Trial Outcomes & Findings for Patient Activation to Address Chronic Pain and Opioid Management in Primary Care (NCT NCT02290223)

Results Overview

The Patient Activation Measure (PAM) is a 13-item instrument for measuring patient beliefs, knowledge and confidence for engaging in a wide range of health behaviors.Each item is rated 1-4 (strongly disagree =1 to strongly agree=4) and a total raw score is generated (0-52). Raw scores are converted to activation scores using a published conversion table. PAM scores are reported on a 1-100 scale, with higher scores associated with positive health outcomes such as participation in health care and treatment adherence.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

376 participants

Primary outcome timeframe

Baseline and 6 and 12 months post randomization

Results posted on

2019-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Patient Activation Group Intervention The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Baseline STARTED	189	187
Baseline COMPLETED	189	187
Baseline NOT COMPLETED	0	0
6 Months STARTED	189	187
6 Months COMPLETED	173	181
6 Months NOT COMPLETED	16	6
12 Months STARTED	182	187
12 Months COMPLETED	166	176
12 Months NOT COMPLETED	16	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Patient Activation Group Intervention The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
6 Months Lost to Follow-up	9	6
6 Months Withdrawal by Subject	5	0
6 Months deceased (not related to study)	2	0
12 Months Lost to Follow-up	16	10
12 Months Refusal	0	1

Baseline Characteristics

Patient Activation to Address Chronic Pain and Opioid Management in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.	Total n=376 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 13.7 • n=5 Participants	60.7 years STANDARD_DEVIATION 12.4 • n=7 Participants	59.8 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	114 Participants n=5 Participants	105 Participants n=7 Participants	219 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	82 Participants n=7 Participants	157 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	153 Participants n=5 Participants	150 Participants n=7 Participants	303 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	141 Participants n=5 Participants	139 Participants n=7 Participants	280 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Patient Activation Measure	65.8 units on a scale STANDARD_DEVIATION 15.0 • n=5 Participants	65.2 units on a scale STANDARD_DEVIATION 15.9 • n=7 Participants	65.5 units on a scale STANDARD_DEVIATION 15.4 • n=5 Participants
Pain intensity	6.7 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	6.7 units on a scale STANDARD_DEVIATION 1.6 • n=7 Participants	6.7 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.

The Patient Activation Measure (PAM) is a 13-item instrument for measuring patient beliefs, knowledge and confidence for engaging in a wide range of health behaviors.Each item is rated 1-4 (strongly disagree =1 to strongly agree=4) and a total raw score is generated (0-52). Raw scores are converted to activation scores using a published conversion table. PAM scores are reported on a 1-100 scale, with higher scores associated with positive health outcomes such as participation in health care and treatment adherence.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Patient Activation baseline	65.8 units on a scale Standard Deviation 15.0	65.2 units on a scale Standard Deviation 15.9
Patient Activation 6 months	67.3 units on a scale Standard Deviation 13.8	67.7 units on a scale Standard Deviation 14.5
Patient Activation 12 months	67.7 units on a scale Standard Deviation 14.8	66.6 units on a scale Standard Deviation 14.0

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.

The PROMIS Global Health score was used to assess general perceptions of health and quality of life. The 10 items that comprise the Quality of Life scale are reported as two dimensions, mental health and physical health. Raw scores for PROMIS Global Physical Health were converted to standardized T-scores using published conversion tables.T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Thus, a person who has T-score of 60 is one standard deviation better (more healthy) than the general population.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Quality of Life: Physical Health baseline	38.3 T score Standard Deviation 6.3	38.2 T score Standard Deviation 6.1
Quality of Life: Physical Health 6 month	40.2 T score Standard Deviation 6.7	39.9 T score Standard Deviation 7.0
Quality of Life: Physical Health 12 month	40.9 T score Standard Deviation 7.6	39.0 T score Standard Deviation 6.3

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.

