Guided Care: Integrating High Tech and High Touch

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of a Guided Care nurse on the quality of the health and well-being of the frail elderly. A specially trained registered nurse will work closely with 1-3 primary care physicians to provide the most complex older patients (and their unpaid caregivers) with health care that is comprehensive, coordinated, patient-centered, and proactive. The study will evaluate the effects of Guided Care on: older persons' physical and mental health, health services utilization, quality of care, self-efficacy, and satisfaction with care; older persons' unpaid caregivers' burden; and primary care physicians' satisfaction with their care of chronically ill patients.

Detailed Description
-----------------
Health care for older Americans with chronic conditions is often fragmented and provider-centric. In response, a team of investigators at Johns Hopkins University has translated the scientific principles of seven successful innovations into one patient-centered system of care. Supported by evidence-based guidelines and state-of-the-art information technology, Guided Care is undergoing a 12-month pilot test in older primary care patients with complex needs. A specially trained Guided Care nurse (GCN), based in a primary care practice, collaborates with two primary care physicians to provide seven services for 40-60 high-risk patients: comprehensive assessment and care planning; best practices for chronic conditions; self-management; healthy lifestyles; coordinating care; educating and supporting unpaid caregivers; and accessing community resources. The proposed multi-site study will measure the effects of Guided Care on the quality and outcomes of care for high-risk older persons, their unpaid caregivers, and their primary care physicians. The panels of 53 physicians in 7 practices will be screened to identify 1350 high-risk older patients. After about 850 have given informed consent and baseline interviews, clusters of 2-5 physicians at each practice site will be randomized to provide either Guided Care or usual care to their consenting patients. Each physician cluster in the Guided Care group will incorporate a GCN into its practice; the physician clusters in the control group will not. Interviews and queries of administrative databases will provide evaluative data at baseline and at 12-, 24-, and 32-month follow-up intervals. The primary outcome variables are the participants' physical health and mental health (SF-36 Summary Scales) and health services utilization. Secondary outcome variables include: the quality of care; unpaid caregivers' burden; self-rated health; patient satisfaction; and primary care physicians' satisfaction. Intention-to-treat analyses will have 85% power (range of 70-97%) to detect clinically meaningful differences between the two groups. The study is designed to facilitate the prompt dissemination of Guided Care, if the results of the trial are favorable. A stakeholders' advisory board, representing consumers, providers, delivery systems, insurers, regulators and policy-makers, will inform the operation and evaluation of the study - and it will facilitate the subsequent dissemination of its tools and technology throughout American health care.

Official Title
-----------------
Guided Care: Integrating High Tech and High Touch

Conditions
-----------------
Chronic Disease

Intervention / Treatment
-----------------
* Behavioral: Guided Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 65 Insured by KPMAG, USFHP/TRICARE, or Medicare FFS High likelihood of use of services in the coming year based on predictive modeling using current year's health care expenses Exclusion Criteria: Moving out of area Currently assigned to case manager/in case management program Cognitive impairment and no legal representative

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided Care<br> | Behavioral: Guided Care<br>* Specially trained registered nurse (Guided Care Nurse) based in a primary care practice collaborates with two primary care physicians to provide seven services for 40-60 high-risk patients: comprehensive assessment and care planning; best practices for chronic conditions; self-management; healthy lifestyles; coordinating care; educating and supporting unpaid caregivers; and accessing community resources.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 Physical Health Summary Scale |  | Baseline, 6, 18, and 32 months | 
| SF-36 Mental Health Summary Scale |  | Baseline, 6, 18, and 32 months | 
| Health Services Utilization | Multiple utilization measures (e.g. hospital admissions, SNF admissions, primary care visits, specialist visits) based on claims data | Baseline, 8, 20, and 32 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Quality of Care | Using Patient Assessment of Chronic Illness Care (PACIC) and Primary Care Assessment Survey (PCAS) | Baseline, 6, 18, and 32 months | 
| Patient Satisfaction with Care |  | Baseline, 6, 18, and 32 months | 
| Physician Satisfaction with Care |  | Baseline, 12, 24, and 36 months | 
| Caregiver Burden | Using Modified Caregiver Strain Index | Baseline, 6, and 18 months | 
| Self-rated Health |  | Baseline, 6, 18, and 32 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Disease, Nurses, Caregivers, Support Groups