Care Redesign

Heart Safe Motherhood: Applying Innovation Methodology for Improved Maternal Outcomes

Case Study · May 22, 2019

Postpartum preeclampsia contributes to a substantial portion of maternal morbidity and mortality in the United States. We used innovation methodology to develop a text-based surveillance system known as Heart Safe Motherhood to target this clinical problem and define a new approach to care delivery.

Key Takeaways

  1. Collaborate with patients to identify the problem and develop the most effective strategy. Partnering with a small number of patients allowed us to receive feedback and make changes in response. Patient interviews led us to identify the various barriers to in-person office visits and develop workable solutions.

  2. Utilize a cost-effective up-front strategy to get the intervention right prior to scale. An agile, phased approach to problem-solving enabled us to move quickly and make data-driven, targeted investments in what worked and what was necessary for the next phase of growth.

  3. Simpler, more accessible technology means a more scalable, more effective solution.

  4. Completing a clinical trial can increase the likelihood of adoption for innovative interventions that dramatically change the standard of care for high-risk populations.

  5. Relying on purely human elements can have challenges; this consideration has led us to think about automation at every step, which also may increase adoption due to ease of use and implementation.

The Challenge

Pregnancy-related hypertension, including preeclampsia, affects up to 10% of pregnancies and is a major contributor to maternal mortality in the United States.1 Although delivery starts to reverse the disease process and associated hypertension, blood pressure may take 3 months to normalize and is likely to spike again in the first 10 days after delivery, leaving mothers at risk of stroke, seizures, and organ failure.2

In 2013, the American College of Obstetricians and Gynecologists (ACOG) issued guidelines to monitor blood pressure in postpartum women with pregnancy-related hypertension at 2 time points — once at 72 hours and again at 7–10 days after delivery — given the risk of persistent or progressive hypertension after hospital discharge.3 Many providers ask patients to return to the office for a blood pressure check. However, because of the various obstacles to attending these visits, including delivery recovery, erratic newborn feeding and sleeping schedules, and transportation barriers, most women find it hard to come to the office during this critical time period. Additionally, home nurse visits are also used by some providers; however, not all insurance policies cover these visits and not all women are willing or able to accept them.

At the Hospital of the University of Pennsylvania, a tertiary care center in West Philadelphia where approximately 4,100 deliveries are performed annually, we were unable to meet ACOG guidelines for blood pressure monitoring in our practices; at best, we obtained outpatient blood pressure readings for 30% to 40% of patients. We were unable to improve on these results despite successive trials of conventional approaches, including alternative staffing models, increased appointment availability, and phone call appointment reminders.

The Goal

Our goal was to develop a remote monitoring program that would capture blood pressure data in order to facilitate timely clinical intervention and improve our quality of care.

Execution and Outcomes

Approach to Innovation

We applied an agile, phased approach to problem-solving, based in design thinking, that focused on getting an intervention right, even at small scale, and then scaling only what worked. In our first phase of work, we tested our idea rapidly and iteratively at low cost to (1) optimize design based on performance and user feedback and (2) determine whether our solution could work. In the second phase, we expanded our testing to include more patients and a more scalable infrastructure to determine whether our solution does work. In the third phase, we established our solution as the standard of care at our hospital and scaled the solution within our health system.

Learning Through Rapid-Cycle Testing

Our initial “aha!” moment occurred when we observed pregnant patients frequently communicating via text messaging in our clinics and asked ourselves, “Why not see how this can be used to improve outcomes?”

We began in 2014 with a series of small, rapid pilots, funded through a Penn Medicine Innovation Accelerator grant, to test our hypothesis that sending patients home with a digital blood pressure monitor and asking them to text us their blood pressures would improve care.4 With 5 to 7 patients per pilot cycle, we enrolled 32 patients in a daily texting program in which they checked and reported their blood pressure over a span of 4 months.

Early pilots used a “fake back end” in which a physician, acting as the automated system that would later be developed, manually sent twice-daily reminders and feedback to the patient. This approach was non-scalable but allowed us to pivot quickly. We used a Plan-Do-Study-Act cycle approach and tried various interventions, including improved nurse-to-patient communication (e.g., through the distribution of preeclampsia education pamphlets at discharge), sending personalized phone messages that mentioned the names of the patient and baby, sending reminders at different times throughout the morning and afternoon, “snoozing” the reminder and sending a repeat alert later in the time period, providing motivational countdowns of the number of days left in surveillance, and sending a reminder to a support person (usually a spouse or mother) if the participant did not respond to a morning message.

We tested the impact of these iterations on compliance by tracking the frequency and timing of blood pressure readings texted in by the patients. Patient interviews (conducted with about 40% of the pilot participants) drove changes at each iteration and provided feedback regarding the frequency and timing of reminders, the convenience of the program, the impact of the messages, and recommendations for improvement.

Over 80% of enrolled patients reported at least 1 blood pressure reading during the first week postpartum, and our ability to meet ACOG guidelines rose to 65%. Following 3 months of rapid-cycle testing, we identified a final texting strategy that worked best for the majority of patients and was the most scalable approach: simple reminders sent in the morning and afternoon. From this small cohort, we determined that this approach could have a positive impact on patient care. Specifically, we were able to initiate medication remotely for 2 patients using data gathered via text message, likely potentially preventing morbidity, and we noted that none of the 32 patients were readmitted because of hypertension.

