Effectiveness of a Peer Visitation Program to Improve Patient Activation and Quality of Life During Amputation Rehabilitation (AC PVP)

Effectiveness of a Peer Visitation Program to Improve Patient Activation and Functional Outcomes and Quality of Life During Amputation Rehabilitation

There is no known interventional clinical trial evidence for existing support and the reintegration strategy of a peer visitation program following amputation. The Amputee Coalition Peer Visitation Program is the only national and VA recognized program for amputees, however, it has not been rigorously tested for effectiveness. Therefore, the objective of this study is to demonstrate the Amputee Coalition Peer Visitation Program (AC PVP) will improve functional outcomes for Service Members, Veterans, and civilians during amputation rehabilitation.

Study Overview

• Status: Unknown
• Conditions: Amputation
• Intervention / Treatment: Behavioral: Peer Visitation Program

Detailed Description

In the fields of medicine and public health management, navigation and peer visitation programs consider patients as are their own important resources, who should be actively involved in the health care organization and throughout the process of care delivery and rehabilitation. The importance of promoting a more active role of patients in the management of their own health care is recognized by health care experts, managers, and policy makers. Programs that engage patients in their own health care are reported as an important strategy to improve adherence, outcomes, satisfaction toward the health care provider, and reduction of health care costs. The emotional adjustment to an amputation is sometimes the most challenging part. Peer visitation allows the patient to speak directly with another amputee who has shared a similar experience, allowing them to relate feelings and concerns about the loss of a limb to someone who has already endured the process and lives with the condition daily.

There is increasing national and international interest in patient education programs. The ultimate anticipated outcome for individuals attending these programs is improvement in quality of life. Patient empowerment, self-efficacy, and self-management have also been found to be key intermediate outcomes of acute amputation rehabilitation, but have been somewhat difficult to operationalize, measure, and subsequently report in terms of patient impact. There is no known interventional clinical trial evidence for existing support and the reintegration strategy of a peer visitation program following amputation.

The Amputee Coalition Peer Visitation Program is the only national and VA recognized program for amputees, however, it has not been rigorously tested for effectiveness. Therefore, the objective of this study is to demonstrate the Amputee Coalition Peer Visitation Program (AC PVP) will improve functional outcomes for Service Members, Veterans, and civilians during amputation rehabilitation.

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason Kahle, M.S.M.S.; Phone Number: 813-971-1100; Email: jason@prostheticdr.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any candidate for lower extremity amputation
• Any immediate post operative lower extremity amputation within 7 days of amputation
• Willing and able to comply with the study protocol
• Able to provide informed consent
• Male or female, of any ethnicity
• 18 - 75 years of age
• Any body weight

Exclusion Criteria:

• Any level of amputation other than lower extremity
• Known cognitive impairment
• Does not speak English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peer Visitation Program (PVP); Participants in this group will begin participation in the Peer Visitation Program (PVP) beginning at amputation date with the initiation window ranging from immediately pre-operative to 7 days post operative.	Behavioral: Peer Visitation Program; The Amputee Coalition's Peer Visitation Program (PVP) trains amputee peer supporters to properly navigate a new or less-experienced amputee through the process of rehabilitation. Peer support plays an important role, following the amputation of a limb, by allowing patients to meet other amputees and discuss lifestyle changes post-amputation. Subjects randomized to the PVP group will receive the intervention (visitation by a Certified Peer Visitor) immediately at amputation. Subjects randomized to the non-PVP group will not receive CPV visits immediately at amputation. Rather, they will receive delayed PVP intervention beginning 60 days after amputation and lasting a total of 60 days (or at 120 days post-amputation).
No Intervention: Delayed Peer Visitation (NoPVP); Not participating in a Peer Visitation Program for 60 days post-operatively, followed by participation and completion in a PVP 60 days later than the PVP group for a total of 120 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function/Quality of Life - PVP Group	The MOS short-form health survey (SF-36) will be used to measure function. The SF-36 measures health status in eight dimensions: physical functioning; role limitations due to physical health problems; bodily pain; general health perceptions; vitality, energy, and fatigue; social functioning; role limitations due to emotional problems; and general mental health covering psychological distress and well-being. Scoring instructions from RAND Health provide guidance regarding scoring for each item in the survey and which items measure the aforementioned items.	60 days post-amputation
Function/Quality of Life -NoPVP group	The MOS short-form health survey (SF-36) will be used to measure function.The SF-36 measures health status in eight dimensions: physical functioning; role limitations due to physical health problems; bodily pain; general health perceptions; vitality, energy, and fatigue; social functioning; role limitations due to emotional problems; and general mental health covering psychological distress and well-being. Scoring instructions from RAND Health provide guidance regarding scoring for each item in the survey and which items measure the aforementioned items.	120 days post-amputation
Depression - PVP group	Depression is a treatable disorder associated commonly with amputation and can impact function and quality of life. The Patient Health Questionnaire (PHQ-9) is a questionnaire that can be entirely self-administered by the patient and interpreted by clinicians. The PHQ, a freely available instrument, assesses 8 diagnoses divided into threshold disorders and sub-threshold disorders	60 days post-amputation
Depression - NoPVP group	Depression is a treatable disorder associated commonly with amputation and can impact function and quality of life. The Patient Health Questionnaire (PHQ-9) is a questionnaire that can be entirely self-administered by the patient and interpreted by clinicians. The PHQ, a freely available instrument, assesses 8 diagnoses divided into threshold disorders and sub-threshold disorders	120 days post-amputation
Patient Activation - PVP Group	Patient activation will be measured using the Patient Activation Measure (PAM), which is an outcome measure with strong psychometric properties in chronic illness and is able to detect the level of patient activation towards their care management	60 days post-amputation
Patient Activation - NoPVP Group	Patient activation will be measured using the Patient Activation Measure (PAM), which is an outcome measure with strong psychometric properties in chronic illness and is able to detect the level of patient activation towards their care management	120 days post-amputation

Collaborators and Investigators

• Sponsor: Prosthetic Design & Research
• Collaborators: Amputee Coalition

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): April 15, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: patient activation; amputee; peer visitation
• Other Study ID Numbers: AC PVP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No