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The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt".
In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions.
Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care.
The study's 4 arms are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced usual care | Active Comparator | Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
|
| Practice facilitation | Experimental | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction |
|
| Peer coach | Experimental | Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. |
|
| Peer coach and Practice facilitation | Experimental | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Practice Facilitation | Behavioral | ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months | Blood pressure (BP) control is defined as systolic pressure less than 140 mm Hg and diastolic pressure less than 90 mm Hg. Difference in BP control at 12 month follow-up between trial arms. BP was assessed in the practice by a research assistant using a standardized protocol at baseline, 6, and 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure Between Baseline and 12 Months | Change in systolic blood pressure between baseline and 12 months, which is analyzed by subtracting the baseline systolic BP from the 12 month systolic BP. | 12 months |
| Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Stroke | Self-reported stroke was defined as participants reporting yes to the question: Since the last time we spoke, were you ever told by a physician that you had a stroke? | 12 months |
| Change in Instrumental Support |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham | Birmingham | Alabama | 35205 | United States | ||
| UNC Chapel Hill |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38497987 | Derived | Safford MM, Cummings DM, Halladay JR, Shikany JM, Richman J, Oparil S, Hollenberg J, Adams A, Anabtawi M, Andreae L, Baquero E, Bryan J, Sanders-Clark D, Johnson E, Richman E, Soroka O, Tillman J, Cherrington AL. Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals: A Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):538-546. doi: 10.1001/jamainternmed.2024.0047. | |
| 37525267 |
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We used a random number generator to randomize practices into 4 trial arms; The goal was to recruit approximately 25 participants at each of the randomized practices. The 4 trial arms were enhanced usual care, practice facilitation, peer coaching, and both practice facilitation and peer coaching. Each participant had baseline, 6 month and 12 month data collected. The intervention duration was one year.
| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Usual Care | Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| FG001 | Practice Facilitation | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Practice Facilitation: ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| FG002 | Peer Coach | Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Peer Coach: Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| FG003 | Peer Coach and Practice Facilitation | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months. Practice Facilitation: ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Peer Coach: Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Usual Care | Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months | Blood pressure (BP) control is defined as systolic pressure less than 140 mm Hg and diastolic pressure less than 90 mm Hg. Difference in BP control at 12 month follow-up between trial arms. BP was assessed in the practice by a research assistant using a standardized protocol at baseline, 6, and 12 months. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants peer coaching. Numbers will be different from final numbers in flow diagram because final sample includes participants that had 6 month or 12 month BP data. | Posted | Number | participants | 12 months |
|
1 year
Sample for serious and non-serious adverse events includes only enrolled participants with follow-up data (6 or 12 month data) on blood pressure, chart review, self-reported sides effects and self-reported hospitalizations/ED visits.
Sample for all-cause mortality includes only enrolled participants with follow-up data (6 or 12 month data) on blood pressure, chart review, self-reported sides effects and self-reported hospitalizations/ED visits OR have an adverse events form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Usual Care | Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any ED Visit | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self reported dizziness upon standing or fainting | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrea Cherrington | University of Alabama at Birmingham | 205-996-2885 | acherrington@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2021 | Mar 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2021 | Nov 8, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
| Peer Coach | Behavioral | Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. |
|
|
| Enhanced usual care | Behavioral | Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
|
Patient Assessment of Care for Chronic Conditions (PACIC) measures how patients perceive their chronic condition(s) are being managed by their health care team. Patients fill out a survey of 20 questions regarding the care of their chronic condition(s) over the last 12 months. Used a Likert scale from 1-5, where 1 signifies "None of the time" and 5 signifying "Always". PACIC was scored by summing participants' responses across all 20 items then dividing by 20. This score was calculated at baseline and 12 months follow-up. A change in score for each participant was created by subtracting the 12 months follow-up PACIC score from the baseline PACIC score. |
| 12 months |
| Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12) | Change in health related quality of life measured using self report scale Short form-12. Six questions comprise the PCS. Of the six questions, one question ranges on a 5 point Likert scale from excellent to poor. Two questions range on a 3 point Likert scale from a lot to not at all. Two questions are dichotomous as yes or no. One question ranges on a 5 point Likert scale from extremely to not at all. Different weights are applied to each item to results in scores ranging from 0-100 with higher scores indicating higher functioning. | 12 months |
| Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12) | Change in health related quality of life measured using self report scale Short form-12. Six questions comprise the MCS. Of the six questions, two questions are dichotomous as yes or no. One question ranges on a 5 point Likert scale from all of the time to none of the time. Three questions range on a 6 point Likert scale from all of the time to none of the time. Different weights are applied to each item to result in a score ranging from 0-100 with higher scores indicating higher mental functioning. | 12 months |
| Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months | Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been seen in an ER/ED but not admitted overnight" were considered having the outcome. Data collectors looked for ED visits in patient's charts between baseline and 6 month visit. The outcome measure timeframe is between baseline and 6 months. | between baseline and 6 months |
| Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months | Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been seen in an ER/ED but not admitted overnight" were considered having the outcome. Data collectors looked for ED visits in patient's charts between their 6 month and 12 month follow-up. The outcome measure timeframe is between 6 months and 12 month follow-up. | between 6 months to 12 month |
| Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months | Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been hospitalized overnight?" were considered having the outcome. Data collectors looked for hospitalization in patient's charts between baseline and 6 month visit. The outcome measure timeframe is between baseline and 6 months. | between baseline to 6 months |
| Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month | Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been hospitalized overnight?" were considered having the outcome. Data collectors looked for hospitalizations in patient's charts between their 6 month and 12 month follow-up. The outcome measure timeframe is between 6 months and 12 month follow-up. | between 6 month to 12 month |
| Change in Perceived Stress | The 4-item Cohen perceived stress scale that are measured on a 5-point scale (0 = never, 1= almost never, 2 = sometimes, 3 = fairly often and 4- very often). Items 2 and 3 are reverse coded and then all for items are summed to created a total score that ranges from 0 -16. A higher score is negative indicating greater perceived stress. | 12 months |
We measured change in perceived instrumental support between baseline and 12 months using the Patient Reported Outcomes Measurement Information System (PROMIS) short-form social functioning scale. To each question subjects were asked to respond with "never," "rarely," "sometimes," "usually," or "always." A numerical value was attached to each of these answers, ranging from 1 ("never") to 5 ("always"). Raw scores were translated to standardized t-scores to allow comparison of our sample to the U.S population. "). The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Raw scores ranged from 4-20. Scale scores ranged from 29.3-69.3 with a higher score indicating greater instrumental support.
| 12 months |
| Change in Perceived Emotional Support | We measured change perceived emotional support between baseline and 12 months using the Patient Reported Outcomes Measurement Information System (PROMIS) short-form social functioning scale. To each question subjects were asked to respond with "never," "rarely," "sometimes," "usually," or "always." A numerical value was attached to each of these answers, ranging from 1 ("never") to 5 ("always"). The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Raw scores were translated to standardized t-scores to allow comparison of our sample to the U.S population. Raw scores ranged from 4-20 and scale scores ranged from 25.7-62 with higher scores indicating greater emotional support. | 12 months |
| Change in Social Isolation | We measured change in isolation between baseline and 12 months using the Social Isolation Patient Reported Outcomes Measurement Information System (PROMIS) short-form social functioning scale. To each question subjects were asked to respond with "never," "rarely," "sometimes," "usually," or "always." A numerical value was attached to each of these answers, ranging from 1 ("never") to 5 ("always"). Raw scores were translated to standardized t-scores to allow comparison of our sample to the U.S population. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. The scale is comprised of 4 items. Raw scores range from 0-20 and scale scores range from 34.8-74.2. Higher scores indicate greater isolation. | 12 months |
| Chapel Hill |
| North Carolina |
| 37599 |
| United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Derived |
| Sutton KF, Richman EL, Rees JR, Pugh-Nicholson LL, Craft MM, Peaden SH, Soroka O, Mackey M, Cummings DM, Cherrington AL, Safford MM, Halladay JR; Southeastern Collaboration to Improve Blood Pressure Writing Group. Implementing practice facilitation in research: how facilitators spend their time guiding practices to improve blood pressure control. Implement Sci Commun. 2023 Jul 31;4(1):89. doi: 10.1186/s43058-023-00470-y. |
| 36718176 | Derived | Shikany JM, Safford MM, Cherrington AL, Halladay JR, Anabtawi M, Richman EL, Adams AD, Holt C, Oparil S, Soroka O, Cummings DM. Recruitment and retention of primary care practices in the Southeastern Collaboration to Improve Blood Pressure Control. Contemp Clin Trials Commun. 2023 Jan 16;32:101059. doi: 10.1016/j.conctc.2023.101059. eCollection 2023 Apr. |
| 36271193 | Derived | Cummings DM, Adams A, Patil S, Cherrington A, Halladay JR, Oparil S, Soroka O, Ringel JB, Safford MM. Treatment Intensity, Prescribing Patterns, and Blood Pressure Control in Rural Black Patients with Uncontrolled Hypertension. J Racial Ethn Health Disparities. 2023 Oct;10(5):2505-2512. doi: 10.1007/s40615-022-01431-2. Epub 2022 Oct 21. |
| 35114739 | Derived | Finch AJ, Ringel JB, Dargar S, Halladay J, Cene C, Cherrington A, Cummings D, Safford MM. Greater Social Functioning Associated With Lower Depressive Symptomatology Among Black Belt African Americans Enrolled in the Southeastern Collaboration to Improve Blood Pressure Control Study. Prim Care Companion CNS Disord. 2022 Feb 3;24(1):21m02988. doi: 10.4088/PCC.21m02988. |
| 34535524 | Derived | Sutton KF, Richman EL, Rees JR, Pugh-Nicholson LL, Craft MM, Peaden SH, Mackey M, Halladay JR; Southeastern Collaboration to Improve Blood Pressure Writing Group. Successful Trial of Practice Facilitation for Plan, Do, Study, Act Quality Improvement. J Am Board Fam Med. 2021 Sep-Oct;34(5):991-1002. doi: 10.3122/jabfm.2021.05.210140. |
| BG001 | Practice Facilitation | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Practice Facilitation: ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| BG002 | Peer Coach | Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Peer Coach: Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| BG003 | Peer Coach and Practice Facilitation | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months. Practice Facilitation: ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Peer Coach: Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline systolic BP, mm Hg | Mean | Standard Deviation | mm Hg |
|
| Educational Attainment less than high school | One participant was missing information on educational attainment. | Count of Participants | Participants |
|
| Annual Household Income | Count of Participants | Participants |
|
| Married | Some participants are missing information on marital status. | Count of Participants | Participants |
|
| Without Health Insurance | Count of Participants | Participants |
|
| Has Diabetes | Count of Participants | Participants |
|
| History of Stroke | Count of Participants | Participants |
|
| General Self-Reported Health | Count of Participants | Participants |
|
| Moderate to severe depression (PHQ-8 score >10) | Personal Health Questionnaire Depression Scale (PHQ-8). The scale is comprised of 8 items each of which is scored 0-3. Items are summed up to create a total score ranging from 0-24 with higher scores indicating more worse outcomes and more depressive symptoms. | Some participants are missing information on depressive symptoms. | Count of Participants | Participants |
|
| Someone helps read written materials from the doctor a little to all of the time | Some participants were missing information on health literacy. | Count of Participants | Participants |
|
| Problems learning about conditions because can't understand written info. | Has problems learning about conditions because can't understand written info a little to all of the time. | Some participants were missing information on health literacy | Count of Participants | Participants |
|
| Reported greater than 1 barrier to medication adherence | Some participants are missing information on barriers to medication adherence. | Count of Participants | Participants |
|
| Social Isolation score (PROMIS) | We measured isolation using the Patient Reported Outcomes Measurement Information System (PROMIS) short-form social functioning scale. To each question subjects were asked to respond with "never," "rarely," "sometimes," "usually," or "always." A numerical value was attached to each of these answers, ranging from 1 ("never") to 5 ("always"). Raw scores were translated to standardized t-scores to allow comparison of our sample to the U.S population. The scale is comprised of 4 items. Raw scores range from 0-20 and scale scores range from 34.8-74.2. Higher scores indicate greater isolation. | Some participants are missing information on social isolation | Median | Inter-Quartile Range | score on a scale |
|
| Baseline perceived emotional support score (PROMIS) | We measured perceived emotional support using the Patient Reported Outcomes Measurement Information System (PROMIS) short-form social functioning scale. For 4 questions, participants were asked to respond with "never," "rarely," "sometimes," "usually," or "always." A numerical value was attached to each of these answers, ranging from 1 ("never") to 5 ("always"). Raw scores were translated to standardized t-scores to allow comparison of our sample to the U.S population. Raw scores ranged from 4-20 and scale scores ranged from 25.7-62 with higher scores indicating greater emotional support. | Participants were missing information on perceived emotional support | Median | Inter-Quartile Range | score on a scale |
|
| Perceived Instrumental Support score (PROMIS) | We measured perceived instrumental support using the Patient Reported Outcomes Measurement Information System (PROMIS) short-form social functioning scale. For 4 questions, subjects were asked to respond with "never," "rarely," "sometimes," "usually," or "always." A numerical value was attached to each of these answers, ranging from 1 ("never") to 5 ("always"). Raw scores were translated to standardized t-scores to allow comparison of our sample to the U.S population. Raw scores ranged from 4-20. Scale scores ranged from 29.3-69.3 with a higher score indicating greater instrumental support. | Some participants were missing information on perceived instrumental support | Median | Inter-Quartile Range | score on a scale |
|
| Perceived Stress Scale | The 4-item Cohen's perceived stress scale that is measured on a 5-point scale (0 = never, 1= almost never, 2 = sometimes, 3 = fairly often and 4- very often). Items 2 and 3 are reverse coded and then all for items are summed to created a total score that ranges from 0 -16. A higher score is negative indicating greater perceived stress. | Some participants were missing information on stress | Median | Inter-Quartile Range | score on a scale |
|
| Patient Assessment of Chronic Illness Care (PACIC) | Patient Assessment of Care for Chronic Conditions (PACIC) measures how patients perceive their chronic condition(s) are being managed by their health care team. Patients fill out a survey of 20 questions regarding the care of their chronic condition(s) over the last 12 months. Responses use a Likert scale from 1-5, where 1 signifies "None of the time" and 5 signifying "Always". PACIC was scored by summing participants' responses across all 20 items then dividing by 20. The range of total score is 1-5 with higher scores indicating better perceived chronic condition care. | Some participants are missing information on the PACIC | Mean | Standard Deviation | score on a scale |
|
| OG001 | Practice Facilitation | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Practice Facilitation: ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| OG002 | Peer Coach | Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Peer Coach: Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
| OG003 | Peer Coach and Practice Facilitation | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months. Practice Facilitation: ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Peer Coach: Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. |
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| Secondary | Change in Systolic Blood Pressure Between Baseline and 12 Months | Change in systolic blood pressure between baseline and 12 months, which is analyzed by subtracting the baseline systolic BP from the 12 month systolic BP. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants peer coaching. | Posted | Mean | Standard Deviation | mm Hg | 12 months |
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| Secondary | Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months | Patient Assessment of Care for Chronic Conditions (PACIC) measures how patients perceive their chronic condition(s) are being managed by their health care team. Patients fill out a survey of 20 questions regarding the care of their chronic condition(s) over the last 12 months. Used a Likert scale from 1-5, where 1 signifies "None of the time" and 5 signifying "Always". PACIC was scored by summing participants' responses across all 20 items then dividing by 20. This score was calculated at baseline and 12 months follow-up. A change in score for each participant was created by subtracting the 12 months follow-up PACIC score from the baseline PACIC score. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12) | Change in health related quality of life measured using self report scale Short form-12. Six questions comprise the PCS. Of the six questions, one question ranges on a 5 point Likert scale from excellent to poor. Two questions range on a 3 point Likert scale from a lot to not at all. Two questions are dichotomous as yes or no. One question ranges on a 5 point Likert scale from extremely to not at all. Different weights are applied to each item to results in scores ranging from 0-100 with higher scores indicating higher functioning. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12) | Change in health related quality of life measured using self report scale Short form-12. Six questions comprise the MCS. Of the six questions, two questions are dichotomous as yes or no. One question ranges on a 5 point Likert scale from all of the time to none of the time. Three questions range on a 6 point Likert scale from all of the time to none of the time. Different weights are applied to each item to result in a score ranging from 0-100 with higher scores indicating higher mental functioning. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months | Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been seen in an ER/ED but not admitted overnight" were considered having the outcome. Data collectors looked for ED visits in patient's charts between baseline and 6 month visit. The outcome measure timeframe is between baseline and 6 months. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Number | participants | between baseline and 6 months |
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| Secondary | Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months | Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been seen in an ER/ED but not admitted overnight" were considered having the outcome. Data collectors looked for ED visits in patient's charts between their 6 month and 12 month follow-up. The outcome measure timeframe is between 6 months and 12 month follow-up. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Number | participants | between 6 months to 12 month |
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| Secondary | Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months | Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been hospitalized overnight?" were considered having the outcome. Data collectors looked for hospitalization in patient's charts between baseline and 6 month visit. The outcome measure timeframe is between baseline and 6 months. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Number | participants | between baseline to 6 months |
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| Secondary | Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month | Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been hospitalized overnight?" were considered having the outcome. Data collectors looked for hospitalizations in patient's charts between their 6 month and 12 month follow-up. The outcome measure timeframe is between 6 months and 12 month follow-up. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Number | participants | between 6 month to 12 month |
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| Secondary | Change in Perceived Stress | The 4-item Cohen perceived stress scale that are measured on a 5-point scale (0 = never, 1= almost never, 2 = sometimes, 3 = fairly often and 4- very often). Items 2 and 3 are reverse coded and then all for items are summed to created a total score that ranges from 0 -16. A higher score is negative indicating greater perceived stress. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Other Pre-specified | Self-reported Stroke | Self-reported stroke was defined as participants reporting yes to the question: Since the last time we spoke, were you ever told by a physician that you had a stroke? | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Number | participants | 12 months |
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| Other Pre-specified | Change in Instrumental Support | We measured change in perceived instrumental support between baseline and 12 months using the Patient Reported Outcomes Measurement Information System (PROMIS) short-form social functioning scale. To each question subjects were asked to respond with "never," "rarely," "sometimes," "usually," or "always." A numerical value was attached to each of these answers, ranging from 1 ("never") to 5 ("always"). Raw scores were translated to standardized t-scores to allow comparison of our sample to the U.S population. "). The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Raw scores ranged from 4-20. Scale scores ranged from 29.3-69.3 with a higher score indicating greater instrumental support. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Mean | Standard Deviation | T score | 12 months |
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| Other Pre-specified | Change in Perceived Emotional Support | We measured change perceived emotional support between baseline and 12 months using the Patient Reported Outcomes Measurement Information System (PROMIS) short-form social functioning scale. To each question subjects were asked to respond with "never," "rarely," "sometimes," "usually," or "always." A numerical value was attached to each of these answers, ranging from 1 ("never") to 5 ("always"). The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Raw scores were translated to standardized t-scores to allow comparison of our sample to the U.S population. Raw scores ranged from 4-20 and scale scores ranged from 25.7-62 with higher scores indicating greater emotional support. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Mean | Standard Deviation | T score | 12 months |
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| Other Pre-specified | Change in Social Isolation | We measured change in isolation between baseline and 12 months using the Social Isolation Patient Reported Outcomes Measurement Information System (PROMIS) short-form social functioning scale. To each question subjects were asked to respond with "never," "rarely," "sometimes," "usually," or "always." A numerical value was attached to each of these answers, ranging from 1 ("never") to 5 ("always"). Raw scores were translated to standardized t-scores to allow comparison of our sample to the U.S population. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. The scale is comprised of 4 items. Raw scores range from 0-20 and scale scores range from 34.8-74.2. Higher scores indicate greater isolation. | There are 4 arms in this study. Arm one is enhanced usual care. Arm 2 is practice facilitation. Arm 3 is peer coaching. In arm 4 practices received practice facilitation and participants received peer coaching. | Posted | Mean | Standard Deviation | T score | 12 months |
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| 2 |
| 344 |
| 177 |
| 342 |
| 66 |
| 342 |
| EG001 | Practice Facilitation | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Practice Facilitation: ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. | 0 | 284 | 152 | 283 | 62 | 283 |
| EG002 | Peer Coach | Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Peer Coach: Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. | 5 | 335 | 162 | 330 | 63 | 330 |
| EG003 | Peer Coach and Practice Facilitation | Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months. Practice Facilitation: ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction Peer Coach: Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months. Enhanced usual care: Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system. | 7 | 284 | 148 | 285 | 41 | 285 |
| Any hospitalization | General disorders | Systematic Assessment |
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| Self reported falls with Ed visit | General disorders | Systematic Assessment |
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| Self reported stroke | General disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment | Systolic Blood Pressure great than or equal to 180 or diastolic blood pressure great than or equal to 110 (from visit) |
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| Hypotension | Cardiac disorders | Systematic Assessment | Systolic blood pressure less than 90 or diastolic blood pressure less than 90 (from visit) |
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| Self reported falls that did not result in an ED visit | General disorders | Systematic Assessment |
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Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| AL |
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| Greater thank 20K |
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| Declined/Don't know |
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| Very Good |
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| Good |
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| Fair |
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| Poor |
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