MedStar Health Blog

MedStar Health regularly updates, revises and creates new policies and procedures for the operational efficiency of the organization.

Please be advised, the following policies and procedures are now in effect.

Effort Commitment and Certification

The Effort Commitment and Certification policy was updated to incorporate changes mandated in the Uniform Guidance to match MHRI Office of Contract & Grants processes in our current accounting system, and to provide a tool for collecting effort information for those staff employed by MedStar but external to MHRI.

There are no substantial changes to our business practices. However, one change does close the loop on a known audit gap regarding the reconciliation of the committed effort and the actual effort expending on a federal award or any award that invokes the federal regulations regarding effort commitment.

• OCG.O-007.01 Effort Commitment and Certification
• OCG.O-007 Effort Commit and Certification 
• OCG.O.007.01 FM1 Effort Allocation Report 

Government Inquiries

These policies have been updated as part of the three year periodic review.

• ORG.O-007.01 Responding and Managing Government Inquiries
• ORG.O-007 Responding to Government Inquiries

Emergency Response Management

It is recommended by MedStar Health ER One Institute that ERM policies are reviewed annually. During the annual review, we work with ER One and they inform us of any MedStar Health changes. In addition, we confirm all contact information (e.g., telephone numbers) are still accurate.

• ERM O-001 Active Shooter and Hostage Plan Code Silver
• ERM O-002 Bomb Threat Suspicious Package Code Gold
• ERM O-003 Bad Weather Emergency Response
• ERM O-004 Fire Prevention and Fire Emergency Code Red
• ERM O-005 Telephone IS Failure
• ERM O-006 Utilities Failure

Any questions regarding the new policy and procedure should be directed to MHRI-OCGM@medstar.net.

When conducting research, some populations of research participants require special considerations. The Code of Federal Regulations (CFR 45 part 46) Protection of Human Subjects includes Subparts B, C and D, that describe special protections and criteria for inclusion of pregnant women, prisoners and children. These protections are meant to safeguard of rights, welfare, and safety of these participants but does not mean they should automatically be excluded from research.

• Pregnant women, human fetuses, and neonates (Subparts B): Because research may pose additional and/or unknown risks to pregnant women, human fetuses and neonates, the regulations require additional safeguards in research. It is important to include pregnant women in research, as their exclusion from research creates a wider gap in understanding and knowledge.

• Prisoners (Subparts C): Because prisoners may not be free to make a truly voluntary and uncoerced decision regarding research participation, the regulations require additional safeguards for the protection of prisoners. For example: In order for an IRB to approve research involving prisoners the membership of the Board must include one or more prisoner representatives and that representative must be involved in the review of the research.

• Children (Subparts D): The CFR defines children as “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.” It is important to include, where appropriate, children as part of a research study. Children of all ages present different disease manifestations than adults, have different pharmacokinetics/ pharmacodynamics than adults and have a different psychology/psychiatry as part of their developing brain.
While the populations afforded special protections have traditionally been labeled “vulnerable” it should be noted that they are not specifically defined as such in Sub Parts B, C and D. The common rule does not define the term “vulnerable population”. The existence of additional protections should not specifically discourage inclusion of these populations in research. Rather, the protections are intended to guide the inclusion of these populations in such a way as to protect the rights and welfare of the individuals.

Although the regulation does not define the term vulnerable they do provide examples of research subjects “that are likely to be vulnerable to coercion or undue influence.” This is different from the special populations traditionally referred to as “vulnerable populations” description of sub parts B, C, and D. While children and prisoners are included in the current list of examples, pregnant women are no longer included as of the 2018 Revised Common Rule. The types of study populations that are likely to be vulnerable to coercion or undue influence may including but are not necessarily limited to:

• Children/minors
• Prisoners
• Employees
• Military persons and students/trainees in hierarchical organizations
• Terminally ill, comatose, physically and intellectually challenged individuals
• Institutionalized, elderly individuals
• Ethnic minorities
• Refugees
• Economically and educationally disadvantaged

When some or all participants are likely to be vulnerable to coercion or undue influence the regulations mandated that the IRB ensure “…additional safeguards have been included in the study to protect the rights and welfare of subjects.”

As previously noted, there has been an historical categorization of pregnant women and women of reproductive potential as a “vulnerable population.” While Sub Part B of the Common Rule describes special protections for pregnant women there is nothing about pregnancy, in and of itself, that renders a woman susceptible to coercion or undue influence. This categorization typically results in a tendency to exclude women, particularly pregnant women, from research. This exclusion may be intended to protect women from potential risk or may be done out of a misunderstanding of the special protection’s provision. Rather than serving to protect women from risk this broad exclusion of women from research has had a detrimental impact. Instead of shielding women and their fetuses from adverse effects, exclusion from clinical research in which they may be able to safely participate has served to limit understanding of pharmacokinetic and pharmacodynamic differences in women’s responses to treatment. Without scientific evidence this has drove the medical community to make potentially faulty assumptions about safety and efficacy of therapeutics when used with pregnant women.

While it is important to protect human subjects in research from coercion, undue influence and unjustified risks, it is equally important to ensure equitable selection of research subjects. This includes (but is not limited to) the inclusion of pregnant women and women of reproductive potential in research. Broad exclusion of any population, absent regulatory restriction or legitimate safety concerns, can serve to create a knowledge gap around the appropriate treatment modalities, appropriate dosing and the potential need to modify treatment modalities for some populations.

