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ESP Reports in Progress

  ESP Topic Nomination  ESP Reports in Progress

The following reports are under development at one of the four ESP sites. If you would like to provide comments about the topic under development, serve as a peer reviewer for the draft report, or know the timeline for completion, please contact the ESP Coordinating Center.

To review the most up-to-date protocols, please visit the PROSPERO website. Protocol registration numbers for an individual project can be found along with the brief abstract for the project, below.

Comparing Antithrombotic Strategies after Bioprosthetic Aortic Valve Replacement: A Systematic Review

PROSPERO registration: CRD42017057064

Background/Objectives of Review

The proposed ESP evidence synthesis review will be used to inform future research within the VA. Specifically, the review would be used to design a VA-based randomized trial of VKA administration in patients after bAVR. Such a study would have the potential to inform clinical guidelines both within and outside of the VA.

Key Questions

KQ1: What are the comparative benefits of antithrombotic strategies for patients who have had bAVR?

KQ1A: Do the benefits differ according to thromboembolic risk profile?

KQ1B: Do the benefits differ according to concomitant procedure (eg, coronary artery bypass graft [CABG])?

KQ2: What are the comparative harms of antithrombotic strategies for patients who have had bAVR?

KQ2A: Do the harms differ according to thromboembolic risk profile?

KQ2B: Do the harms differ according to concomitant procedure (eg, coronary artery bypass graft [CABG])?

KQ3: What are the comparative benefits and harms of antithrombotic strategies for patients who have had transcatheter aortic valve replacement (TAVR)?

KQ3A: Do the benefits or harms differ according to thromboembolic risk profile?

KQ3B: Do the benefits or harms differ according to concomitant procedure (eg, percutaneous transluminal coronary angioplasty [PTCA] with stent)?

PICOTS

Population(s): Adult patients who have had bioprosthetic aortic valve replacement (bAVR; Key Questions 1 and 2) or transcatheter aortic valve replacement (TAVR) with stenting of aortic valves (Key Question 3).

Exclude: Patients receiving bAVRs no longer used in practice; patients with valve replacements in positions other than the aorta (eg, mitral valve, Ross procedure); pregnant women.

Interventions: Antithrombotic strategies/agents:

  • Vitamin K antagonist (VKA)
  • VKA plus acetylsalicylic acid (ASA; aspirin) or other antiplatelet agents
  • ASA or other antiplatelet agents
  • Dual antiplatelet therapy
  • Direct oral anticoagulants (DOACs)/novel oral anticoagulants (NOACs)

Comparator: Any of the above antithrombotic strategies (ie, one strategy vs another strategy), or no therapy.

Outcome(s): Primary outcomes:

  • Mortality
  • Thromboembolic events
  • Stroke
  • Major bleeding events

Secondary outcomes:

Benefits:

  • Myocardial infarction
  • Heart failure
  • Readmission rates
  • Need for valve reoperation (eg, valve thrombosis)
  • Length of stay
  • Need for change in antithrombotic strategy

Harms:

  • Other/minor bleeding
  • Readmission rates
  • Pericardial or pleural effusion (we will prioritize effusions requiring intervention)

Timing: Perioperative (defined as in-hospital or within 30 days) and long-term (defined as > 30 days to 1 year or longer) are of interest for each outcome.

General Search Strategy

Search strategies will be developed in consultation with a research librarian. We plan to conduct a primary review of the literature by systematically searching, reviewing, and analyzing the scientific evidence as it pertains to the research questions. To identify relevant articles, we will begin by searching Ovid MEDLINE, Elsevier EMBASE, and Ovid EBM Reviews Cochrane Database of Systematic Reviews. We will further review the bibliographies of relevant articles for additional studies. To identify in-progress or unpublished studies, we will search ClinicalTrials.gov, OpenTrials, and the WHO International Clinical Trials Registry Platform (ICTRP). We will also search the AHRQ Registry of Patient Registries to identify relevant registries of bAVR patients.

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Effectiveness of Interventions to Improve Emergent Department Efficiency

Background/Objectives of Review

The proposed evidence review would be used by the National Director of Emergency Medicine and the Emergency Medicine Field Advisory Committee (EMFAC) to prioritize national and local interventions to enhance access to emergency care and develop a research agenda around the delivery of emergency services within VHA. The results of an evidence review would also be used at an upcoming Field-Based Conference and meeting of the Emergency Medicine Field Advisory Committee to further refine the key questions that affect VHA emergency medicine.

In addition, the findings from this evidence review would be used to prioritize the performance measures monitored through the VA Emergency Medicine Management Tool (EMMT). The EMMT is a national data report which provides reporting on key performance measures for VA emergency medicine.

