Escoge Salud (Choose Health): a Chronic Pain Self-Management Program in Middle to Older Age Hispanic Americans
- Conditions
- Chronic Pain
- Interventions
- Behavioral: Chronic Disease Self-Management Program (CDSMP) for chronic pain in SpanishBehavioral: Remote feedback control groupBehavioral: Remote feedback active group
- Registration Number
- NCT04554576
- Lead Sponsor
- Kaiser Permanente
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- Spanish Speaking
- Had 1 or 2 outpatient dispense records of NSAIDS between Jan 1 2018 to Dec 31 2018.
- 5 doctor office visits between 07/01/2017 - 12/31/2018 for any health program.
- Non-malignant musculoskeletal pain for at least 6 months
- Interested in learning self-management
- Ability to have telephone/video visit every 6 weeks
- Ability to travel to medical center 1x/week for 6 weeks in the afternoon for 2.5 hours
- Major psychiatric or substance abuse problem
- Mild cognitive impairment/dementia
- Malignant pain or terminal illness
- Listed in the Non-contact database
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6-week self-management and control group for 6 months Remote feedback control group All participants will receive the 6-week self-management program and after, half will be randomized to a 6 month control grup 6-week self-management and remote feedback for 6 months Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish All participants will receive the 6-week self-management program and after, half the group will be randomized to an every 6th week healthcare provider feedback phone or video visit session for 6 months (4 visits over 24 months). 6-week self-management and remote feedback for 6 months Remote feedback active group All participants will receive the 6-week self-management program and after, half the group will be randomized to an every 6th week healthcare provider feedback phone or video visit session for 6 months (4 visits over 24 months). 6-week self-management and control group for 6 months Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish All participants will receive the 6-week self-management program and after, half will be randomized to a 6 month control grup
- Primary Outcome Measures
Name Time Method Self Efficacy baseline to 6-weeks Spanish Arthritis self-efficacy scale (ASES). This tool has 8 questions rating 'certainty' in ability to manage health and chronic pain. It is scored on a visual analogue scale from 1-10, 1= very uncertain to 10= very certain. Higher scores indicate more self-efficacy.
Health Distress baseline to 6-weeks Health Distress Scale evaluates distress and worry due to illness. It has 4 question that are answered on a 5-point Likert scale where 0= none of the time and 5= all of the time. Higher scores indicate more distress and worry.
Patient Global Impression baseline to 6-weeks Patient Global Impression of Change (PGIC) captures the patients satisfaction with the intervention by asking "How satisfied or dissatisfied are you with the self-management program?' and is scored on a 7-point scale where 7-point scale where -3 =very dissatisfied 0= neither satisfied or dissatisfied and 3= very satisfied.
Patient Satisfaction baseline to 6-weeks Adapted from Camino con Gusto study. 3 questions on satisfaction with the intervention scored on scored on a 4-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Agree, 4 = Strongly agree.
Patient Reported Outcome Measurement Information System (PROMIS) Global Health baseline to 6-weeks Spanish PROMIS Global Health v1.2 measures global physical, mental and social health. It has 10 questions, 9 of which are answered on a 5-point Likert scale and 1 question on a visual analogue scale where 0=no pain and 10=worst pain imaginable. PROMIS measures are scored on a t-score metric where 50 is set to be the population norm and higher scores indicate better global health.
Pain Catastrophizing baseline to 6-weeks Spanish Pain Catastrophizing Scale (PCS) evaluates 3 distinct phenomenon which are characterized by feelings of helplessness, active rumination and excessive magnification associated with pain experience. The questionnaire has 13 questions and is scored on a 5-point Likert scale, 0= not at all to 4 = all the time. Higher scores indicate more catastrophizing.
- Secondary Outcome Measures
Name Time Method Self Efficacy 6-weeks to 30-34 weeks Spanish Arthritis self-efficacy scale (ASES). This tool has 8 questions rating 'certainty' in ability to manage health and chronic pain. It is scored on a visual analogue scale from 1-10, 1= very uncertain to 10= very certain.
Emergency Room use 6 weeks to 30-34 weeks Number of Emergency Room visits
Health Distress 6-weeks to 30-34 weeks Health Distress Scale evaluates distress and worry due to illness. It has 4 question that are answered on a 5-point Likert scale where 0= none of the time and 5= all of the time
PROMIS Global Health 6-weeks to 30-34 weeks Spanish PROMIS Global Health v1.2 measures global physical, mental and social health. It has 10 questions, 9 of which are answered on a 5-point Likert scale and 1 question on a visual analogue scale where 0=no pain and 10=worst pain imaginable.
Doctors office visits 6 weeks to 30-34 weeks Number of Primary Care doctors office visits
Pain Catastrophizing 6-weeks to 30-34 weeks Spanish Pain Catastrophizing Scale (PCS) evaluates 3 distinct phenomenon which are characterized by feelings of helplessness, active rumination and excessive magnification associated with pain experience. The questionnaire has 13 questions and is scored on a 5-point Likert scale, 0= not at all to 4 = all the time
Trial Locations
- Locations (1)
KaiserPermanente
🇺🇸San Francisco, California, United States