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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03100526
Other study ID # PIM Evaluation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date September 2017

Study information

Verified date May 2020
Source Veteran Affairs Office of Patient Care Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while the patient is still in the ambulatory care setting.

Goal:

- Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients

- Improve Veteran and staff satisfaction

Objectives:

- Maintain the patient in the home setting as much as possible

- Secure appropriate home environment to facilitate health and well-being

- Utilize comprehensive team-based care

- Engage appropriate Veteran Health Administration (VHA) programs to provide interdisciplinary, coordinated, and timely management of complex medical issues


Recruitment information / eligibility

Status Completed
Enrollment 2210
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- selected for intensive management

Exclusion Criteria:

- enrolled in other intensive case management at VA

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PACT Intensive Management
Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while they are still in the ambulatory care setting. Goal: Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients Improve Veteran and staff satisfaction Objectives: Maintain the patient in the home setting as much as possible Secure appropriate home environment to facilitate health and well-being Utilize comprehensive team-based care Engage appropriate VHA programs to provide interdisciplinary, coordinated, and timely management of complex medical issues

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Veteran Affairs Office of Patient Care Services VA Office of Research and Development, VA Palo Alto Health Care System, VHA Primary Care Services

Outcome

Type Measure Description Time frame Safety issue
Other Patient Engagement The investigators will look at patient PIM enrollment data by utilizing qualitative data. The data will be collected through qualitative interviews with patients and PACT providers.
Provider Interviews questions:
Tell me what kinds of things you and your team have been doing to try to engage patients What types of patients have you been able to engage most successfully? Once patients have started to engage with the PIM team, how do you prioritize what to work on with them?
Patient Interview questions:
Has working with the PIM team made a difference in your health? Have you changed how you take care of yourself since you have been part of PIM? If you were going to tell another Veteran about this program, what would you say (are the pros and cons)? How would you say you have benefitted from being in this program? What have been the drawbacks of being in this program?
2 years (two 1-year points)
Other Functional status Patient report of their physical, social, and mental functional status is routinely collected as part of their medical visit as health factor data. The data will be abstracted through the VA central repository administrative data. The variables used to measure functional status are the following:
In general, how would you rate your satisfaction with your social activities and relationships? (Excellent, Very good, Good, Fair, Poor)
In general, please rate how well you carry out your usual social activities and roles. (This includes activities at home, at work and in your community, and responsibilities as a parent, child, spouse, employee, friend, etc.) (Excellent, Very good, Good, Fair, Poor)
Administer Katz Index of Independence in Activities of Daily Living (Independence=1 point; dependence = 0 points for each of the six item pairs)
Administer the Lawton Instrumental Activities of Daily Living (IADL) Scale (score 0-8)
2 years (two 1-year points)
Other Patient Quality of Life Status Patient assessment of their quality of life collected as part of their medical care as a health factor. This information will be electronically abstracted through the VA central repository administrative data center. The variables used to assess a patient's quality of life are the following:
Patient's self-rating of quality of life in general: Excellent, Very Good, Good, Fair, Poor
Patient's self-rating of mental health, including mood and ability to think: Excellent, Very Good, Good, Fair, Poor
2 years (two 1-year points)
Other Patient Symptom Burden Patient assessment of symptom burden is routinely collected as part of their care and documented in their medical record and will be electronically abstracted through the VA central repository administrative data center. Mental Health and physical burdens are abstracted from the medical record utilizing ICD-9 and ICD-10 code. It will be assessed as yes/no if present. 2 years (two 1-year points)
Other Anxiety Generalized Anxiety Disorder 2-item (GAD-2): (Not at all; several days; More than half the days, nearly every day). The higher the score the higher the anxiety. 2 years (two 1-year points)
Other Substance Abuse The 3-item AUDIT-C scored on a scale of 0-12; Drugs: How many times in the past year, have you used an illegal drug or used a prescription medication for nonmedical reasons? (Yes/No, Number of times). The greater the score the worse the substance abuse status. 2 years (two 1-year points)
Other Cognitive Status The Blessed-Short and/or the Mini-Cog where the lower the score the more impairment. 2 years (two 1-year points)