Key Questions

KQ1: What types of interventions have been evaluated to reduce ED crowding or other operational performance measures?

KQ2: Which interventions to reduce ED crowding or other operational performance measures have been the most effective and which are the most generalizable to the VHA population?

KQ3: What are the benefits and harms of interventions to reduce ED crowding or other operational performance measures to patients?

PICOTS

Population(s): Adult patients presenting to emergency departments (EDs)

Interventions: Any intervention designed to reduce ED overcrowding or improve other measures of ED operational performance

Comparator: Usual ED care

Outcome(s): Operational outcomes including ED length of stay, wait time, leaving without being seen, admissions data; clinical outcomes including mortality and harms; and cost or resource utilization of the intervention and ED.

General Search Strategy

A preliminary literature scan conducted by the ESP coordinating center identified multiple publications with data from primary research studies, as well as multiple systematic reviews. Publications included in these systematic reviews, as well as the primary research study publications, were eligible for inclusion. Studies to be included are hypothesis testing studies, including randomized controlled trials and observational studies that compared relevant outcomes across different ED interventions or organizational structure, either across institutions or within institution across time points. Studies of single conditions are excluded.

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Impact of Family Caregiving on Care Recipients with Mental Illness or Cognitive Impairment

PROSPERO registration: CRD42017053516

Background/Objectives of Review

The ESP report will be used by the VA Caregiver Support Program to refine and standardize its eligibility assessment process for patients requiring informal/family caregiver support and to identify future research needs to inform program practices and policies.

Key Questions

KQ1: For which patient groups (ie, patients with posttraumatic stress disorder (PTSD), traumatic brain injury (TBI), and polytrauma,) that receive family care has the impact on care recipient outcomes been assessed?

KQ2: What are the effects of programs/strategies to support or train family caregivers on care recipient (ie, patients with PTSD, TBI, polytrauma) and caregiver outcomes? Outcomes of interest include psychological symptoms, care recipient independence, function, quality-of-life indicators, physical health, health care utilization, economic status, and clinical eligibility for specific programs or services.

PICOTS

Population(s): Adults with conditions listed above AND functional cognitive, psychosocial or other impairments that limit ability to independently perform functions of daily life

Interventions: Programs to train family caregivers or support family caregiving (unpaid custodial or basic medical care) consisting of one or more of the following: caregiver training, day to day practical support or in-home respite care, financial assistance, education or information about the healthcare system or other resources, social or emotional support. Interventions may be delivered in person or by telephone; directed at caregiver or dyad.

Comparator: Any including: waitlist, usual care, attention control, active comparators

Outcome(s): Care recipient:

Functional status (physical, social, mental), disease-specific symptoms, health-related quality of life, healthcare utilization (outpatient, inpatient, institutional, total); adverse effects

Caregiver (if ONLY caregiver, ONLY KQ1):

Caregiver burden; depressive or anxiety symptoms; family functioning; household economic status (income, wealth); adverse effects

Setting: Community, home, clinic

General Search Strategy

Types of studies to be included: RCT and quasi-experimental (non-randomized controlled trials; controlled before-after studies (CBA); interrupted time series (ITS)

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Social Determinants of Health for Veterans

PROSPERO registration: CRD42017060165

Background/Objectives of Review

The review will be used to guide Population Health work to improve Veteran health status by informing policy and operations in the VHA and VA. Population Health leadership will use the review findings to foster and guide collaboration with program offices with Patient Care Services, VHA, VA, and other entities to shape policy and guide operations based on understanding social determinants of Veteran health. Identification of Veteran-specific social determinants of health and data/metrics for use in tracking and evaluation will be of particular utility in care of Veterans with medical and social complexity.

Key Questions

KQ1: How do Veterans compare to non-Veterans in prevalence and characteristics of social determinants of health?

KQ2: Does variation in social determinants of health account for differences in health services access, health-related behaviors, and health outcomes between Veterans and non-Veterans?

KQ3: How do Veterans enrolled in the VHA compare to Veterans not enrolled, or Veterans accessing VHA care compare to Veterans not accessing VHA care, in prevalence and characteristics of social determinants of health?

KQ4: Does variation in social determinants of health account for differences in health services access, health-related behaviors, and health outcomes between Veterans enrolled in the VHA compared to Veterans not enrolled, or Veterans accessing VHA care compared to Veterans not accessing VHA care?

PICOTS

Population(s): Adults, Veterans and non-Veterans.

