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Physician-Delivered Interventions: The Options Project (NIMH grant 1R01 MH594378) Jeffrey D. Fisher, Ph.D., Director Center for HIV Intervention and Prevention University of Connecticut (email: jfisher@uconnvm.uconn.edu). August 3, 2001

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Physician-Delivered Interventions: The Options Project(NIMH grant 1R01 MH594378)Jeffrey D. Fisher, Ph.D., DirectorCenter for HIV Intervention and PreventionUniversity of Connecticut(email: jfisher@uconnvm.uconn.edu)

August 3, 2001

Conference sponsored by the Center for Mental Health Research on AIDS, National Institute of Mental Health (NIMH)

slide2

Project Staff

Jeffrey D. Fisher, Ph.D, Principal Investigator

University of Connecticut

William A. Fisher, Ph.D., Co-Principal Investigator

University of Western Ontario

Gerald Friedland, M.D., Co-Principal Investigator

Yale University

Deborah H. Cornman, Ph.D., Project Manager

University of Connecticut

Rivet Amico, Ph.D., Assistant Research Professor

University of Connecticut

slide3

Project Staff (Continued)

Tim Evans, Health Educator

University of Connecticut

Liz Harmon, Health Educator

University of Connecticut

Christine Woolley, Health Educator

University of Connecticut

Stephen Arnold, Abby Levine, Ianita Zlateva

University of Connecticut

Jack Ross, M.D., Investigator

Hartford Hospital

special thanks to participating health care providers

Special Thanks to Participating Health Care Providers:

Ken Abriola, MD; Frederick Altice, MD;

Nancy Angoff, MD; Martha Buitrago, MD;

Elizabeth Cooney, MD; Steve Farber, PA;

Tim Hatcher, PA; Michael Kozal, MD;

Michael Lawlor, MD; Neil Olson, MD;

Phillip Pierce, MD; Tanya Schreibman, MD;

Lynn Sullivan, MD; Jonathan Tress, MD;

Holenarasipur Vikram, MD;

Ann Williams, PhD; Madeline Wilson, MD;

Hussein Zaioor, MD

slide5

The Problem: HIV+ patients in clinical care may engage in risky behaviors that can adversely affect their own and others’ health.

gender ethnicity and age n 315
Gender, Ethnicity, and Age(N=315)

Mean Age: 43.92 (7.66), range 22.93 to 66.96

past and present injection drug use
Past and Present Injection Drug Use

About 62% of participants who were questioned reported ever having used injection drugs, while 25% reported injection drug use in the past month.

  • Of those who used injection drugs in the past month, 28% borrowed or lent uncleaned works or needles during this interval.

61% of those who have ever used injection drugs have been in recovery for a year or more.

sexual events in the preceding three months n 315 participants
Sexual Events in the Preceding Three Months(N=315 participants)

49% (155) of the whole sample reported engaging in a vaginal and/or anal sexual event in the preceding three months.

42% (65) of these individuals reported some degree of risk (events with no condom use) during one or more of these events.

in the preceding three months 155 participants engaged in 3838 vaginal and or anal sex events
In the preceding three months, 155 participants engaged in 3838 Vaginal and/or Anal Sex events

63%

2432 sex events were protected

37%

1406 sex events were unprotected

of the 1406 unprotected sex events reported by the 65 participants reporting risky sexual behaviors
Of the 1406 unprotected sex events reported by the 65 participants reporting risky sexual behaviors:

34%

(482 events) involved HIV Positive Partners

66%

(924 events) involved HIV Negative and/or Unknown Partners

potential partners exposed to hiv
Potential Partners Exposed to HIV

Our estimates indicate that in the past three months, participants engaged in risky vaginal and/or anal sex with a minimum of 391 partners of negative or unknown HIV status.

slide17
Given mounting evidenceof the transmissionof resistant strains of HIV, this is even more problematic than in the past
slide18

