Preventing Prescription Opioid Overdoses: Changing Patients Risky Opioid Use Behavior by Amy Bohnert, PhD

Preventing Prescription Opioid Overdoses:

Changing patients’ risky opioid use behavior.

Amy Bohnert, PhD

Disclosures

• Affiliations– University of Michigan

– VA Center for Clinical Management Research

• Funding– NIH (NIDA)

– CDC (UM Injury Research Center)

– VA (HSR&D, QUERI)

• Conflicts of Interest– None to report

Colleagues

• Mark Ilgen

• Fred Blow

• Matt Bair

• Erin Bonar

• Steve Chermack

• Rebecca Cunningham

• Mark Greenwald

• Kris Haenchen

• Maureen Walton

Project Staff

• Carrie Bourque

• Anna Eisenberg

• Mary Jannausch

• Lynn Massey

• Phil Nulph

• Laura Thomas

• Jing Wang

• Emily Yeagley

• Lisa Zbizek-Nulph

Acknowledgements

A behavioral intervention to

reduce overdose risk behaviors

Support: CDC R49 CE002099

Objective

• To describe a pilot randomized controlled

trial of a brief intervention (BI) to address

overdose risk in Emergency Department

(ED) patients.

Rationale

Why the Emergency Department?

• 1/3 of patients in the ED get an opioid

• Non-medical use of opioids common

• Setting of acute treatment for overdoses

Rationale (con’t)

Why a Behavioral Intervention?

• Existing data on brief motivational

interventions for substance use

• Not all overdose risk well-suited to naloxone

as a prevention approach; maximizing

potential of conversation accompanying

naloxone dispensing

• Potentially low cost

Setting

• Location: University of Michigan Emergency Department (ED)

Protocol

• Research staff approached patients while waiting for care once in

private rooms

• Consent and screen via computer tablet (Part 1)

• Those eligible recruited and consented for a baseline survey via

computer tablet (Part 2)

• Computer randomized to intervention

or enhanced usual care

Eligibility Criteria

• Past 3 month prescription opioid misuse• Positive screen on 8 items of Current Opioid Misuse

Measure (COMM)

• Age 18-60

• Able to provide informed consent

• English speaking

• Oversampled individuals with prior overdose

• Exclusion criteria: being treated for suicidality or sexual assault, active psychosis, medically unstable, altered mental status, unable to give contact information for follow-up

Intervention

• Brief Motivational Enhancement (ME) Interventions– Non-judgmental, empathetic

– Focused on increasing self-efficacy, setting goals, overcoming barriers to change

• Behavioral targets1. Reducing risky overdose-related behaviors and

opioid misuse

2. Improve response when witnessing an overdose

3. Outreach to at-risk friends

Intervention Delivery

Master’s level trained therapists

Computer aid to enhance fidelity

and provide prompts as needed

Enhanced Usual Care: pamphlets

Intervention Content Outline

EXPLORE• Introduction and Agenda Setting

• Personal Strengths and Values

• Goals

• Review Behavioral History

• Review Overdose History

• Review Witnessed Overdoses

GUIDE• Benefits to Changing

CHOOSE• Strategies to Handle Risky Situations

• Selecting Change Goals

• Tools

• Strategic Summary

Witnessing OverdosesPurpose: provide psychoeducation about responding to someone else’s overdose

Therapist Strategies: Active listening (perception of use), open-ended questions, normalize fears/concerns about responding

1. Review history of witnessing overdoses

2. Elicit participant knowledge of how to respond to an overdose

• “What have you heard/seen about responding to an overdose?”

• “What concerns would you have about responding?”

3. Provide information of overdose responses as needed

Key factors: checking for consciousness, calling 911, placing in recovery position/on

side, CPR if possible

4. Elicit participant’s response to new information

5. Review concerns about witnessed overdoses (for people I care about, for myself if I responded)

NEXT: Responding, Concerns about Overdosing Prompt

Responding to Overdoses Check for consciousness/pulse

Call 911 or take them to the ER

Roll the person on their side (recovery position) to prevent

choking if they vomit

If you know CPR, do it

Cause pain safely to try to wake them up Sternum Rub

Naloxone

What are your concerns about what might happen to you if you were to witness an overdose?

