This website was made possible by funding from ViiV Healthcare, a global specialist HIV company established in 2009, majority owned by GSK, with Pfizer and Shionogi as shareholders

The PROgress Project: Implementing Patient Reported Outcomes Within Routine HIV Care.

• Helping patients share information with their doctor about their health, situation, needs and preferences that may otherwise not be discussed
• Improving patient provider discussions and relationships to facilitate better-informed care and improve clinical efficiency

The PROgress project, “Improving HIV Care Through The Implementation Of PROs within Routine Patient Management,” is a ViiV Healthcare sponsored research workstream in collaboration with the University of Washington. The goal of the project is to collate and supplement evidence, insights and resources that can support the implementation of patient reported outcomes and measures (PROs) within routine HIV care.

PROgress included work on three core interrelated components:
1.   The PROgress North American Site Study: This is an implementation science study of the integration of PROs in routine care within two North American HIV outpatient clinics.
2.   The PROgress Implementation Toolkit: This is a practical resource developed for health care practitioners considering the implementation of PROs within routine clinical HIV care.
3.   The PROgress Evidence Review and Summary: This collates evidence relevant to PROs in the care of PLWH, highlighting the potential of a well implemented process within routine HIV care to benefit PLHIV, providers and clinics.

Each were designed as complementary outputs of PROgress, to support future HIV practice.

This website is a collation of outputs from PROgress, drawing upon the expertise and insights of patients, providers, and researchers involved in the workstream.

Updated 1 November 2020.

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What are PROs?

In the context of this evidence review, we focus on brief PRO assessments useful for clinical care, typically but not always collected on touch-screen tablets at the start of clinic appointments to improve care with summary results made available to providers for the clinic visit. Other approaches are also possible such as interviewer-based collection or electronic health record patient portals; however, we emphasize these much less due to the high costs, staff burden, and under-reporting of risk behaviors with interviewer-based approaches, and the exclusion of so many potentially high-risk patients with patient portals that require a level of technological sophistication and access that is not inclusive of entire HIV clinic populations.

Patient reported outcome measures, or PROs, gather patients’ assessments and experiences of clinically important issues, typically through brief, validated questionnaires. PROs offer insight beyond what may be directly observable by the provider in several dimensions of care.

PROs may include one or more dimensions of care: physical symptoms; mental health (e.g, depression, anxiety); health behaviors (e.g., medication adherence, substance use, sexual risk behavior); functioning (e.g., cognitive, physical); life circumstances (e.g., current housing, nutrition, family history of chronic illness, intimate partner violence); identity (e.g., sexual orientation, gender identity); social well-being (e.g., social support, HIV stigma); health-related quality of life (HRQL); and patient satisfaction with care.

On-site PRO collection prior to routine clinical care appointments, via hand-held computer tablets with real-time results available to providers during clinic visits, has improved provider ability to detect and address depression/suicidal ideation, inadequate antiretroviral (ART) adherence, and substance use in HIV care ^1,2 . Integrating PROs into clinical care of patients with chronic conditions, such as HIV, cancer and rheumatoid arthritis, have also been shown to be acceptable to patients and providers and valuable in clinical care ^2-4 ; they have improved patient-provider communication ^5-9 and increased patient satisfaction with care ^8,10-12.

The Value For HIV Providers

Improve identification of health issues and behaviors through improved patient-provider communication

PROs have been valuable in helping providers detect previously unrecognized problems ^1,2. Controlled trials have found PROs improve provider ability to identify highly personal or stigmatizing symptoms or behaviors, including suicidal ideation, depression ^1,13 , substance use ¹ ,inadequate ART adherence ¹ , and sexual behavior ¹⁴ . PROs have also improved detection of a broad range of symptoms in several clinical populations ^7,15-20 as well as less-observable quality-of-life issues, such as social functioning ^5,8,14,21.

Improve patient health outcomes

Evidence suggests the use of PROs has contributed to improved health outcomes including fewer emergency department visits and hospitalizations ^22,23 , increased survival rates among cancer patients ^22,23 , improved outcomes for mental health conditions ²⁴ , lower symptom distress ^16,17,25 and better health-related quality of life ⁷ .

