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Pain SMART: Shared Medical Appointments to Refocus Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707886
Recruitment Status : Unknown
Verified October 2018 by VA Connecticut Healthcare System.
Recruitment status was:  Enrolling by invitation
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
VISN1 Career Development Award Program
Information provided by (Responsible Party):
VA Connecticut Healthcare System

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: Pain SMART Other: minimally enhanced usual care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pain SMART: Shared Medical Appointments to Refocus Treatment
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.




Primary Outcome Measures :
  1. Feasibility of participant recruitment [ Time Frame: 3 months ]
    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


Secondary Outcome Measures :
  1. Pain management strategies used - Chronic Pain Coping Inventory [ Time Frame: 3 months ]
    The chronic pain coping inventory measures the use of pain self-management strategies (e.g., activity pacing)


Other Outcome Measures:
  1. Pain management strategies used - Self-reported use of pain management strategies [ Time Frame: 3 months ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707886


Locations
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United States, Connecticut
Va Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
VISN1 Career Development Award Program
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Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT03707886    
Other Study ID Numbers: 02103-0001
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VA Connecticut Healthcare System:
chronic pain
shared medical appointment
veterans
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations