Integrative Medicine Group Visits: Who Does Well in the Group Visits and Who Attends the Group Visits?

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1 + Integrative Medicine Group Visits: Who Does Well in the Group Visits and Who Attends the Group Visits? Integrative Medicine for the Underserved Conference, 2018 Paula Gardiner MD MPH Man Luo MPH Salvatore D Amico BS

2 + Background 133 million Americans live with at least one chronic illness; their medical care accounts for >75% of health care spending. Most chronic illness care takes place in primary care offices; time constraints and inadequate health care systems can limit the quality of care. Complementary and alternative medicine (CAM) is also used to manage symptoms of chronic illness: Yoga for chronic low back pain Acupuncture for osteoarthritis Mindfulness-Based Stress Reduction for depression, anxiety, pain (CDC, 2009; Ostbye et al 2005; Wagner et al, 2001; Kung et al, 2008) (Cramer et al, 2013; Yeh et al, 2011; Berman et al, 2004; Khan Niazi & Khan Niazi, 2011)

3 + Background (cont.) Group medical visits might be especially beneficial to the Boston Medical Center/Community health center population Patients in this population are more likely to use fairly expensive urgent care services. The IMGV model may help avoid over use of these services

4 + Rationale Integrative Medicine Group Visits (IMGV) incorporates MBSR and Integrative medicine with a conventional group medical visit to improve the health and well-being of patients with multiple chronic conditions

5 + IMGV Model Structure of group visits 9-weekly sessions with 10 th follow up session patients 2 facilitators, clinician and meditation instructor Patients record own vitals at start of each group Discuss different health and wellness topics Learn pain self-management techniques End group with a healthy meal

6 + PCORI IMGV Grant PI: Paula Gardiner, MD, MPH RCT of IMGV vs. Standard of Care for patients with chronic pain and depression 3 years 6 pilot groups 7 Intervention groups 159 RCT participants

7 + RCT Study Flow 7 Screening Baseline and Study Enrollment Intervention or Control 9 Week Survey Maintenance 21 Week Survey Exclusion Criteria: Active suicidality Bipolar disorder or current psychosis Alcohol, Cocaine or Heroin abuse Intervention: Integrative Medical Group Visits Control: Usual Care (PCP Visits) Completed after 9 th group visit for all participants in cohort 3 month period after 9-week group visits. Intervention participants continue to have access to OWL Completed after 10 th group visit for all participants in cohort. After all participants complete their 21 week surveys that cohort is considered completed.

8 + Methods Patients were recruited across three sites Boston Medical Center Codman Square Community Health Center DotHouse Health Upon enrollment, patients completed baseline survey with a trained research assistant Collected information on age, gender, race, ethnicity, education level, work status, income, pain severity and depressive symptoms Outcome measures were collected at baseline, nine weeks and 21 weeks post enrollment

9 + Inclusion Criteria Patients age 18 years or older Have primary care provider at one of the three study sites Report chronic pain level greater than or equal to 4 on 0-10 scale for at least past 12 weeks Score of 5 or greater on PHQ-9 depression scale English comprehension sufficient to provide informed consent and participate in group medical visits

10 + Exclusion Criteria Previous participation in an IMGV group Medical condition that would prevent attendance at all group visits New pain treatment within the past month or scheduled new pain treatment within the next three months Active alcohol abuse, cocaine or heroine use Symptoms of psychosis or mania Pregnant or planning to become pregnant Actively involved in worker s compensation or personal injury lawsuit Attempted suicide within the past year

11 + Recruitment Strategies Patient lists generated using ICD-9/ICD-10 diagnosis codes for chronic pain, depression and other co-morbidities in EMR Lists sorted by PCP Providers mail recruitment letters to potentially eligible patients Flyers distributed throughout health centers Encourages patients to self-refer to study Research assistants meet with PCPs at all sites to inform them of study inclusion/exclusion criteria Providers refer potentially eligible patients through EMR or directly to study staff

12 + Recruitment Strategies (cont.) Information regarding study featured on community health center websites and BMC internal blasts to employees at study sites BUMC sponsored website with information about study for patients and providers Direct referrals or warm hand-offs at clinics On pre-scheduled days, clinics are notified that study staff will be available for direct referrals Study staff available to meet with potentially eligible participants after scheduled clinic appointments

13 + Screening and Enrollment Process Patients provide consent and are screened for eligibility according to inclusion/exclusion criteria Takes place either by phone or in person with trained RA Patients provide informed consent to study participation Baseline data collection with trained RA Patients randomized to intervention or control group RA provides patients with appropriate study materials according to treatment group

14 + Consort Diagram Boston Medical Center Codman Square Community Health Center DotHouse Health 172 screened 98 screened 73 screened 95 eligible 61 eligible 53 eligible 159 total enrolled 80 randomized to Intervention 79 randomized to Control

15 + Table 1a: Patient Characteristics Variable Age (22-84) Total Baseline (N=159) =50 (sd=12.2) Gender n % Female Male Race White Black Other Ethnicity Hispanic Non-Hispanic

