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Options for Pain Management Using Nonpharmacological Strategies (OPTIONS)

Primary Purpose

Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Options for Pain Management using Non-medication Strategies
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Chronic Pain, Self management, Pain management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for at least 3 months,
  • have at least moderate pain intensity and interference with function, defined by a score of 4 (possible range: 0-10) on the PEG, a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity (obtained from phone screener),
  • have a primary care appointment scheduled or due in approximately the next three months.
  • open to trying new pain treatments

Exclusion Criteria:

  • a psychiatric hospitalization in the past 6 months,
  • long-term opioid therapy
  • severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure) which includes heart attack, stroke, and cancer, or
  • if the eligibility screener reveals cognitive impairment, defined by a score of >3 (possible range: 0-6) on MMSE cognitive screen (obtained from phone screener), or
  • if the eligibility screener reveals active suicidal ideation, or
  • severe hearing/speech impairment.

Sites / Locations

  • Richard L. Roudebush VA Medical Center, Indianapolis, INRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OPTIONS Intervention Coaching

OPTIONS Waitlist Control

Arm Description

Intervention participants will participate in a series of four coaching sessions focused on helping patients clarify their values and treatment goals, aligning these values and goals and their lifestyle with nonpharmacological treatment options, working on overcoming barriers to use and adherence of nonpharmacological treatment options (using motivational interviewing), and preparing patients to discuss these options with their primary care providers. A decision aid will be used during these coaching sessions.

Participants randomized into waitlist control group will receive the intervention decision aid after completing the last survey at 9 months. Participants will also be offered the opportunity to have a brief 20-minute session with a member of the OPTIONS study staff to help walk them through this decision aid.

Outcomes

Primary Outcome Measures

Pain Interference Brief Pain Inventory (BPI)
The pain interference score from the Brief Pain Inventory averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Lower scores are better outcomes.

Secondary Outcome Measures

Use of Nonpharmacological and Self-Care Approaches (NSCAP)
This measure was developed by members of the VA/DoD/NIH Pain Management Collaboratory, which is comprised of national experts in NPTs and is led by Dr. Robert Kerns of the VA PRIME Center. The NSCAP asks about use of 9 Non-pharmacological treatments , including the 6 included in the OPTIONS Decision Aid, and assesses details of use such as frequency and patients' judgments of effectiveness. Space is provided for additional Non-pharmacological treatments patients may be using.
Patient Activation Measure (PAM)
Patient activation will be measured with the 13-item Patient Activation Measure (PAM) Short Form, which assesses patient knowledge, skill, and confidence for self-management of one's chronic health condition. The PAM has good reliability ( =.87-.88) and validity in many studies, including our own.
VR-12
Health-related quality of life will be measured with the VR-12, a modified version of the Medical Outcomes Study SF-12. Internal consistency is high, ranging from =.87-.96.73
Depression PHQ-8
Depression will be measured with the widely-used 8-item PHQ-8
Anxiety GAD-7
Anxiety will be measured with the GAD-7, which has strong psychometric properties.
Pain catastrophizing
Pain catastrophizing will be measured with the 13-item Pain Catastrophizing Scale, which is a strong predictor of treatment response and has strong psychometric properties.

Full Information

First Posted
September 27, 2022
Last Updated
November 30, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05563792
Brief Title
Options for Pain Management Using Nonpharmacological Strategies
Acronym
OPTIONS
Official Title
Options for Pain Management Using Nonpharmacological Strategies (OPTIONS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to help Veterans learn about different ways they can manage chronic pain that do not involve medications. Veterans will work with a coach to explore the Veterans' values and goals and how different non-medication approaches may fit into these values and goals.
Detailed Description
Non-pharmacological treatments (NPTs) for chronic pain are safe, effective, and widely available in VA. In response to the widespread harms associated with opioids and high-quality evidence supporting NPTs for chronic pain the Centers for Disease Control, American College of Physicians, Department of Defense, and Veterans Health Administration (VHA) released guidelines or adopted policies to move away from opioids toward multimodal approaches that prioritize evidence-based nonpharmacological pain treatments (NPTs) NPTs include both traditional (e.g., cognitive behavioral therapy, exercise/movement) and complementary/integrative health (CIH) (e.g., acupuncture, yoga) approaches. VA has been a leader in expanding access to these approaches, and in 2016 the Comprehensive Addiction and Recovery Act mandated that VA expand availability of CIH therapies. A survey published in 2021 revealed that this expansion has been successful. VA medical centers offered an average of 5 CIH approaches, with 63 sites offering at least 10. Expansion of CIH therapies has also been one of three key components of VA's Whole Health Initiative, implemented by VA's Office of Patient-Centered Care and Cultural Transformation (one of the investigators' operational partners). In addition, as a result of implementation in 2012, cognitive-behavioral therapy for chronic pain is available at 92% of VAs. Consequently, NPTs are widely available across VA. Despite these efforts, pain remains a significant problem among Veterans. In 2017, 66% of Veterans reported pain, with 9% reporting severe pain. Compared to non-Veterans, Veterans had 1.5 times the odds of having severe pain, and Veterans aged 18-39 had 3 times the odds of having severe pain compared to non-Veterans of the same age. A survey of over 9,000 Veterans with pain, published in 2020, revealed that Veterans continue to report high pain levels. Veterans reported a past-week mean pain severity of 6.75 on a 0-10 scale and a mean of 6.8 different pain locations. Over half (56%) of Veterans reported the effectiveness of the Veterans' pain treatment as fair to poor, with only 12% rating the Veterans' pain treatment as very good or excellent. Continued opioid-related harms, high levels of Veteran-reported pain, and low satisfaction with pain care indicate that, despite VA efforts to improve pain management, additional efforts are needed to help Veterans effectively manage chronic pain using safe, evidence-based approaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Chronic Pain, Self management, Pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized control trial with behavioral intervention
Masking
Outcomes Assessor
Masking Description
The assessors will be blinded to the treatment assignment when administering baseline outcome assessments
Allocation
Randomized
Enrollment
296 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OPTIONS Intervention Coaching
Arm Type
Experimental
Arm Description
Intervention participants will participate in a series of four coaching sessions focused on helping patients clarify their values and treatment goals, aligning these values and goals and their lifestyle with nonpharmacological treatment options, working on overcoming barriers to use and adherence of nonpharmacological treatment options (using motivational interviewing), and preparing patients to discuss these options with their primary care providers. A decision aid will be used during these coaching sessions.
Arm Title
OPTIONS Waitlist Control
Arm Type
No Intervention
Arm Description
Participants randomized into waitlist control group will receive the intervention decision aid after completing the last survey at 9 months. Participants will also be offered the opportunity to have a brief 20-minute session with a member of the OPTIONS study staff to help walk them through this decision aid.
Intervention Type
Behavioral
Intervention Name(s)
Options for Pain Management using Non-medication Strategies
Other Intervention Name(s)
OPTIONS
Intervention Description
The purpose of this study is to help Veterans learn about different ways they can manage chronic pain that do not involve medications. Veterans will work with a coach to explore their values and goals and how different non-medication approaches may fit into these values and goals.
Primary Outcome Measure Information:
Title
Pain Interference Brief Pain Inventory (BPI)
Description
The pain interference score from the Brief Pain Inventory averages seven ratings, 0 (does not interfere) to 10 (interferes completely), of interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Lower scores are better outcomes.
Time Frame
Change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Use of Nonpharmacological and Self-Care Approaches (NSCAP)
Description
This measure was developed by members of the VA/DoD/NIH Pain Management Collaboratory, which is comprised of national experts in NPTs and is led by Dr. Robert Kerns of the VA PRIME Center. The NSCAP asks about use of 9 Non-pharmacological treatments , including the 6 included in the OPTIONS Decision Aid, and assesses details of use such as frequency and patients' judgments of effectiveness. Space is provided for additional Non-pharmacological treatments patients may be using.
Time Frame
Change from baseline to 6 months
Title
Patient Activation Measure (PAM)
Description
Patient activation will be measured with the 13-item Patient Activation Measure (PAM) Short Form, which assesses patient knowledge, skill, and confidence for self-management of one's chronic health condition. The PAM has good reliability ( =.87-.88) and validity in many studies, including our own.
Time Frame
Change from baseline to 6 months
Title
VR-12
Description
Health-related quality of life will be measured with the VR-12, a modified version of the Medical Outcomes Study SF-12. Internal consistency is high, ranging from =.87-.96.73
Time Frame
Change from baseline to 6 months
Title
Depression PHQ-8
Description
Depression will be measured with the widely-used 8-item PHQ-8
Time Frame
Change from baseline to 6 months
Title
Anxiety GAD-7
Description
Anxiety will be measured with the GAD-7, which has strong psychometric properties.
Time Frame
Change from baseline to 6 months
Title
Pain catastrophizing
Description
Pain catastrophizing will be measured with the 13-item Pain Catastrophizing Scale, which is a strong predictor of treatment response and has strong psychometric properties.
Time Frame
Change from baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for at least 3 months, have at least moderate pain intensity and interference with function, defined by a score of 4 (possible range: 0-10) on the PEG, a 3-item measure of pain intensity, interference with enjoyment of life, and interference with general activity (obtained from phone screener), have a primary care appointment scheduled or due in approximately the next three months. open to trying new pain treatments Exclusion Criteria: a psychiatric hospitalization in the past 6 months, long-term opioid therapy severe medical conditions likely precluding participation (e.g., NY Heart Association Class III or IV heart failure) which includes heart attack, stroke, and cancer, or if the eligibility screener reveals cognitive impairment, defined by a score of >3 (possible range: 0-6) on MMSE cognitive screen (obtained from phone screener), or if the eligibility screener reveals active suicidal ideation, or severe hearing/speech impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne S Matthias, PhD MS BA
Phone
(317) 988-4514
Email
marianne.matthias@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Morgan H Traylor, MBA BS
Email
morgan.traylor@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Sassi Matthias, PhD MS BA
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela L Rollins, PhD
Phone
(317) 679-0434
Email
Angela.Rollins@va.gov
First Name & Middle Initial & Last Name & Degree
Linda A Collins, BS CRA
Phone
(317) 988-2722
Email
linda.collins4@va.gov
First Name & Middle Initial & Last Name & Degree
Marianne Sassi Matthias, PhD MS BA

12. IPD Sharing Statement

Plan to Share IPD
No

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Options for Pain Management Using Nonpharmacological Strategies

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