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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| The Cleveland Clinic | OTHER |
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The primary objective of the Implementation of Effective Hypertension Management Approaches: Cleveland Clinic program is to improve blood pressure control for patients diagnosed with hypertension (HTN) and uncontrolled blood pressure, specifically defined as a blood pressure greater than 150/95, across all Cleveland Clinic Northeast Ohio primary care practices. The project will scale up the availability of resources for treating hypertension in 56 primary care practices within the Cleveland Clinic Health System in Northern Ohio, reaching up to approximately 3800 patients. This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings.
Primary care providers will offer the program to patients in Northeast Ohio with a hypertension diagnosis and aged 18-85, except those who are pregnant, have stage 5 chronic kidney disease or end stage renal disease, or enrolled in hospice care. The project time frame is 48 months. Quantitative and qualitative methods will be used to evaluate implementation and effectiveness outcomes associated with the program. Electronic medical records and surveys will be the key data sources for the quantitative evaluation. Qualitative data collection methods will include semi-structured interviews, field observations, and periodic reflections.
Specific Aims Aim 1. To prepare for implementation of the intensive HTN management program across all Northeast Ohio Primary Care Practices (Pre-Implementation) Pre-Implementation Phase (12 months)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IN-HOME BP: titrating BP medications based on patient-recorded home blood pressure readings | This project will utilize evidence from a randomized controlled trial by Margolis et al.(1) to build upon Cleveland Clinic's existing team-based primary care provider (PCP) collaboration with pharmacists and advanced practice providers (APP) and will use a mechanism that allows titrating blood pressure medications based on patient-recorded home blood pressure readings. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN-HOME BP | Other | A team-based approach with a primary care provider (PCP) collaborating with pharmacists and advanced practice providers (APP) and will use a mechanism (frequent follow-up- phone or virtual appointments) that allows titrating blood pressure medications based on patient-recorded home blood pressure readings. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure Change | The main effectiveness finding the investigators expect to report at the end of the proposed implementation project is the change in patient systolic blood pressure from baseline to 12 months post-implementation. The expected change in systolic blood pressure based upon Margolis et al.(1) is -18mmHg. The period of evaluation will be from the time of program enrollment, with home BP measurements assessed every 2-3 weeks until the blood pressure is less than 135/85 and at 12 months. The blood pressure will continue to be measured every 6 months through the full the 24-month implementation/intervention period (allowing all sites to roll out the intervention) and a 9-month maintenance period. | Patients will be followed for up to 33 months: 24-month implementation/intervention period and 9-month maintenance period. |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure Change | Change in the patient's diastolic blood pressure from baseline as measured in mmHg. | The patient's blood pressure will be measured for up to 33 months (24-month implementation/intervention period and 9-month maintenance period). Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance. |
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Inclusion Criteria:
Exclusion Criteria:
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Per inclusion criteria and that the patient has at least 2 encounters with a HTN diagnosis within the past 24 months; had an encounter within the past 12 months at their PCPs assigned location; had a documented systolic blood pressure of >150 or diastolic blood pressure of >95 at the most recent encounter at the primary care location, and a previous encounter within the health system within the past 24-month qualifying time frame with a documented systolic blood pressure of >150 or diastolic blood pressure of >95.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anita Misra-Hebert, MD, MPH, FACP | Contact | 216-445-8542 | MISRAA@ccf.org | |
| Christopher Babuich, MD | Contact | 440 204-7400 | babiucc@ccf.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28851459 | Background | Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. | |
| 19543809 | Background | Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19. |
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Data used for this study includes human research participant data that are sensitive and cannot be publicly shared due to legal and ethical restrictions by the Cleveland Clinic regulatory bodies, including the institutional review board and legal counsel. We will make our data sets available on request, under appropriate data use agreements with the specific parties interested in academic collaboration.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Reach (Actual): Patients Offered, Initiated, Completed | Number of patients who were offered, who initiated, and completed the intensive HTN intervention program. Measured by total number at sorted by each: offered, initiated, completed. | Measured every 3 months for up to 33 months. |
| Effectiveness: Equity in Outcomes (Race) | Blood pressure change stratified by demographic factors, specifically race. Measured as percentage of black, white, and other. | Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months. |
| Effectiveness: Equity in Outcomes (Ethnicity) | Blood pressure change stratified by demographic factors, specifically ethnicity. Measured by percentage of Hispanic and non-Hispanic | Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months. |
| Effectiveness: Equity in Outcomes (Gender) | Blood pressure change stratified by demographic factors, specifically gender. Measured by percentage of male and female. | Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months. |
| Effectiveness: Equity in Outcomes (Age) | Blood pressure change stratified by demographic factors, specifically age group. Measured in years. | Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months. |
| Effectiveness: Equity in Outcomes (Insurance) | Blood pressure change stratified by demographic factors, specifically insurance. Measured in number of insurance: Medicare, Medicaid, Commercial, Self-pay. | Every 2-3 weeks during intervention, at 12 months, then every 6 months through maintenance: for up to 33 months. |
| Effectiveness: Medication change | Change from baseline medication regimen (medication class and dosage). | Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months. |
| Effectiveness: Medication Adherence | Pharmacy Fill Data | Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months. |
| Effectiveness: Cardiovascular outcomes | Sustained blood pressure control resulting in decreased cardiovascular risk: reported myocardial infarction, acute coronary syndrome, stroke, heart failure, arrhythmia, and death. | Baseline, and every 6 months through maintenance: for up to 33 months. |
| Effectiveness: Acute Renal Failure - Change in glomerular filtration rate (GFR). | Assessing acute renal failure by change in glomerular filtration rate (GFR) as measured in milliliters/minute/1.73 meters squared. | Every 6 months through maintenance: for up to 33 months. |
| Effectiveness: PROMIS-10 Survey | See improvement of patient report outcomes captured at pre-visit PROMIS-10 survey(12) administration as part of routine clinical care. As measured by assessing scores over time. | Baseline at intake visit then at 12 months: up to 24-months. |
| Effectiveness: Adverse Effects | Patient reported adverse effects at follow-up visits during intervention. Measured as number of effects reported by patient. | Every 2-3 weeks during intervention then every 6 months through maintenance: for up to 33 months. |
| Implementation: Provider views of the Acceptability, Appropriateness, and Feasibility survey | Captured through surveys, provider views of Acceptability, Appropriateness, Feasibility (13). Providers views of intervention may impact adoption of intervention for patients. Measured by change in item scored over time. | Every 6 months starting throughout active implementation and maintenance: for up to 33 months. |
| Primary Care Provider Adoption | Number of providers in each practice group referring to the Intensive HTN program will be measured by the number of referrals attributed to practice group. | Every 3 months during intervention period: for up to 24 months |
| Pharmacist Adoption | Number of patients in the program attributed to the trained pharmacy providers eligible to deliver the program. | Every 3 months during intervention period: for up to 24 months. |
| Advanced Practice Provider Adoption | Number of patients in the program attributed to the trained Advanced Practice Providers (APP) eligible to deliver the program. | Every 3 months during intervention period: for up to 24 months. |
| Formal Qualitative Assessment of context of high proportion of HTN control and low proportion of HTN control practices: Pre-Implementation | To understand barriers and facilitators to achieving HTN control
| Pre-Implementation: up to 12 months. |
| Formal Qualitative Assessment: Observations of Employee and Patient Advisory Panels | To examine anticipated barriers and facilitators to implementation and to assess ongoing implementation activities. Qualitative methodologists will analyze the qualitative data (fieldnotes) will be coded to reflect key domains of interest and emergent themes. | Quarterly meetings throughout pre- and active implementation: up to 36 months. |
| Formal Qualitative Assessment: Semi-structured Interviews with Patients at High/Low proportion of HTN Control | Inviting a sample of patients receiving the intervention at high and low proportion of HTN control practices to participate in interviews to assess perceptions of acceptability of the intensive HTN management program. Qualitative methodologists will analyze the qualitative data (transcripts) will be coded to reflect key domains of interest and emergent themes. | Baseline, 6 months, 12 months during active implementation: up to 24 months. |
| Formal Qualitative Assessment: Periodic Reflections with agents of implementation | Periodic reflections conducted with a subgroup of pool of primary care providers, pharmacists, and APPs across practice locations to understand barriers and facilitators to achieving hypertension control. Qualitative methodologists will analyze the qualitative data (descriptive fieldnotes) will be coded to reflect key domains of interest and emergent themes. | Monthly or bimonthly throughout active implementation and maintenance: for up to 33 months. |
| Outcome measure type: Effectiveness (Hospitalizations / Emergency Department Visits) | Hospitalizations and Emergency Department Visits: number of acute care hospitalizations, number of emergency department visits. Determining association between intensive HTN management and acute care utilization. | Every 6 months: up to 33 months. |
| Outcome Measure Type: Effectiveness (Outpatient Visits) | Outpatient visits other than for the intensive HTN management program. Number of outpatient visits (in-clinic or virtual, primary care and specialty). To determine association between intensive HTN management and acute care utilization. | Every 6 months: up to 33 months. |
| 36281763 | Background | Margolis KL, Bergdall AR, Crain AL, JaKa MM, Anderson JP, Solberg LI, Sperl-Hillen J, Beran M, Green BB, Haugen P, Norton CK, Kodet AJ, Sharma R, Appana D, Trower NK, Pawloski PA, Rehrauer DJ, Simmons ML, McKinney ZJ, Kottke TE, Ziegenfuss JY, Williams RA, O'Connor PJ. Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial. Hypertension. 2022 Dec;79(12):2708-2720. doi: 10.1161/HYPERTENSIONAHA.122.19816. Epub 2022 Oct 25. |