Co-existing with this risk, substantial numbers of patients were in Prochaska’s maintenance stage of behavior change (consistently using condoms during sex for 6 months or more)

slide19
55% of 174 participants reporting sex events over the last 3 months were in Prochaska’s maintenance stage of condom use behavior.
slide20
Health care providershave an excellent opportunity to address risky and reinforce safer behaviors in their HIV+ patients
  • Many have a trusting relationship with their patients.
  • Many have repeated contacts with their patients over long periods of time.
slide21
This affords the opportunity

for brief, repeated, provider-initiated interventions with

powerful cumulative

effects

slide22

But health care providers’ interactions with patients about patients’ risky and safer behaviors are relatively infrequent

slide23
Research reveals that sexually active HIV+ patients do not receive adequate HIV prevention counseling (Janssen et al., 2001).
  • There is great variability between health care providers in the extent to which they initiate HIV prevention discussions with HIV+ patients (Wilson & Kaplan, 2000).
slide24
A recent literature review found little evidence of rigorously evaluated, effective interventions involving health care providers attempting to assist HIV + patients with safer sex behavior (Janssen et al., 2001).
why health care providers do not discuss hiv prevention
Why health care providers do not discuss HIV prevention

Information Factors

  • Many health care providers have minimal knowledge about risk reduction strategies (Epstein et al., 1999).
  • Most have not participated in educational programs to heighten their ability to perform such interventions (Epstein et al., 1999).

Motivational Factors

  • Other issues involve lack of time, physician/patient discomfort, and confidentiality (Elford et al., 2000).
    • Some physicians are especially uncomfortable discussing sexual and drug related issues.
reasons why health care providers do not discuss hiv prevention continued
Reasons why health care providers do not discuss HIV prevention(continued)

Behavioral Skills Factors

  • Many health care providers lack the necessary skills to discuss HIV risk reduction (Elford et al., 2000).
  • Communication barriers to providers engaging in HIV risk reduction include: lack of a good “opening line,” vague language, and the provider-centered interview style (Epstein et al., 1999).
slide27

The Options Project:

A collaboration between health care providers, HIV+ patients, and researchersto assist HIV+ patients address risky behaviors

specific aims of the options project
Specific aims of The Options Project:
  • Conduct elicitation research:
    • To better understand the dynamics of HIV risk behaviors among HIV+ patients in clinical care.
    • To assess health care providers’ views about performing HIV prevention interventions.
specific aims continued
Specific aims (continued)

(2) Work with health care providers and their

patients:

  • To elicit recommendations about effective provider-initiated HIV prevention interventions for HIV+ patients in clinical care.
  • To elicit recommendations about how best to integrate HIV prevention into the day-to-day clinical care routine.
specific aims continued30
Specific aims (continued)

(3)Based on elicitation findings:

  • Design and implement the Options Project, a theoretically and empirically based provider-initiated HIV prevention program.
specific aims continued31
Specific aims (continued)

(4) Conduct long-term intervention

outcome research comparing the

experimental intervention condition

with a standard of care control

condition.

slide33

The Information - Motivation - Behavioral Skills Model of HIV Prevention

HIV Prevention Information

HIV Preventive Behavior

HIV Prevention Behavioral Skills

HIV Prevention Motivation

(J. Fisher & Fisher, 1992, 2000; W. Fisher & Fisher, 1993)

slide34

Motivational Interviewing is used as a vehicle to deliver an Information-Motivation- Behavioral Skills intervention.

step 1 setting the agenda to discuss safer sex and safer drug use
Step 1: Setting the agenda to discuss safer sex and safer drug use
  • “There are a couple of things that I talk about with all of my patients – safer sex and safer drug use. I know that these are not easy issues to talk about, but I do think that they are important ones. So I would like to spend a few minutes talking with you about these issues, if that is okay with you.”
step 2 assessing risk behavior
Step 2: Assessing risk behavior
  • “Many of my patients are finding it challenging to practice safer sex and safer needle use on a day to day basis…Now, I don’t know if these are issues for you, but if they are, I would appreciate it if you would help me to understand what this struggle is like for you. What works for you and what doesn’t, when it comes to safer sex?… [or clean needle use?]”
step 3 summarize risky behaviors and ask the patient to choose one behavior on which to focus
Step 3: Summarize risky behaviors, and ask the patient to choose one behavior on which to focus
  • “You said that you are doing [riskbehavior x] and [risk behavior y]. Let’s just focus on one of these areas for today. Which one would you prefer to talk about?”
slide40

Step 4: Determine how to proceed by first having patients rate the “importance” of changing the risk behavior they chose, and then their “confidence” that they could change it.

slide41

Importance and confidence ratings inform the provider about how to proceed by reflecting the patient’s:

  • Stage of change
  • Level of Information, Motivation, and Behavioral Skills
slide42

Assessing Importance and Confidence:

I would like to better understand how you feel about [changing behavior x or y]. Can you help me by answering a couple of questions?…

    • (1) On a scale from 0 to 10 where 0 is ‘not at all important’ and 10 is ‘extremely important,’ how important is it to you to [change or maintain this behavior]?…
    • (2) On a scale from 0 to 10 where 0 is ‘not at all confident’ and 10 is ‘extremely confident,’ how confident are you that you can [change or maintain this behavior].
slide43

Step 5: Based on Importance and Confidence scores and the Options algorithm, further explore either Importance OR Confidence

slide44

IS RATING

FOR IMPORTANCE

< 7 ?

