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Adult Health Outcomes Research

Health Outcomes Research by Investigator

Larry Allen:

"A Multicenter Trial of a Shared Decision Support Intervention for Patients and their Caregivers Offered Destination Therapy for End-Stage Heart Failure."


Informed by pilot work, stakeholder input, and International Patient Decision Aid Standards, we have developed decision aids to help people with severe heart failure considering DT LVAD. We now aim to test the implementation and dissemination of a DT shared decision making process that includes these decision aids. Specifically we will:
1. Evaluate the ability of the DT decision making process to reach its target audience.
2. Test the effectiveness of the DT shared decision making process to improve patient and caregiver experiences.
3. Assess the adoption, implementation, and maintenance of the DT shared decision making process across stakeholder groups.
Our objectives align with PCORI’s desire for “increasing patient and caregiver awareness of healthcare options” and “participation in care decisions and in shared decision making”.


We propose to test the decision aid using a stepped-wedge cluster-randomized controlled trial design where 6 participating medical centers are transitioned from their current process to a DT LVAD decision making process that incorporates the paper and video decision aid (total N ~120 patients). We will employ the RE-AIM framework to evaluate the implementation and dissemination, including site surveys and questionnaires of patients and their caregivers, with comparisons within each institution before and after implementation of the intervention.2

 Patient Outcomes (Projected)

The primary outcome will be improvement in knowledge of DT LVAD. Secondary outcomes shall include how well decisions agree with patient and caregiver values, and the amount of decision regret. The study will also characterize how the intervention reaches the target audience, is adopted by key personnel, is consistently implemented, and maintained over time. 3


Daugherty (Submission)

Using values affirmation to reduce the effects of perceived discrimination on hypertension disparities


Over 80% of African Americans report experiences of discrimination in the past year; perceived discrimination is linked to health disparities including poor adherence. Poor adherence may contribute to the high prevalence of uncontrolled hypertension in African Americans. We propose an innovative approach using values affirmation to overcome the threat of discrimination to increase patient activation, improve adherence and thereby reduce disparities in hypertension outcomes. Our proposal is based upon our pilot study demonstrating a brief values affirmation exercise done immediately before a clinic visit resulted in improved communication between African American patients and providers during the visit and suggested improved medication adherence 6-months after the visit. We propose to advance our prior work and fill gaps in the evidence by conducting a randomized controlled trial comparing a values affirmation exercise to a control exercise among 1100 patients with hypertension from three health systems. The primary outcome is 6-month change in adherence to antihypertensive therapies with the secondary outcome of change in blood pressure. We will also explore possible mechanisms of the intervention effect and formally evaluate for dissemination.1


  • In aim 1, we will compare the effects of the values affirmation exercise to a control exercise on antihypertensive medication adherence in African American patients across three clinical settings.  We hypothesize patients randomized to values affirmation will have greater adherence change at 6-months compared to controls and the effect will be partially moderated by patient factors (prior experiences of discrimination), independent of provider factors (implicit racial bias, past disparities training, self-efficacy caring for minority patients) and mediated by patient activation.
  • In aim 2, we will compare the effects of values affirmation exercise in African American patients to its effects in white patients with hypertension.  We hypothesize that values affirmation will improve adherence to a greater degree in African American patients suggesting the intervention is targeting perceived discrimination related to race.
  • In aim 3, we will formally evaluate the intervention for widespread dissemination using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework. We hypothesize the intervention will have favorable characteristics for widespread dissemination within primary care.


The project is innovative, as it will use a novel intervention that has not been widely applied in the healthcare setting.  Since values affirmation is not specific to hypertension or African Americans, this study will be the first to provide evidence for a low-resource intervention that has the potential to reduce healthcare disparities across a wide range of health care conditions and populations.3


Russell E. Glasgow

“Understanding How Local Health Care Adaptions Affect Primary Care” 
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A study on how primary care settings adapt evidence-based interventions to local circumstances. The project will develop a conceptual model of adaptations relevant to primary care delivery and validate the model for primary care practices that implemented the target interventions.1


The Foundation's initiative, Innovations in Evaluation, was designed to integrate practice and theory for the field of evaluation through four innovative evaluation projects.Under this project, the researchers will study how primary care settings adapt two evidence-based interventions to local circumstances--in Phase 1, focusing on the Prescription for Health program, funded by the Robert Wood Johnson Foundation to incorporate prevention into primary care, and in Phase 2, focusing on the Patient-Centered Medical Home intervention as implemented in Colorado. The investigators will develop a conceptual model of adaptations relevant to primary care delivery and validate the model for primary care practices that implemented these two interventions. Analysis will identify clusters and types of adaptations, their frequency, and whether they are associated with outcomes that improved, worsened, or did not change. Dissemination will include publications, how-to guides, workshops, and webinars.2

Bill Henderson/Patty Braun

"Evaluation of dental Hygienist Co-Location."

