Evaluation of Intensive Management Patient Aligned Care Team

Primary Health Care Clinical Trial

— ImPACT  

Official title:

Evaluating Innovative Care Models for High-Utilizing Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932228
• Other study ID #: PPO 13-117
• Status: Completed
• Phase: N/A
• Start date: January 1, 2013
• Est. completion date: May 1, 2015

Study information

• Verified date: May 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This evaluation will examine the feasibility, implementation, and effectiveness of a quality improvement intervention-Intensive Management Patient Aligned Care Team (ImPACT)-for high-risk patients.

Description:

Background: VA's highest-utilizing patients generally have complicated health care needs-including complex and multiple chronic conditions, comorbid mental health conditions, and social stressors-that contribute to high rates of hospitalization, emergency services, and specialty care use. Inspired by emerging intensive primary care models for high-utilizers, VA Palo Alto launched a quality improvement program to augment existing VA primary care (provided by Patient Aligned Care Teams, PACT) with intensive care delivered by a multidisciplinary team. The Intensive management PACT (ImPACT) intervention encompasses a number of evidence-based strategies, including a comprehensive intake process, coordination of specialty care, chronic condition case management, provision of social services, rapid response to deteriorations in health, and facilitation of transitions after high-acuity events.

The ImPACT program was designated as quality improvement (non-research) by the Palo Alto VA. A retrospective evaluation using deidentified data was approved by the Stanford University IRB.

Objectives: The objectives of this evaluation are to assess ImPACT's feasibility, implementation, and effectiveness, and lay the groundwork for future larger-scale efforts and evaluations within the VA system.

Methods: We will partner with the implementation team of VA Palo Alto's ImPACT clinic to conduct a Hybrid Type 1 evaluation of the program's feasibility, implementation, and effectiveness. Specifically, the evaluation will aim to:

1. Evaluate the feasibility and implementation of the pilot ImPACT intervention. Using semi-structured interviews with ImPACT and PACT team members and leadership, we will evaluate the success of intervention delivery, including patient identification, recruitment, and retention; provision and uptake of planned services; and monitoring of patient participation and key outcomes.

2. Evaluate ImPACT's effect on utilization and costs of care. We will use a difference-in-differences approach, wherein we compare changes in VA health care costs (total, as well as inpatient, outpatient, and fee-basis) and utilization (including hospitalizations, emergency department visits, and specialty care) among ImPACT patients and high-utilizing patients who are receiving usual PACT care.

3. Examine the association between ImPACT participation and patient-centered outcomes. Using data from surveys administered in the ImPACT clinic, we will assess patient satisfaction with the ImPACT intervention and overall care, as well as changes in patient-reported outcomes, including health status, symptom burden, and function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: May 1, 2015
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient receives care from one of 14 primary care providers (MDs, NPs) who have at least three half-days of clinic per week

• Total VA healthcare costs in the top 5% for VA Palo Alto facility during the 9-month eligibility phase (10/1/11-6/30/12) AND/OR

• Risk for one-year hospitalization in November 2012 in the top 5% (using the VA's Care Assessment Need risk-prediction algorithm)

Exclusion Criteria:

• Enrollment in VA's mental health intensive case management program, home-based primary care, or palliative care programs

• Recipient of inpatient care for over half of the 9-month eligibility phase (10/1/11-6/30/12).

• Total VA healthcare costs in the lowest cost decile in the 9-month eligibility phase (10/1/11-6/30/12)

• Risk for one-year hospitalization in November 2012 in the lowest risk quartile (using the VA's Care Assessment Need risk-prediction algorithm).

Related Conditions & MeSH terms

• Health Care Costs
• Primary Health Care

Intervention

Other:
• ImPACT
The ImPACT team offers the following services: An intensive intake process, including a home visit if deemed appropriate Frequent contact (in-person, telephone, or secure messaging) tailored to a patient's needs After-hours access to on-call team member in order to avoid unnecessary emergency care Optimization of chronic condition management using evidence-based protocols Navigation of transitions between hospital and home Coordination of specialty care, including contact with specialists when indicated Rapid response to signs of health status deterioration or other stressful events Assess patient goals, advance directives, Physician Orders for Life-Sustaining Treatment

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

References & Publications (11)

Breland JY, Asch SM, Slightam C, Wong A, Zulman DM. Key ingredients for implementing intensive outpatient programs within patient-centered medical homes: A literature review and qualitative analysis. Healthc (Amst). 2016 Mar;4(1):22-9. doi: 10.1016/j.hjds — View Citation

Breland JY, Chee CP, Zulman DM. Racial Differences in Chronic Conditions and Sociodemographic Characteristics Among High-Utilizing Veterans. J Racial Ethn Health Disparities. 2015 Jun;2(2):167-75. doi: 10.1007/s40615-014-0060-0. Epub 2014 Nov 8. — View Citation

Breland JY, Greenbaum MA, Zulman DM, Rosen CS. The effect of medical comorbidities on male and female Veterans' use of psychotherapy for PTSD. Med Care. 2015 Apr;53(4 Suppl 1):S120-7. doi: 10.1097/MLR.0000000000000284. — View Citation