Preparing for Scale

Given the promising pilot results, we transitioned to an automated, more scalable process with support and funding from two institutional grants, including the Patient-Centered Outcomes Research Pilot Studies Program and Penn Presbyterian Harrison Fund. We partnered with Way to Health, a HIPAA-compliant technology platform developed at the University of Pennsylvania to enable research, development, and deployment of evidence-based patient engagement strategies. The platform — which facilitates communication through integrated wireless devices, two-way texting, and interactive online homes — has been used successfully in projects focused on improving healthy behavior and supporting new care models in clinical settings.

After discharge, Way to Health starts patients on a provider-derived monitoring protocol, with twice-daily reminders to send blood pressure readings over a 10-day surveillance period. Way to Health automates responses to patients on the basis of our three-tiered, provider-developed algorithm for normal, slightly elevated, and severely elevated blood pressures. We use an exception-handling model for providers, alerting them only when blood pressures are high enough to necessitate intervention. This model has allowed us to increase efficiency such that one provider can manage our hospital’s entire caseload of postpartum women with hypertensive disorders — representing an average of 40 patients delivered within a 10-day period — in a few hours per week.

Heart Safe Motherhood and Way to Health Two-Way Texting for Blood Pressure Monitoring for Postpartum Women with Preeclampsia

  Click To Enlarge.

Gathering the Evidence

While many innovations can scale without trial-quality evaluation, we decided that an IRB-approved randomized controlled trial comparing the Heart Safe Motherhood approach with the standard care protocol (consisting of onetime, office-based blood pressure checks) would meaningfully increase the likelihood of adoption of our intervention in a high-risk population. Two hundred and six eligible women with hypertensive disorders of pregnancy were randomized to either text-based surveillance or standard office care, and the ability to obtain a single outpatient blood pressure reading in the first 10 days postpartum was compared between the two arms.5 Baseline characteristics (including age, insurance, medical comorbidities, gestational age at the time of diagnosis of pregnancy-related hypertension, and severity of disease) were similar between the two groups, as described in the randomized trial.

From this randomized trial, we again found that text messaging resulted in an increase in our ability to obtain at least 1 blood pressure reading within 10 days after discharge as well as in our ability to meet ACOG guidelines, with >90% of patients in the Heart Safe Motherhood intervention group texting in at least 1 blood pressure reading and 84% of patients in that group texting in blood pressure readings at the 2 ACOG-recommended time points.

Heart Safe Motherhood Randomized Controlled Trial Results Summary

  Click To Enlarge.

Heart Safe Motherhood not only enables providers to receive real-time notification of severely elevated blood pressures, but it also allows them to request additional blood pressure readings following any medication changes. By adapting a similar algorithm already in place for office visits, which specifies the blood pressure reading at which medication should be started as well as the specific agent and dosage to be used, we were able to safely start antihypertensive medications remotely. The readmission rate was 0% among patients who were enrolled in the texting program. In addition, patients in the texting group were significantly more likely to attend their postpartum visit, which represents a valuable touch point for the evaluation of physical and mental well-being after delivery, given the importance of interpregnancy care and contraception.

Changing the Standard of Care

On the basis of the results of our trials, we implemented Heart Safe Motherhood as the standard of care at two of the five hospitals in the Penn Medicine system that offer obstetrical services. The Hospital of the University of Pennsylvania and Pennsylvania Hospital together perform over 9,000 deliveries a year. With funding through our department, we have monitored the blood pressure for nearly 1,300 women with hypertensive disorders associated with pregnancy (from a total of about 4,100 deliveries) in the first year at scale at the Hospital of the University of Pennsylvania and have enrolled over 300 women in 5 months at Pennsylvania Hospital.

Overall, we have been able to obtain blood pressure readings remotely at both time points recommended by ACOG for nearly 85% of our patients. We have been able to intervene and start medications remotely and have continued to observe strong patient and provider satisfaction at both sites (as indicated by patient surveys and provider discussions at meetings).

Specifically, patients have found the program to be convenient and effective, and providers have reported increased reassurance in association with closer, more frequent hypertension surveillance of their high-risk patients. Although we have not been able to completely eliminate postpartum hypertension readmissions after the introduction of the program at scale, the postpartum hypertension readmission rate at the Hospital of the University of Pennsylvania has dropped from 5% prior to Heart Safe Motherhood to 1% and hypertension is no longer the leading cause of 7-day obstetrical readmissions. Similar results are projected for Pennsylvania Hospital.

Success Factors

Technology choices played an important role in our success. We weighed the benefit of Bluetooth devices against the additional cost, added complexity, and limited patient access to wireless service in our population.6 Simpler, more accessible technology (in our case, text messaging sent via cell phones) meant a more scalable, more effective solution.