Interventions: Not applicable

Comparator: Not applicable

Outcome(s): Prevalence and differences in social determinants of health. Differences in health services access, health-related behaviors, and health outcomes, as related to differences in social determinants of health.

General Search Strategy

MEDLINE, PsychINFO, and Sociological Abstracts databases plus grey literature sources including census reports, VA reports, and reports from known cohorts (eg, NHANES, Behavioral Risk Factor Surveillance Survey, Health and Retirement Study, National Veteran surveys).

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Integrated Outpatient Palliative Care in Oncology

PROSPERO registration: CRD42017057541

Background/Objectives of Review

The Hematology/Oncology Palliative Care Research Committee and the Hospice and Palliative Care Program of the Office of Patient Care Services will use this review of the evidence to help clarify which aspects of palliative care provide the most benefits to patients with advanced cancer and help identify best practices for successful implementation of integrated palliative care services.

Key Questions

KQ1: In patients with symptomatic or advanced cancer, what are the benefits and harms of integrated outpatient palliative care and oncology care compared with usual oncology care?

KQ2: Which features of integrated palliative and oncology care are associated with greater benefit to patients with symptomatic or advanced cancer?

KQ3: What are the most common and important barriers to implementing integrated palliative and oncology care in Veterans Administration settings?

PICOTS

Population(s): Adults (>18 years of age) with symptomatic or advanced malignancy defined as:

  • malignancy causing symptoms such as fatigue, pain, or breathlessness, or unmet needs related to the malignancy, or
  • malignancy without curative treatment options, or
  • advanced stage (eg, stage III or IV malignancy).

Interventions: Integrated palliative care as defined by: an individual or multidisciplinary team of clinicians who work together with a patient's oncology physician(s) and have a focus on relief of symptoms and stress of serious illness. The goal is to improve quality of life for the patient and family. One or more of the palliative care clinicians must have specialized training in palliative care and the intervention must be multidimensional Integration will be defined broadly and may range from basic collaboration at a distance (eg, information exchanged to address specific patient treatment issues) to co-located care, to fully integrated care. We will provisionally include studies where palliative care services are delivered concurrently with oncology care services, even if the degree of integration is unclear or low.

Comparator: KQ1, KQ2: Usual oncology care

KQ3: no comparator required for studies conducted in VA settings. For studies conducted outside of VA settings, the study must have an eligible comparator as specified for KQ1 and KQ2.

Outcome(s):

KQ1, KQ2:

  • Care recipient:

a) Functional status or healthcare quality of life (QOL). Quality of life is defined as overall quality of life (ie, global quality of life) and then further conceptualized to include function status, including physical functioning (eg, activities of daily living), general psychological functioning (eg, psychological well-being) and social functioning (eg, social well-being).

b) Disease related symptoms: overall symptom burden. If overall symptom burden not reported, will accept symptom assessment of fatigue, pain, or sleep

c) Care experience

d) Survival

e) Site of death

f) Healthcare utilization: emergency department, inpatient, ICU days, total costs

g) Adverse effects

  • Caregiver:

a) Care experience

b) Carer burden (eg, Caregiver Strain Index), depression (eg, PHQ9)

KQ3: Barriers to implementation (eg, workforce, stigma, financial, logistical [space, communication and coordination between clinicians])

General Search Strategy

We will conduct a primary search of MEDLINE(via PubMed), the Cochrane Central Register of Controlled Trials, and CINAHL. We will also evaluate the reference lists of systematic or nonsystematic reviews for relevant studies. We anticipate using a combination of MeSH keywords and selected free-text terms to search titles and abstracts.

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Management of Antiplatelet Therapy among Patients on Antiplatelet Therapy for Cerebrovascular Disease or Peripheral Vascular Diseases Undergoing Elective Surgery

Key Questions

KQ1: Among patients on APT for vascular disease undergoing elective surgical procedures, including intraocular procedures, what are the benefits and harms of holding APT prior to surgery? The populations of patients considered in this review should include:

a. Patients on APT for cerebrovascular disease or peripheral vascular disease.

KQ2: How does benefit/risk vary by the timing of discontinuation?

KQ3: How does benefit/risk vary by type of surgical procedure, including intraocular procedures?

KQ4: How does benefit/risk vary by type of APT?

KQ5: How does benefit/risk vary by the timing of resuming APT?

PICOS

Population(s): Patients with known CVD undergoing elective surgical procedures (including intraocular procedures) who had stents placed in the peripheral vascular system or carotid arteries

Interventions: Stopping all or some of the APT

Comparator: Not stopping or stopping at different times relative to the surgical procedure as well as by drug(s)

Outcome(s): Thrombotic outcomes, hemorrhagic outcomes, death, disability

Setting: All patients will be in the hospital undergoing surgery

General Search Strategy

We ran a search in PubMed on 10/13/2016 using search terms related to antiplatelet therapy and elective surgery, limited to English language. Types of studies to be included are: RCTs, cohort studies, and case series with N>10.