Workflow impact

Providers reported PROs allowed for more comprehensive identification of issues and concerns that was generally regarded as an additional but manageable impact on workflow that was regarded as a valuable tradeoff. Both patients and providers described high acceptability of PROs in routine care and high added value.

Sample PRO results page

Value For Patients

Optimize your care

Patients living with HIV have found the use of PROs improved communication with their provider in a number of ways. Specifically, it has 1) offered an opportunity to take inventory of current health needs, symptoms, health behaviors, and quality of life, including mental health and social well-being, improving their ability to advocate for their needs; 2) offered a preview in advance of the appointment of potential topics for discussion; and 3) helped patients to initiate, structure and prioritize discussion topics with their provider. 4) enabled easier discussion of sensitive or highly personal topics, such as mental health, sexual health, and substance use.²⁸ .

Improve health outcomes

Sample PRO results page

Honestly, I was surprised at how useful I was going to find it….I figured my patients and I have a pretty good relationship…they're gonna tell me all these things. [But I was] hearing things I hadn't heard before. You're almost glancing behind a curtain.
-HIV Physician

It really did a lot for me because you had a lot of questions that I probably wouldn't have asked the doctor, or she probably wouldn't have asked me.
-Patient living with HIV

From HIV Providers and Patients Living with HIV

Two key areas for which patients and providers believed PROs had an impact: ^2,26,27

1) Identifies and helps address less-observable and difficult-to-discuss behaviors and conditions (examples include suicide ideation, depression, anxiety, alcohol use, substance use, IPV, adherence and treatment satisfaction)
From HIV providers:	From patients living with HIV:
Today, the patient sat down [and] said, “Yeah, things are okay, I’m just not sleeping good.” But when I looked at the PROs that he had just answered, he was suicidal a couple of times last week. -(Physician, San Diego)	It's a lot different to say things in person because you're scared of the facial expressions, you're scared of the reactions. The iPad is not going to look at you because you say you do crack every day, it's not going to do that…. so you can be a lot more open when you're doing it with the iPad by yourself. So…if you don't feel comfortable talking to a doctor about it at first it's a lot easier at least when they come in [with the iPad PRO results] and they already know. -(Patient, Ft. Pierce, FL)
I didn’t know the extent of one guy’s alcohol use ... we hadn’t talked about it for some time. So it’s actually quite useful to say “here’s what you told the [PROs], let’s talk more about that”. -(Physician, Boston)	I feel like the computer is impartial. It’s completely impartial. I think it’s harder [to answer PRO questions] if it’s somebody you know all the time. You don’t want to let them down. -(Patient, Ft. Pierce, FL)
[If] you look at someone and they're clearly distraught, maybe tearful and that sort of thing, you can engage in questions around that. But as everyone knows… you can mask that stuff very easily. People do it all the time every day. And unless prompted or asked specifically around depression and suicidal ideation, people won't admit to it…there's also a big stigma and shame around mental health issues. So unless it was very obvious … I wouldn't [have asked]. And in these cases, these are literally people that I don't think I would have flagged...at the end of the day, the best element of this tool is, if nothing else, it helps us engage in a topic or conversation that would be awkward otherwise. -(Physician, Toronto)	I find that it's easier to answer to an iPad than it is to a person. I found certain questions, like the alcohol question, I was a little more honest about on the iPad versus [in person]– because I feel like you're expecting a judgmental look back, even though my doctor is actually extremely great no matter what I've done –or not done. [Answering PROs on an iPad] takes away from that,– because [results are] on a sheet of paper, someone else is going to make their look while they're reading it, so you don't have to see it. You don't have to acknowledge it. -(Patient, Toronto)
Honestly, I was surprised at how useful I was going to find it….I figured my patients and I have a pretty good relationship…they're gonna tell me all these things. [But I was] hearing things I hadn't heard before. You're almost glancing behind a curtain. -(Physician, Ft. Pierce, FL)