16 + Table 1a: Patient Characteristics (cont.) Variable Total Baseline (N=159) Income n % Less than $5K $5K-$29.99K $30K-$74.99K 13 8 $75K and over 2 1 Refused/DK/No personal income Work Status Full/Part time Unemployed Retired/Homemaker Sick Leave/Disability Other 18 11

17 Number of Patients + Results Distribution of Attendance by number of participants who attended Numbers of Patients by Attendance to Group Sessions Number of Group Sessions Attended

18 + Demographic Data Variable Attended 4 or less sessions (N= 18) Age (22-84) =41 (sd=10.14) Attended 5-6 sessions (N=22) Attended 7 or more sessions (N=36) =47 (sd=10.85) =55 (sd=11.86) Gender N (%) N (%) N (%) Female 12 (92) 17 (77) 30 (83) Race White 1 (8) 4 (18) 5 (14) Black 9 (69) 11 (50) 23 (64) Other 3 (23) 7 (32) 8 (22) Ethnicity Hispanic 3 (23) 1(5) 6 (17) Non-Hispanic 10 (77) 21(95) 30 (83) Income < than $5K 2 (15) 1 (5) 5 (14) $5K-$29.99K 7 (54) 11 (50) 16 (45) $30K and over 1 (8) 2 (9) 3 (8) Refuse/None 3 (23) 8 (36) 12 (33) Work Status Full/Part time 3 (23) 3 (14) 8 (22) Unemployed 2 (15) 2 (9) 5 (14) Retired 1 (8) 0 (0) 8 (22) Leave/Disability 5 (39) 13 (59) 11 (31) Other 2 (15) 4 (18) 4 (11) Education Level < high school 2 (15) 5 (23) 5 (14) HS degree 5 (38) 6 (27) 11 (30) Some college 5 (38) 8 (36) 15 (42)

19 + Participants in the intervention group who attended 4 sessions or less Higher pain Pain severity Depression (PHQ score =14.23) Highest rates of opioid use (46%) Poorest sleep (PSQI score =14.46) Highest risk of opioid use (COMM score =15.08)

20 + Participants in the intervention group who attended 7 sessions or more African American Low income Working full-time Retired or on disability High school education or above

21 Average PHQ-9 Score (0-27) + Average PHQ-9 Scores by Attendance to IMGV Baseline 9 Weeks 21 Weeks Data Collection Time Points 1-4 Sessions 5-6 Sessions 7-10 Sessions Control

22 Average Pain Score (0-10) + Average Pain Scores by Attendance to IMGV Baseline 9 Weeks 21 Weeks Data Collection Time Points 1-4 Sessions 5-6 Sessions 7-10 Sessions Control

23 Percentages of Patients taking Pain Med in Past Week + Percentage of Participants Replying Yes to taking Pain Medication in the Past Week 100% 95% 90% 85% 80% 75% 70% 65% Baseline 9 Weeks 21 Weeks Data Collection Time Points 1-4 Sessions 5-6 Sessions 7-10 Sessions Control

24 + Exploratory attendance analysis of specific aim outcomes using low, medium, and high attendance to sessions Sessions attended in 9-week Sessions attended in 21-Week Average painᵖ 1.21 (0.94,1.57) 1.09 (0.87, 1.36) 1.13 (0.93,1.37) 0.85 (0.69, 1.06) 0.80 (0.67, 0.95)* 0.87 (0.76,1.00)* BPI Interferenc eᵖ 1.11 (0.86, 1.43) 0.91 (0.69, 1.21) 0.91 (0.70,1.18) 1.27 (0.96, 1.66) 1.20 (0.91, 1.59) 0.99 (0.73, 1.33) BPI Severityᵖ 1.11 (0.90, 1.36) 0.96 (0.81,1.13) 0.93 (0.77,1.11) 1.07 (0.86, 1.33) 0.94 (0.79, 1.12) 0.91 (0.75, 1.10) PHQ (0.73, 1.30) 0.72 (0.54,0.97)* 0.82 (0.62,1.08) 0.76 (0.54, 1.07) 0.67 (0.47, 0.95)* 0.70 (0.53,0.92)*

25 + Participants who attended 5 to 6 sessions 28 % reduction in depression at nine weeks (RR: 0.72, 95% CI: 0.54, 0.97) 33% reduction of depression at 21 weeks (RR: 0.67, 95% CI: 0.47, 0.95) This is clinically meaningful result as there is a 4-5 point difference in PHQ score (At baseline the average PHQ-9 score was and at 21 weeks it was 8.05).

26 + Participants who attended 7 sessions or more 30% reduction in depression (RR: 0.70, 95% CI: 0.53, 0.92) compared with participants who did not attend a PCP visit. Although not significant, there was a reduction in pain interference and pain severity in those who attended 7 or more groups at 21 weeks.

27 + Discussion Differences between the three attendance groups Participants who attended 7 or more sessions significantly decreased depression symptoms and average pain at 21 weeks Participants who attended 5 to 6 sessions significantly decreased average pain at 21 weeks and significantly decreased depression symptoms at 9 weeks and 21 weeks Participants who attended 4 or less sessions did not have any significant change in average pain and depression symptoms

28 + Discussion (cont.) Future research will focus on understanding the barriers to attendance and increasing patient s ability to attend medical group visits (telemedicine) as this seems to be a relationship in symptom reduction and attendance

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