The table below includes the populations used as exemplars in the common rule for subjects that “…likely to be vulnerable to coercion or undue influence…” The table includes a notation for those included as examples in the pre-2018 Common Rule (Former Common Rule) and those now listed in the 2018 Revised Common Rule.

If you have any questions or concerns, please contact MHRI’s Office of Research Integrity Director, Jim Boscoe, at James.H.Boscoe@medstar.net.

Diabetes researches from across MedStar Health sought to develop a strategy to enable hospital nursing unit staff to deliver diabetes survival skills education to adults with type 2 diabetes within their usual workflow using an adaptation of the Diabetes to Go (D2Go) program to fill the gap in education delivery on inpatient units.

Diabetes survival skills education (DSSE) focuses on core knowledge and skills necessary for safe, effective, short-term diabetes self-care. Inpatient diabetes survival skills education delivery approaches are needed. “Diabetes to Go-Inpatient: Pragmatic Lessons Learned from Implementation of Technology-Enabled Diabetes Survival Skills Education Within Nursing Unit Workflow in an Urban, Tertiary Care Hospital” was published in The Joint Commission Journal on Quality and Patient Safety. Diabetes to Go is an evidence-based diabetes survival skills education program originally designed for outpatients.

The Practical, Robust Implementation and Sustainability Model (PRISM) was used to help redesign D2Go for delivery and evaluate the feasibility of integrating a high-tech tablet computer-enabled DSSE program for hospital inpatients. The study team conducted interviews and focus groups with stakeholders to identify perceived barriers and facilitators for implementation; redesigned the D2Go program via stakeholder feedback and education and human factors principles; developed implementation design for tablet delivery and patient engagement by unit staff; and completed a prospective cohort implementation feasibility study on three medical/surgical units.

The results identified 596 adults with type 2 diabetes on three medical/surgical units, 415 (69.6%) were program eligible. Of those eligible, 59 (14.2%) received, accessed, and engaged with the platform; and among those, 43 (72.9%) completed the intervention, representing just 10.4% of those eligible. Multilevel implementation barriers were encountered: staff (receptivity, time, production pressures, culture); process (electronic health record [EHR] integration, patient identification, data tracking, bedside delivery); and patient (receptivity, acuity, availability, accessibility).

In conclusion, strategies are needed to enable effective delivery of diabetes survival skills education to inpatients with type 2 diabetes. System and staffing barriers coupled with patient and technology barriers limited successful implementation of the delivery of diabetes education at the bedside. As a result, adoption of a tablet-based diabetes survival skills e-learning program in a high-acuity care setting was limited.

The Joint Commission Journal on Quality and Patient Safety, 2021. DOI: 10.1016/j.jcjq.2020.10.007

Every February at MedStar Health Research Institute, we celebrate “Heart Healthy” and take the time to “Go Red!” for heart health. Associates were invited to wear red in support of the American Heart Association’s (AHA) fight against heart disease in February. Throughout the month, associates submitted photos with their teams to show their commitment to heart health. 

As we have for the last nine years, we accepted submissions for a photo challenge! Associates showed off in their red outfits and team spirit to show their commitment to heart health. View all the photo submissions from Research Institute teams below. 

Thank you to all who showed their support for this important cause!

Researchers from MedStar Health evaluated emergency department care coordination processes and their perceived effectiveness across Maryland’s hospital system, which were seeking to reduce hospital admissions due to financial considerations led by Maryland-state governance. “Emergency Department Care Coordination Strategies and Perceived Impact Under Maryland’s Hospital Payment Reforms” was published in the American Journal of Emergency Medicine. The goals of the study were to characterize the scope and variation of emergency department care coordination strategies in response to Maryland reforms and describe how physician leaders and care coordination staff perceive the effectiveness of specific strategies.

In 2014, Maryland expanded its all-payer hospital rate-setting model into a population-based global budget revenue model, which replaced fee-for-service hospital payments and introduced quality pay-for performance incentives for acute-care hospitals. The model has incentivized a shift towards non-hospital care and reduced hospital admissions. The research team conducted a total of 25 semi-structured interviews across 18 different hospital emergency departments with emergency department physician leadership (n = 14) and care coordination staff (n = 11) to examine emergency department care coordination processes and understand the focus of care coordination efforts. The interviews assessed the perceived efficacy of care coordination and identified barriers to success, as well as the influence of Maryland’s payment reform model on emergency department care coordination strategies.

The results showed that across all emergency departments, there was significant variation in the hours and types of care coordination staff coverage and the number of initiatives implemented to improve care coordination. Most participants perceived Maryland’s reform with global budgeting as having a mixed impact on emergency department care coordination and overall emergency department care. Participants perceived emergency department care coordination as effective in facilitating safer discharges, improving outpatient follow-up and addressing social determinants of health; however, adequate access to outpatient providers was a significant barrier. Emergency department physician leaders identified improved care transitions and patient care but experienced increased workloads to avoid admissions and support safe transitions among their discharged patients.

Although the observed care coordination initiatives were perceived to produce positive results, Maryland's global budgeting policies were also perceived to produce barriers to improving emergency department care. Further research is needed to determine the association of the different strategies to improve emergency department care coordination with patient outcomes to inform practice leaders and policymakers on the efficacy of the various approaches.  This research was led by Dr. Jessica Galarraga, a MedStar Health economics investigator and emergency medicine physician.

American Journal of Emergency Medicine, 2021. DOI: 1016/j.ajem.2020.12.048