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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish
Remote feedback active group
Remote feedback control group
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Hispanic American, Latino, self-management training, sustainability, health care utilization

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KaiserPermanente

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

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

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Self Efficacy
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.
Patient Reported Outcome Measurement Information System (PROMIS) Global Health
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
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.
Health Distress
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 Satisfaction
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 Global Impression
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.

Secondary Outcome Measures

Doctors office visits
Number of Primary Care doctors office visits
Emergency Room use
Number of Emergency Room visits
Self Efficacy
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.
PROMIS Global Health
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.
Pain Catastrophizing
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
Health Distress
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

Full Information

First Posted
January 2, 2020
Last Updated
May 26, 2022
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT04554576
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Hispanic American, Latino, self-management training, sustainability, health care utilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6-week self-management and remote feedback for 6 months
Arm Type
Experimental
Arm Description
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).
Arm Title
6-week self-management and control group for 6 months
Arm Type
Active Comparator
Arm Description
All participants will receive the 6-week self-management program and after, half will be randomized to a 6 month control grup
Intervention Type
Behavioral
Intervention Name(s)
Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish
Other Intervention Name(s)
CDSMP for chronic pain in Spanish
Intervention Description
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
Intervention Name(s)
Remote feedback active group
Intervention Description
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
Intervention Name(s)
Remote feedback control group
Intervention Description
After the 6-week self-management program, half the participants will be randomized to a control group for 6 months.
Primary Outcome Measure Information:
Title
Self Efficacy
Description
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.
Time Frame
baseline to 6-weeks
Title
Patient Reported Outcome Measurement Information System (PROMIS) Global Health
Description
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.
Time Frame
baseline to 6-weeks
Title
Pain Catastrophizing
Description
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.
Time Frame
baseline to 6-weeks
Title
Health Distress
Description
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.
Time Frame
baseline to 6-weeks
Title
Patient Satisfaction
Description
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.
Time Frame
baseline to 6-weeks
Title
Patient Global Impression
Description
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.
Time Frame
baseline to 6-weeks
Secondary Outcome Measure Information:
Title
Doctors office visits
Description
Number of Primary Care doctors office visits
Time Frame
6 weeks to 30-34 weeks
Title
Emergency Room use
Description
Number of Emergency Room visits
Time Frame
6 weeks to 30-34 weeks
Title
Self Efficacy
Description
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.
Time Frame
6-weeks to 30-34 weeks
Title
PROMIS Global Health
Description
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.
Time Frame
6-weeks to 30-34 weeks
Title
Pain Catastrophizing
Description
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
Time Frame
6-weeks to 30-34 weeks
Title
Health Distress
Description
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
Time Frame
6-weeks to 30-34 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Major psychiatric or substance abuse problem Mild cognitive impairment/dementia Malignant pain or terminal illness Listed in the Non-contact database
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Gladin, DPT
Organizational Affiliation
senior physical therapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
KaiserPermanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study will share de-identified health status pre/post and healthcare utilization information to other investigators upon request
IPD Sharing Time Frame
December 2019 to December 2020
IPD Sharing Access Criteria
Available to Investigators upon request

Learn more about this trial

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

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