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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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This is a multi-center randomized controlled trial comparing the effectiveness of community health worker (CHW) vs. usual clinician support in helping chronically-ill patients with low socioeconomic status to improve their health outcomes.
Community Health Workers (CHWs) have the potential to improve chronic disease outcomes among patients with low socioeconomic status (SES). Yet, widespread use of CHWs has been hampered by lack of standardized, scalable and evidence-based models. Our community-academic-health system team used participatory action research with low-SES patients to design IMPaCT (Individualized Management for Patient-Centered Targets). A randomized controlled trial (RCT) of 446 hospitalized patients with varied diseases demonstrated that a 2-week dose of IMPaCT improved access to care, mental health, activation, and quality of communication, while reducing recurrent hospital readmissions. We have adapted IMPaCT for use among low-SES primary care patients with multiple chronic conditions.
This RCT is designed to evaluate the newly adapted IMPaCT model in 3 primary care settings - academic, federally qualified health center, and VA. Upon enrollment in the trial, patients will collaboratively set a chronic disease management goal with their primary care provider. Patients will then be randomized to collaborative goal-setting versus goal-setting augmented by 6 months of support from an IMPaCT CHW. Follow-up will be conducted at 6- and 9- months post-enrollment.
The study design is a single-blinded, 2- armed, multi-site randomized controlled trial involving three clinic sites and 444 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual clinician support | Placebo Comparator | Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. |
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| CHW support | Experimental | Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMPaCT | Behavioral | The IMPaCT intervention has three stages:
|
| Measure | Description | Time Frame |
|---|---|---|
| Short Form Health Survey (SF-12) Physical Component Score (PCS) | The main dependent variable is mean change in standardized score for SF-12 PCS. The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We measure the between-arm difference in mean change in SF-12 PCS between baseline and 6-month follow-up assessment. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Chronic Disease Control - Diabetes | We will asses change in chronic disease control using biometric testing (HgA1c). At six months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: HgbA1c. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Baseline, 6 months, 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A. Long, MD | University of Pennsylvania/Philadelphia Veterans Affairs Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30422224 | Derived | Kangovi S, Mitra N, Norton L, Harte R, Zhao X, Carter T, Grande D, Long JA. Effect of Community Health Worker Support on Clinical Outcomes of Low-Income Patients Across Primary Care Facilities: A Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1635-1643. doi: 10.1001/jamainternmed.2018.4630. |
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Study enrollment took place at: a Veterans Affairs medical center primary care practice, a federally qualified health center and an academic family medicine clinic. Patients were recruited between January 28th, 2015 and March 28, 2016 at which time the trial was stopped because we had reached our pre-specified sample size target.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Clinician Support | Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care |
| FG001 | CHW Support | Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 Month Follow-Up |
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| |||||||||||||||||||||
| 9 Month Follow-Up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Clinician Support | Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care |
| 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 | Short Form Health Survey (SF-12) Physical Component Score (PCS) | The main dependent variable is mean change in standardized score for SF-12 PCS. The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We measure the between-arm difference in mean change in SF-12 PCS between baseline and 6-month follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months |
|
Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
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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 | Usual Clinician Support | Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood infection | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsey Norton | University of Pennsylvania School of Medicine | 215-573-9961 | lindsey.turr@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| Usual care | Other |
|
| Change in Chronic Disease Control - Obesity | We will asses change in chronic disease control using biometric testing (kg/m^2). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: height and weight. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Baseline, 6 months, 9 months |
| Change in Chronic Disease Control - Tobacco Use | We will asses change in chronic disease control using patient self-report (cigarettes per day). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Baseline, 6 months, 9 months |
| Change in Chronic Disease Control - Hypertension | We will asses change in chronic disease control using biometric testing (systolic blood pressure in mm Hg). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Baseline, 6 months, 9 months |