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Identification and Evaluation of Women's Telehealth

PROSPERO registration: CRD42017065965

Key Question

What is the quantity, distribution, and characteristics of evidence for the use of telehealth services designed specifically for women?

PICOTS

Population(s): Adult biological or transgender women only

Interventions: Eligible telehealth interventions must meet the following 4 criteria:

1.) Be for any of the following three conditions:

a.) women-specific conditions (eg, obstetrical, gynecological)

b.) the following conditions that predominantly affect women:

- migraines

- fibromyalgia

- breast cancer risk assessment (eg, risk assessment tools – Gail model, genetic counseling) and management decision-making for women at high risk for breast cancer (eg, counseling for pharmacoprophylactic treatment). Studies promoting breast cancer screening will be excluded.

- intimate partner or sexual violence, military sexual trauma or domestic violence

c.) gender non-specific conditions, but interventions designed specifically for women;

2.) Use technologies and tactics (eg, secure messaging, text messaging*, e-consultation, video-conferencing, interactive voice response) to deliver healthcare services for the purpose of diagnosis, consultation, treatment, and/or prevention (eg, tele-gynecology, tele-colposcopy, tele-mental health, tele-pharmacy, tele-care coordination, tele-primary care, tele-wellness);

3.) Involve transmission of clinical information via a telecommunication technology between patients and members of the medical/mental health care team** or provider-to-provider interactions who are at a distance;

4.) Includes bidirectional synchronous or asynchronous communication.

* Text messaging systems that are interactive based on a pre-determined algorithm are included even if there is not real-time human participation on the clinical end of the interaction.

** Team members can include those who are without formal medical training (eg, health coaches, nonskilled healthcare workers).

Comparator: Any (require an active or inactive control)

Outcome(s): As this is a mapping project, we will accept any outcomes reported by eligible studies. However, specific outcomes of interest and scope of outcomes accepted are listed under primary outcomes, below. There are no secondary outcomes in a mapping scenario.

Primary outcomes:

- Patient health outcomes (condition-specific): especially readiness/motivation to change, access to care (eg, no-show rates), patient satisfaction, treatment adherence, patient engagement

- Provider-level outcomes

- System-level outcomes

Setting: Any clinical setting in any country (will plan to assess for country and categorized according to low/middle/high income status).

General Search Strategy

We will search MEDLINE (via PubMed) and Embase. We anticipate using a combination of MeSH keywords and selected free-text terms to search titles and abstracts. To ensure completeness, search strategies will be developed in consultation with a master librarian and will be informed by search strategies recommended by the Cochrane Effective Practice and Organization of Care Group.

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Pay-for-Performance and Veteran Care: Effects, Implementation, and Unintended Consequences

Background/Objectives of Review

In the Veterans Health Administration (VHA) and in the community, provider payment has become more frequently linked to quality performance. Providers in the VHA have been paid for performance since the passage of the Department of Veterans Affairs (VA) Health Care Personnel Enhancement Act of 2004. In addition, with 25.5 million Veteran appointments in the community in 2016, and CMS' Merit-Based Incentive Payment System (MIPS) under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), incentives linked to performance measures have become increasingly common among providers in the community caring for Veteran populations. In their final report, the Commission on Care established as part of the Veterans Access, and Accountability Act of 2014, recommended that providers in community networks be paid using contemporary strategies that incentivize quality and appropriate utilization, citing MACRA as an example. Given the increased numbers of Veterans receiving care in the community, Commission recommendations, and the complexity of pay-for-performance (P4P) programs, an understanding of these issues from the perspective of Veteran care is critical.

In 2015, the Portland Evidence-based Synthesis Program (ESP) completed a systematic review broadly examining the benefits and harms associated with P4P in healthcare. The review examined three key questions.

  • KQ1 examined the effects of P4P on processes of care and patient outcomes. In January 2017, we published an update of this key question that concluded that P4P programs may be associated with improved processes of care in ambulatory settings—particularly in the short term, and that there was no consistent evidence of an effect on health outcomes in any setting.
  • KQ2 examined implementation processes. In addition to addition to synthesizing data from primary studies, we interviewed key informants. Interviews with key informants supported study findings that measures should be aligned with organizational goals, that incentive structures should be carefully considered, and importance of factors such as infrastructure and public reporting.
  • KQ3 examined the positive and negative unintended consequences associated with P4P. In general, we found evidence of both positive and negative spillovers to unincentivized measures as well as unincentivized populations, mixed findings related to risk selection, and very little empirical evidence related to the presence or absence of gaming.

