Clinical Support Tool for Preventing Cognitive Decline

(PCOT Trial)

Overseen By Venkatraghavan Sundaram, Ph.D.

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Dementia, Alzheimer's, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 years

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new tool, the Clinical Support Decision Tool, can help doctors manage high blood pressure more effectively to potentially prevent memory problems like dementia. Participants will either receive usual care or use a decision support tool that shares blood pressure data with doctors to guide treatment. The trial seeks individuals aged 70 or older who have high blood pressure, have recently visited a primary care doctor, and own a smartphone.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future healthcare practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Clinical Support Decision Tool is safe for preventing cognitive decline?

Research has shown that clinical decision support tools are generally safe and easy to use. These tools assist doctors in making better decisions by utilizing up-to-date information and electronic health records. Studies have found that they can improve treatment accuracy and reduce delays without harming patients. Although specific safety data for this tool is limited, its use in healthcare has not been linked to any major problems. The tool in this trial aims to better manage blood pressure, which should safely lower the risk of cognitive decline. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Clinical Support Decision (CDS) tool for preventing cognitive decline because it offers a more personalized approach to managing blood pressure, a key factor in cognitive health. Unlike standard care, which relies on physicians making treatment decisions based on periodic office visits, this tool uses real-time home blood pressure data sent via smartphone apps. This continuous monitoring allows for more timely adjustments in blood pressure management, potentially reducing the risk of cognitive decline associated with hypertension. By integrating technology into routine care, the CDS tool empowers physicians with data-driven insights, potentially leading to better patient outcomes.

What evidence suggests that the Clinical Support Decision Tool is effective for preventing cognitive decline?

Studies have shown that tools designed to assist doctors in decision-making can improve health outcomes. In this trial, participants in the intervention arm will use a Clinical Decision Support (CDS) tool to manage high blood pressure. These tools use real-time data to help doctors adjust treatment plans effectively. Research indicates that using these tools can lead to better blood pressure control, which is linked to a lower risk of memory and thinking problems, such as mild cognitive impairment and dementia. In some cases, these tools have made treatment recommendations more accurate and efficient. Although specific data on preventing memory decline with this tool is limited, the link between managing blood pressure and brain health suggests potential benefits. Participants in the usual care arm will continue with their standard hypertension management without the CDS tool. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people aged 70 or older with high blood pressure, defined as two readings of SBP >= 130 or DBP >=80 in the last 24 months. Participants must be able to communicate in English or Spanish, have visited a primary care provider within the last two years, and own a smartphone or tablet.

Inclusion Criteria

I have had high blood pressure readings in the last 2 years.

I have seen my primary care doctor in the last 2 years.

I am 70 years old or older and can understand and agree to the study's procedures.

Exclusion Criteria

I do not have recent severe heart issues or organ transplants.

I am currently undergoing or have undergone chemotherapy.

Your doctors believe you have less than a year to live.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intensive blood pressure management with clinical decision support and team-based care

4 years

Monthly visits for BP monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Quality of Life Assessment

Quality of life scores are assessed annually using the PROMIS Scale v1.2 - Global Health instrument

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Support Decision Tool

Trial Overview The PCOT study tests if patients receiving team-based care and using a clinical decision support tool have better blood pressure control and lower rates of mild cognitive impairment compared to those getting usual medical care.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Home BP data will be averaged each month via OmronConnect app on the patients' smartphone, which is programmed to send home BP readings to MyChart via Apple or Google Health.Participants whose home blood pressure reading average is systolic ≥ 130 and diastolic ≥ 80 will trigger the CDS (Clinical Decision Support) tool to assist their physicians with their blood pressure management. Study Team will not be involved in treatment decision making, it will be determined by subject's treating physician. .

Group II: Usual Care Arm Active Control 1 Intervention

Physicians will continue to make decisions about the participant's blood hypertension management as usual without the CDS tool.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Parkland Health and Hospital System

Collaborator

Trials

20

Recruited

99,300+

Published Research Related to This Trial

A clinical decision support (CDS) system was developed to provide personalized pain management recommendations for dentists, aiming to reduce opioid prescriptions after dental extractions, and was implemented in a study involving patients from February 2020 to May 2021.

The CDS tool, which integrates with electronic health records and utilizes patient-specific data, showed variable provider engagement, with up to 87.4% of providers using it during extraction encounters, indicating its potential for improving pain management practices in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Decision Support to Reduce Opioid Prescriptions for Dental Extractions using SMART on FHIR: Implementation Report. Rindal, DB., Pasumarthi, DP., Thirumalai, V., et al.[2023]

The advanced clinical decision support system (CDSS) HIGEA effectively generated alerts for potential adverse drug events (ADEs), with 51% of alerts leading to interventions that prevented possible medication errors during a 6-month observational study.

The most effective intervention program was for dose adjustments in renal impairment, achieving a positive predictive value (PPV) of 0.51, indicating that the system significantly improved medication safety across various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of a Clinical Decision Support System to Improve Medication Safety. Ibáñez-Garcia, S., Rodriguez-Gonzalez, C., Escudero-Vilaplana, V., et al.[2020]

Clinical decision support (CDS) tools integrated into electronic health records can significantly enhance patient care outcomes by providing real-time data analysis for clinicians during critical decision-making processes.

The implementation of CDS tools in a community hospital setting has shown positive outcome data, indicating their effectiveness in improving healthcare organization performance, especially as financial reimbursement models shift towards patient care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support. How CDS tools impact patient care outcomes. Anton, BB., Schafer, JJ., Micenko, A., et al.[2019]

A survey of 930 dental clinicians revealed a strong willingness to adopt clinical decision support (CDS) tools integrated into electronic health records, with a focus on improving patient care rather than business processes.

Positive attitudes towards the implementation of CDS tools were significantly associated with job satisfaction, comfort with the EHR, and a sense of control over work, while feelings of burnout negatively impacted these attitudes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider Attitudes Toward the Implementation of Clinical Decision Support Tools in Dental Practice. Mertz, E., Bolarinwa, O., Wides, C., et al.[2018]

The article highlights the need for improved patient-centered clinical decision support (PC CDS) tools to enhance healthcare decision-making, emphasizing the importance of making research findings more shareable and publicly available.

A comprehensive assessment involving a technical expert panel, literature review, and interviews with 18 stakeholders identified key areas for improvement, including the need for standardized processes to integrate clinical guidelines and patient-generated health data into PC CDS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The technical landscape for patient-centered CDS: progress, gaps, and challenges. Dullabh, P., Heaney-Huls, K., Lobach, DF., et al.[2022]

The study involving 60 registered nurses demonstrated that clinical decision support (CDS) tools significantly improved the adoption of best practices and reduced care planning time compared to a control group, indicating their effectiveness in enhancing evidence-based decision-making.

While all CDS formats (text, text + graph, and text + table) showed similar adoption rates, the study found that RNs with higher numeracy and graph literacy performed better in terms of care planning time, suggesting that the effectiveness of CDS tools may vary based on individual skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Meaningful Care Plan Clinical Decision Support: Feasibility and Effects of a Simulated Pilot Study. Keenan, GM., Lopez, KD., Yao, Y., et al.[2022]

Medication-related clinical decision support (CDS) systems are crucial for improving medication safety, but their effectiveness relies on users valuing and acting on alerts, highlighting the need for better alert specificity and sensitivity.

To enhance the efficacy of CDS, it is essential to integrate patient-specific factors, standardize processes, and apply human factors design principles, as many systems are still underdeveloped and can lead to alert fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving medication-related clinical decision support. Tolley, CL., Slight, SP., Husband, AK., et al.[2022]

A systematic review of 10 studies on clinical decision support (CDS) in cancer management found that CDS can significantly improve clinician decision-making processes in 5 out of 9 studies.

Among the studies measuring patient outcomes, 4 out of 6 showed significant improvements, indicating that CDS informed by clinical practice guidelines may enhance both decision-making and patient care in cancer settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support for therapeutic decision-making in cancer: A systematic review. Beauchemin, M., Murray, MT., Sung, L., et al.[2020]

In a study involving 16 junior doctors over 4 months, only 24% of their interactions with mobile clinical decision support (mCDS) tools occurred during their shifts, indicating limited engagement with these tools in the workplace.

Despite concerns about the safety of using mobile devices in clinical settings, patients generally had positive perceptions of mCDS, viewing it as a beneficial part of clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Mobile Clinical Decision Support Software by Junior Doctors at a UK Teaching Hospital: Identification and Evaluation of Barriers to Engagement. Patel, R., Green, W., Shahzad, MW., et al.[2018]

A study involving 22 multidisciplinary healthcare providers identified key themes influencing the design and acceptance of a clinical decision support (CDS) care map for thoracic trauma, emphasizing the importance of usability and minimal extra workload for end users.

The research highlighted eight dominant themes, including the need for a minimalistic design and evidence-based support, which are crucial for improving user acceptance and ultimately enhancing patient care outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to and Facilitators for Acceptance of Comprehensive Clinical Decision Support System-Driven Care Maps for Patients With Thoracic Trauma: Interview Study Among Health Care Providers and Nurses. Jones, EK., Banks, A., Melton, GB., et al.[2023]

A study analyzing the usability of clinical decision support systems (CDSS) for community-acquired pneumonia and neutropenic fever found 422 recorded events, including 3 mistakes that could have been life-threatening, highlighting the critical need for careful design and evaluation of these systems.

Incorporating usability engineering principles early in the design of CDSS can help identify interface issues that may lead to adverse medical events, emphasizing the importance of user-friendly software in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How usability of a web-based clinical decision support system has the potential to contribute to adverse medical events. Graham, TA., Kushniruk, AW., Bullard, MJ., et al.[2022]

A systematic review of 63 articles identified 327 barriers and 291 facilitators affecting the acceptance of medication-related Clinical Decision Support Systems (CDSS) among clinicians, highlighting issues related to the perceived usefulness and ease of use of these systems.

The findings suggest that improving the relevance and efficiency of CDSS could enhance clinician engagement and decision-making, paving the way for more effective medication management in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators influencing medication-related CDSS acceptance according to clinicians: A systematic review. Westerbeek, L., Ploegmakers, KJ., de Bruijn, GJ., et al.[2021]

Citations

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Real World Evidence: Clinical Decision Support Impact of a clinical decision support tool on adherence to the Ottawa Ankle Rules. Am J Emerg Med. 34(3):412–8. doi:10.1016/j.ajem.2015.11.028. PMID ...

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Harnessing the power of clinical decision support systems A CDSS is a health information technology tool that provides doctors, nurses and other healthcare professionals with clinical decision-making ...