Improving Outcomes Following Limb Loss: PALS Plus
Condition: Amputation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Limb loss can result from a variety of etiologies including diabetes, trauma and cancer.
      Following limb loss, individuals are at elevated risk for activity limitations and
      participation restrictions with significant impact on health and quality of life.
      Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and
      established the effectiveness of a self-management program (PALS) to improve health and
      outcomes following limb loss. Literature suggests that the access to, and effectiveness and
      utilization of, this class of interventions may be enhanced by the concerted use of early
      intervention, peer mentorship, motivational interviewing and provider training. Objectives:
      Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention-
      PALS Plus. The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention
      in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS
      Plus intervention in maximizing utilization of self-management interventions for persons with
      limb loss. A cohort of 200 patients will be enrolled prior to implementation of the
      intervention and will serve as the control group. Subsequently, a second cohort of 200
      patients will be enrolled and receive the PALS Plus intervention and will serve as the
      intervention group. Assessment will be at baseline, treatment completion and six month
      follow-up. Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood.
      Secondary outcome measures are: function, participation and bothersomeness of limitations.
      The investigation will also provide unique and valuable information regarding patients'
      acceptance and use of peer visitation and self-management following limb loss. Relevance: By
      establishing the utility and effectiveness of the enhanced self-management intervention,
      there is the potential to improve the health, activity, participation and quality of life for
      individuals with disabilities. The intervention addresses the areas of activity and
      participation in such a way that it can be implemented in local health care facilities
      working in combination with a national consumer based organization - the Amputee Coalition of
      America.
    

Detailed description: 
      Limb loss can result from a variety of etiologies including diabetes, trauma and cancer.
      Following limb loss, individuals are at elevated risk for activity limitations and
      participation restrictions with significant impact on health and quality of life.
      Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and
      established the effectiveness of a self-management program (PALS) to improve health and
      outcomes following limb loss. Literature suggests that the access to, and effectiveness and
      utilization of, this class of interventions may be enhanced by the concerted use of early
      intervention, peer mentorship, motivational interviewing and provider training. Objectives:
      Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention-
      PALS Plus. The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention
      in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS
      Plus intervention in maximizing utilization of self-management interventions for persons with
      limb loss. Study Design and Participants: The prospective clinical trial will use a two
      group, lagged-control design to evaluate the intervention at five health care facilities. A
      cohort of 200 patients will be enrolled prior to implementation of the intervention and will
      serve as the control group. Subsequently, a second cohort of 200 patients will be enrolled
      and receive the PALS Plus intervention and will serve as the intervention group. Assessment
      will be at baseline, treatment completion and six month follow-up. Outcomes: Primary outcome
      measures are: pain, depressed mood, and positive mood. Secondary outcome measures are:
      function, participation and bothersomeness of limitations. Improvements in primary and
      secondary outcomes will result through the impact on self efficacy, patient activation,
      catastrophizing and social support. The investigation will also provide unique and valuable
      information regarding patients' acceptance and use of peer visitation and self-management
      following limb loss. Relevance: By establishing the utility and effectiveness of the enhanced
      self-management intervention, there is the potential to improve the health, activity,
      participation and quality of life for individuals with disabilities. The intervention
      addresses the areas of activity and participation in such a way that it can be implemented in
      local health care facilities working in combination with a national consumer based
      organization - the Amputee Coalition of America.
    

Intervention name(s): Self-management and peer support
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amputation; Self-management; Rehabilitation; Peer support