An interventional study of Practice Facilitation and Peer Coach in Hypertension, sponsored by University of Alabama at Birmingham. Completed at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
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:
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 1,592 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Enhanced usual care
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
Behavioral: Practice Facilitation · Behavioral: Enhanced usual care
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.
Behavioral: Peer Coach · Behavioral: Enhanced usual care
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.
Behavioral: Practice Facilitation · Behavioral: Peer Coach · Behavioral: Enhanced usual care
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
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.
Also known as: Taking Control of Your Health
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.
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.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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?
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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.
| Milestone | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Started | 406 | 382 | 424 | 380 |
| Completed | 342 | 260 | 332 | 275 |
| Not completed | 64 | 122 | 92 | 105 |
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.
| participants | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| 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 | 112 | 87 | 130 | 92 |
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.
| mm Hg | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Change in Systolic Blood Pressure Between Baseline and 12 Months | -11 ± 23 | -10 ± 24 | -11 ± 21 | -12 ± 22 |
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.
| score on a scale | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months | 0 ± 1 | 0 ± 1 | 0 ± 1 | 0 ± 1 |
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.
| score on a scale | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12) | 2 ± 9 | 1 ± 9 | 2 ± 9 | 2 ± 10 |
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.
| score on a scale | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12) | 3 ± 11 | 2 ± 11 | 3 ± 12 | 3 ± 12 |
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.
| participants | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months | 90 | 53 | 77 | 65 |
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.
| participants | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months | 78 | 59 | 66 | 55 |
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.
| participants | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months | 32 | 29 | 32 | 28 |
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.
| participants | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month | 24 | 35 | 32 | 30 |
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.
| score on a scale | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Change in Perceived Stress | 0 ± 3 | -1 ± 4 | -1 ± 4 | -1 ± 4 |
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?
| participants | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Self-reported Stroke | 6 | 14 | 5 | 4 |
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.
| T score | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Change in Instrumental Support | 0 ± 8 | 2 ± 9 | 1 ± 10 | 1 ± 8 |
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.
| T score | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Change in Perceived Emotional Support | 0 ± 8 | 2 ± 9 | 2 ± 9 | 2 ± 10 |
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.
| T score | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Change in Social Isolation | -1 ± 9 | -2 ± 10 | -2 ± 10 | -1 ± 10 |
Collected over 1 year. Non-serious events are listed at a 05% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enhanced Usual Care | 2/344 (0.6%) | 177/342 (51.8%) | 66/342 (19.3%) |
| Practice Facilitation | 0/284 (0%) | 152/283 (53.7%) | 62/283 (21.9%) |
| Peer Coach | 5/335 (1.5%) | 162/330 (49.1%) | 63/330 (19.1%) |
| Peer Coach and Practice Facilitation | 7/284 (2.5%) | 148/285 (51.9%) | 41/285 (14.4%) |
| Event | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Any ED VisitGeneral disorders | 108/342 | 81/283 | 105/330 | 85/285 |
| HypertensionCardiac disorders | 55/342 | 54/283 | 37/330 | 44/285 |
| Any hospitalizationGeneral disorders | 45/342 | 44/283 | 52/330 | 41/285 |
| Self reported strokeGeneral disorders | 14/342 | 24/283 | 8/330 | 12/285 |
| HypotensionCardiac disorders | 19/342 | 9/283 | 19/330 | 18/285 |
| Self reported falls with Ed visitGeneral disorders | 7/342 | 15/283 | 8/330 | 5/285 |
| Event | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation |
|---|---|---|---|---|
| Self reported falls that did not result in an ED visitGeneral disorders | 47/342 | 43/283 | 40/330 | 20/285 |
| Self reported dizziness upon standing or faintingGeneral disorders | 22/342 | 29/283 | 31/330 | 26/285 |
| Age, Continuous(years) | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation | Total |
|---|---|---|---|---|---|
| Mean | 59 ± 12 | 56 ± 11 | 58 ± 12 | 57 ± 12 | 58 ± 12 |
| Sex: Female, Male(Participants) | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation | Total |
|---|---|---|---|---|---|
| Female | 206 | 153 | 205 | 184 | 748 |
| Male | 136 | 107 | 127 | 91 | 461 |
| Ethnicity (NIH/OMB)(Participants) | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 15 | 7 | 16 | 13 | 51 |
| Not Hispanic or Latino | 327 | 251 | 316 | 261 | 1155 |
| Unknown or Not Reported | 0 | 2 | 0 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 342 | 260 | 332 | 275 | 1209 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation | Total |
|---|---|---|---|---|---|
| United States — NC | 182 | 158 | 134 | 145 | 619 |
| United States — AL | 160 | 102 | 198 | 130 | 590 |
| Baseline systolic BP, mm Hg(mm Hg) | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation | Total |
|---|---|---|---|---|---|
| Mean | 158 ± 18 | 156 ± 17 | 153 ± 14 | 157 ± 17 | 156 ± 16 |
| Educational Attainment less than high school(Participants) | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation | Total |
|---|---|---|---|---|---|
| Count of participants | 81 | 63 | 64 | 60 | 268 |
| Annual Household Income(Participants) | Enhanced Usual Care | Practice Facilitation | Peer Coach | Peer Coach and Practice Facilitation | Total |
|---|---|---|---|---|---|
| Less than 20K | 141 | 139 | 146 | 121 | 547 |
| Greater thank 20K | 148 | 84 | 138 | 117 | 487 |
| Declined/Don't know | 53 | 37 | 48 | 37 | 175 |
14 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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University of Alabama at Birmingham