Escoge Salud (Choose Health): a Chronic Pain Self-Management Program in Middle to Older Age Hispanic Americans

NCT ID: NCT04554576

Last Updated: 2022-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-14
• Study Completion Date: 2021-12-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6-week self-management and remote feedback for 6 months

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).

Group Type: EXPERIMENTAL

Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish

Intervention Type: BEHAVIORAL

The CDSMP meets for 2.5 hours for 6 weeks. Topics covered are: understanding pain, finding resources, mindfulness, pain science, pacing, exercise, relaxation, communication, sex/intimacy, healthy eating, weight and medication management, making treatment decisions and confronting fears.

Participants are encouraged to create their own personal health goals and make weekly action plans to meet their personal goals. Each week participants learn new tools and problem-solving techniques to meet their health goals and themes are repeated throughout 6-week period to ensure understanding and integration. Participants are encouraged to problem-solve and ask questions to the group about creating and carrying out their self-management plan.

The intervention follows the content of the book Programa de Manejo Personal del Dolor Crónico (Living a Healthy Life with Chronic pain)

Remote feedback active group

Intervention Type: BEHAVIORAL

After the 6-week self management program, half the participants will be randomized to an every 6 weeks for 6 months phone or video visit from a health care provider, in Spanish. The phone or video sessions will include: review previous action-plans (goals) and provide support in forming new action-plans (goals)

6-week self-management and control group for 6 months

All participants will receive the 6-week self-management program and after, half will be randomized to a 6 month control grup

Group Type: ACTIVE_COMPARATOR

Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish

Intervention Type: BEHAVIORAL

The CDSMP meets for 2.5 hours for 6 weeks. Topics covered are: understanding pain, finding resources, mindfulness, pain science, pacing, exercise, relaxation, communication, sex/intimacy, healthy eating, weight and medication management, making treatment decisions and confronting fears.

Participants are encouraged to create their own personal health goals and make weekly action plans to meet their personal goals. Each week participants learn new tools and problem-solving techniques to meet their health goals and themes are repeated throughout 6-week period to ensure understanding and integration. Participants are encouraged to problem-solve and ask questions to the group about creating and carrying out their self-management plan.

The intervention follows the content of the book Programa de Manejo Personal del Dolor Crónico (Living a Healthy Life with Chronic pain)

Remote feedback control group

Intervention Type: BEHAVIORAL

After the 6-week self-management program, half the participants will be randomized to a control group for 6 months.

Interventions

Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish

The CDSMP meets for 2.5 hours for 6 weeks. Topics covered are: understanding pain, finding resources, mindfulness, pain science, pacing, exercise, relaxation, communication, sex/intimacy, healthy eating, weight and medication management, making treatment decisions and confronting fears.

Participants are encouraged to create their own personal health goals and make weekly action plans to meet their personal goals. Each week participants learn new tools and problem-solving techniques to meet their health goals and themes are repeated throughout 6-week period to ensure understanding and integration. Participants are encouraged to problem-solve and ask questions to the group about creating and carrying out their self-management plan.

The intervention follows the content of the book Programa de Manejo Personal del Dolor Crónico (Living a Healthy Life with Chronic pain)

Intervention Type: BEHAVIORAL

Remote feedback active group

After the 6-week self management program, half the participants will be randomized to an every 6 weeks for 6 months phone or video visit from a health care provider, in Spanish. The phone or video sessions will include: review previous action-plans (goals) and provide support in forming new action-plans (goals)

Intervention Type: BEHAVIORAL

Remote feedback control group

After the 6-week self-management program, half the participants will be randomized to a control group for 6 months.

Intervention Type: BEHAVIORAL

Other Intervention Names

CDSMP for chronic pain in Spanish

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Gladin, DPT

Role: PRINCIPAL_INVESTIGATOR

senior physical therapist

Locations

KaiserPermanente

San Francisco, California, United States

Countries

United States

Other Identifiers

1326143-3

Identifier Type: -

Identifier Source: org_study_id