Chronic PainIMPPRESSNCT01748227
IMproving Pain Using Peer RE-inforced Self-management Skills
A study testing Peer-Delivered Pain Self-Management in people with Chronic Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The overall purpose of this pilot study is to conduct a formative evaluation of (veteran)peer delivery of a chronic pain self-management program to veterans with chronic musculoskeletal pain. 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?
- Peer-Delivered Pain Self-Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Peers will be eligible if they have chronic musculoskeletal pain and have completed a pain self-management program from any of these chronic pain trials:
- Stepped Care for Depression and Musculoskeletal Pain (SCAMP)
- Evaluation of Stepped Care for Chronic Pain in Iraq and Afghanistan Veterans (ESCAPE)
- CAre Management for the Effective use of Opioids (CAMEO)
- Or participants of the VA Pain School or VA Pain program
- Peers may also be recommended by their primary care providers at the VA
- Eligible patients must have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) that has persisted for 3 months
- And have pain of at least moderate intensity as defined by a Brief Pain Inventory score 5
Who cannot join
- Patients will be excluded if they have active suicidal ideation
- Have been hospitalized for psychiatric or substance abuse reasons in the last 6 months pending back surgery
- Current substance dependence
- Severe medical conditions (e.g., New York Heart Association Class III or IV heart failure) that precludes participation
- Or severe hearing or speech impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, 46202-2884
About this study
Official title: Improving Pain Using Peer RE-inforced Self-management Skills (IMPPRESS)
The overall purpose of this pilot study is to conduct a formative evaluation of (veteran)peer delivery of a chronic pain self-management program to veterans with chronic musculoskeletal pain.
Our specific aims are as follows:
Aim 1: Evaluate the feasibility of identifying, recruiting, training, and retaining veteran peers to implement a self-management program for chronic pain.
Aim 2: Identify facilitators and barriers to peer-delivery of a chronic pain self-management program.
Aim 3: Convene an expert panel to review the results of Aims 1 and 2, help to interpret the results, and plan next steps.
Read the detailed description
This is a one-arm pilot study with a pretest/posttest design. Thus, participants' (n=20) baseline scores were compared to their final outcome assessment scores (i.e., change scores.) There was no control group.
This study is an intervention using peer coaches to deliver pain self-management instruction to patients. Peer coaches thus delivered the intervention and underwent a 3-hour training session prior to initiation of the study. Because peers served as intervention facilitators and not as recipients of the intervention, this study was not focused on peer outcomes.
Patients (n=20) attended a 2-hour didactic session led by the study nurse. Then patients were assigned a peer (2 patients per peer). Patients met with their peers for 4 months to discuss pain self-management with the guidance of a study manual. Peers were asked to contact patients a minimum of bi-weekly via telephone or in-person.
Peers reviewed each of the topic areas covered in the self-management manual. Peers reviewed a different topic each session, ask if the patient has questions, and discuss his or her personal experience with the topic being covered during that session. Modeling what the nurse care manager has done in prior studies, peers worked with patients to help them to set goals and to evaluate whether these goals are realistic. A new goal was set at each session, with the peer following up on the previous goals with the patient, whether they were accomplished, and if not, possible courses of action (e.g., modifying the goal or offering other advice to accomplish the goal). Throughout these sessions peers were encouraged to draw on their own experiences and how they personally overcame obstacles and handled setbacks and frustrations. Peers did not advise on or discuss medications or medical questions with patients.
Participating patients (n=20) were given outcome assessments at baseline and at 4-month follow-up.
- Conditions
- Chronic Pain
- Being tested
- Peer-Delivered Pain Self-Management
- Keywords
- self-management, peer support, social support
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-Delivered Pain Self-ManagementBehavioural
Patients (n=20) were assigned a peer coach to meet with for 4 months to discuss pain self-management.
| Study group | Role | What they receive |
|---|---|---|
| Peer-Coached Pain Self-Management | Other | Participants (n=20) were assigned to a peer coach, who delivered self-management instruction one-on-one over a 4-month period. Receives: Behavioral: Peer-Delivered Pain Self-Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain/Enjoyment of Life/General Activity
3-item version of the Brief Pain Inventory. Possible range: 0-30. 0=no pain/interference, 30=maximum pain/interference. Thus lower values represent a better outcome.
