Chronic Pain
Conditions
Keywords
self-management, peer support, social support
Brief summary
To maximize implementation potential of pain self-management in the VA, alternative delivery methods are needed to provide Veterans with education and support needed to self-manage their pain, without requiring additional resources from healthcare teams. A novel and promising approach is a peer coaching model, in which Veterans with chronic pain who are successfully managing their pain offer information, support, and mentorship to other Veterans with pain.
Detailed description
The investigators' goal is to test the effectiveness of a peer coaching model among Veterans. The investigators are examining feasibility for implementation alongside effectiveness, to shorten the timeline to implementation. Aim 1 (primary aim): To compare 6-month (primary endpoint) and 9-month (sustained effects) effects of peer-supported chronic pain self-management versus controls on overall pain (intensity and function). Hypothesis 1: Veterans in the peer support arm will experience reduced overall pain compared to controls. Aim 2 (secondary aim): To compare 6- and 9-month effects of peer-supported chronic pain self-management versus controls on self-efficacy, social support, pain coping, patient activation, health-related quality of life, and health service utilization. Hypothesis 2: Veterans in the peer support arm will experience greater self-efficacy, social support, pain coping, patient activation, and health-related quality of life, and lower health service utilization, compared to controls. Aim 3 (pre-implementation aim): To explore facilitators and barriers to implementation of peer support for chronic pain, intervention costs, and fidelity to the model.
Interventions
BEHAVIORALPeer Coach Assignment
Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for 3 months * have at least moderate pain severity, defined by pain 5 on a 0 (no pain) to 10 (worst pain imaginable) scale * indicate willingness to engage in phone or in-person contact on a regular basis with another Veteran
Exclusion criteria
* if the electronic medical record indicates a diagnosis of a psychotic disorder (e.g., International Classification of Diseases (ICD) ICD-9 codes 295-295.9 for schizophrenia) * current substance dependence (e.g., ICD-9 codes 304-304.9) * severe medical conditions precluding participation (e.g., New York Heart Association Class III or IV heart failure, ICD-9 codes 428-428.9 ) * if the eligibility screener given to prospective participants reveals active suicidal ideation severe hearing or speech impairment * pending surgery for a musculoskeletal condition (e.g., back surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory (BPI) (Overall Pain Assessment) | 6 months | The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing | 6 months | Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing) |
| Perceived Social Support | 6 months | Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support) |
| Self Efficacy | 6 months | Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy) |
| Anxiety | 6 months | GAD-7 (Range 0-21, higher numbers = higher anxiety) |
| Depression | 6 months | PHQ-8 (Range: 0-24, higher numbers = higher depression) |
| Patient Activation | 6 months | Patient Activation Measure (Range: 0-100, higher numbers = higher activation) |
| General Health Perceptions | 6 months | SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions) |
Countries
United States
Participant flow
Pre-assignment details
Two participants who enrolled withdrew prior to completing baseline assessments, leaving 119 randomized to the intervention and 94 to the control group.
Participants by arm
| Arm | Count |
|---|---|
| Peer Coach Assignment Veteran participants will be assigned to a peer coach, who delivered self-management instruction one-on-one over a 6-month period.
Peer Coach Assignment: Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management. | 119 |
| Control Veteran participants will attend a 2-hour class in pain basics and pain self-management. Veterans will aso be given a set of pamphlets related to pain self-management. | 94 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 4 |
| Overall Study | Withdrawal by Subject | 20 | 8 |
Baseline characteristics
| Characteristic | Peer Coach Assignment | Total | Control |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 12.6 | 56.8 years STANDARD_DEVIATION 13 | 58.6 years STANDARD_DEVIATION 13.3 |
| Anxiety | 6.1 units on a scale STANDARD_DEVIATION 5.3 | 6.1 units on a scale STANDARD_DEVIATION 5.3 | 6.2 units on a scale STANDARD_DEVIATION 5.4 |
| Brief Pain Inventory Total | 5.8 units on a scale STANDARD_DEVIATION 1.9 | 5.8 units on a scale STANDARD_DEVIATION 1.9 | 5.8 units on a scale STANDARD_DEVIATION 1.9 |
| Depression | 9.3 units on a scale STANDARD_DEVIATION 6.4 | 9.2 units on a scale STANDARD_DEVIATION 6.2 | 8.9 units on a scale STANDARD_DEVIATION 6 |
| General Health Perceptions | 52.2 units on a scale STANDARD_DEVIATION 20.9 | 52.5 units on a scale STANDARD_DEVIATION 21 | 52.8 units on a scale STANDARD_DEVIATION 21.1 |
| Pain Catastrophizing | 20.8 units on a scale STANDARD_DEVIATION 13.1 | 21.1 units on a scale STANDARD_DEVIATION 13.2 | 21.5 units on a scale STANDARD_DEVIATION 13.3 |
| Patient Activation | 60.6 units on a scale STANDARD_DEVIATION 13.5 | 59.4 units on a scale STANDARD_DEVIATION 13.7 | 57.9 units on a scale STANDARD_DEVIATION 13.8 |
| Perceived Social Support | 62.2 units on a scale STANDARD_DEVIATION 16.5 | 62.3 units on a scale STANDARD_DEVIATION 17.2 | 62.6 units on a scale STANDARD_DEVIATION 18.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 59 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 22 Participants | 8 Participants |
| Race (NIH/OMB) White | 77 Participants | 132 Participants | 55 Participants |
| Region of Enrollment United States | 119 participants | 213 participants | 94 participants |
| Self-Efficacy | 6.1 units on a scale STANDARD_DEVIATION 2.2 | 6.1 units on a scale STANDARD_DEVIATION 2.2 | 6.2 units on a scale STANDARD_DEVIATION 2.3 |
| Sex: Female, Male Female | 24 Participants | 40 Participants | 16 Participants |
| Sex: Female, Male Male | 95 Participants | 173 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 94 |
| other Total, other adverse events | 0 / 119 | 0 / 94 |
| serious Total, serious adverse events | 0 / 119 | 0 / 94 |
Outcome results
Primary
Brief Pain Inventory (BPI) (Overall Pain Assessment)
The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable)
Time frame: 6 months
Population: 21 withdrew and 14 were lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Brief Pain Inventory (BPI) (Overall Pain Assessment) | 5.6 units on a scale | Standard Deviation 2 |
| Control | Brief Pain Inventory (BPI) (Overall Pain Assessment) | 5.6 units on a scale | Standard Deviation 1.9 |
p-value: 0.981Regression, Linear
Primary
Brief Pain Inventory (BPI) (Overall Pain Assessment)
The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable)
Time frame: 9 months
Population: 7 withdrew and 4 were lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Brief Pain Inventory (BPI) (Overall Pain Assessment) | 5.4 units on a scale | Standard Deviation 2 |
| Control | Brief Pain Inventory (BPI) (Overall Pain Assessment) | 5.3 units on a scale | Standard Deviation 2 |
p-value: 0.774Regression, Linear
Secondary
Anxiety
GAD-7 (Range 0-21, higher numbers = higher anxiety)
Time frame: 9 months
Population: 7 withdrew and 4 lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Anxiety | 6.5 units on a scale | Standard Deviation 5.5 |
| Control | Anxiety | 6.4 units on a scale | Standard Deviation 5.3 |
p-value: 0.999Regression, Linear
Secondary
Anxiety
GAD-7 (Range 0-21, higher numbers = higher anxiety)
Time frame: 6 months
Population: 21 withdrew and 14 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Anxiety | 6.9 units on a scale | Standard Deviation 5.4 |
| Control | Anxiety | 6.2 units on a scale | Standard Deviation 4.9 |
p-value: 0.78Regression, Linear
Secondary
Depression
PHQ-8 (Range: 0-24, higher numbers = higher depression)
Time frame: 6 months
Population: 21 withdrew and 14 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Depression | 10.1 units on a scale | Standard Deviation 6.7 |
| Control | Depression | 9.1 units on a scale | Standard Deviation 5.4 |
p-value: 0.997Regression, Linear
Secondary