| Short Form Health Survey (SF-12) - Mental Component Summary (MCS) | The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We will assess this outcome using the SF-12 Mental Component Summary (MCS) score. The MCS reliably detects differences in mental health over time. We will measure the between-arm difference in mean change in SF-12 MCS score between baseline, 6- and 9- month follow-up. | Baseline, 6 months, 9 months |
| Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness | We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the comprehensiveness question at 6 and 9 months post-enrollment. | 6 months, 9 months |
| Number of Participants With Any Hospital Admission | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months |
| Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome | At 6-months post-enrollment, a trained qualitative interviewer on our study team will conduct an in-depth qualitative semi-structured interview with 40 intervention arm patients and their CHWs. Qualitative interviews will be audio-taped and transcribed. Patients will be purposively sampled across each study site in order to be able to make comparisons between those who achieved a minimally important improvement in the primary outcome and those who did not. These interviews will be guided by the Integrative Behavior Model (IBM). UPDATE: After beginning interviews, our team decided that 26 interviews was sufficient to reach thematic saturation. | 6 months |
| Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management | We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the supportiveness of disease self-management question at 6 and 9 months post-enrollment. | 6 months, 9 months |
| Number of Participants With Multiple Hospital Admissions | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months |
| Number of Participants With 30 Day Hospital Readmissions | We will measure admission to hospital at 30 days after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 30 days |
| Hospital Admission - Total Hospital Days | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months |
| Hospital Admission - Mean Number of Hospitalizations | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months |
| Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization) | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months |
| NOT COMPLETED |
|
|
| BG001 |
| CHW Support |
Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Employed | Not all participants answered this question. | Count of Participants | Participants |
|
| Household Income | Count of Participants | Participants |
|
| Trauma History | Not all participants answered this question. | Count of Participants | Participants |
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| Low Social Support | Not all participants answered this question. | Count of Participants | Participants |
|
| Short Grit Scale (Grit-S) | This scale asks 8 questions relating to a person's passion and perseverance. Each question is graded on a five point likert scale where respondents rate statements as being somewhere from 'Not like me at all' to 'Very much like me'. Scores from each of the 8 questions are averaged for a total grit score with 5 being high grit (high passion/perseverance) and 1 being low grit. | Not all participants answered this question. | Mean | Standard Deviation | units on a scale |
|
| Adult Attachment Questionnaire (AAQ) | The Adult Attachment Questionnaire (AAQ) is an 11-item scale that measures secure, avoidant, and anxious attachment styles. For each question, the participant is asked to rate a statement on a scale of 1-6 (Strongly agree, agree, slightly agree, slightly disagree, disagree, strongly disagree). Scores are then averaged to get a final score between 1 and 6. Some of the questions can be combined to create subscores for avoidance and anxiety. Higher scores on these dimensions reflect greater avoidance or anxiety. Greater attachment security is defined by lower scores on both scales. | Mean | Standard Deviation | units on a scale |
|
| Delayed Health Need | Not all participants answered this question. | Count of Participants | Participants |
|
| Unmet health Need | Not all participants answered this question. | Count of Participants | Participants |
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| Lack of Basic needs | Count of Participants | Participants |
|
| Alcohol Overuse | Not all participants answered this question. | Count of Participants | Participants |
|
| Drug Use | Not all participants answered this question. | Count of Participants | Participants |
|
| Short Form Health Survey (SF-12) | The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. | Not all participants answered these questions. | Mean | Standard Deviation | score on a scale |
|
| Patient Activation Measure (PAM) | The PAM is a 13-item survey that assesses a person's underlying knowledge, skills, and confidence integral to managing his or her own health and healthcare. Respondents are asked to strongly agree, agree, disagree, or strongly disagree with each statement. Responses are then scored into a 100 point scale where higher scores indicate increased patient activation (higher knowledge, skills, and confidence for managing their own health/healthcare). | Not all participants answered these questions. | Mean | Standard Deviation | units on a scale |
|
| Perceived Stress Scale (PSS) | The PSS measures how much stress a person attributes to various situations in their life. While the PSS is a 10 point scale, a short form of 4 questions was used for this study. Each question on the scale is rated from Never (0) to Very Often (4). Scores are then summed. For the 4 question short form there is a range of scores between 0 and 16 with 16 being the highest level of stress and 0 being no stress. | Not all participants answered these questions. | Mean | Standard Deviation | units on a scale |