Health• I could be or become depressed• I would have contact with othersWork, School, or Financial• Legal problems for me, getting into trouble• May need to help them with financesFamily and Friends• Could lose someone I care aboutOther• Please specify:• Please specify:

Health• They could feel really bad for a couple of days • They could be or become depressed• They could die • They could have long-lasting health effects from an overdose

Work, School, or Financial• They could have legal problems • They could lose housing

Family and Friends• They could get angry with me

Other• Please specify:• Please specify:

What are your concerns about what might happen to your friend or family member if they were to have an overdose?

Sample Demographics

• N=204 completed baseline and

randomized, 177 (87%) followed at 6

months

• 64% female

• Age: mean 37 (SD=11)

• Race: 20% Black, 75% White, 5% Other

Opioid Use and Pain in the Sample

• 75% had an overdose/serious drug event history

• 56% had a chronic pain diagnosis

• 69% had been prescribed opioids in the prior 6

months

• 48% had moderate or high risk prescription

opioid involvement, per ASSIST

Examining Outcomes: regression models based on

outcome measure distribution

• Independent Variable of interest a group indicator (1=

intervention, 0=EUC only)

• Models adjusted for baseline level of the outcome

• Two-sided p < 0.05

Analysis Strategy

Outcomes

6 Month Outcomes:

Overdose Risk Behavior

Overdose Risk Behavior Items

1. How often have you used opioid pain medications when nobody else was around?

2. How often have you used opioid pain medications in a place where you don’t usually use them?

3. How often did you drink alcohol within 2 hours before or after using opioid pain medications?

4. How often did you take sedatives (such as Xanax) within 2 hours before or after using opioid pain

medications?

5. How often did you use heroin within 2 hours before or after using opioid pain medications?

6. How often did you use uppers (such as crack, cocaine, crystal/meth) within 2 hours before or after using

opioid pain medications?

7. How often have you increased the amount of opioid pain medications you used to more than you usually

use?

8. How often have you snorted any drugs?

9. How often have you injected any drugs?

Reponses options were “never (0),” “rarely (1),” “sometimes (2),” “often (3),” and “very often (4),” except for #6, which was “never (0),” “once

(1),” or “more than once (2).” Sum score range: 0-32.

Poisson regression

• The intervention group had lower ORB scores at 6 months compared to EUC.

• The percent decrease in average overdose risk behavior frequency was 40.5% in intervention participants and 14.7% in EUC only participants.

Analysis of the Overdose Risk

Behavior outcome

Model 1: Overdose Risk Behaviors, n=172

IRR SE 95% CI

Intervention Group vs. EUC only 0.72 0.07 0.59, 0.87

Baseline Level of Overdose Risk Behaviors 1.07 0.01 1.06, 1.08

Secondary Outcome: Non-Medical

Opioid Use

Current Opioid Misuse Measure Items

1. How often have you had to go to someone other than your prescribing physician to get sufficient pain

relief from opioid pain medications? (i.e., another doctor, the Emergency Room, friends, street sources)

2. How often have you taken your opioid pain medications differently from how they are prescribed?

3. How much of your time was spent thinking about opioid pain medications (having enough, taking them,

dosing schedule, etc.)?

4. How often have you needed to take opioid pain medications belonging to someone else?

5. How often have you been worried about how you’re handling your opioid pain medications?

6. How often have you had to take more of your opioid pain medication than prescribed?

7. How often have you borrowed opioid pain medication from someone else?

8. How often have you used your opioid pain medicine for symptoms other than for pain (e.g., to help you

sleep, improve your mood, or relieve stress)?

Response options were “never (0),” “rarely (1),” “sometimes (3),” “often (4),” and “very often (5);” points

based on Butler et al. Sum score range: 0-40.

Poisson regression

• Lower levels of non-medical opioid use over the six months of

follow-up in Intervention compared to EUC participants.

• Percent decrease in average COMM score was 50.0% in

intervention participants and 39.5% in EUC participants.

Analysis of the Non-Medical Opioid

Use Outcome

Model 5: Non-Medical Opioid Use, n=163

IRR SE 95% CI


Baseline Level of Non-Medical Opioid Use 1.04 0.003 1.03, 1.05

Conclusions

• BI is feasible and highly acceptable to

patients who are at risk for overdose.

• Positive findings for behavioral outcomes.