2) Improves patient-provider communication, helping both patients and providers to initiate, structure and prioritize discussion topics
From HIV providers:	From patients living with HIV:
You have the whole picture of what needs to be addressed in that visit, what we are missing, which normally, like I said, you won't be able to ask so many questions in such a short period of time. So to me, it's a great tool. -(Physician, Ft. Pierce, FL)	…maybe if I…already have an idea of what the question gonna be, the person asked me, I wouldn't even answer, yeah. But just the fact that I already read it and aware of it, so when the question asked, I was more prepared -(Patient, Toronto)
It’s a nice starting point with a conversation as opposed to the more traditional, you know, starting at the bottom and working up.-(Physician, Birmingham)	It really did a lot for me because you had a lot of questions that I probably wouldn't have asked the doctor, or she probably wouldn't have asked me. -(Patient, Ft. Pierce, FL)
Patients always have their agenda when they’re coming in, but through the PROs they’re also getting a sense of what our agenda is ... what I found interesting was that a few of the patients who completed the [PROs], they’ll kind of launch and tell me what’s going on with their tobacco use – without my even asking ... -(Physician, Seattle)	The questionnaire is a good thing, because I imagine not everybody does come mentally prepared in terms of having questions and a goal, "I should have asked at the doctor that. Why didn't I ask him that when I was there?" So this is a good way for both parties, the doctor and the patient, to receive and give information. -(Patient, Toronto)
It makes patients feel as if they're more involved in their care and that's important -(Physician, Ft. Pierce, FL)

Clinical Topics Measured by PROs

PROs cover a broad range of topics clinically relevant to patients living with HIV, including symptoms, mental health, health behaviors, basic needs, social context, and quality of life. A resulting report summarizes results and displays topics of interest in order of clinical priority, and can depict changes over time. Alerts for critical issues such as significant anxiety or distress, interference with function, or suicidal ideation, may be sent to an appropriate provider or displayed to the patient, depending on whether the patient is within or outside a clinical setting when using the PROs. The following are just a sample of PRO measures, and is non-exhaustive.

Mental Health

Common PRO measures of mental health include the PHQ-9 ^29,30 for depression, the PHQ-5 ^29,30 and GAD-7 ³¹ for anxiety.

Substance Use

Common PRO measures of substance use include the AUDIT-C/AUDIT ^32,33 (alcohol use), and the ASSIST ^34,35 (drug use). A measure by Bruneck et al ³⁶ measures tobacco use. Past substance use treatment may be assessed via the Treatment Services Review. ³⁷

Antiretroviral Adherence

PRO measures available include the adherence Self-Rating Scale, 30-day visual analog scale, AACTG adherence instruments (7 day missed dose, last missed dose, weekend missed dose). ^38-40

Sexual Risk Behavior

Sexual risk behavior is measurable via the Sexual Risk Behavior Inventory ⁴¹ , which includes perceived partner attributes such as gender, HIV status, and ART/PrEP use, as well as concern for recent STI exposure.

Basic Needs

Basic needs include housing, and nutrition. Housing status is assessable via the CNICS Housing Measure ⁴² ; an option for measuring nutrition is the Canadian Nutrition Screening Tool ⁴³ .

Social Environment

Measures to evaluate social environment and circumstance include Multifactorial Assessment of Perceived Social Support-Short Form (MAPSS-SF) ⁴⁴ and the HIV Stigma Mechanism Measure ⁴⁵ (adapted)

Quality of Life

The EQ-5D ⁴⁶ is a commonly-used measure of health-related quality of life and PozQoL is an emerging option. Specific questions from the HATQOL are also used in the PROgress Study.

Symptom Tracking

Symptoms and level of severity is measurable via the HIV Symptom Index. ⁴⁷

Exposure to Violence

The Intimate Partner Violence 4-item measure (IPV-4) ⁴⁸ is a brief measure assessing physical, sexual, and psychological violence. The Adverse Childhood Experiences-International Questionnaire (ACE-IQ) ⁴⁹ (adapted) assesses childhood household violence prior to age 18.

Sample PRO Results Page

PRO results reporting can be tailored to suit the needs of any clinic. Modifiable aspects of PRO results reporting include highlighting/prioritization of the most clinically urgent topics through use of placement, bold font, or color; the use of multiple time points to note change over time; and style and degree of scoring and interpretation needed. In addition, responses to clinically urgent questions, such as suicidal ideation, can be programmed to trigger pager alerts in real time for relevant staff.

