comorbidity.  
Unanticipated problems (UAP), also the phrase “unanticipated problems involving risks to 
subjects or others”, in general, include any incident, experience, our outcome that meets all of 
the following: 
1. Unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the protocol-related documents, such as the IRB-
approved research protocol and informed consent document; and (b) the characteristics 
of the subject population being studied; 
2. Related or possibly related to participation in the research (possibly related means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and 
3. Suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously known 
or recognized. 
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that results in 
death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant 
disability/incapacity, results in congenital anomalies/birth defects, or, in the opinion of the 
investigators, represents other significant hazards or potentially serious harm to research 
participants or others.  
 

 
 
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Reporting Requirements  
Study coordinators conduct medical record reviews at the regular study intervals coinciding with 
assessments (baseline, 6 week, and 6 month). Coordinators also review the medical record 
periodically (at 3 weeks, 18 weeks, 1 year) following the baseline assessment to determine if 
any anticipated AEs, SAEs, or UAEs occurred. Study staff are also informed to contact the site 
PI upon learning of a participant AE. The site PI reviews the AE to determine how to record and 
report the event, if applicable. Directing AE information to the site PI that is discovered 
separately from medical record review helps ensure that the study coordinator remains naïve to 
the treatment group (intervention or control). All AE reports are reviewed by the site PI before 
final documentation and submitting a report.  
Notably, although the expected occurrence of non-study related anticipated AEs is high, the 
expected occurrence of study-related AEs associated with the intervention (participation in a 
group based self-management program), control (individual education support program), or 
study assessments (self-report questionnaires and cognitive testing) is low.  
The VAPSHCS will evaluate the implications of AE information according to an identified 
protocol, specifically, the occurrence of 5 or more AEs or 2 or more SAEs will prompt a review 
of the study procedures for safety. 
 
All anticipated AEs will be tracked and recorded on eCRFs used at regular study assessments, 
as well as at intervals of scheduled chart reviews. Study staff are trained to follow VA Central 
IRB reporting requirements for unanticipated SAEs and UAPs involving risks to participants or 
others. Reports must be submitted on the template (See Appendix F) to the VA Central IRB 
within 5 business days after the study staff becomes aware of the event. Additionally, site study 
staff (coordinators and PIs) should receive a copy of the SAE/UAP report.  
All AEs (includes anticipated AEs, UAEs, UAPs, and SAEs) must be followed until resolution or 
a stable endpoint is reached, such as:  
• 
AE is resolved and has returned to normal/baseline values or has stabilized. 
• 
Subject is lost to follow-up or has withdrawn consent. 
• 
AE is judged by the site PI, lead PI/SC, and/or Co-PI to be no longer clinically significant. 
• 
Participant has completed study required follow-ups (6 month visit). 
 
Additionally, the investigators will monitor all AEs and study activity. Although it is unlikely, the 
following conditions would trigger an immediate suspension of the research project: 
• 
There was reason to believe the study procedures (assessments, intervention, control) 
were adversely affecting a participant’s overall health, including mental health, as 
demonstrated by inpatient hospitalizations for mental health or suicide. 
• 
The occurrence of 5 or more study-related AEs or 2 or more study-related SAEs in 
either condition will trigger a review of the protocols at the time of occurrence. It will 
better accommodate the expected low-base rate of problems and allow for the early 
identification issues than would a DSMB that met at an arbitrary regular interval.  

 
 
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6.2 Protocol Deviations  
Definitions  
A protocol deviation is any unplanned excursion from the protocol that is not implemented or 
intended as a systematic change. A protocol deviation could be a limited prospective exception 
to the protocol. Deviations initiated by the PI must be reviewed and approved by the IRB and 
sponsor prior to implementation, unless the change is necessary to eliminate apparent 
immediate hazards to human subjects (21 CFR 312.66), or to protect the life or physical well-
being of the participant (21 CFR 812.35(a)(2)). A protocol deviation is also any other, 
unplanned, instance(s) of protocol non-compliance.  
Reporting Requirements  
Study sites, under the direction of the site PI, are responsible for reporting any protocol 
deviations, violations, or non-compliance to the VA Central IRB within 5 business days after 
being made aware of the deviation (see Appendix F). Study sites must report any protocol 
deviations that are likely to substantially adversely affect: 
• 
The rights, safety, or welfare of the research participant; 
• 
The participant’s willingness to continue participation; or 
• 
The integrity of the research data, including VA information security requirements.  
 
Additionally, the PI/SC should be informed by the site coordinator and/or site PI of the protocol 
deviation at the earliest opportunity and should receive a copy of the report of protocol 
deviations, violations, and/or non-compliance.  
8.0 
Privacy and Confidentiality 
The study has a HIPAA Authorization Form (Appendix B) that participants review and 
sign following the informed consent process. This study uses Protected Health 
Information (PHI) related to amputation surgery and post-operative care.  
We will protect participant’s privacy interests by the doing the following:  
• 
Screening and consent will take place in a private clinic room, hospital room, room in 
the Clinical Research Unit, another quiet area of the hospital, or by telephone/mail 
following initial contact and study introduction by a provider.  
• 
The EDC system used for data collection stores the information collected in a 
PostrgreSQL database secured by the webhost for this application (Heroku, 
https://heroku.com/policy/security). A username and password will be required for 
each person accessing the database and will only be supplied after credentials are 
verified with Spectrum Research, Inc. Data collected and stored in the database are 
coded and do not contain protected health information.  
• 
Site study coordinators maintain an electronic screening and enrollment log. All 
participants who complete the screening process receive a screening ID (e.g. S1001, 
S1002, etc.) where the first digit runs 1-5 based on the number of VA sites. A 

 
 
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screening log is maintained locally by each site in a password protected file, in a 
restricted access folder, on the VA network behind the VA firewall. A master web-
based electronic screening log will be maintained by Spectrum Research. This file 
will not contain individual identifying information such as last names or first initials of 
the participants, but will contain the screening ID, date of screening, eligibility status, 
and reason for screen failure/refusal, and if enrolled, the enrollment study ID. Access 
to the master screening log is regulated by a secure login ID and password for each 
user.  
• 
Once the participant signs a consent form, the site study coordinator assigns an 
enrollment study ID number (e.g. 1001, 1002, etc.) where 1-5 designates the VA site. 
The sites maintain a consent enrollment log that links the study ID to the participant’s 
name, last 4 SSN, and date of consent. The sites also maintain a contact information 
log that includes necessary contact information for telephone and mail contact, or 
sites can access this information in the CPRS medical record. All identifiable 
information, including the crosswalk document (consent enrollment log) is stored 
locally in a password protected file, on a restricted access folder, on the VA network 
and behind the VA firewall. Only IRB-approved researchers have access to this 
document. These documents will never leave the VA sites, and Spectrum Research 
and The University of Washington never receive information that could identify 
patients.  
• 
In the event a site study coordinator is unavailable to perform baseline and follow-up 
assessments, the Seattle study coordinator or project coordinator may conduct these 
assessments by phone. Site study staff will share participant ID number, name, and 
phone number with Seattle staff. This exchange will take place by PKI-encrypted 
email or telephone. Seattle staff will maintain a crosswalk document that is stored 
locally at the VAPSHCS in a password protected file, on a restricted access folder, 
on the VA network and behind the VA firewall. This log will also include dates the 
assessments occurred by telephone and any other relevant notes. This information 
will only be stored temporarily at VAPSHCS. Once the site study coordinator is 
available, this information will be returned to the site by PKI-encrypted email or 
telephone and will be removed from the temporary crosswalk file.  
• 
Once a group of 8 participants (±2 when necessary) complete the baseline 
assessment, the coordinator alerts the site PI and VETPALS facilitator. Because the 
coordinator is blind to treatment group, the site PI or VETPALS facilitator enter a 
secure web-based randomization scheme also maintained by Spectrum Research. 
The user access the website with a secure login ID and password and selects 
participant IDs from the electronic master screening log to obtain the treatment 
group. The group treatment allocation will be automatically matched to the study IDs 
in the system. The randomization technique will allow for a random distribution 
without providing any discernible pattern. Each site PI will also maintain a separate 
randomization log containing study IDs, name, and randomization group. This log will 
be in a password protected file, in a restricted access folder, on the VA network 
behind the VA firewall. Only the site PI and VETPALS facilitator have access to this 
file.  
• 
Data from each eCRF is stored into a secure database electronically using the web-
application provided by Spectrum Research. Study coordinators will have the ability 
to log into this web-application with their designated log-in credentials. Once the 
coordinator has logged in, the ability to enter participant data into a variety of web-
forms becomes available. The coordinator will not have the ability to edit or view data 