|
| Single Item Literacy Screener (SILS) | This single item screener assesses how much assistance respondents need in reading health-related materials. This is scored as a 5 point likert scale with a range of 1 - 5. A lower score on this scale indicates high health literacy (never or rarely needing assistance reading health-related materials). A higher score indicates low health literacy (often or always needing assistance reading health-related materials). | Not all participants answered this question. | Mean | Standard Deviation | units on a scale |
|
| ER visits in prior 12 months | Mean | Standard Deviation | Avg # of visits |
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| Admissions in prior 12 months | Mean | Standard Deviation | Avg # of admissions |
|
| Chronic Disease Prevalence - Hypertension | Count of Participants | Participants |
|
| Chronic Disease Prevalence - Obesity | Count of Participants | Participants |
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| Chronic Disease Prevalence - Diabetes | Count of Participants | Participants |
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| Chronic Disease Prevalence - Tobacco Dependence | Count of Participants | Participants |
|
| Selected Condition | Count of Participants | Participants |
|
| Hypertension | Baseline clinical parameters and health goal among those participants who focused on a hypertension reduction goal. To measure this outcome, we are assessing systolic blood pressure values in mmHg | Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study. | Mean | Standard Deviation | mmHg |
|
| Diabetes | Baseline clinical parameters and collaboratively set health goal among those participants who focused on a diabetes goal. Patients were asked to set a goal with their health care provider to lower their Hemoglobin A1c. | Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study. | Mean | Standard Deviation | HbA1c% |
|
| Obesity - Baseline Clinical Parameters | Baseline clinical parameters among those participants who focused on an obesity reduction goal. | Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study. | Mean | Standard Deviation | kg/m^2 (BMI) |
|
| Obesity - Health Goal | Collaboratively set health goal among those participants who focused on an obesity reduction goal. Patients were asked to set a goal with their health care provider to lower their BMI. The goal was set in pounds. | Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study. | Mean | Standard Deviation | pounds |
|
| Tobacco Use | Baseline number of cigarettes smoked per day among those participants who focused on a tobacco cessation goal. This was measured by self-reported daily tobacco use ("How many cigarettes do you smoke a day?"). All participants who focused on tobacco use were asked to set a quit smoking goal so there is no collaboratively set goal indicator for this chronic disease outcome. | Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study. | Mean | Standard Deviation | number of cigarettes |
|
| OG001 | CHW Support | Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages:
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| Secondary | Change in Chronic Disease Control - Diabetes | We will asses change in chronic disease control using biometric testing (HgA1c). At six months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: HgbA1c. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Each participant was only analyzed for their chosen chronic condition. | Posted | Mean | Standard Deviation | HbA1c% | Baseline, 6 months, 9 months |
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| Secondary | Change in Chronic Disease Control - Obesity | We will asses change in chronic disease control using biometric testing (kg/m^2). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: height and weight. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Each participant was only analyzed for their chosen chronic condition. | Posted | Mean | Standard Deviation | kg/m^2 (BMI) | Baseline, 6 months, 9 months |
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| Secondary | Change in Chronic Disease Control - Tobacco Use | We will asses change in chronic disease control using patient self-report (cigarettes per day). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Each participant was only analyzed for their chosen chronic condition. | Posted | Mean | Standard Deviation | cigarettes per day | Baseline, 6 months, 9 months |
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| Secondary | Change in Chronic Disease Control - Hypertension | We will asses change in chronic disease control using biometric testing (systolic blood pressure in mm Hg). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Each participant was only analyzed for their chosen chronic condition. | Posted | Mean | Standard Deviation | mm Hg | Baseline, 6 months, 9 months |
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| Secondary | Short Form Health Survey (SF-12) - Mental Component Summary (MCS) | The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We will assess this outcome using the SF-12 Mental Component Summary (MCS) score. The MCS reliably detects differences in mental health over time. We will measure the between-arm difference in mean change in SF-12 MCS score between baseline, 6- and 9- month follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, 9 months |
