Hypertension
Conditions
Brief summary
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: 1. Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care 2. Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques 3. Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. 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 4. Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.
Interventions
BEHAVIORALPractice 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
BEHAVIORALPeer 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.
BEHAVIORALEnhanced 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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* African American adults aged 19-85 years * Uncontrolled HTN, defined as BP \>140/90 mm Hg at the time of study enrollment * Black Belt resident * English speaking * Willing to work with a peer coach * Willing to sign informed consent
Exclusion criteria
* Plans to move out of the area within the next two years * Advanced illness with limited life expectancy * Pregnant or plans to get pregnant in the next year * Advanced chronic kidney disease (estimated glomerular filtration rate \<45 ml/min/1.73 m2) * Unwillingness to work with a peer coach or to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12) | 12 months | 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. |
| Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months | between 6 months to 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 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. |
| Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months | between baseline to 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. |
| Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month | between 6 month to 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. |
| Change in Perceived Stress | 12 months | 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. |
| Change in Systolic Blood Pressure Between Baseline and 12 Months | 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. |
| Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months | 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. |
| Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12) | 12 months | 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. |
| Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Emotional Support | 12 months | 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. |
| Change in Social Isolation | 12 months | 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. |
| Change in Instrumental Support | 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. |
| Self-reported Stroke | 12 months | 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? |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 342 |
| 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. | 260 |
| 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. | 332 |
| 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. | 275 |
| Total | 1,209 |
Baseline characteristics
| Characteristic | Total | Peer Coach and Practice Facilitation | Peer Coach | Practice Facilitation | Enhanced Usual Care |
|---|---|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 12 | 57 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 12 | 56 years STANDARD_DEVIATION 11 | 59 years STANDARD_DEVIATION 12 |
| Annual Household Income Declined/Don't know | 175 Participants | 37 Participants | 48 Participants | 37 Participants | 53 Participants |
| Annual Household Income Greater thank 20K | 487 Participants | 117 Participants | 138 Participants | 84 Participants | 148 Participants |
| Annual Household Income Less than 20K | 547 Participants | 121 Participants | 146 Participants | 139 Participants | 141 Participants |
| Baseline perceived emotional support score (PROMIS) | 56 score on a scale | 62 score on a scale | 53 score on a scale | 53 score on a scale | 62 score on a scale |
| Baseline systolic BP, mm Hg | 156 mm Hg STANDARD_DEVIATION 16 | 157 mm Hg STANDARD_DEVIATION 17 | 153 mm Hg STANDARD_DEVIATION 14 | 156 mm Hg STANDARD_DEVIATION 17 | 158 mm Hg STANDARD_DEVIATION 18 |
| Educational Attainment less than high school | 268 Participants | 60 Participants | 64 Participants | 63 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 51 Participants | 13 Participants | 16 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1155 Participants | 261 Participants | 316 Participants | 251 Participants | 327 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
| General Self-Reported Health Excellent | 21 Participants | 3 Participants | 7 Participants | 5 Participants | 6 Participants |
| General Self-Reported Health Fair | 469 Participants | 106 Participants | 134 Participants | 101 Participants | 128 Participants |
| General Self-Reported Health Good | 464 Participants | 98 Participants | 128 Participants | 97 Participants | 141 Participants |
| General Self-Reported Health Poor | 97 Participants | 24 Participants | 22 Participants | 29 Participants | 22 Participants |
| General Self-Reported Health Very Good | 158 Participants | 44 Participants | 41 Participants | 28 Participants | 45 Participants |
| Has Diabetes | 568 Participants | 124 Participants | 161 Participants | 123 Participants | 160 Participants |
| History of Stroke | 111 Participants | 24 Participants | 32 Participants | 27 Participants | 28 Participants |
| Married | 435 Participants | 99 Participants | 110 Participants | 89 Participants | 137 Participants |
| Moderate to severe depression (PHQ-8 score >10) | 253 Participants | 52 Participants | 89 Participants | 59 Participants | 53 Participants |
| Patient Assessment of Chronic Illness Care (PACIC) | 3 score on a scale STANDARD_DEVIATION 1 | 3 score on a scale STANDARD_DEVIATION 1 | 3 score on a scale STANDARD_DEVIATION 1 | 3 score on a scale STANDARD_DEVIATION 1 | 3 score on a scale STANDARD_DEVIATION 1 |
| Perceived Instrumental Support score (PROMIS) | 63 score on a scale | 63 score on a scale | 63 score on a scale | 54 score on a scale | 63 score on a scale |
| Perceived Stress Scale | 5 score on a scale | 5 score on a scale | 6 score on a scale | 6 score on a scale | 4 score on a scale |
| Problems learning about conditions because can't understand written info. | 475 Participants | 99 Participants | 121 Participants | 132 Participants | 123 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1209 Participants | 275 Participants | 332 Participants | 260 Participants | 342 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States AL | 590 Participants | 130 Participants | 198 Participants | 102 Participants | 160 Participants |
| Region of Enrollment United States NC | 619 Participants | 145 Participants | 134 Participants | 158 Participants | 182 Participants |
| Reported greater than 1 barrier to medication adherence | 961 Participants | 225 Participants | 262 Participants | 212 Participants | 262 Participants |
| Sex: Female, Male Female | 748 Participants | 184 Participants | 205 Participants | 153 Participants | 206 Participants |
| Sex: Female, Male Male | 461 Participants | 91 Participants | 127 Participants | 107 Participants | 136 Participants |
| Social Isolation score (PROMIS) | 46 score on a scale | 43 score on a scale | 48 score on a scale | 48 score on a scale | 43 score on a scale |