 
 
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that has been entered from another VA site, and user-privileges will be assigned to 
limit or advance the abilities of the coordinator. Without a proper username and 
password there is no ability to view/edit any of the study data.  
• 
Coded research data obtained from the eCRFs will be stored through SSL database 
encryption, behind local and master firewalls hosted by Heroku, and encrypted if 
necessary. Again, data will only be accessible with a valid and confirmed user ID and 
password. Each user ID will be assigned viewing/editing privileges based on the 
needs of that user, allowing or disallowing the viewing/editing of select data.  
The data, after it has been entered by a verified user, will be transmitted from one of 
the web-application’s data collection forms via SSL (Secure Socket Layer) encryption 
and stored in a PostgreSQL database using the encrypted database connection. 
HTTPS will also be enabled for this website. Ultimately this means that the data will 
be securely transferred from over the Internet via HTTPS, and then stored in the 
database using a SSL encrypted database connection. 
Heroku’s physical infrastructure is hosted and managed within Amazon’s secure data 
centers and utilizes Amazon Web Service (AWS) technology. Amazon continually 
manages risk and undergoes recurring assessments to ensure compliance with 
industry standards. Heroku utilizes ISO 27001 and IFSMA certified data centers that 
are managed by Amazon. The AWS technology is currently in compliance with a 
variety of regulations, standards, and best-practices. Please review these sources for 
a 
more 
complete 
understanding: 
https://www.heroku.com/policy/security/ 
https://aws.amazon.com/compliance/ 
Data files, which are coded and do not contain any identifiable information or HIPAA 
identifiers, will be periodically downloaded from database to a physical computer for 
the purpose of analysis and will be password protected and encrypted on these 
devices. These files will only be accessible by the data manager and IRB approved 
study personnel who will be handling the data for analysis purposes. 
• 
Research records, including eCRFs, will be identified with a unique study ID. The 
crosswalk documents (enrollment log and randomization log) will be stored 
separately from all other study data at each VA site. Again, all of the study files will 
be stored on a VA secure network behind VA firewall with required password 
protections, at each VA site. Only IRB-approved study personnel have access to the 
study records. 
• 
All paper records for the study (telephone scripts, paper screening CRFs, consent 
forms, and other study-related documents) will be secured in locked filing cabinets in 
locked VA offices that only the IRB-approved research personnel have access to. 
• 
VA-issued laptop computers (with FIPS 140-2 encryption) and VA-issued desktop 
computers are used to enter all electronic data (screening log, eCRFs) and access 
all study-related files on the VA network. When not in use, the laptops will be stored 
in locked cabinets inside of locked offices at each site. 
• 
VA-issued and approved digital voice recorders (with FIPS 140-2 encryption) are 
used to audio-record the VETPALS and focus group sessions. Voice files from each 

 
 