The PROMIS Global Health score was used to assess general perceptions of health and quality of life. The 10 items that comprise the Quality of Life scale are reported as two dimensions, mental health and physical health. Raw scores for PROMIS Global Mental Health were converted to standardized T-scores using published conversion tables.T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Thus, a person who has T-score of 60 is one standard deviation better (more healthy) than the general population.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Quality of Life: Mental Health 12 month	47.8 T score Standard Deviation 8.0	46.2 T score Standard Deviation 7.8
Quality of Life: Mental Health baseline	45.8 T score Standard Deviation 9.4	45.1 T score Standard Deviation 8.3
Quality of Life: Mental Health 6 month	47.4 T score Standard Deviation 8.1	46.9 T score Standard Deviation 8.3

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. Measure of overall health is based on a single item/rating: "In general, would you say your health is:". Answers are reported on scale 1-5, with 1=poor to 5=excellent. Average raw scores are reported, with higher scores reflecting higher functioning.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Overall Health baseline	2.7 units on a scale Standard Deviation 0.9	2.6 units on a scale Standard Deviation 0.9
Overall Health 6 month	2.8 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 0.9
Overall Health 12 month	2.7 units on a scale Standard Deviation 0.9	2.4 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.

Depression was measured using the Patient Health Questionnaire-9 (PHQ-9), a reliable and well validated instrument. Mean scores are reported in range 0-27, with higher score indicating severity of depression: mild (5-9), moderate (10-14), moderately severe (15-19) and over 20 indicating severe depression.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
PHQ-9 Depression baseline	6.7 score Standard Deviation 5.3	7.0 score Standard Deviation 5.3
PHQ-9 Depression 6 month	5.6 score Standard Deviation 5.1	6.2 score Standard Deviation 5.6
PHQ-9 Depression 12 month	5.5 score Standard Deviation 4.8	6.2 score Standard Deviation 4.7

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.

Satisfaction with primary care provider is reported on a scale from 1-10, where "1" is the worst possible care and "10" is the best possible care. Mean scores are reported, and higher scores indicates more satisfaction with care.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Satisfaction With Care baseline	8.6 units on a scale Standard Deviation 1.8	8.6 units on a scale Standard Deviation 1.7
Satisfaction With Care 6 month	8.5 units on a scale Standard Deviation 1.8	8.6 units on a scale Standard Deviation 1.8
Satisfaction With Care 12 month	8.7 units on a scale Standard Deviation 1.7	8.5 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: The numbers at 6/12 months are lower than at baseline due to lost to follow up/withdrawals. In addition, the denominators for 6/12 month SOAPP are lower than other outcomes because questions were ONLY asked if participants took opioids at 6/12 (therefore, 36 excluded at 6 months, n=19 INT, n=17 UC, and 44 excluded at 12 months, n=25 INT, n=19 UC).

The Screener and Opioid Assessment for Patients in Pain (SOAPP-5) is a 5 item survey used to identify aberrant behaviors related to long-term opioid treatment. Each item is rated 0 to 4 (with 0=never and 4=very often); ratings are added for all 5 items resulting in a range of possible scores 0-20. A higher score indicates greater risk for patients on long term opioids, and a score of =\> 4 is considered positive. Results reported are the number and % of participants who score =\> 4.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Opioid Misuse SOAPP baseline	48 Participants	59 Participants
Opioid Misuse SOAPP 6 months	28 Participants	28 Participants
Opioid Misuse SOAPP 12 months	25 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: The numbers at 6/12 months are lower than at baseline due to lost to follow up/withdrawals. In addition, the denominators for 6/12 month COMM are lower than other outcomes because questions were ONLY asked if participants took opioids at 6/12 (therefore, 36 excluded at 6 months, n=19 INT, n=17 UC, and 44 excluded at 12 months, n=25 INT, n=19 UC).

The Current Opioid Misuse Measure (COMM) is used to identify aberrant behaviors related to long-term opioid treatment. It is a clinical screening tool for monitoring patients for opioid overuse and misuse in six areas. The COMM contains 17 items with total score range of 0-68, and a score of 9 or greater is considered positive. It uses a low cut off value as it is intended to over-identify misuse. Results reported are the number and % of participants who score =\> 9.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Opioid Misuse COMM 6 months	22 Participants	25 Participants
Opioid Misuse COMM 12 months	14 Participants	22 Participants
Opioid Misuse COMM baseline	57 Participants	68 Participants

SECONDARY outcome

Timeframe: 6 and 12 months post randomization

Population: For brevity purposes, the baseline values are not included in the table (n=189 intervention and n=187usual care). There were 354 participants included in the 6 mo analysis (n=173 intervention and n=181 usual care) and 342 participants in 12 mo analysis (n=166 intervention and n=176 usual care).

The 42-item Chronic Pain Coping Inventory (CPCI) is used to assess behavioral and cognitive pain coping strategies. It contains 8 subscales: Guarding, Resting, Asking for Assistance, Relaxation, Task Persistence, Exercising/Stretching, Coping Self-Statements, and Seeking Social Support. For each subscale, patients were asked the number of days (0-7 days) he/she performed each task (4-7 tasks). The mean score for each subscale is reported, with possible range of scores 0-7. The CPCI was developed to assess the behavioral coping strategies that are taught and encouraged during treatment (eg, relaxation, exercising, task persistence), ones that are discouraged (eg, guarding, resting, asking for assistance), and one neutral strategy (seeking social support). Active strategies are defined as adaptive coping responses (eg, staying busy or active), and higher scores are associated with positive coping.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=173 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=181 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Pain Coping 6 month Guarding	3.6 units on a scale Standard Deviation 1.9	3.7 units on a scale Standard Deviation 1.8
Pain Coping 6 month Resting	4.3 units on a scale Standard Deviation 1.8	3.9 units on a scale Standard Deviation 2.0
Pain Coping 12 month Resting	3.8 units on a scale Standard Deviation 1.7	3.8 units on a scale Standard Deviation 2.0
Pain Coping 6 month Asking for assistance	2.5 units on a scale Standard Deviation 2.2	2.7 units on a scale Standard Deviation 2.3
Pain Coping 12 month Asking for assistance	2.5 units on a scale Standard Deviation 2.3	2.5 units on a scale Standard Deviation 2.4
Pain Coping 6 month Task persistence	4.8 units on a scale Standard Deviation 1.8	4.7 units on a scale Standard Deviation 1.7
Pain Coping 12 month Task persistence	4.9 units on a scale Standard Deviation 1.8	4.7 units on a scale Standard Deviation 1.8
Pain Coping 6 month Exercise/stretching	3.2 units on a scale Standard Deviation 1.9	3.1 units on a scale Standard Deviation 2.0
Pain Coping 6 month Seeking social support	2.9 units on a scale Standard Deviation 2.1	2.8 units on a scale Standard Deviation 2.1
Pain Coping 12 month Seeking social support	3.0 units on a scale Standard Deviation 2.1	2.8 units on a scale Standard Deviation 2.2
Pain Coping 6 month Coping self-statements	4.5 units on a scale Standard Deviation 2.0	4.4 units on a scale Standard Deviation 2.1
Pain Coping 12 month Guarding	3.4 units on a scale Standard Deviation 2.0	3.6 units on a scale Standard Deviation 2.0
Pain Coping 6 month Relaxation	3.0 units on a scale Standard Deviation 1.8	2.5 units on a scale Standard Deviation 2.0
Pain Coping 12 month Relaxation	2.9 units on a scale Standard Deviation 2.0	2.3 units on a scale Standard Deviation 1.9
Pain Coping 12 month Exercise/stretching	3.3 units on a scale Standard Deviation 2.1	2.8 units on a scale Standard Deviation 2.0
Pain Coping 12 month Coping self-statements	4.5 units on a scale Standard Deviation 2.1	4.4 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