Measured: Change from baseline to 4 month assessment
Secondary outcomes (4)
Pain Catastrophizing Scale
Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.
Measured: Baseline and 4 month assessment (final assessment)
Multidimensional Perceived Social Support Scale (MPSS).
12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).
Measured: Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance
Patient Reported Outcome Measurement System (PROMIS)
Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.
Measured: Change from baseline to 4 month assessment
Pain Centrality Scale
Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.
Measured: 4 month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marianne Sassi Matthias, PhD MS BA, Principal investigator, Richard L. Roudebush VA Medical Center, Indianapolis, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748227
- Sponsor's protocol ID
- RRP 12-438
- Acronym
- IMPPRESS
- Status last verified
- Apr 2015
- First submitted
- 21 Nov 2012
- Last updated
- 15 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Matthias MS, McGuire AB, Kukla M, Daggy J, Myers LJ, Bair MJ. A brief peer support intervention for veterans with chronic musculoskeletal pain: a pilot study of feasibility and effectiveness. Pain Med. 2015 Jan;16(1):81-7. doi: 10.1111/pme.12571. Epub 2014 Oct 14.
PubMed 25312858Matthias MS, Kukla ME, McGuire AB, Bair MJ. Peer support for chronic pain self-management: A qualitative study of peer coaches' experiences. [Abstract]. Journal of general internal medicine. 2014 Apr 16; 29(1):169-170.
Matthias MS, McGuire AB, Kukla ME, Daggy J, Myers L, Bair MJ. Effectiveness of a brief peer support intervention for veterans with chronic pain. [Abstract]. Journal of general internal medicine. 2014 Apr 16; 29(1):80.
Matthias MS, Kukla M, McGuire AB, Bair MJ. How Do Patients with Chronic Pain Benefit from a Peer-Supported Pain Self-Management Intervention? A Qualitative Investigation. Pain Med. 2016 Dec;17(12):2247-2255. doi: 10.1093/pm/pnw138. Epub 2016 Jul 8.
PubMed 28025359
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pain Using Peer RE-inforced Self-management Skills (IMPPRESS)
- ClinicalTrials.gov ID
- NCT01748227
- Acronym / sponsor ID
- IMPPRESS / RRP 12-438
- Conditions
- Chronic Pain
- Keywords
- self-management, peer support, social support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Posted 19 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this pilot study is to conduct a formative evaluation of (veteran)peer delivery of a chronic pain self-management program to veterans with chronic musculoskeletal pain.
Our specific aims are as follows:
Aim 1: Evaluate the feasibility of identifying, recruiting, training, and retaining veteran peers to implement a self-management program for chronic pain.
Aim 2: Identify facilitators and barriers to peer-delivery of a chronic pain self-management program.
Aim 3: Convene an expert panel to review the results of Aims 1 and 2, help to interpret the results, and plan next steps.
Detailed description
This is a one-arm pilot study with a pretest/posttest design. Thus, participants' (n=20) baseline scores were compared to their final outcome assessment scores (i.e., change scores.) There was no control group.
This study is an intervention using peer coaches to deliver pain self-management instruction to patients. Peer coaches thus delivered the intervention and underwent a 3-hour training session prior to initiation of the study. Because peers served as intervention facilitators and not as recipients of the intervention, this study was not focused on peer outcomes.
Patients (n=20) attended a 2-hour didactic session led by the study nurse. Then patients were assigned a peer (2 patients per peer). Patients met with their peers for 4 months to discuss pain self-management with the guidance of a study manual. Peers were asked to contact patients a minimum of bi-weekly via telephone or in-person.
