HypertensionIMPaCTNCT02347787
A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients
A study testing IMPaCT in people with Hypertension and Diabetes, run by University of Pennsylvania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes, Obesity
- What is being tested?
- IMPaCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 592 participants
- Where
- No sites listed yet
- Study dates
- 28 Jan 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of specific practice (Mutch/St.Leonards Court, Spectrum, PVAMC) for at least 1 yr defined as having one office visit within preceding 12 months
- Resident of home ZIP code including ANY of the following 19104, 19131, 19139, 19142, 19143, 19145, 19146, \& 19151
- Has 2 or more of the following conditions: 1. Obesity: BMI30 2. HTN: ICD9 relating to HTN from EMR problem list or EMR ICD9 encounter diagnosis x2) 3.DM: ICD9 relating to DM from EMR problem list or EMR ICD9 encounter diagnosis x2) 4. tobacco (from EPIC Social History/Vital Signs)
- Has at least one poorly controlled condition based on the most recent value prior to enrollment: Obesity (BMI>=35); HTN (SBP >= 160); DM (HgBA1c >=9); Tobacco Use (>0 cigarettes)"
- Is uninsured, insured by Medicaid, or dually eligible for Medicare and Medicaid or VA Insurance
- Has a scheduled appointment at a study clinic in the future.
- Community Health Workers/CHWs/IMPaCT Partners involved in the care of patients of the three practices will be included in the qualitative portion of this study.
Who cannot join
- Will not provide informed consent for this study.
- Does not have the capacity to provide informed consent for this study.
- Previously enrolled in this study.
- Currently enrolled in another study focusing on chronic disease management.
- Currently has a CHW
- No one will be excluded on the basis of sex or race.
About this study
Official title: A Multi-center Trial of Clinician Versus Community Health Worker Support to Help Low Socioeconomic, Chronically-ill Patients Achieve Health Goals
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.
Read the detailed description
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.
- Conditions
- Hypertension, Diabetes, Obesity, Tobacco Dependence
- Being tested
- IMPaCT, Usual care
- Medical subject headings
- Hypertension, Diabetes Mellitus, Obesity, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPaCTBehavioural
The IMPaCT intervention has three stages:
- Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans.
- Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals.
- Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Usual care |
| 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. Receives: Behavioral: IMPaCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months
Secondary outcomes (14)
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.
Measured: Baseline, 6 months, 9 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study start28 Jan 2015
- Primary completion5 Jan 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Judith A. Long, MD, Principal investigator, University of Pennsylvania/Philadelphia Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347787
- Sponsor's protocol ID
- 821368
- Acronym
- IMPaCT
- Status last verified
- Jun 2019
- First submitted
- 21 Jan 2015
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30422224
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Trial of Clinician Versus Community Health Worker Support to Help Low Socioeconomic, Chronically-ill Patients Achieve Health Goals
- ClinicalTrials.gov ID
- NCT02347787
- Acronym / sponsor ID
- IMPaCT / 821368
- Conditions
- Hypertension, Diabetes, Obesity, Tobacco Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 28 Jan 2015 (actual)
- Primary completion
- 5 Jan 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual clinician support | Placebo comparator | Other: Usual carePrior 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. |
| CHW support | Experimental | Behavioral: IMPaCTPrior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient of specific practice (Mutch/St.Leonards Court, Spectrum, PVAMC) for at least 1 yr defined as having one office visit within preceding 12 months
- Resident of home ZIP code including ANY of the following 19104, 19131, 19139, 19142, 19143, 19145, 19146, \& 19151
- Has 2 or more of the following conditions: 1. Obesity: BMI30 2. HTN: ICD9 relating to HTN from EMR problem list or EMR ICD9 encounter diagnosis x2) 3.DM: ICD9 relating to DM from EMR problem list or EMR ICD9 encounter diagnosis x2) 4. tobacco (from EPIC Social History/Vital Signs)
- Has at least one poorly controlled condition based on the most recent value prior to enrollment: Obesity (BMI>=35); HTN (SBP >= 160); DM (HgBA1c >=9); Tobacco Use (>0 cigarettes)"
- Is uninsured, insured by Medicaid, or dually eligible for Medicare and Medicaid or VA Insurance
Key exclusion criteria (6 listed)
- Will not provide informed consent for this study.
- Does not have the capacity to provide informed consent for this study.
- Previously enrolled in this study.
- Currently enrolled in another study focusing on chronic disease management.
- Currently has a CHW
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPaCTThe IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group. | Behavioural | CHW support |
| Usual care | Other | Usual clinician support |
Primary outcome
Short Form Health Survey (SF-12) Physical Component Score (PCS)
Time frame: Baseline, 6 months
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.
14 secondary outcomes
Change in Chronic Disease Control - Diabetes
Time frame: Baseline, 6 months, 9 months
Change in Chronic Disease Control - Obesity
Time frame: Baseline, 6 months, 9 months
Change in Chronic Disease Control - Tobacco Use
Time frame: Baseline, 6 months, 9 months
Change in Chronic Disease Control - Hypertension
Time frame: Baseline, 6 months, 9 months
Short Form Health Survey (SF-12) - Mental Component Summary (MCS)
Time frame: Baseline, 6 months, 9 months
Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness
Time frame: 6 months, 9 months
Number of Participants With Any Hospital Admission
Time frame: 6 months and 9 months
Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome
Time frame: 6 months
Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management
Time frame: 6 months, 9 months
Number of Participants With Multiple Hospital Admissions
Time frame: 6 months and 9 months
Number of Participants With 30 Day Hospital Readmissions
Time frame: 30 days
Hospital Admission - Total Hospital Days
Time frame: 6 months and 9 months
Hospital Admission - Mean Number of Hospitalizations
Time frame: 6 months and 9 months
Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization)
Time frame: 6 months and 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30422224Kangovi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith A. Long, MD principal investigator
University of Pennsylvania/Philadelphia Veterans Affairs Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing IMPaCT in people with Hypertension and Diabetes, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Health Survey (SF-12) Physical Component Score (PCS) (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02347787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.