• Not a definitive trials – not powered to detect clinical

outcomes, relatively small sample size

• Not possible to validate outcomes with urine drug

screens

• Does not overcome barriers to staffing in the ED

Limitations

• Challenges to proposed chain-referral/snowball

sampling

• Challenges to assess some important risk behaviors like

total dose and breaks in use, and for assessment in the

absence of well-validated outcomes

• Potential for using motivational interviewing for harm

reduction messaging

Lessons Learned

• Trials in other settings

• NIDA R34 – Three session intervention for overdose and HIV risk

behaviors during residential addictions treatment

• VA IIR – Pragmatic trial of brief intervention overlaid on opioid informed

consent, compared to equal attention control and delivered by PC-MHI

clinicians

Next Steps

• Full-scale trial to measure health outcomes

• mHealth strategies to increase dissemination potential

• Combining with naloxone dispensing

Next Steps

Amy Bohnert

[email protected]

Comments and Unanswered

Questions?

Supplementary Slides

Detailed Sample DescriptionCharacteristic

Overall

n=204

Intervention

n=102

EUC only

n=102p-value a

Mean (SD) Mean (SD) Mean (SD)

Age 36.8 (11.1) 37.5 (11.4) 36.1 (10.9) 0.38

n (%) n n

Female 130 (64) 61 (60) 69 (68) 0.24

Race: White b 153 (75) 73 (72) 80 (78) 0.26

Black 40 (20) 24 (24) 16 (16) 0.16

Other/Missing 12 (6) 10 (10) 2 (2) 0.03

Education: High School Degree or Less 51 (25) 27 (26) 24 (24) 0.80

Some College 91 (45) 46 (45) 45 (44)

Competed College 62 (30) 29 (28) 33 (32)

Employment Status: Disabled 75 (37) 40 (39) 35 (35) 0.31

Full- or Part-Time Employment 93 (46) 42 (41) 51 (51)

Unemployed 31 (15) 19 (19) 12 (12)

Retired 4 (2) 1 (1) 3 (3)

Prior Overdose (any) 153 (75) 77 (75) 76 (75) 0.87

Number of past year ED visits: 0 25 (12) 12 (12) 13 (13) 0.06

1-2 76 (37) 32 (31) 44 (43)

3-5 57 (28) 37 (36) 20 (20)

6+ 46 (23) 21 (21) 25 (25)

Past 3 Month Substance Use

Any Alcohol Use 124 (61) 54 (53) 70 (69) 0.02

Use Frequency: Weekly or Greater 51 (25) 21 (21) 30 (29) 0.15

Any Marijuana Use 77 (38) 39 (38) 38 (37) 0.89


Any Cocaine Use 19 (9) 9 (9) 10 (10) 1.00


Any Non-Medical Sedative Use 44 (22) 26 (26) 18 (18) 0.17


Chronic Pain Diagnosis, Lifetime c 115 (56) 57 (56) 58 (57) 0.89

Prescribed Opioids in Prior 6 Months, Self-Reported 0.13

None 64 (31) 32 (31) 32 (31)

For Acute Pain Only 37 (18) 19 (19) 18 (18)

For Chronic Pain Only 38 (19) 13 (13) 25 (25)

For Acute and Chronic Pain 65 (32) 38 (37) 27 (26)

Prescription Opioid Involvement, ASSIST 0.85

Low Risk 106 (52) 51 (50) 55 (54)

Moderate Risk 80 (39) 42 (41) 38 (37)

High Risk 18 (9) 9 (9) 9 (9)

Key Element Description Therapist Goals and MI Strategies

EXPLORE

Introduction: Agenda

Setting

Thank for participation

Set agenda and discuss autonomy

Answer client questions

Develop rapport and set plan

Affirm participation

Personal Strengths and

Values

Identify personal strengths in the domains of health, work,

school, financial, family and social connections, and other

Affirm strengths

Remember later for strategic summary and other tools

Goals Identify personal goals in the domains of health, work, school,

financial, family and social connections, and other

Establish goals

Active listening, identifying discrepancies, open-ended

questions, reflect and affirm goals, summarize

Review Behavioral History Review prescription opioid use frequency and reasons for use,

concurrent use of other medications, alcohol use, and other

drug use

Identify personal risky opioid use behaviors

Open-ended prompts

Active listening

Role with resistance

Review Overdose History Discuss prior overdose experience(s)