 Specific Aims

Specific Aim 1: Recruit Colorado medical practices to participate in the Co-Location 2.0 Program
Timeline: October 2014 – December 2014
Through a Competitive Request for Application (RFA) process administered by DDCF, Colorado medical practices will be recruited and selected to participate in the Co-Location 2.0 Project. The COR research team will work with Dr. Braun and the DDCOF staff to write the RFA, review all applications, establish selection criteria, and ultimately select the Colorado practices. 
Deliverables: List of selected practices will be submitted by December 15, 2014.
Specific Aim 2: Assist in recruitment and hire of RDHs to co-locate into selected medical practices.
Timeline: October 2014 - September 2015
The selected medical practices will be responsible for the recruitment and hiring of their dental hygienist.  The COR research team and Dr. Braun, along with DDCOF program, will provide technical assistance to the medical practices as needed to complete this aim.
Deliverables: List of hired dental hygienists for Phase I will be submitted by March 31, 2015 and for Phase II by May 31, 2016.
Specific Aim 3. Educate the medical and dental staff of all participating medical practices on the Cavity Free at Three oral health promotion and prevention model.
Timeline: October 2014 – December 2015
The COR research team and Dr. Braun will help coordinate the delivery of the Cavity Free at Three Curriculum to all selected practices. They will work with the Cavity Free at Three Team at CDPHE in these efforts. The CDPHE team will provide the basic Cavity Free at Three training to all selected co-location practices. The COR research team and Dr. Braun will provide expert consult to the CDPHE team and participate in as many trainings as practically possible to best ensure the “buy-in” of the participating practices in the Co-Location Program.
Deliverables: List of completed training dates and practice evaluations of trainings will be submitted in conjunction with the bi-annual progress reports.
Specific Aim 4. Support the practice-specific development of medical-dental integration with co-located dental hygienists in medical practices.

 Timelines and Deliverables

Timeline: Support will be provided throughout duration of project.
The COR research team, in collaboration with the DDCOF Program staff and Dr. Braun, will provide ongoing technical assistance and practice coaching to all practices selected to participate in the Co-Location Program. The COR research team and Dr. Braun will help lead the DDCOF Associate Program Officer in the implementation of the AHRQ-sponsored Tool Kit: Integrating Chronic Care and Business Strategies in the Safety Net as described in the Evaluation Proposal. In summary, the Integration Steps include:
a.       Create supportive strategies for and eliminate barriers to RDH Co-Location.
a.       Build consensus with the practices
b.      Facilitate adoption of the medical-dental integration model.
c.       Empower the practice to be actively involved.
d.      Align practice leadership with program goals.
e.      Develop practice plan to introduce the project to practice staff.
f.        Assist practices to build program team.
b.      Actively coach practice program team to gradually implement the medical-dental integration model into practice. 
c.       Gradually withdraw technical support as practice program team becomes more comfortable and functional with the practice change.
Deliverables: Progress reports of all practice coaching activities will be submitted as part of bi-annual progress reports. A Co-Location Took Kit will be submitted by September 30, 2016. A Co-Location White Paper will be completed by December 30, 2017.
Specific Aim 5. Evaluate the Dental Hygienist Co-Location 2.0 Program.
The COR research team and Dr. Braun will carry out the multi-level (practice-level, parent/caregivers-level, and child-level) evaluation of Co-Location Program. The COR research team and Dr. Braun will develop the evaluation strategy and all necessary measures to successfully complete the evaluation. The COR research team and Dr. Braun will guide the analyses of the multi-level data and the development and publication of peer-reviewed manuscripts describing the program and program evaluation.
Deliverables: At least 2 nationally-presented abstracts and at least 1 publication in a peer-reviewed journal will be submitted by September 30, 2019.
The research team will provide Project Reports to DDCOF every six months, as outlined in the Special Conditions section.


