Pain SMART: Shared Medical Appointments to Refocus Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Pain SMART; Other: minimally enhanced usual care

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).

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Veteran Inclusion Criteria:

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

Veteran Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain SMART (Intervention Arm); The Intervention Arm will be invited to participate in a one-time group intervention, Pain SMART	Behavioral: 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.
Placebo Comparator: Minimally Enhanced Usual Care; The Minimally Enhanced Usual Care group will receive educational information via mail.	Other: minimally enhanced usual care; The minimally enhanced usual care group will receive educational information via mail about non-pharmacological approaches to pain management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of participant recruitment	ability to recruit Veterans to enroll in the study and attend group, as evidenced by randomizing 80 veterans over the study period and by having at least 60% of veterans randomized to attend the group show up to to the group	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain management strategies used - Chronic Pain Coping Inventory	The chronic pain coping inventory measures the use of pain self-management strategies (e.g., activity pacing)	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain management strategies used - Self-reported use of pain management strategies	We have developed a measure that asks participants if they have tried any pain management strategies in the past three months (e.g., acupuncture, cognitive behavioral therapy).	3 months

Collaborators and Investigators

• Sponsor: VA Connecticut Healthcare System
• Collaborators: VISN1 Career Development Award Program

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: October 14, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 14, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: chronic pain; veterans; shared medical appointment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 02103-0001

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