Peers reviewed each of the topic areas covered in the self-management manual. Peers reviewed a different topic each session, ask if the patient has questions, and discuss his or her personal experience with the topic being covered during that session. Modeling what the nurse care manager has done in prior studies, peers worked with patients to help them to set goals and to evaluate whether these goals are realistic. A new goal was set at each session, with the peer following up on the previous goals with the patient, whether they were accomplished, and if not, possible courses of action (e.g., modifying the goal or offering other advice to accomplish the goal). Throughout these sessions peers were encouraged to draw on their own experiences and how they personally overcame obstacles and handled setbacks and frustrations. Peers did not advise on or discuss medications or medical questions with patients.
Participating patients (n=20) were given outcome assessments at baseline and at 4-month follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer-Coached Pain Self-Management | Other | Behavioral: Peer-Delivered Pain Self-ManagementParticipants (n=20) were assigned to a peer coach, who delivered self-management instruction one-on-one over a 4-month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Peers will be eligible if they have chronic musculoskeletal pain and have completed a pain self-management program from any of these chronic pain trials:
- Eligible patients must have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) that has persisted for 3 months
- And have pain of at least moderate intensity as defined by a Brief Pain Inventory score 5
Key exclusion criteria (5 listed)
- Patients will be excluded if they have active suicidal ideation
- Have been hospitalized for psychiatric or substance abuse reasons in the last 6 months pending back surgery
- Current substance dependence
- Severe medical conditions (e.g., New York Heart Association Class III or IV heart failure) that precludes participation
- Or severe hearing or speech impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-Delivered Pain Self-ManagementPatients (n=20) were assigned a peer coach to meet with for 4 months to discuss pain self-management. | Behavioural | Peer-Coached Pain Self-Management |
Primary outcome
Pain/Enjoyment of Life/General Activity
Time frame: Change from baseline to 4 month assessment
3-item version of the Brief Pain Inventory. Possible range: 0-30. 0=no pain/interference, 30=maximum pain/interference. Thus lower values represent a better outcome.
4 secondary outcomes
Pain Catastrophizing Scale
Time frame: Baseline and 4 month assessment (final assessment)
Multidimensional Perceived Social Support Scale (MPSS).
Time frame: Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance
Patient Reported Outcome Measurement System (PROMIS)
Time frame: Change from baseline to 4 month assessment
Pain Centrality Scale
Time frame: 4 month assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25312858Matthias MS, McGuire AB, Kukla M, Daggy J, Myers LJ, Bair MJ. A brief peer support intervention for veterans with chronic musculoskeletal pain: a pilot study of feasibility and effectiveness. Pain Med. 2015 Jan;16(1):81-7. doi: 10.1111/pme.12571. Epub 2014 Oct 14.
- Results publicationMatthias MS, Kukla ME, McGuire AB, Bair MJ. Peer support for chronic pain self-management: A qualitative study of peer coaches' experiences. [Abstract]. Journal of general internal medicine. 2014 Apr 16; 29(1):169-170.
- Results publicationMatthias MS, McGuire AB, Kukla ME, Daggy J, Myers L, Bair MJ. Effectiveness of a brief peer support intervention for veterans with chronic pain. [Abstract]. Journal of general internal medicine. 2014 Apr 16; 29(1):80.
- Derived from this study: PubMed 28025359Matthias MS, Kukla M, McGuire AB, Bair MJ. How Do Patients with Chronic Pain Benefit from a Peer-Supported Pain Self-Management Intervention? A Qualitative Investigation. Pain Med. 2016 Dec;17(12):2247-2255. doi: 10.1093/pm/pnw138. Epub 2016 Jul 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Sassi Matthias, PhD MS BA principal investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-Delivered Pain Self-Management in people with Chronic Pain, run by US Department of Veterans Affairs 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 8 inclusion and 5 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 15 May 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain/Enjoyment of Life/General Activity (time frame: Change from baseline to 4 month assessment). 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 NCT01748227, which also lists 4 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 15 May 2015.