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site will be stored on VA computers on the VA network in restricted-access folders 
that only the site PI, Co-I, and VETPALS facilitator have access to. Sites will transfer 
voice files to the main study site, VAPSHCS. Files may be transferred by one of the 
following methods: (1) PKI-encrypted email, (2) burned to encrypted CD and mailed 
using a secure, traceable mail service (e.g. UPS, FedEx), (3) uploaded to a secure 
SharePoint that is only accessible by IRB-approved research staff. At the main study 
site, the PI/SC, Co-PI/SC, Co-I, and VETPALS facilitator will also store these files on 
the VA network in a restricted-access folder. Voice files will also be reviewed by Dr. 
Dawn Ehde, PhD from the University of Washington who is a Co-I on this project. 
Files will be reviewed at the VAPSHCS, via secure VPN connection to the VA. When 
not in use, the digital voice recorders will be stored in locked cabinets inside of 
locked offices at each site.  
• 
Following the completion of all study-related procedures, the master subject-ID and 
identifier crosswalk from each site will be securely shipped (e.g., via UPS with 
shipment tracking or transferred electronically using a VA-approved encryption 
method and will be consolidated and retained in Seattle. Individual, redundant, site 
cross walks will be destroyed. Coded datasets (that do not contain any HIPAA 
identifiers or other identifiable information) will remain at Spectrum Research, 
University of Washington, and OHSU for analysis purposes. These datasets will be 
password protected and encrypted on computers located at Spectrum Research, 
Inc., 705 S. 9th Street, Tacoma, WA 98405, Room 203. Additionally, datasets will be 
password protected and encrypted on computers located at University of 
Washington, and at OHSU in the office of the biostatistician, Dr. David Yanez 
(Gaines Hall, Room 155). Spectrum Research, University of Washington, and OHSU 
do not receive or have access to the key to the code. Data will be returned to VA 
Puget Sound no later than two years following the completion of the last period of 
data analysis.  
9.0 
Communication Plan 
General Communications  
The PI/SC and LSIs are responsible for training all applicable staff at participating sites. 
The PI/SC will hold a series of pre-study training conference calls to establish regular 
communication among the site study coordinators and site PIs. Prior to the start of 
recruitment, VAPSHCS in Seattle will host a kick-off meeting for LSIs, VETPALS 
facilitators, and study coordinators. The protocol will be reviewed during this meeting, 
including a plan for keeping in regular communication.  
The site PIs and coordinators will also participate in regular monthly conference calls. 
The purpose of the monthly meetings is to discuss study progress, issues with 
recruitment, enrollment, and retention, and to share strategies to ensure the success of 
the study at each site. The meeting frequency may adjust throughout the course of the 
study (e.g. meetings occur bi-weekly at the start of the project), but staff will meet 
monthly at a minimum. 
Additionally, the site PIs, VETPALS facilitators, and other investigator-level staff (e.g. 
Drs. Turner, Czerniecki, Williams, Ehde, Norvell, Wegener, Yanez) will meet monthly to 
discuss any issues related to randomization, intervention delivery or fidelity, AEs, SAEs 
and UAPs, and other necessary topics.  

 
 
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Site Communications 
In order to ensure adherence to the protocol and Central IRB reporting requirements, the 
PI/SC and VAPSHCS study personnel will do the following: 
• 
Collect and track site* IRB approval letters prior to study initiation. 
• 
Collect and track site* R&D approval letters, including ACOS letters, prior to 
study initiation.  
• 
Collect and track all site protocol modifications and continuing review approvals 
for IRB and R&D.  
• 
Distribute amendments and the most current version of the protocol, consent 
form, and HIPAA authorization form to all sites. Staff will also track the receipt of 
these documents by all sites, including the approval of any required protocol 
modifications.  
• 
The PI/SC will contact the director of the telehealth partner sites via written 
Memorandum by email to notify the site contact and hospital director that the 
research study was approved by Central IRB and assistance in participant 
identification and referrals can begin.  
• 
VAPSHCS will track all written and verbal communication with all sites, including 
telehealth partner sites, using a communications log.  
• 
Discuss any AEs and SAEs during monthly teleconference meetings and review 
reporting requirements as necessary.  
*Site IRB approval letters will be issued by VA Central IRB. VA Central IRB is the 
IRB of record for all participating study sites. Sites will submit the study to their local 
R&D Committee for review and approval.  
 
Additional details on site communications for this VA multi-site study can be found in the 
Protocol-Supplement for Multi-Site Studies Overseen by the VA Central IRB (Appendix 
G).  
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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