Fred Masoudi

"Improving the Care of Persons with Complex Health Needs:  Realigning the Patient, Primary Care and Specialty Care Relationship Toward Patient-Centered Care."

This is a three year implementation grant to pilot, evaluate, and begin to create demand for a new patient goals directed care approach that aligns primary and specialty care to what patients with complex conditions want and need. Dr. Masoudi, representing the perspective of cardiologists, will be integrally involved in the development of the primary/specialty technical assistance component. Dr. Masoudi will also participate as a representative of the American College of Cardiology, as we engage national provider organizations to review and modify the technical assistance and training materials.  Dr. Masoudi, along with Dr. Michael Parchman, will help lead efforts that promote wider dissemination and uptake of Carealign.



Colleen McIlvennan

"An Acceptability and Feasibility Study of Decision Aids for Patients and Their Caregivers Considering Destination Therapy Left Ventricular Assist Device."
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Shared decision making is important for preference-sensitive decisions such as destination therapy left ventricular assist device (DT LVAD). Based upon a detailed needs assessment with diverse stakeholders, pamphlet and video decision aids (DAs) for DT LVAD were developed to help patients and their caregivers think through, forecast, and deliberate their options. These DAs are the foundation of the DECIDE-LVAD project, a randomized-controlled trial aimed at understanding the effectiveness and implementation of a shared decision support intervention for patients considering DT LVAD.1


With medicine’s expanding array of life-prolonging technologies, older and sicker people are
increasingly offered invasive interventions. The use of one such therapy, the left ventricular assist
device (LVAD), is growing rapidly among people dying from end-stage heart failure who are ineligible
for heart transplant. These patients elect to live out the remainder of their lives dependent on a partial
artificial heart – so called “destination therapy” (DT). Of the 6,000,000 Americans with heart failure, up
to 250,000 are potentially eligible for DT LVAD.
DT LVAD is a stark example of the difficult decisions created by new technologies for people with
end-stage illness. For eligible patients who decide not to get a device, 2-year survival is <10%. With
DT LVAD 2-year survival is approximately 70%. But there are risks: stroke (11%), serious infection
(33%), severe bleeding (25%), and reoperation (10%). Additionally, patients must be connected to
electricity at all times. Chronic conditions that make patients transplant ineligible persist. Further,
substantial burden is placed on family caregivers.
In a 2012 American Heart Association Scientific Statement, the co-investigators championed shared
decision making for DT LVADs. Our prior research shows problems with current DT LVAD decision
making, including: 1) hospital variation; 2) overly complicated consent forms; 3) use of biased industry
materials; and 4) fear among patients and caregivers. In response, we have worked with a diverse
group of patient, caregiver, provider, and policy-maker stakeholders to develop a patient/caregiver
decision aid in both pamphlet and video formats.
We now propose a single-center pilot study to gain valuable implementation information prior to
entering in to a multicenter trial.

 Specific Aims

Specific Aim 1: Examine acceptability and feasibility of a decision aid to improve decision making for
patients and caregivers offered DT LVAD.
a. Measure the acceptability of the decision aids using the decision aid acceptability scale;
b. Measure the feasibility by evaluating the proportion of patients offered DT LVAD who
ultimately were recruited, consented, and delivered the decision aids;
c. Conduct a preliminary assessment of outcomes by assessing decision quality (knowledge and
value concordance), decision conflict, decision regret, decision choice, and decision
Specific Aim 2: Determine the relative value of the decision aids through in-depth interviews from
study participants.


Beth McManus

"The effect of Part C eligibility policy change."


This project will examine the relationship between Part C eligibility and therapy service utilization, therapy access-sensitive utilization, and spending among infants and toddlers with developmental delays and disabilities. Restricting Part C eligibility appears, on the surface, to be a way for states to reduce spending.  However, reductions in access to therapy can potentially lead to increased cost and utilization downstream if the needs of infants and toddlers with developmental delays and disabilities are not met.  With the implementation of the Affordable Care Act, states will increasingly be faced with policy decisions related to Medicaid program funding.  Restricting eligibility for Part C will continue to be an option for states even though the relationship between eligibility and total spending is not well understood.  This proposed research will address the R40 MCH Policy Analysis program goals including assessing 1) MCH Title V programs to inform the design and implementation of the ACA and 2) coordination of efforts between Medicaid and Title V and Strategic Research Issue III: Services and Systems to Assure Quality of Care for MCH population.1