Gidwani R, Zulman D. Association Between Acute Medical Exacerbations and Consuming or Producing Web-Based Health Information: Analysis From Pew Survey Data. J Med Internet Res. 2015 Jun 23;17(6):e145. doi: 10.2196/jmir.3801. — View Citation

Hummel DL, Hill C, Shaw JG, Slightam C, Zulman DM. Nurse practitioner-led intensive outpatient team: Effects on end-of-life care. The Journal for Nurse Practitioners. 2017 Mar 14; 13(5):e245-e248

Hunter G, Yoon J, Blonigen DM, Asch SM, Zulman DM. Health Care Utilization Patterns Among High-Cost VA Patients With Mental Health Conditions. Psychiatr Serv. 2015 Sep;66(9):952-8. doi: 10.1176/appi.ps.201400286. Epub 2015 May 1. — View Citation

Wu FM, Slightam CA, Wong AC, Asch SM, Zulman DM. Intensive Outpatient Program Effects on High-need Patients' Access, Continuity, Coordination, and Engagement. Med Care. 2018 Jan;56(1):19-24. doi: 10.1097/MLR.0000000000000833. — View Citation

Zulman DM, Ezeji-Okoye SC, Shaw JG, Hummel DL, Holloway KS, Smither SF, Breland JY, Chardos JF, Kirsh S, Kahn JS, Asch SM. Partnered research in healthcare delivery redesign for high-need, high-cost patients: development and feasibility of an Intensive Ma — View Citation

Zulman DM, Jenchura EC, Cohen DM, Lewis ET, Houston TK, Asch SM. How Can eHealth Technology Address Challenges Related to Multimorbidity? Perspectives from Patients with Multiple Chronic Conditions. J Gen Intern Med. 2015 Aug;30(8):1063-70. doi: 10.1007/s11606-015-3222-9. Epub 2015 Feb 18. — View Citation

Zulman DM, Pal Chee C, Ezeji-Okoye SC, Shaw JG, Holmes TH, Kahn JS, Asch SM. Effect of an Intensive Outpatient Program to Augment Primary Care for High-Need Veterans Affairs Patients: A Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 1;177(2):166-175 — View Citation

Zulman DM, Pal Chee C, Wagner TH, Yoon J, Cohen DM, Holmes TH, Ritchie C, Asch SM. Multimorbidity and healthcare utilisation among high-cost patients in the US Veterans Affairs Health Care System. BMJ Open. 2015 Apr 16;5(4):e007771. doi: 10.1136/bmjopen-2015-007771. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility: Time to Enrollment	To evaluate ImPACT's feasibility, we will assess time to enrollment for invited participants. Number is reported is number of participants still enrolled in ImPACT program after 9 months	9 months
Other	Feasibility: Participation	We will evaluate proportion of patients who participate in ImPACT and the frequency of their contact with ImPACT team members. Outcome measure is the average number of patient-ImPACT provider in person contacts per month from 2/2013-6/2014	9 months
Other	Implementation Process	Interviews with ImPACT team members, PACT providers, and VA facility leadership will be used to understand the ImPACT program implementation process. Outcome measure is number of participants enrolled and completed interviews.	9 months
Other	Patient Satisfaction	We will assess patient satisfaction with the ImPACT intervention and changes in satisfaction with overall care. The Patient Satisfaction Questionnaires ask: Please describe your satisfaction with ImPACT Clinical Services; Medical care; Social work services; Recreational and community services; After-hours services; The 4 items were combined to create a mean overall satisfaction with ImPACT care score, which ranges from 1-4, 4 indicating better satisfaction with the program. The scale is measured on a 4 point scale with 1 meaning "strongly disagree" and 4 meaning "strongly agree".	9 months
Other	Health Status (Patient-reported)	We will assess patient-reported health status through a patient survey administered at time of enrollment and 4-9 months after enrollment. Outcome measure includes mean patient activation scores between baseline and follow up survey periods. Activation is measured on a scale from 0-100, with higher numbers corresponding to higher levels of patient activation.	up to 9 months
Other	Symptom Burden (Patient-reported)	We will assess changes in patient-reported symptom burden, including pain through a patient survey administered at time of enrollment and 4-9 months after enrollment. Outcome measure below is the mean number of participants who rate their "pain in the last weeks" on a 10 point scale where 0=None and 10=severe pain, a higher value indicates worse symptom burden.	up to 9 months
Other	Functional Status (Patient-reported)	We will assess changes in patient-reported functional status through a patient survey administered at time of enrollment and 4-9 months after enrollment. The outcome measure includes percentage of patients(from 0-100%) who indicated having some difficulty, much difficulty, or inability to perform tasks due to functional limitations. A higher score indicates more functional limitations	9 months
Primary	VA Health Care Costs	Estimated programs effect on cost among all patients, and correspond to the change in monthly costs among patients in impact minus the change in costs for patients in PACT.	17 months
Secondary	Hospitalization	Admission rates and length of stay of acute medical/surgical, acute mental health, extended medical, and extended mental health inpatient care. Outcome reported is mean(SD) number of hospital admissions using intent to treat analysis between both groups.	17 months
Secondary	Emergency Department Utilization	Number of Emergency Department visits	17 months
Secondary	Outpatient Utilization	Number of visits to primary, specialty, and mental health clinics. Number reported is mean primary care visits between ImPACT and PACT.	17 months