Pain Self-Efficacy Questionnaire (PSEQ) is an established 10-item measure of pain self-efficacy that is widely used in clinical settings to assess confidence in one's ability to work and lead a normal life despite pain. Each item is rated on a 7-point scale with 0= not at all confident and 6=extremely confident. A total score is calculated by summing the scores for each of 10 items, yielding max score of 60. A higher score indicates higher self-efficacy.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Self-Efficacy baseline	34.1 units on a scale Standard Deviation 13.3	35.7 units on a scale Standard Deviation 13.4
Self-Efficacy 6 months	40.2 units on a scale Standard Deviation 12.6	39.6 units on a scale Standard Deviation 13.1
Self-Efficacy 12 months	42.3 units on a scale Standard Deviation 11.8	40.0 units on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

Measured with the Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument. PROMIS is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. Pain intensity is assessed using a single item ("How would you rate your pain, on average?"). The average raw score is reported on scale 1-10, with 1=no pain to 10= worst imaginable.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Pain Intensity 6 month	5.9 units on a scale Standard Deviation 1.8	5.9 units on a scale Standard Deviation 1.9
Pain Intensity 12 month	5.8 units on a scale Standard Deviation 2.1	6.1 units on a scale Standard Deviation 1.7
Pain Intensity baseline	6.7 units on a scale Standard Deviation 1.4	6.7 units on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. This function domain is based on a single item: "To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair?" Answers are reported on scale 1-5, with 1=not at all to 5=completely. Average raw scores are reported, with higher scores reflecting higher functioning.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Function: Everyday Physical Activities baseline	3.4 units on a scale Standard Deviation 1.0	3.3 units on a scale Standard Deviation 1.0
Function: Everyday Physical Activities 6 month	3.4 units on a scale Standard Deviation 1.1	3.4 units on a scale Standard Deviation 1.1
Function: Everyday Physical Activities 12 month	3.6 units on a scale Standard Deviation 1.1	3.3 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. This function domain is based on a single item: "In general, please rate how well you carry out your usual social activities and roles. (This includes activities at home, at work and in your community, and responsibilities as a parent, child, spouse, employee, friend, etc.)" Answers are reported on scale 1-5, with 1=poor to 5=excellent. Average raw scores are reported, with higher scores reflecting higher functioning.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Function: Social Activities and Roles baseline	3.3 units on a scale Standard Deviation 1.1	3.1 units on a scale Standard Deviation 1.1
Function: Social Activities and Roles 6 month	3.3 units on a scale Standard Deviation 0.9	3.3 units on a scale Standard Deviation 1.0
Function: Social Activities and Roles 12 month	3.3 units on a scale Standard Deviation 1.0	3.1 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

The Communication Assessment Tool (CAT) measures patients' perceptions of physician performance with regard to communication and interpersonal skills. It is a 14-item instrument that asks respondents to rate their primary primary care physician based on the last couple of visits. The answers are reported using a 5-point rating scale, with 1=poor to 5=excellent. Average scores are reported.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Patient Provider Communication 12 month	4.3 units on a scale Standard Deviation 1.0	4.2 units on a scale Standard Deviation 1.0
Patient Provider Communication baseline	4.3 units on a scale Standard Deviation 0.8	4.2 units on a scale Standard Deviation 0.9
Patient Provider Communication 6 month	4.2 units on a scale Standard Deviation 1.0	4.2 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

The Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) is used to measure patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians.Ten questions are measured on a scale from 1 (not at all confident) to 5 (very confident) and the range of possible scores is 10-50. Average scores are reported, with higher score reflecting more confidence in interacting with his/her physician.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Patient Provider Interactions baseline	43.4 units on a scale Standard Deviation 7.8	43.3 units on a scale Standard Deviation 7.9
Patient Provider Interactions 6 month	44.9 units on a scale Standard Deviation 6.6	44.7 units on a scale Standard Deviation 6.9
Patient Provider Interactions 12 month	45.6 units on a scale Standard Deviation 6.8	45.9 units on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: EHR data were extracted for all study participants who remained active Kaiser members in the follow-up period, regardless of whether they completed the follow-up surveys or not. Due to incomplete membership in the follow-up period, 13 people were excluded from the 6-month EHR outcomes, and 16 people were excluded from the 12-month EHR outcomes.