WHICH RATING IS LOWER?

IF SAME, CHOOSE IMPORTANCE

YES

LOW

IMPORTANCE

LOW

CONFIDENCE

YES

PROBLEM-SOLVE STRATEGIES FOR OVERCOMING BARRIERS

(OR PREVENTING RELAPSE)

START

HERE

Options/Opciones Project

Algorithm

ARE RATINGS FOR BOTH

IMPORTANCE AND CONFIDENCE

9 OR 10? (often true for maintenance)

NO

NO

DISCUSS BARRIERS TO CHANGING BEHAVIOR

(OR DO RELAPSE PREVENTION IF NOT ENAGING IN ANY

RISKY BEHAVIORS)

ASK:

(1) Why is importance that score and not lower? (elicits self-motivating statements)

(2) What would need to happen to raise that score? (directs provider on how to proceed)

ASK:

(1) Why is confidence that score and not lower? (elicits self-motivating statements)

(2) What would need to happen to raise that score? (directs provider on how to proceed)

slide45
Step 6: Summarize the patient’s responses, and then elicit a menu of specific strategies from the patient for raising his or her score.
  • If the patient does not offer any strategies, ask permission to suggest some, and then provide a menu of strategies.
slide46
Step 7: Negotiate a goal or action plan with the patient by having the patient select a goal for the next clinic visit from a menu of goals.
  • Allow the patient to choose a goal that is realistic and attainable in the context of his/her life.
slide47
Step 8: Record the goal or action plan on the Options Prescription Pad and give the “behavioral prescription” the to patient.
slide48

Prevention

Date:________________

Name:____________________________________

Plan:_____________________________________

_________________________________________

_________________________________________

_________________________________________

_________________________________________

_________________________________________

____________________________

Prevention

Prescription

Date:________________

Name:____________________________________

Plan:_____________________________________

_________________________________________

_________________________________________

_________________________________________

_________________________________________

_________________________________________

____________________________

Signature

subsequent options meetings
Subsequent Options Meetings
  • Review documentation from last visit.
  • Explore what, if any, progress the patient made toward achieving the goal set on the last visit.
  • Reassess Importance and Confidence.
  • Negotiate an attainable, specific goal for the next visit.
  • Document the new goal on the Options Prescription Pad and give the new behavioral prescription to the patient.
training providers in the options protocol
Training Providers in the Options Protocol
  • We have used a four-hour didactic and interactive training (including substantial role-playing) with the following agenda:
slide51

Provider Training Agenda

  • Overview of Training
  • Project History, Background, and Theory
  • Behavior Change Exercise
  • Introduction of Motivational Interviewing
  • Overview of Intervention Protocol
  • Video Demonstration of Protocol
  • Step-by-Step Practice of Protocol
  • Practice of Entire Protocol
  • Logistics of Implementation
evaluating and ensuring intervention fidelity
Evaluating and Ensuring Intervention Fidelity
  • Intervention fidelity was ensured and evaluated with multiple methods, including…
    • Our assessment of provider delivery of the protocol with simulated patients during training and post-training booster sessions
      • training continues until our criterion is reached
    • In-vivo observation of actual protocol delivery
      • a trained observer documents provider performance with actual patients in terms of specific steps and global elements
evaluating and ensuring intervention fidelity continued
Evaluating and Ensuring Intervention Fidelity (continued)
  • Patient Exit Questionnaires
    • document the patient’s perception of whether the provider enacted critical protocol elements
  • Patient Record Forms
    • document the provider’s perception of his or her implementation of critical protocol elements
intervention fidelity
Intervention Fidelity
  • All 15 providers performed to criterion after the training and booster sessions.
  • The majority of Options/Opciones protocol implementations conform to the protocol steps.

