NCT03707886

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

August 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

1.5 years

First QC Date

August 28, 2018

Last Update Submit

October 14, 2018

Conditions

Keywords

chronic painshared medical appointmentveterans

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain management strategies used - Chronic Pain Coping Inventory

    3 months

Other Outcomes (1)

  • Pain management strategies used - Self-reported use of pain management strategies

    3 months

Study Arms (2)

Pain SMART (Intervention Arm)

EXPERIMENTAL

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

Behavioral: Pain SMART

Minimally Enhanced Usual Care

PLACEBO COMPARATOR

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

Other: minimally enhanced usual care

Interventions

Pain SMARTBEHAVIORAL

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.

Pain SMART (Intervention Arm)

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

Minimally Enhanced Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Va Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

October 16, 2018

Study Start

August 31, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations