Clinical trial NCT04554576: Escoge Salud (Choose Health): a Chronic Pain Self-Management Program in Middle to Older Age Hispanic Americans
Official title: Escoge Salud (Choose Health) Effects and Sustainability of a Chronic Pain Self-Management Program in Middle to Older Age Hispanic Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Hispanic American
Latino
self-management training
sustainability
health care utilization
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective study with a secondary randomization to a remote, nonfrequent provider feedback sustainability intervention. All participants will receive the 6-week self-management intervention and do pre/post evaluations. After the 6-week intervention, half the group will be randomized to a every 6th week for 6 months healthcare provider phone/video visit session and half will be received to no treatment control for 6 months.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate patient satisfaction and health status before and after a 6-week established self-management training program for middle to older age Hispanic Americans living with chronic musculoskeletal pain in a large, hospital based urban health maintenance organization. The secondary aim is to evaluate the effects of remote, nonfrequent healthcare provider feedback for 6 months on health care utilization, health status and patient satisfaction.

Detailed description: Managing chronic pain in the US costs approximately $635 billion and half of this expenditure is for joint and arthritis related pain syndromes. Interestingly, compared with non-Hispanic whites (NHWs), Hispanic Americans (HAs) report significantly lower rates of chronic pain with consistently higher levels of pain intensity in both population and clinically based studies. Chronic musculoskeletal pain (CMP) incidence increases with age and the HA aging population is among the fastest growing segments of the US population. Despite reporting more intense pain, HA are less likely to seek medical care versus NHWs for acute and chronic pain. Lack of access, cultural stoicism and an external locust of control are thought to explain why HAs seek care at a reduced rate. Psychological factors play a significant role in pain experience, HAs may employ catastrophic thinking and experience more pain related anxiety which are predictors of exacerbated pain experience. Pain comorbidities may be amenable to treatment with appropriate, culturally sensitive treatment focusing on enhancing self-efficacy to manage the complex array of psychological pain comorbidities. There is a societal impact of undertreating chronic pain in the HA population. While HAs have the lowest rate of short-term sick usage (\<1-2 days), they have the highest rate of long-term sick usage (\>31 days). This increased long-term time off puts HAs at risk of losing their job if the time off exceeds Family Leave and Medical Act minimums. Lastly, it is well documented, HAs are hesitant to take strong pain medication and there is conflicting evidence surrounding taking over-the-counter medications for pain management. There is a need to provide culturally sensitive, effective chronic pain management treatments for HAs.

There have been 5 well designed studies (n=931) demonstrating efficacy of a trans-created Spanish version of the Chronic Disease Self-Management Program (CDSMP) for HAs with chronic musculoskeletal pain. CDSMP has demonstrated effectiveness in improving pain intensity, self-efficacy (SE) and health behaviors in a community setting . The intervention is a healthcare provider and/or peer led 2.5 hour self-management training session, 1 time per week for 6 weeks taught in a group setting in Spanish. The program is grounded in Bandura's Social Cognitive Theory and uses goal setting and problem solving as corner stones to create a personalized self-management program. Improvements post-intervention in SE predict sustainability of health behaviors and maintenance of improved health status in the long term. Additionally, remote non-frequent health care provider feedback has been associated with maintenance of health behaviors, however this his not been tested in the HA population.

The purpose of this study is to test the feasibility (patient satisfaction and change in health status) after bringing the CDSMP programming to a large urban hospital based medical center that does not currently offer a culturally sensitive, self-management training program in Spanish middle to older age HAs with chronic pain. The secondary aim is to pilot the effectiveness of an every 6th week phone/video visit feedback visit for 24 months on both health status and healthcare utilization.

Eligibility criteria: Inclusion Criteria:

1. Spanish Speaking
2. Had 1 or 2 outpatient dispense records of NSAIDS between Jan 1 2018 to Dec 31 2018.
3. 5 doctor office visits between 07/01/2017 - 12/31/2018 for any health program.
4. Non-malignant musculoskeletal pain for at least 6 months
5. Interested in learning self-management
6. Ability to have telephone/video visit every 6 weeks
7. Ability to travel to medical center 1x/week for 6 weeks in the afternoon for 2.5 hours

Exclusion Criteria:

1. Major psychiatric or substance abuse problem
2. Mild cognitive impairment/dementia
3. Malignant pain or terminal illness
4. Listed in the Non-contact database

Primary outcomes:
measure: Self Efficacy
timeFrame: baseline to 6-weeks
measure: Patient Reported Outcome Measurement Information System (PROMIS) Global Health
timeFrame: baseline to 6-weeks
measure: Pain Catastrophizing
timeFrame: baseline to 6-weeks
measure: Health Distress
timeFrame: baseline to 6-weeks
measure: Patient Satisfaction
timeFrame: baseline to 6-weeks
measure: Patient Global Impression
timeFrame: baseline to 6-weeks
Secondary outcomes:
measure: Doctors office visits
timeFrame: 6 weeks to 30-34 weeks
measure: Emergency Room use
timeFrame: 6 weeks to 30-34 weeks
measure: Self Efficacy
timeFrame: 6-weeks to 30-34 weeks
measure: PROMIS Global Health
timeFrame: 6-weeks to 30-34 weeks
measure: Pain Catastrophizing
timeFrame: 6-weeks to 30-34 weeks
measure: Health Distress
timeFrame: 6-weeks to 30-34 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: KaiserPermanente
state: California
Study officials:
affiliation: senior physical therapist
name: Amy Gladin, DPT
role: PRINCIPAL_INVESTIGATOR
References: