- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02136732
Chronic Care Management for Adults at FQHCs
Chronic Care Management Model Translation to Multimorbid Aging Adults at FQHCs
With a growing aging population, the number of persons with chronic conditions continues to escalate and challenges related to chronic care quality, effectiveness and cost remain unresolved.Federally Qualified Health Centers (FQHC) have experienced increasing numbers of patient visits for chronic conditions, and FQHC patients are more likely to have serious chronic conditions when compared to patients being cared for by non-FQHC providers.
The Chronic Care Intervention (CCI) combines home visiting with health activation coaching and has resulted in improved health status and reduced expenditures (Preliminary Studies). Implementing the CCI for aging adults with multimorbidity (2 or more chronic conditions) and high baseline acute care utilization, allows us to test and expand the efficacy, external validity and cost effectiveness of the proposed intervention model. The investigators seek to improve patients' and FQHCs' abilities to effectively manage chronic conditions and reduce acute care use. This contribution is significant because it potentially extends our knowledge about effective community partnerships and best practices that can enhance the effectiveness of health homes in providing patient-centered team-based care for patients with multimorbidity and high baseline health care utilization.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
With a growing aging population, the number of persons with chronic conditions continues to escalate and challenges related to chronic care quality, effectiveness and cost remain unresolved. Federally Qualified Health Centers (FQHC) have experienced increasing numbers of patient visits for chronic conditions, and FQHC patients are more likely to have serious chronic conditions when compared to patients being cared for by non-FQHC providers. Effectively managing multiple chronic conditions is particularly challenging for both patients and health professionals, and costs of care rise as the number of co-morbid conditions increases. FQHCs primarily serve patients with public insurance or those who are uninsured. Consequently, simultaneously controlling costs and improving chronic care is a critical issue for the FQHC system. Two approaches that have been used to improve health status and reduce health care utilization are preventive home visiting and patient activation counseling. Preventive home visiting allows for multidimensional assessment and individualized, patient-centered care, and there is wide agreement that engaging patients to be an active part of the care process is an essential element of the quality of care. This concept is known as "health activation".
The Chronic Care Intervention (CCI) combines home visiting with health activation coaching and has resulted in improved health status and reduced expenditures (Preliminary Studies). Implementing the CCI for aging adults with multimorbidity (2 or more chronic conditions) and high baseline acute care utilization, allows us to test and expand the efficacy, external validity and cost effectiveness of the proposed intervention model. The investigators seek to improve patients' and FQHCs' abilities to effectively manage chronic conditions and reduce acute care use. This contribution is significant because it potentially extends our knowledge about effective community partnerships and best practices that can enhance the effectiveness of health homes in providing patient-centered team-based care for patients with multimorbidity and high baseline health care utilization.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Spokane, Washington, United States, 99201
- Community Health Association of Spokane
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 45 years of age or older, 2 or more chronic conditions, 2 or more emergency department visits or hospital admissions in previous 12 months.
Exclusion Criteria:
- terminal illness, dementia, case management elsewhere, resident of adult family home, boarding home or skilled nursing facility, homeless.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active self-management intervention
Participants will receive home visits and phone calls from a registered nurse and social worker.
The registered nurse and social worker will provide participants one on one coaching, education, support and referrals to community resources to help them manage their chronic conditions.
|
Participants will set health goals at baseline.
They will then receive, at minimum, a visit or a phone call to assess how progress and coaching toward meeting goals on a monthly basis from a nurse and/or social worker.
The frequency and exact activities associated with the intervention are dependent on each participant's unique health goals.
|
Active Comparator: Attention control phone calls
Participants will receive an initial visit and then a phone call every other month from a social services aide who can provide information about community resources that might be helpful.
|
Participants will be called by a social service aide at 2, 4, 6, 8, 10, and 12 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient activation
Time Frame: change from baseline to 3, 6, and 12 months
|
Patient activation will be measured using the Patient Activation Measure.