Elicit concerns about overdose in the future for self and others

Identify personal history of overdose

Open-ended prompts

Active listening

Role with resistance

Establish discrepancy between values/goals and behavior

Review Witnessed

Overdoses

Review history of witnessed overdoses

Elicit participant knowledge of overdose response actions

Provide information as needed

Review concerns about witnessed overdose for self and victim

Open-ended prompts

Active listening

Normalize fears/concerns

GUIDE

Benefits of Changing Elicit potential benefits to making changes to opioid use and

overdose risk

Eliciting and elaborating change talk, clarify ambivalence

Repeat steps for reducing personal overdose risk and outreach

to others

Open-ended prompts

Reflections and affirmations

Confidence and importance rulers

CHOOSE

Risky Situations Elicit current strategies to reduce risk

Provide information on additional strategies

Elicit reaction to potential new strategies

Open-ended prompts

Active listening

Roll with resistance

Transition to concerns, impact of use, future use

Selecting Change Goals Select goals for reducing personal overdose risk, response to

witnessed overdose, and outreach to others about overdose

Open-ended prompts

Active listening

Reflections and affirmations

Tools Elicit tools to help deal with challenges

Review menu of options for risk reduction

Confidence rulers

Reflections and explore change talk, affirmations

Recall strengths

Summary Address readiness to change

Strategic summary of session

Readiness rulers

Affirmations

All Models

Primary Outcomes

Model 1: Overdose Risk Behaviors, n=172

IRR SE 95% CI


Baseline Level of Overdose Risk Behaviors 1.07 0.01 1.06, 1.08

Model 2: Behavioral Intentions, n=169

IRR SE 95% CI


Baseline Level of Behavioral Intentions 1.04 0.004 1.03, 1.05

Model 3: Overdose Risk Knowledge, n=169

IRR SE 95% CI


Baseline Level of Overdose Risk Knowledge 1.05 0.03 1.01, 1.10

Model 4: Overdose Symptom Knowledge, n=172

B SE 95% CI

Intervention Group vs. EUC only 0.10 0.15 -0.20, 0.40


Secondary Outcome

Model 5: Non-Medical Opioid Use, n=163

IRR SE 95% CI


Baseline Level of Non-Medical Opioid Use 1.04 0.003 1.03, 1.05

Response options were on a scale of 1 (“Not Likely”) to 10 “Very Likely”). Sum score range 3-30.

Outcome 2 – Behavioral Intentions

Behavioral Intentions

1. If you receive an opioid prescription, how likely it is that you would use prescription

opioids as prescribed by a medical professional?

2. How likely is it that you will reduce or avoid using alcohol, drugs, and/or medications

(recreationally)?

3. How likely is it that you will avoid combining alcohol, drugs, and/or medications?

Poisson regression

• No difference between groups.

• Note: higher levels indicate less intention to reduce overdose risk.

Analysis of the Behavioral

Intentions Outcome

Model 2: Behavioral Intentions, n=169

IRR SE 95% CI


Baseline Level of Behavioral Intentions 1.04 0.004 1.03, 1.05

Outcome 3 - KnowledgeOverdose Knowledge d

Risk Factors: For each item, please check “Yes” for the items that you believe can lead to an overdose or “No” if you believe it

cannot cause an overdose.

(1) Taking more alcohol, drugs, and/or medications than usual

(2) Taking less alcohol, drugs, or medications than usual*

(3) Having an illness

(4) Drug impurities

(5) Drugs, alcohol and/or medications stronger than expected

(6) Injecting drugs

(7) Using drugs at a young age*

(8) Combining drugs

(9) Combining different medications

(10) Drinking alcohol with drugs and/or medications

(11) Combining drugs and medications

(12) Low tolerance

(13) Emotional problems or life difficulties

(14) Suicide attempt.

Symptoms: For each item below, please check “Yes” for the items that you believe to be a symptom of an overdose or “No” if

you believe it is not a symptom of overdose:

(1) Shallow breathing

(2) Turning blue

(3) Bloodshot eyes*

(4) Loss of consciousness

(5) Deep snoring

(6) Pinpoint pupils

(7) (7) Blurred vision*

* Denotes intentionally incorrect item that was reverse coded for scoring. Sum score

range 0-14 for risk factors and 0-7 for symptoms.

Poisson and Linear Regression models

• No difference between groups.

• Note: overdose risk knowledge reverse coded.

Analysis of the Knowledge

Outcomes

Model 3: Overdose Risk Knowledge, n=169

IRR SE 95% CI



Model 4: Overdose Symptom Knowledge, n=172

B SE 95% CI

Intervention Group vs. EUC only 0.10 0.15 -0.20, 0.40


Health & Medicine

Preventing Prescription Opioid Overdoses: Changing Patients Risky Opioid Use Behavior by Amy Bohnert, PhD