Pay-for-performance programs are heterogeneous, both in program structure and implementation. Thus, the breadth of our original approach was necessary to identify findings and lessons learned from other systems and countries that might be relevant to integrated health systems like the VHA. Now, a more focused approach is needed to help guide practical decision making as the VA's community integration efforts mature. The purpose of the current project is to examine what is known about the effects and implementation of, and unintended consequences associated with P4P programs targeting the health of Veteran patient populations by updating, synthesizing, and distilling the prior review and key informant discussions to a Veteran-specific focus.

Key Questions

KQ1: What are the effects of pay-for-performance programs on the quality of care and health of Veterans?

KQ2: In Veteran populations, what are the potential unintended consequences of pay-for-performance in healthcare?

KQ3: What measures have been commonly incentivized in published P4P programs?

KQ4: In Veteran populations, what implementation factors modify the effectiveness of pay-for-performance programs?

KQ5: What novel approaches and/or current or recently closed research projects funded by the VA Office of Research Development (ORD) examine the effectiveness, implementation factors, or unintended consequences associated with pay-for-performance in Veteran populations?

PICOTS

Population(s): Healthcare providers at the individual, managerial (eg, VISN directors), group, and institutional levels; Veteran populations whose providers/health care systems are being incentivized based on performance measures.

Interventions: Pay-for-performance programs targeting providers, managers, health care systems

Comparator: Other financial incentive models; other payment models (eg, fee for service, bundled payments)

Outcome(s): Utilization of healthcare services; Quality of healthcare services: intermediate/process of care measures, patient evaluations of care; Patient health outcomes

Timing: Long or short term

Setting: KQs 1-3: VHA, CBOCs, or community sites serving Veteran populations; KQ4: Settings in healthcare systems similar to the VHA or the U.S. generally; KQ5: VHA, CBOCs, or community sites serving Veteran populations

General Search Strategy

To identify primary evidence examining P4P in Veteran populations, we will evaluate the studies included in the VA ESP's 2015 pay-for-performance review and subsequent journal articles. In addition, we will conduct a search of PubMed, PsycINFO©, and CINAHL© for studies published since the original systematic review (January 2014 to March 2017), using the same search strategy, and applying a VA filter. To identify current and recently closed studies funded by the VA Office of Research and Development, we will search the Health Services Research and Development (HSR&D) website from 2016 to the March 2017. We will use snowball sampling to identify additional studies and novel approaches currently being tested or implemented in the VHA, starting with members of our TEP and VHA leadership.

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Enhanced Recovery After Surgery (ERAS) Programs for Patients Undergoing Colorectal Surgery

PROSPERO registration: CRD42017067991

Key Questions

KQ1: What is the comparative effectiveness of ERAS versus usual care or a subset of ERAS components for adults undergoing elective colorectal surgery?

KQ2: What are the harms of ERAS versus usual care or a subset of ERAS components for adults undergoing colorectal surgery?

KQ3: Do comparative effectiveness and harms vary by fidelity to ERAS components?

KQ4: Do comparative effectiveness and harms vary by type of colorectal surgery (eg, anatomical site, laparoscopic versus open surgery, reasons for open surgery, etc)?

KQ5: What are the barriers to and facilitators of implementation of ERAS programs?

PICOTS

Population(s): Adults (18 and over) undergoing elective colorectal surgery

Interventions: ERAS programs (as defined by study authors)

Comparator: Usual care or subset of ERAS components

Outcome(s): Intermediate: Gastro-intestinal function (time to oral feeding, bowel function, nausea), intravenous fluid administration, mobilization, pain scale scores

Final Health Outcomes:

1.) Length of stay (initial stay, total)

2.) Overall morbidity

3.) Mortality

4.) Readmission rate

5.) Ileus

6.) Clinically important difference in pain scores

7.) Clinically meaningful changes in quality of life

Harms: Surgical complications (infection, anastomotic leakage), non-surgical complications (cardiovascular, respiratory, urinary tract infection), need for re-operation, bleeding, Foley catheter re-insertion and complications, aspiration pneumonia, readmission

General Search Strategy

Types of studies to be included: 1.) For effectiveness of ERAS programs: randomized controlled trials or controlled trials with comparator of usual care or subset of ERAS components (as defined by study authors); 2.) For barriers to and facilitators of implementation: any study design if study is conducted in healthcare system relevant to VA.

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