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Chronic PainPhase 1OPTINCT02230722

Improving Opioid Safety in Veterans Using Collaborative Care and Decision Support

A Phase 1 study testing Motivational Interviewing in people with Chronic Pain, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators propose to develop a novel intervention that targets the system (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid pain management alternatives. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
Nov 2014to 12 Jun 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current Male or Female patient at San Francisco VA Medical Center or affiliated VA clinics
  • Must be older than 18 years
  • Chronic musculoskeletal pain of at least 6 months duration and
  • Prescribed one or more opioid pain medication for more than three months and
  • Evidence of being a high-risk opioid user as determined by PI, electronic medical record, and study measures

Who cannot join

  • Non-English speakers
  • Plans to relocate within 6 months; not able to come to San Francisco VA Medical Center for three in-person visits
  • Cancer or other terminal illness involving palliative care with opioid medications
  • Serious or untreated mental illness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Francisco VA Medical Center

    San Francisco, California, 94121

Other trials in United States

About this study

The investigators propose to develop a novel intervention that targets the system (Collaborative Care), PCP (computerized decision support for opioid therapy) and veteran (CM-delivered MI) to reduce problematic prescription opioid use and encourage non-opioid pain management alternatives.

Read the detailed description

The investigators will develop and test the acceptability, feasibility, and preliminary efficacy of a Collaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain. Specifically, after honing the intervention, the investigators will conduct a pilot randomized controlled trial of Collaborative Care/Motivational Interviewing in 100 veterans (ages 18 and older) with chronic pain in primary care who are prescribed opioid pain medications and exhibit at least one "high-risk" opioid use behavior (e.g. obtaining early opioid refills, etc.). Using ATHENA-OT decision support, PCPs will make guideline-concordant recommendations to all enrolled study patients and initiate a Pain Care Plan. Veterans randomized to Collaborative Care, will have one MI session with their assigned study Care Manager followed by 3 Care Manager-delivered telephone MI/monitoring sessions; patients randomized to the Attention Control arm will have one brief session with their assigned Care Manager, followed by 3 Care Manager-delivered neutral telephone sessions

Conditions
Chronic Pain
Being tested
Motivational Interviewing, Attention Control
Keywords
opioids, chronic pain, collaborative care
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational InterviewingBehavioural

  • Attention ControlBehavioural

Study groups in NCT02230722
Study groupRoleWhat they receive
Attention ControlActive comparatorThe neutral 10-15 minute visit with the Care Manager will consist of a brief review of ATHENA-OT safety education and the patient's Pain Care Plan. The CM will answer patient questions, but will avoid using Motivational Interviewing communication. The Care Manager will review upcoming telephone check-in and assessment sessions.
Receives: Behavioral: Attention Control
Collaborative CareExperimentalCollaborative Care intervention in which one of two Care Managers delivering both interventions will assist primary care providers (PCPs) by using Motivational Interviewing to communicate computer-based ATHENA-OT (opioid therapy) decision support guidelines to veterans with chronic pain.
Receives: Behavioral: Motivational Interviewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention.

    • PCPs and the CM in the Collaborative Care arm will report greater self-efficacy in communicating ATHENA-OT pain management recommendations and in developing a Pain Care Plan with chronic pain patients
    • The CM will conduct MI communication with high fidelity.
    • Veterans in the Collaborative Care arm will report greater satisfaction with pain-related care.

    Measured: 20 weeks post baseline

Secondary outcomes (1)

  1. To preliminarily evaluate the efficacy of ATHENA-OT decision support plus Collaborative Care (CC) to improve prescription opioid safety and adherence to non-opioid pain management alternatives among primary care patients.

    Compared to ATHENA-OT plus Attention Control:

    H2.a. Veterans randomized to Collaborative Care (CC) will be more likely to achieve a decrease in opioid risk behavior that is sustained during an 8-week post-intervention period of no contact.

    H2.b. Veterans randomized to CC are more likely to initiate and sustain ≥ 1 non-opioid strategies.

    H2.c. Veterans randomized to CC are more likely to report sustained improvements in pain disability.

    H2.d. Substance use disorders and treatment will moderate CC efficacy; Care Manager MI-consistent communication in the CC arm will correlate with reduced opioid risk behavior in veterans.

    Measured: 20 weeks post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion12 Jun 2017
  4. Study completion12 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02230722
Sponsor's protocol ID
13-11892
Other IDs
R34AT008319-01
Acronym
OPTI
Status last verified
Jun 2017
First submitted
25 Aug 2014
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • Okie S. A flood of opioids, a rising tide of deaths. N Engl J Med. 2010 Nov 18;363(21):1981-5. doi: 10.1056/NEJMp1011512. No abstract available.

    PubMed 21083382

  • Paulozzi LJ, Kilbourne EM, Desai HA. Prescription drug monitoring programs and death rates from drug overdose. Pain Med. 2011 May;12(5):747-54. doi: 10.1111/j.1526-4637.2011.01062.x. Epub 2011 Feb 18.

    PubMed 21332934

  • Boudreau D, Von Korff M, Rutter CM, Saunders K, Ray GT, Sullivan MD, Campbell CI, Merrill JO, Silverberg MJ, Banta-Green C, Weisner C. Trends in long-term opioid therapy for chronic non-cancer pain. Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1166-75. doi: 10.1002/pds.1833.

    PubMed 19718704

  • Paulozzi LJ; Centers for Disease Control and Prevention (CDC). Drug-induced deaths - United States, 2003-2007. MMWR Suppl. 2011 Jan 14;60(1):60-1. No abstract available.

    PubMed 21430623

  • Seal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234.

    PubMed 22396516

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Motivational Interviewing in people with Chronic Pain, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the feasibility, acceptability, and usability of augmenting ATHENA-OT decision support with a Collaborative Care intervention. (time frame: 20 weeks post baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02230722, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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