Other Pain level Pain in past 24 hours on scale of 0 = no pain, to 10 = worst pain imaginable. 2 years (two 1-year points)
Other Shortness of Breath Shortness of breath in past 24 hours on a scale of 0, no shortness of breath, to 10, worst imaginable. 2 years (two 1-year points)
Other Problems with constipation Constipation in past 24 hours on a scale from 0, no constipation, to 10, worst imaginable. 2 years (two 1-year points)
Other Sleep Problems Sleep problems in past 24 hours on a scale from 0, no sleep problems, to 10, worst imaginable. 2 years (two 1-year points)
Other Level of Fatigue Fatigue in past 24 hours on a scale from 0, no fatigue, to 10, worst imaginable. 2 years (two 1-year points)
Other Risk of Falls Falls (Patient reports no falls in past 12 months;Patient reports no problems with walking or balance; Patient reports problems with walking or balance; Patients reports falls in past 12 months 2 years (two 1-year points)
Other Implementation Outcome/challenges Implementation barriers and facilitators, feasibility, and sustainability will be obtained through stakeholder interviews of patients, staff and facility leaders. PIM Staff topics include program goals, patient enrollment, engagement strategies, patient decision making; target population, gaps in care, care coordination, readiness, resource adequacy, and sustainability. PIM program leader topics include lessons learned, impact and sustainability, and implementation process. Patient topics include experience in program, engagement in care and suggestions for improvement. PACT teamlet topics include exposure to PIM, the impact on workload, the services PIM provides, feasibility of providing PIM services, impact and sustainability of PACT on working with PIM team. Facility leaders topics include PIM program goals, specialty service programs, target population, and services for high-risk patients, PACT functioning, PIM affects patients on services, and facility. 2 years (two 1-year points)
Other Primary Care Staff Job Satisfaction We will survey Primary Care Providers (PCPs) (physicians, MDs/DOs; nurse practitioners, NPs; physician assistants, PAs) and nurses (registered nurses, RNs; licensed practical nurses, LPNs; licensed vocational nurses-LVNs) at the five healthcare systems that have a PIM team. We will use both online using RedCap and paper-and-pen versions of the survey to increase response rate. We will survey Primary Care staff at baseline and one year later. Primary Care Staff Job Satisfaction is measured by a single item "Overall, I am satisfied with my job," rated on a 5-point Likert agreement scale. (Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree). The higher the score the higher the satisfaction.
• Overall, I am satisfied with my job. (Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree). The higher the score the higher the satisfaction.
3 years (two waves)
Other Primary Care staff Intention to Stay at the VA We will survey Primary Care Providers (PCPs) (physicians, MDs/DOs; nurse practitioners, NPs; physician assistants, PAs) and nurses (registered nurses, RNs; licensed practical nurses, LPNs; licensed vocational nurses-LVNs) at the five healthcare systems that have a PIM team. We will use both online using RedCap and paper-and-pen versions of the survey to increase response rate. We will survey Primary Care staff at baseline and one year later. Intention to Stay at the VA is measured by a single item "I intend to continue working in PC at the VA for the next two years," rated on a 5-point Likert agreement scale. (Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree). The higher the score the higher the satisfaction. 3 years (two waves)
Primary VA health care cost Total costs of VA care, including inpatient, outpatient, pharmacy and fee-basis services. 2 years (two 1-year points)
Secondary Healthcare Utilization VA central repository administrative data will be analyzed to calculate utilization of hospital, emergency and outpatient primary and specialty care. This information will be electronically abstracted through the VA central repository administrative data center 2 years (two 1-year points)
Secondary Total Medicare Cost Data will be extracted from VHA's Corporate Data Warehouse to capture patient Medicare cost. Medicare claims data to measure total patient inpatient and outpatient cost for services reimbursed by Medicare. Inpatient cost will be measured as cost for total acute hospitalizations, and subcategories: medical, surgical, psychiatric, rehabilitation, hospice and ambulatory care-sensitive conditions. Outpatient cost will be measured as the cost for combined visits in VHA and elsewhere reimbursed by Medicare in 9 categories: primary care, specialty care, mental health, surgical, home health, nursing home, diagnostic, rehabilitation and ED. 2 years (two 1-year points)
Secondary Total Medicare Utilization Data will be extracted from VHA's Corporate Data Warehouse to capture patient utilization. Medicare claims data to measure total patient inpatient and outpatient utilization for services reimbursed by Medicare. Inpatient utilization will be measured as counts of total acute hospitalizations, and subcategories: medical, surgical, psychiatric, rehabilitation, hospice and ambulatory care-sensitive conditions. Outpatient utilization will be measured as the number of combined visits in VHA and elsewhere reimbursed by Medicare in 9 categories: primary care, specialty care, mental health, surgical, home health, nursing home, diagnostic, rehabilitation and ED. 2 years (two 1-year points)
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