Pain SMART: Shared Medical Appointments to Refocus Treatment

NCT ID: NCT03707886

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2020-03-31

Brief Summary

The proposed study will test whether a shared medical appointment for Veterans with chronic pain is feasible and acceptable to veteran patients and their providers. The shared medical appointment, called Pain SMART (Shared Medical Appointments to Refocus Treatment), is a brief, one-visit shared medical appointment where providers in primary care and a behavioral health specialist (e.g., a psychologist) meet with a group of patients with chronic pain. The overall goal of Pain SMART is to improve pain care for Veterans. Veterans will be randomized in equal numbers to either attend a Pain SMART visit or to receive educational information in the mail. The primary outcome of this pilot study is whether or not the shared medical appointment is feasible and acceptable to patients and providers.

Detailed Description

Objectives: The primary purpose of this study is to understand the feasibility and acceptability of a shared medical appointment for patients with chronic pain called Pain SMART (Shared Medical Appointments to Refocus Treatment).

Intervention: The overall goal of Pain SMART is to increase the use of evidenced-based pain management strategies including pain self-management and other non-pharmacological pain management approaches. Pain SMART is a brief one-visit shared medical appointment delivered by primary care team members (e.g., primary care providers) and a behavioral health specialist (e.g., a clinical health psychologist). Pain SMART uses motivational interviewing to enhance effective and mutually rewarding communication among providers and Veterans to increase pain self-management, including uptake of non-pharmacological approaches to pain management, to ultimately enhance quality of care and Veteran functioning.

Study Participants: Primary care providers/staff will be recruited to participate in Pain SMART visits as shared medical appointment facilitators. Additionally, up to 80 veterans with chronic pain will be recruited.

Research Design: This study is a randomized pilot study in which Veteran participants are randomized to attend Pain SMART or to a minimally enhanced usual care condition (i.e., receive an educational brochure via mail). Veteran participants will be randomized in equal numbers to both conditions. Data collected from Veteran participants at baseline and three months following baseline; data will also be collected from primary care participants regarding their experience with Pain SMART. Data collection will include quantitative measures (e.g., information regarding pain and pain management approaches used) and qualitative measures (e.g., interviews about participants' experiences with Pain SMART).

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pain SMART (Intervention Arm)

The Intervention Arm will be invited to participate in a one-time group intervention, Pain SMART

Group Type: EXPERIMENTAL

Pain SMART

Intervention Type: BEHAVIORAL

Pain SMART is a brief, one-visit shared medical appointment where providers in primary care and a behavioral health specialist (e.g., a psychologist) meet with a group of patients with chronic pain to discuss pain management approaches.

Minimally Enhanced Usual Care

The Minimally Enhanced Usual Care group will receive educational information via mail.

Group Type: PLACEBO_COMPARATOR

minimally enhanced usual care

Intervention Type: OTHER

The minimally enhanced usual care group will receive educational information via mail about non-pharmacological approaches to pain management.

Interventions

Pain SMART

Pain SMART is a brief, one-visit shared medical appointment where providers in primary care and a behavioral health specialist (e.g., a psychologist) meet with a group of patients with chronic pain to discuss pain management approaches.

Intervention Type: BEHAVIORAL

minimally enhanced usual care

The minimally enhanced usual care group will receive educational information via mail about non-pharmacological approaches to pain management.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Receives primary care from provider at VA Connecticut who is participating in the study
• Prescribed an opioid for chronic pain

Exclusion Criteria

• Active suicidal ideation
• Psychotic disorder
• Active consult to opioid reassessment clinic at VA Connecticut

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VISN1 Career Development Award Program

UNKNOWN

Sponsor Role: collaborator

VA Connecticut Healthcare System

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Va Connecticut Healthcare System

West Haven, Connecticut, United States

Countries

United States

Other Identifiers

02103-0001

Identifier Type: -

Identifier Source: org_study_id