PROgress Implementation Toolkit

The PROgress Implementation Toolkit provides practical advice to support the introduction of clinical PRO assessments into routine HIV care. These insights draw from a range of sources, including practical experience integrating PROs into HIV clinical care, published literature, and primary interviews with stakeholders with experience integrating PROs into HIV clinical care. Its focus is on implementation of tablet-based patient self-administered PRO assessments in clinical care yet many of the lessons are applicable across different types of applications. The toolkit includes information on:

Assessing clinic readiness and preparing for PRO implementation
Stakeholder engagement strategies
Building and/or selecting technical infrastructure for electronic data collection
Creating a PRO assessment that best suits the needs of your clinic and its patients, including an online time-budget tool to minimize patient response burden and impact on clinic flow
PRO integration and sustainability success
Staff training needs
Monitoring and evaluating successful PRO integration

PROgress Evidence Review and Summary

An evidence summary document has been collated to raise awareness of the potential value of well implemented PRO instruments within routine HIV care. It draws upon evidence from published literature characterizing the impact of PROs in routine clinical care for patients with chronic comorbidities, including HIV-related literature as well as other fields, particularly oncology. It includes real-world evidence surrounding the impact on patient outcomes, care processes, and the usability and acceptability of PRO platforms.

Evidence Review and Summary PDF

PROgress North American Site Study Summary

The PROgress study implemented patient-reported measures and outcomes (PROs) in two HIV outpatient clinical care settings to answer two overarching research questions:

What is the added value of implementing PROs into routine HIV care for the salient stakeholders, including the patient, the providers, and other clinic staff?
What are the essential program elements that can improve the sustainable adoption and implementation of PROs into routine HIV care across a range of differently resourced clinics?

The two North American outpatient HIV care clinics were:

Midway Specialty Care Center, Fort Pierce, Florida, USA.
St. Michael’s Hospital, Toronto, Ontario, Canada.

The PRO assessments included measures of symptoms (e.g., depression, anxiety), behaviors (e.g. adherence to antiretroviral therapy (ART), substance use), and other circumstances and perspectives (e.g., housing status, intimate partner violence, HIV medication satisfaction).

Using an implementation science framework (RE-AIM) and a mixed methodology quantitative and qualitative approach, we sought effectiveness and implementation insights. Data collection included 1761 completed patient PROs, 600 chart reviews, 47 qualitative interviews, 200 patient questionnaires, 17 provider questionnaires, training evaluations and a significant volume of implementation data and insights.

RESULTS:
Reporting of the results will be made available on this website as we publish our findings in peer reviewed journals and at conferences. These will also be integrated into the PROgress Evidence Review and Summary

Published Posters from 2020

Fredericksen RJ. Short D. Fitzsimmons E. Musten A. Jacobs B. Suri S. Korlipara D. Hodge V. Gough K. Ramgopal M. Bacon J. McReynolds J. Lober W. Crane HM. Patient perceptions of the utility and impact of a same-day self-administered routine electronic patient-reported outcomes (PRO) assessment in HIV care in two North American clinics. Virtual poster presentation, ISOQOL 27th Annual Conference, October 2019.

ISOQOL Patient Acceptability Poster

Fredericksen RJ. Short D. Fitzsimmons E. Musten A. Jacobs B. Suri S. Korlipara D. Hodge V. Gough K. Ramgopal M. Bacon J. McReynolds J. Lober W. Crane HM. Provider perceptions of utility and impact of a same-day routine electronic patient reported outcomes (PRO) assessment in clinical HIV care. Virtual poster presentation, ISOQOL 27th Annual Conference, October 2020.

ISOQOL Provider Acceptability Poster

References and Acknowledgements

This website was made possible by funding from ViiV Healthcare, a global specialist HIV company established in 2009, majority owned by GSK, with Pfizer and Shionogi as shareholders. We thank the patients, providers, and research staff from two PROgress Study clinics, Midway Specialty Care in Ft. Pierce, FL, and St. Michael’s Hospital in Toronto, ON, for their rich insights and commitment to this work. We thank the staff of the Ontario HIV Treatment Network and affiliated clinics for their continued collaborative partnership in advancing the role of PROs in HIV care. We also thank the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS), and the University of Washington Clinical Informatics Research Group (CIRG), for provision of resources and expertise in development of this website. Finally, we thank the PROgress Study Steering Committee, comprised of an expert panel of patients living with HIV, HIV care providers, clinic directors, and health care researchers, for their oversight and guidance.

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