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| Secondary | Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness | We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the comprehensiveness question at 6 and 9 months post-enrollment. | Posted | Count of Participants | Participants | 6 months, 9 months |
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| Secondary | Number of Participants With Any Hospital Admission | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | Posted | Count of Participants | Participants | 6 months and 9 months |
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| Secondary | Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome | At 6-months post-enrollment, a trained qualitative interviewer on our study team will conduct an in-depth qualitative semi-structured interview with 40 intervention arm patients and their CHWs. Qualitative interviews will be audio-taped and transcribed. Patients will be purposively sampled across each study site in order to be able to make comparisons between those who achieved a minimally important improvement in the primary outcome and those who did not. These interviews will be guided by the Integrative Behavior Model (IBM). UPDATE: After beginning interviews, our team decided that 26 interviews was sufficient to reach thematic saturation. | This data point contains qualitative, not quantitative data. The study team is still analyzing this data set and has not yet completed analysis for this outcome. Below, we report the number of interviews completed for each clinical site (VA, Federally Qualified Health Center, Academic Site). We will not complete any more interviews. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management | We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the supportiveness of disease self-management question at 6 and 9 months post-enrollment. | Posted | Count of Participants | Participants | 6 months, 9 months |
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| Secondary | Number of Participants With Multiple Hospital Admissions | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | This outcome was only assessed for participants who had hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study. | Posted | Count of Participants | Participants | 6 months and 9 months |
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| Secondary | Number of Participants With 30 Day Hospital Readmissions | We will measure admission to hospital at 30 days after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | This outcome was only assessed for participants who had hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study. | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Hospital Admission - Total Hospital Days | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | Posted | Number | Days | 6 months and 9 months |
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| Secondary | Hospital Admission - Mean Number of Hospitalizations | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | This outcome was only assessed for participants who had a hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study. | Posted | Mean | Standard Deviation | Hospitalizations | 6 months and 9 months |
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| Secondary | Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization) | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | This outcome was only assessed for participants who had a hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study. | Posted | Mean | Standard Deviation | days | 6 months and 9 months |
|
|
|
|
| 3 |
| 288 |
| 32 |
| 288 |
| 0 |
| 288 |
| EG001 | CHW Support | Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages:
| 1 | 304 | 35 | 304 | 0 | 304 |
| Allergic reaction to meds | Metabolism and nutrition disorders | Systematic Assessment |
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| Angioplasty | Cardiac disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bowel Issues | Gastrointestinal disorders | Systematic Assessment |
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| Bacterial Infection | Infections and infestations | Systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Injuries due to fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gynecological Issues | Reproductive system and breast disorders | Systematic Assessment |
|
| Diabetes Complications | Endocrine disorders | Systematic Assessment |
|
| Blood Pressure Issues | Blood and lymphatic system disorders | Systematic Assessment |
|
| Kidney Issues | Renal and urinary disorders | Systematic Assessment |
|
| Knee Replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Swelling and pain in lower extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sleep Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Death - Cause Unknown | General disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pregnancy Complications | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| Ulcers | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dog Bite | Social circumstances | Systematic Assessment |
|
| Skin wound | General disorders | Systematic Assessment |
|
| Gallstones | Renal and urinary disorders | Systematic Assessment |
|
| Heart Attack | Vascular disorders | Systematic Assessment |
|
| Hernia Repair | General disorders | Systematic Assessment |
|
| Hit by a car | Social circumstances | Systematic Assessment |
|
| Inpatient Psych Evaluation | Social circumstances | Systematic Assessment |
|
| General disorders | Systematic Assessment |
|
| Respiratory Issues | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dehydration | Social circumstances | Systematic Assessment |
|
| Blood Transfusion | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| Unknown or Not Reported |
|
| Unknown |
|
| Diabetes |
|
| Tobacco Dependence |
|