Primary care services (number of non-urgent outpatient visits) and acute care services (number of emergency room (ER) visits and inpatient stays) within KPNC as extracted from the electronic health records are reported. Average number of visits are reported for 6 month period prior to baseline, for 3 months prior to 6 month interview, and 6 months prior to 12 month interview. For all three time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Health Care Utilization Service Visits (EHR) 6 month Inpatient stays	0.0 visits Standard Deviation 0.3	0.0 visits Standard Deviation 0.2
Health Care Utilization Service Visits (EHR) baseline primary care visits	2.9 visits Standard Deviation 3.3	2.7 visits Standard Deviation 2.5
Health Care Utilization Service Visits (EHR) 6 month primary care visits	1.2 visits Standard Deviation 1.6	1.2 visits Standard Deviation 1.5
Health Care Utilization Service Visits (EHR) 12 month primary care visits	2.9 visits Standard Deviation 3.0	2.7 visits Standard Deviation 3.5
Health Care Utilization Service Visits (EHR) baseline ER visits	0.4 visits Standard Deviation 0.7	0.5 visits Standard Deviation 1.9
Health Care Utilization Service Visits (EHR) 6 month ER visits	0.1 visits Standard Deviation 0.4	0.2 visits Standard Deviation 0.5
Health Care Utilization Service Visits (EHR) 12 month ER visits	0.3 visits Standard Deviation 0.8	0.3 visits Standard Deviation 0.9
Health Care Utilization Service Visits (EHR) baseline Inpatient stays	0.1 visits Standard Deviation 0.4	0.2 visits Standard Deviation 0.5
Health Care Utilization Service Visits (EHR) 12 month Inpatient stays	0.1 visits Standard Deviation 0.3	0.1 visits Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: EHR data were extracted for all study participants who remained active Kaiser members in the follow-up period, regardless of whether they completed the follow-up surveys or not. Due to incomplete membership in the follow-up period, 13 people were excluded from the 6-month EHR outcomes, and 16 people were excluded from the 12-month EHR outcomes.

Use of Kaiser's online portal is extracted from electronic health record. Results are reported as number and % of patients who used the portal during specified time periods: 1) 6 month period prior to baseline, 2) 3 months prior to 6 month interview, and 3) 6 months prior to 12 month interview. For all three time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Health Care Utilization Portal Use (EHR) baseline	168 Participants	157 Participants
Health Care Utilization Portal Use (EHR) 6 month	164 Participants	152 Participants
Health Care Utilization Portal Use (EHR) 12 month	160 Participants	156 Participants

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

Use of Kaiser's online portal (kp.org) was reported by participants on questionnaire at baseline, 6 and 12 months. Participants were asked different ways in which portal was used, and if they used kp.org's health and wellness resources (healthy lifestyle programs, wellness coaching, audio podcasts, recipe blogs, tools/calculators, videos). Results reported here are number and % of patients who reported using Kaiser's online health and wellness resources during specified time period ("ever" at baseline, and "past 6 months" at 6/12 months).

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Use of Online Health and Wellness Resources (Self-reported) baseline	47 Participants	42 Participants
Use of Online Health and Wellness Resources (Self-reported) 6 month	68 Participants	50 Participants
Use of Online Health and Wellness Resources (Self-reported) 12 month	76 Participants	50 Participants

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

Attendance at Kaiser's health education classes was reported by participants on questionnaire at baseline, 6 and 12 months. Results are reported as number and % of patients who attended health education class during specified time period ("ever" at baseline, and "past 6 months" at 6/12 months).