| Someone helps read written materials from the doctor a little to all of the time | 455 Participants | 94 Participants | 109 Participants | 120 Participants | 132 Participants |
| Without Health Insurance | 194 Participants | 35 Participants | 52 Participants | 56 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 344 | 0 / 284 | 5 / 335 | 7 / 284 |
| other Total, other adverse events | 66 / 342 | 62 / 283 | 63 / 330 | 41 / 285 |
| serious Total, serious adverse events | 177 / 342 | 152 / 283 | 162 / 330 | 148 / 285 |
Outcome results
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Usual Care | 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 participants |
| 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 | 87 participants |
| Peer Coach | 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 | 130 participants |
| 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 | 92 participants |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care | Change in Perceived Stress | 0 score on a scale | Standard Deviation 3 |
| Practice Facilitation | Change in Perceived Stress | -1 score on a scale | Standard Deviation 4 |
| Peer Coach | Change in Perceived Stress | -1 score on a scale | Standard Deviation 4 |
| Peer Coach and Practice Facilitation | Change in Perceived Stress | -1 score on a scale | Standard Deviation 4 |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care | Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12) | 2 score on a scale | Standard Deviation 9 |
| Practice Facilitation | Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12) | 1 score on a scale | Standard Deviation 9 |
| Peer Coach | Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12) | 2 score on a scale | Standard Deviation 9 |
| Peer Coach and Practice Facilitation | Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12) | 2 score on a scale | Standard Deviation 10 |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care | Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months | 0 score on a scale | Standard Deviation 1 |
| Practice Facilitation | Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months | 0 score on a scale | Standard Deviation 1 |
| Peer Coach | Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months | 0 score on a scale | Standard Deviation 1 |
| Peer Coach and Practice Facilitation | Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months | 0 score on a scale | Standard Deviation 1 |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care | Change in Systolic Blood Pressure Between Baseline and 12 Months | -11 mm Hg | Standard Deviation 23 |
| Practice Facilitation | Change in Systolic Blood Pressure Between Baseline and 12 Months | -10 mm Hg | Standard Deviation 24 |
| Peer Coach | Change in Systolic Blood Pressure Between Baseline and 12 Months | -11 mm Hg | Standard Deviation 21 |
| Peer Coach and Practice Facilitation | Change in Systolic Blood Pressure Between Baseline and 12 Months | -12 mm Hg | Standard Deviation 22 |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care | Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12) | 3 score on a scale | Standard Deviation 11 |
| Practice Facilitation | Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12) | 2 score on a scale | Standard Deviation 11 |
| Peer Coach | Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12) | 3 score on a scale | Standard Deviation 12 |
| Peer Coach and Practice Facilitation | Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12) | 3 score on a scale | Standard Deviation 12 |
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.
Time frame: between baseline and 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Usual Care | Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months | 90 participants |
| Practice Facilitation | Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months | 53 participants |
| Peer Coach | Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months | 77 participants |
| Peer Coach and Practice Facilitation | Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months | 65 participants |
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.
Time frame: between 6 months to 12 month
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Usual Care | Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months | 78 participants |
| Practice Facilitation | Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months | 59 participants |
| Peer Coach | Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months | 66 participants |
| Peer Coach and Practice Facilitation | Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months | 55 participants |
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.
Time frame: between 6 month to 12 month
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Usual Care | Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month | 24 participants |
| Practice Facilitation | Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month | 35 participants |
| Peer Coach | Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month | 32 participants |
| Peer Coach and Practice Facilitation | Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month | 30 participants |
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.
Time frame: between baseline to 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Usual Care | Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months | 32 participants |
| Practice Facilitation | Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months | 29 participants |
| Peer Coach | Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months | 32 participants |
| Peer Coach and Practice Facilitation | Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months | 28 participants |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care | Change in Instrumental Support | 0 T score | Standard Deviation 8 |
| Practice Facilitation | Change in Instrumental Support | 2 T score | Standard Deviation 9 |
| Peer Coach | Change in Instrumental Support | 1 T score | Standard Deviation 10 |
| Peer Coach and Practice Facilitation | Change in Instrumental Support | 1 T score | Standard Deviation 8 |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care | Change in Perceived Emotional Support | 0 T score | Standard Deviation 8 |
| Practice Facilitation | Change in Perceived Emotional Support | 2 T score | Standard Deviation 9 |
| Peer Coach | Change in Perceived Emotional Support | 2 T score | Standard Deviation 9 |
| Peer Coach and Practice Facilitation | Change in Perceived Emotional Support | 2 T score | Standard Deviation 10 |
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Usual Care | Change in Social Isolation | -1 T score | Standard Deviation 9 |
| Practice Facilitation | Change in Social Isolation | -2 T score | Standard Deviation 10 |
| Peer Coach | Change in Social Isolation | -2 T score | Standard Deviation 10 |
| Peer Coach and Practice Facilitation | Change in Social Isolation | -1 T score | Standard Deviation 10 |
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?
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Usual Care | Self-reported Stroke | 6 participants |
| Practice Facilitation | Self-reported Stroke | 14 participants |
| Peer Coach | Self-reported Stroke | 5 participants |
| Peer Coach and Practice Facilitation | Self-reported Stroke | 4 participants |