Higher scores on this tool indicate that the patient is more involved in self-managing care and partnering with health care professionals to achieve better health outcomes.
|
change from baseline to 3, 6, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute care utilization
Time Frame: change in acute care utilization from baseline year to intervention year
|
Acute care utilization is defined as visits to the emergency department and admissions to the hospital
|
change in acute care utilization from baseline year to intervention year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Participant's Health-Related Quality of Life.
Time Frame: change in quality of life from baseline to 3 months, 6 months, 9 months, 12 months.
|
change in quality of life from baseline to 3 months, 6 months, 9 months, 12 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cynthia Corbett, Ph.D., Washington State University College of Nursing
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01AG042467-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Any Condition in N73.0 Specified as Chronic
-
Washington State UniversityProvidence Medical Research CenterUnknownAdult Disease | Pharmacological Action | Any Condition in N73.0 Specified as ChronicUnited States
-
Universitätsklinikum Hamburg-EppendorfCompletedAny Condition Treated in Primary CareGermany
-
Sorin Group CanadaCompletedAny Patient Who Fulfills the Inclusion Criteria to be Implanted With a Dual Chamber Pacemaker Maybe Included in the Study as Per ACC/AHA GuidelinesCanada
-
Guy's and St Thomas' NHS Foundation TrustObstetric Anaesthetists' AssociationRecruitingCervical Incompetence in Pregnancy as Antepartum ConditionUnited Kingdom
-
McMaster UniversityDairy Farmers of CanadaCompletedObesity | Type 2 Diabetes | Weight Gain | Excessive Weight Gain in Pregnancy as Antepartum ConditionCanada
-
Federico II UniversityRecruitingObesity | Birth Weight | Breast Feeding | Gestational Weight Gain | Allergies | Chronic Diseases in Children | Gestational Complications | Perinatal ConditionItaly
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Pregnolia AGRecruitingPremature Birth | Preterm Birth | Diagnosis | Threatened Preterm Labor | Cervical Incompetence in Pregnancy as Antepartum Condition | Premature Labor | Cervical Incompetence, With DeliveryNetherlands
-
University College, LondonUniversity College London HospitalsCompletedQuality of Life | Precancerous Conditions | Patient Engagement | Patient Participation | Oral Disease | Patient Satisfaction | Health Behavior | Precancerous Lesions | Oral Leukoplakia | Dental Diseases | Oral Lichen Planus | Dysplasia | Patient Preference | Information Seeking Behavior | Oral Epithelial Dysplasia | Oral... and other conditionsUnited Kingdom
-
Erasmus Medical CenterLeiden University Medical Center; Medical Center Haaglanden; Rijnstate Hospital; Maasstadziekenhu... and other collaboratorsRecruitingHIV Infections | Acquired Immunodeficiency Syndrome | Sexually Transmitted Diseases, Viral | Pneumonia | Psoriasis | Weight Loss | Thrombocytopenia | Leukopenia | Dermatitis, Seborrheic | Herpes Zoster | Lymphadenopathy | Uterine Cervical Dysplasia | Primary Health Care | Diarrhea Chronic | Candida Infection | Infectious... and other conditionsNetherlands
Clinical Trials on Active self-management intervention
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedMultiple Sclerosis | Low Back Pain | Chronic Pain | Muscular Dystrophies | Spinal Cord Injury | Other and Unspecified Amputation Stump ComplicationsUnited States
-
Aalborg UniversityCompleted
-
Universidad de GranadaCompleted
-
University Health Network, TorontoCanadian Institutes of Health Research (CIHR)Completed
-
University of North Carolina, Chapel HillCompletedChronic Obstructive Pulmonary DiseaseUnited States
-
Diakonhjemmet HospitalThe Norwegian Rheumatism AssociationActive, not recruiting
-
Johns Hopkins UniversityAmerican Thoracic Society; Asociacion Benefica Prisma; Hospital Nacional Cayetano...Completed
-
Emirhan KarakuşCompletedSystemic Sclerosis | SclerodermaTurkey
-
University of WashingtonCompletedMultiple SclerosisUnited States
-
Skidmore CollegePenn State UniversityCompleted