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Attendance at Health Education Classes (Self-reported) baseline	113 Participants	108 Participants
Attendance at Health Education Classes (Self-reported) 6 month	22 Participants	20 Participants
Attendance at Health Education Classes (Self-reported) 12 month	22 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: EHR data were extracted for all study participants who remained active Kaiser members in the follow-up period, regardless of whether they completed the follow-up surveys or not. Due to incomplete membership in the follow-up period, 13 people were excluded from the 6-month EHR outcomes, and 16 people were excluded from the 12-month EHR outcomes.

Opioid prescription dispensations were extracted from electronic health records and converted into morphine milligram equivalent (MME), by multiplying the quantity of each prescription by the strength of prescription (milligrams of opioid/unit dispensed). The resulting product is then multiplied by the conversion factor for MMEs. We calculated the average daily MME dispensed for the relevant time periods. Results are reported for 3 time periods: 1) 6 months prior to baseline, 2) 3 months prior to 6 month interview, and 3) 6 months prior to 12 month interview. For all 3 time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Prescription Opioid Use (EHR) Baseline	35.8 MME Standard Deviation 68.9	32.1 MME Standard Deviation 43.8
Prescription Opioid Use (EHR) 6 months	30.4 MME Standard Deviation 64.3	28.2 MME Standard Deviation 35.5
Prescription Opioid Use (EHR) 12 months	28.0 MME Standard Deviation 70.7	25.3 MME Standard Deviation 32.9

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

Participants were asked to identify which of the following they were currently using to manage their pain: opioid medication prescribed by a doctor; non-opioid medication prescribed by a doctor; over the counter medication; complementary/alternative medicine; meditation, relaxation, or mindfulness practice; pain classes or therapy; massage or other bodywork; exercise, stretching or physical therapy; or other. Results are reported as number and percent of participants who endorsed "mindfulness, meditation and relaxation". Only the outcomes with significant differences between two arms at 6 and/or 12 months are reported.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Pain Management Strategies- Mindfulness, Meditation and Relaxation Baseline	64 Participants	50 Participants
Pain Management Strategies- Mindfulness, Meditation and Relaxation 6 months	75 Participants	45 Participants
Pain Management Strategies- Mindfulness, Meditation and Relaxation 12 months	61 Participants	34 Participants

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

Participants were asked to identify which of the following they were currently using to manage their pain: opioid medication prescribed by a doctor; non-opioid medication prescribed by a doctor; over the counter medication; complementary/alternative medicine; meditation, relaxation, or mindfulness practice; pain classes or therapy; massage or other bodywork; exercise, stretching or physical therapy; or other. Results are reported as number and percent of participants who endorsed "exercise, stretching or physical therapy". Only the outcomes with significant differences between two arms at 6 and/or 12 months are reported.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Pain Management Strategies- Exercise, Stretching or Physical Therapy Baseline	108 Participants	95 Participants
Pain Management Strategies- Exercise, Stretching or Physical Therapy 12 months	127 Participants	100 Participants
Pain Management Strategies- Exercise, Stretching or Physical Therapy 6 months	120 Participants	123 Participants

SECONDARY outcome

Timeframe: baseline

Participants were asked at baseline about their long-term goals for using prescription opioids for pain management. Results are presented as number and percent who wanted to stay the same/increase use, and number and percent who wanted to decrease or stop use of prescription opioids.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Goals for Opioid Use at Baseline Stay same/increase use	67 Participants	76 Participants
Goals for Opioid Use at Baseline Decrease/stop use	122 Participants	111 Participants

SECONDARY outcome

Timeframe: 6 and 12 months post-randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

Participants were asked at 6 and12 months to what extent they felt they met goals for opioid use stated at baseline. Results are presented as number and percent who reported "to a great extent"/"somewhat", vs. "very little"/"not al all".