Depression
PHQ-8 (Range: 0-24, higher numbers = higher depression)
Time frame: 9 months
Population: 7 withdrew and 4 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Depression | 9.2 units on a scale | Standard Deviation 6.2 |
| Control | Depression | 8.3 units on a scale | Standard Deviation 5.8 |
p-value: 0.999Regression, Linear
Secondary
General Health Perceptions
SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)
Time frame: 6 months
Population: 21 withdrew and 14 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | General Health Perceptions | 52.7 units on a scale | Standard Deviation 21.7 |
| Control | General Health Perceptions | 50.1 units on a scale | Standard Deviation 19.7 |
p-value: 0.999Regression, Linear
Secondary
General Health Perceptions
SF-36 General Health Perceptions (Range: 0-100, higher numbers = higher health perceptions)
Time frame: 9 months
Population: 7 withdrew and 4 were lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | General Health Perceptions | 50.9 units on a scale | Standard Deviation 21.5 |
| Control | General Health Perceptions | 51.9 units on a scale | Standard Deviation 21 |
p-value: 0.999Regression, Linear
Secondary
Pain Catastrophizing
Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing)
Time frame: 9 months
Population: 7 withdrew and 4 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Pain Catastrophizing | 19.0 units on a scale | Standard Deviation 13.5 |
| Control | Pain Catastrophizing | 20.5 units on a scale | Standard Deviation 12.4 |
p-value: 0.999Regression, Linear
Secondary
Pain Catastrophizing
Pain Catastrophizing Scale, a 13-item scale that assesses catastrophizing - a pain belief that has been found to be a strong predictor of poor treatment response. (Range: 0-52, higher numbers = higher catastrophizing)
Time frame: 6 months
Population: 21 withdrew and 14 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Pain Catastrophizing | 21.8 units on a scale | Standard Deviation 13.8 |
| Control | Pain Catastrophizing | 22.0 units on a scale | Standard Deviation 11.8 |
p-value: 0.999Regression, Linear
Secondary
Patient Activation
Patient Activation Measure (Range: 0-100, higher numbers = higher activation)
Time frame: 9 months
Population: 7 withdrew and 4 were lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Patient Activation | 62.8 units on a scale | Standard Deviation 14.7 |
| Control | Patient Activation | 60.5 units on a scale | Standard Deviation 14.9 |
p-value: 0.999Regression, Linear
Secondary
Patient Activation
Patient Activation Measure (Range: 0-100, higher numbers = higher activation)
Time frame: 6 months
Population: 21 withdrew and 14 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Patient Activation | 63.5 units on a scale | Standard Deviation 14.9 |
| Control | Patient Activation | 58.7 units on a scale | Standard Deviation 14.3 |
p-value: 0.914Regression, Linear
Secondary
Perceived Social Support
Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)
Time frame: 6 months
Population: 21 withdrew and 14 lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Perceived Social Support | 62.0 units on a scale | Standard Deviation 17.9 |
| Control | Perceived Social Support | 60.4 units on a scale | Standard Deviation 16.4 |
p-value: 0.999Regression, Linear
Secondary
Perceived Social Support
Measures perceptions of social support.(Range: 12-84, higher numbers = higher perceptions of social support)
Time frame: 9 months
Population: 7 withdrew and 4 were lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Perceived Social Support | 63.6 units on a scale | Standard Deviation 17.8 |
| Control | Perceived Social Support | 62.1 units on a scale | Standard Deviation 17.3 |
p-value: 0.999Regression, Linear
Secondary
Self Efficacy
Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)
Time frame: 6 months
Population: 21 withdrew and 14 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Self Efficacy | 6.3 units on a scale | Standard Deviation 2.3 |
| Control | Self Efficacy | 6.1 units on a scale | Standard Deviation 2.1 |
p-value: 0.98Regression, Linear
Secondary
Self Efficacy
Adapted from the Arthritis Self Efficacy Scale (Range 0-10, higher numbers = higher self efficacy)
Time frame: 9 months
Population: 7 withdrew and 4 lost to follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peer Coach Assignment | Self Efficacy | 6.4 units on a scale | Standard Deviation 2.2 |
| Control | Self Efficacy | 6.1 units on a scale | Standard Deviation 2.2 |
p-value: 0.864Regression, Linear