For example…

    • Importance and Confidence were assessed 86% of the time
    • A goal was agreed upon 88% of the time
    • A behavioral prescription was given 74% of the time
feasibility of the intervention
Feasibility of the Intervention
  • The intervention was consistently implemented in the experimental arm, despite providers’ demanding schedules and time constraints
      • Thus far there have been 245 medical visits that have included the delivery of the Options/Opciones protocol. On average, an Options/Opciones patient received the intervention protocol on 80% (median) of his or her medical visits.
      • 88% (117) of baselined participants who have had a medical appointment since baseline have participated in one or more Options intervention protocol(s).
slide58

Effects on Behavior

  • As of July 2001, 157 completed pre-intervention baseline surveys had been collected in the experimental arm, while 158 baseline surveys had been collected in the control arm.
  • 6-month follow-up data was available for a total of 80 participants, 45 in the experimental arm and 35 in the control arm.
effects on behavior
Effects on Behavior

Using the completed 6 month post-intervention surveys, we sought to provide a preliminary response to the question:

Did the intervention decrease criticalriskbehaviors reported at time II for participants who had a history of such behaviors pre-intervention (i.e., risky participants)?

slide60
Critical Risk Behaviors involve unprotected vaginal, anal, and/or oral sex with partners of unknown or negative serostatus.
  • Risky Participants are individuals who practiced critical risk behaviors pre-intervention.
hypothesis
Hypothesis
  • Patients with critical risk behaviors at time I who receive the intervention (Risk Hx • Tx) will make greater gains in risk reduction than those with similar risk histories who do not receive the intervention (Risk Hx • No Tx).
statistical methods
Statistical Methods
  • Analysis of Covariance was used to assess differences in mean critical risk behaviors at time II:
    • between the Experimental and Control arm
    • between those who had critical risk behaviors at baseline and those who did not (who were probably in maintenance)
    • and the interaction of these factors
  • Pre-intervention baseline critical risk behaviors were controlled for (covaried).
statistical methods63
Statistical Methods
  • This resulted in a 2x2 Analysis of Covariance
statistical methods64
Statistical Methods
  • For these analyses we operationalized critical risk behavior in two ways:
  • Total number of unprotected vaginal, anal, and/or oral risk behaviors at time II with partners of negative and/or unknown HIV status.
  • Total number of unprotected vaginal and/or anal risk behaviors at time II with partners of negative and/or unknown HIV status.
results
Results

Marginal means of time II total critical risk behavior (including vaginal, anal, and/or oral events) with time I scores covaried showed:

A significant Intervention X Critical Risk History

interaction effect: F(1,75) = 8.763 p = .004

results66
Results
  • Those with a critical risk behavior history who received the intervention made greater gains in risk reduction than those with similar risk histories who did not receive the intervention.
  • For those who reported no history of critical risk behavior pre-intervention (most likely those in maintenance), the experimental and control groups were not different (both maintained a low base rate of risk behavior).
results67
Results
  • When oral events were removed and critical risk was defined as risky vaginal and anal events, the pattern of results were similar, though not significant (interaction term F(1,77) = 2.81, p = .098), possibly due to the low N.
limitations
Limitations
  • With only 80 completed 6-month follow-up surveys, inferences based on this data are not advisable.
  • Follow-up assessments continue to accrue and more definitive longitudinal outcome evaluation is anticipated to begin in the next few months.
  • Ultimately, with three waves of follow-up data, evaluations of outcome will provide for reasonable confidence in any inferences made from the data.
overall conclusions
Overall Conclusions
  • Patients in clinical care engage in substantial risky behaviors.
  • Although it is a complex environment, the health care setting offers an excellent context to address these behaviors over time, and in large numbers of patients.
overall conclusions continued
Overall Conclusions (continued)
  • Providers can be trained quickly and effectively in how to practice the Options protocol.
  • Patients who practice critical risk behavior pre-intervention respond well to the Options protocol, showing a decrease in critical risk behavior at time II.
future data available from the options project
Future Data Available from the Options Project
  • Definitive behavioral intervention outcome data at three post-intervention intervals (over 18 months).
  • Data on:
    • Psychosocial predictors of pre-intervention risk behavior, and of HIV risk behavior change over time.
    • Psychosocial and other factors associated with the presence of antiretroviral resistance.
    • Risk behavior patterns of individuals with antiretroviral reistance.
future data available from the options project73
Future data available from the Options Project
  • Naturalistic cohort study (using the control group) of risk behavior in HIV+ patients as a function of subjective and objective health status, treatment, antiretroviral resistance, medication adherence, and time.