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Met Baseline Goals for Opioid Use at 6 and 12 Months 12 months · To a great extent/somewhat	131 Participants	127 Participants
Met Baseline Goals for Opioid Use at 6 and 12 Months 12 months · Very little/not at all	35 Participants	45 Participants
Met Baseline Goals for Opioid Use at 6 and 12 Months 6 months · To a great extent/somewhat	131 Participants	132 Participants
Met Baseline Goals for Opioid Use at 6 and 12 Months 6 months · Very little/not at all	42 Participants	49 Participants
Met Baseline Goals for Opioid Use at 6 and 12 Months 6 months · missing	0 Participants	0 Participants
Met Baseline Goals for Opioid Use at 6 and 12 Months 12 months · missing	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and 6 and 12 month post-randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. Categories do not add up to number analyzed because answer were "check all that apply" and multiple answers per respondent were allowed.

Participants were asked about 9 categories of substance use in past 3 months, based on NIDA-modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Results are reported as number and percent for three categories: prescription/street opioids, cannabis and sedatives/sleeping pills. Remaining categories (cocaine, methamphetamines, stimulants, inhalants) were collapsed into "other" category.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Substance Use Baseline substance use : Cannabis	23 participants who used given substance	29 participants who used given substance
Substance Use Baseline substance use : Sedatives/sleeping pills	53 participants who used given substance	51 participants who used given substance
Substance Use Baseline substance use : Opioids	160 participants who used given substance	173 participants who used given substance
Substance Use Baseline substance use : Other	11 participants who used given substance	10 participants who used given substance
Substance Use 6 month substance use : Cannabis	19 participants who used given substance	20 participants who used given substance
Substance Use 6 month substance use : Sedatives/sleeping pills	35 participants who used given substance	35 participants who used given substance
Substance Use 6 month substance use : Opioids	135 participants who used given substance	147 participants who used given substance
Substance Use 6 month substance use : Other	3 participants who used given substance	1 participants who used given substance
Substance Use 12 month substance use : Cannabis	22 participants who used given substance	17 participants who used given substance
Substance Use 12 month substance use : Sedatives/sleeping pills	51 participants who used given substance	43 participants who used given substance
Substance Use 12 month substance use : Opioids	132 participants who used given substance	147 participants who used given substance
Substance Use 12 month substance use : Other	6 participants who used given substance	2 participants who used given substance

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post-randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

The number and percent of participants who report "heavy drinking" in past 3 months are reported at baseline and 6 and 12 months. Heavy drinking is defined as 5+ drinks per day or 15+ drinks per week for males under age 65, and 4+ drinks per day or 8+ drinks per week for females and males over age 65.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Alcohol Use 12 months	8 Participants	8 Participants
Alcohol Use baseline	11 Participants	10 Participants
Alcohol Use 6 months	8 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline and 6 and 12 months post-randomization

Population: Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.

Participants were asked how many days they had smoked cigarettes in past 30 days at baseline, 6 and 12 months. Results are reported as number and percent who reported they smoked cigarettes on at least one day in past 30 days.

Outcome measures

Outcome measures
Measure	Patient Activation Group Intervention n=189 Participants The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week plus usual care which is is determined by patients' individual providers, according to practice guidelines related to specific conditions. Behavioral Based Treatment Model: The experimental procedure is a behavioral based treatment model, structured in the form of four group sessions, one meeting per week.	Usual Care n=187 Participants Usual care is determined by patients' individual providers, according to practice guidelines related to specific conditions.
Tobacco Use Baseline	26 Participants	27 Participants
Tobacco Use 6 months	17 Participants	24 Participants
Tobacco Use 12 months	15 Participants	18 Participants

Adverse Events

Patient Activation Group Intervention

Serious events: 16 serious events

Other events: 0 other events

Deaths: 2 deaths

Usual Care

Serious events: 26 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Monique Does, Project Manager

Kaiser NCAL Division of Research

Phone: 510-891-3612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place