 Research Design

This policy analysis will utilize a “natural experiment” (difference-in-difference design using existing de-identified claims data from three State Medicaid Programs: Colorado, which restricted eligibility during the sample period, and two comparison states, Washington and North Carolina, which did not. Among the primary study population of children 0-18 years of age who were enrolled in fee-for-service Medicaid programs in these states, from January 1, 2006 to December 31, 2010, we will create a sub-sample for each state that includes infants and toddlers (ages birth to 36 months) with a diagnosis of developmental disability or developmental delay.2


Dependent variables are therapy service utilization intensity and costsIntensity or total dosage of therapy service delivery will be calculated based upon type, frequency, and duration of services. Therapy access-sensitive utilization will include hospitalizations and increased use of medications. Costs will be calculated based upon fee-for-service rates. Econometric models will be used to describe the effect of restricting EI eligibility on 1) therapy service dosage, 2) occurrence and number of therapy access-sensitive events, and 3) costs.3


Previous studies of children’s therapy service utilization have been criticized for 1) reliance on parent-report, and 2) limitations for causal inference.  In this study, administrative claims databases will be utilized to derive therapy service utilization and  the robust study design will allow for causal inference.4


Lisa Schilling

"Agency for Healthcare Research and Quality: R01 HS022956 SAFTINet: Optimizing Value and Achieving Sustainability."  

Goal: This project seeks to enhance the capabilities of an existing data network, the Scalable Architecture for Federated Translational Inquiries Network (SAFTINet), by improving its ability to answer impactful questions about the best health care treatments and the best way to provide health care, with special emphasis on the medically disadvantaged.


Stevens-Lapsley - Submitted

R03 proposal in response to Program Announcement PA-15-147, entitled: “Developing Individualized Estimates of Patient Prognosis Following Knee Replacement.”


In the United States, TKA is an elective procedure—the most common inpatient elective procedure performed (~700,000 per year)—but it is also a serious surgery with an unpredictable course of recovery. The current standard for postoperative planning and rehabilitation monitoring relies on the average patient prognosis (APP)—or the estimated trajectory of recovery for the average patient. Thus, rehabilitation strategies remain protocol-based (e.g. 3x/week for 6 weeks), assuming the same general recovery for all patients. However, given the heterogeneity in the population, this standard is inadequate. A more appropriate approach would be to estimate the individual patient prognosis (IPP), or the anticipated trajectory of recovery for this patient, at this point in time. Patients and providers could use such estimates to weigh the appropriateness of surgery and develop individualized rehabilitation plans. Moreover, physical therapists could better detect deviations from expected recovery throughout rehabilitation, thereby improving rehabilitation monitoring. The focus of this application is to develop IPPs through use of novel methodologies that allow for the prediction of a new patient’s post-TKA prognosis on the basis of previous patients with similar characteristics. This approach—often referred to as the “nearest neighbors” or “patients-like-me” approach—has yet to be applied in rehabilitation science. Furthermore, we plan to utilize a database of measures collected in routine clinical practice, developed in partnership with clinicians at Proaxis Physical Therapy (see letter of support), to enable the estimation of IPPs in a clinical population that is not exposed to the eligibility criteria (and associated selection bias) of research studies. Thus, we also anticipate an improved representation of minority populations in this study. 1


Our approach involves a two-phase process for estimating prognosis in three key areas: a) pain, b) self-reported function, and c) physical performance. First (Aim 1), we will develop predictive models for postoperative (6-month) outcomes, using a comprehensive battery of preoperative measures, spanning domains of 1) physical function, 2) psychological distress, and 3) health status. Second (Aim 2), we will utilize a combination of the most robust predictors (identified in Aim 1), to develop IPPs via multiple imputation techniques, for the following outcomes: a) pain, b) self-reported function, and c) physical performance. We hypothesize that postoperative prognoses can be made significantly more precise through use of IPPs, thereby aiding AHRQ efforts to develop and evaluate “strategies for incorporating evidence into decision-making for patients and providers.” The IPP paradigm proposed in this application represents a shift from traditional evidence-based thinking and will set a new standard for personalized monitoring following TKA.2