Four main factors helped us to achieve buy-in for our solution. First, we had dramatic, real-world results. We chose a problem with significant room for improvement, and testing our idea quickly and cheaply gave us a persuasive advantage. Second, we had an evidence-based, accessible solution to a nationally recognized problem. With poor maternal outcomes on the rise in Philadelphia and across the country and new ACOG recommendations, there was a clear call to action and an audience eager for a solution. Third, we had external validation. We proactively elevated the visibility of our work through publications, conferences, and innovation competitions, demonstrating to stakeholders that respected organizations were taking note. Finally, we had a business model that led to improved quality, outcomes, and patient experience while simultaneously reducing costs.

When taking into account the number of readmissions prior to the introduction of Heart Safe Motherhood, the average cost of a readmission, payer reimbursements, and the cost savings resulting from annual avoided hypertension readmissions following the introduction of the program, we grossly estimate the program can save the hospital over $20,000 a year. While we are in the process of completing a more formal business analysis, this contribution margin likely underestimates the program savings given that (1) office blood pressure checks potentially can be replaced by other revenue-generating visits and (2) inpatient postpartum lengths of stay potentially can be decreased as providers become more comfortable with earlier discharge and the use of remote blood pressure monitoring for their patients.

When we compare the program cost of about $50 per patient (including blood pressure monitors, educational materials, platform set up and maintenance, and the cost for a managing provider) with the average direct variable cost of $4,450 for a hypertension readmission (excluding overhead and other indirect costs), we estimate that the cost of the program for every 90 patients is similar to the cost of a single readmission. As this estimate is specific to our patient population and implementation model (in which a single attending-level physician manages all blood pressures), we hope to obtain more critical cost-effectiveness data that will be generalizable for different populations, payer practices, and practice models as we implement the program in different hospital systems and perform more formal return-on-investment calculations.

Hurdles

Technology was one major hurdle. In our institution, text messages were not considered sufficiently secure for personal health information. However, approved communication channels such as the telephone and secure e-mail were ineffective. We were able to persuade the organization that ineffective use of authorized communication channels resulted in increased maternal morbidity in this vulnerable population and therefore the privacy policy should be adjusted. The compromise was that we could use text messaging if patients consented in advance.

Although patients were eager to receive care in the comfort of their homes, providers were less comfortable using telehealth and telemedicine in a population at risk of stroke and seizure. Education regarding our positive results at every step of development, including the randomized trial, ultimately led to widespread acceptance and adoption among >25 attending physicians and >40 residents involved in obstetrical care. Improvements to workflow were appreciated by nurses, physicians, and midwives, and outpatient providers received positive feedback from their patients, further increasing support.

Finally, even with a highly automated program, there is an element of manual work. The program relies on patient identification, provider experience, and quick response to patient health care needs. Simple human errors have led to missed patient enrollments and missed opportunities for intervention. We hope to develop a data-analytics approach that will enable us to (1) identify and automatically enroll eligible patients via the electronic health record and (2) use our blood pressure data to predict those who are at highest risk for intervention in order to lower intervention costs and increase impact.

Next Steps

We are thinking strategically about growth and are purposefully testing delivery channels with payers who may reimburse for program costs, providers, home health nurses, research partners, and technology platforms to make this solution available to as many patients as possible. Through expansion to hospitals beyond our own, we are learning about replicability and about customizing the program to adapt to different contexts and populations, including different non-centralized models of obstetrical care at non-academic centers. Payment model innovations such as readmission penalties and quality incentives, as well as new CPT codes that allow for reimbursement for remote data review and management, will accelerate widespread adoption of this type of valuable patient-centered program.

Within our own population, we are refining our approach to increase patient engagement and to assess broader applicability. We are studying differences between patients who text their blood pressure readings and those who do not in order to provide better care to more patients, and we are working to simplify the inpatient enrollment process through connections to the electronic medical record and program-specific patient education videos. The program not only opens doors to new research opportunities, but it also provides a model for text-based communication that can be used to target other critical elements of postpartum care, such as depression and breastfeeding support.

 

Disclosures: The authors have no conflict of interest to disclose, including no financial conflict of interest with the Way to Health.

References

1. Creanga AA, Syverson C, Seed K, Callaghan WM. Pregnancy-related mortality in the United States, 2011-2013. Obstet Gynecol. 2017;130(2):366–73.

2. Too G, Wen T, Boehme AK, Miller EC, Leffert LR, Attenello FJ, Mack WJ, D’Alton ME, Friedman AM. Timing and risk factors of postpartum stroke. Obstet Gynecol. 2018;131(1):70–8.

3. American College of Obstetricians and Gynecologists, Task Force on Hypertension in Pregnancy. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122(5):1122–31.

4. Hirshberg A, Bittle MD, Vandertuyn M, Mahraj K, Asch DA, Rosin R, Bennett I, Srinivas SK. Rapid-cycle innovation testing of text-based monitoring for management of postpartum hypertension. J of Clin Outcomes Manage. 2017;24(2):77–85.

5. Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018;27:871–7.

6. Gilbert J, Schnoll R, Morrison MF, Srinivas SK, Pond T, Curtis B, Henry J, Kranzler HR. Smoking and cellular telephone use among pregnant women seeking prenatal care: opportunities for intervention. Addict Disord Their Treat. 2015;14(4):203–10.

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