- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439452
Telemedicine-Based Collaborative Care to Reduce Rural Disparities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
An experimental study design and an intent-to-treat analysis will be used to determine the effectiveness and cost-effectiveness of telemedicine-based collaborative care relative to practice-based collaborative care. The research setting will be six Community Health Centers located in medically underserved areas of Arkansas which serve rural, low income and minority populations. Potentially eligible patients will be identified through screening by Community Health Centers clinic staff or primary care provider referrals. Patients eligible for the study will be consented and randomized to receive either telemedicine-based or practice-based collaborative care, and followed for 18 months to assess processes and outcomes. On-site clinical staff will screen patients for depression over an 18 month period and refer all patients with clinically significant depression (PHQ9≥10) to the study.
Two types of health care professionals will be involved in the practice-based collaborative care model: 1) primary care providers (MD and RNP); and 2) a depression care manager (LPN or Social Worker). The on-site care managers will provide care management activities by phone or face-to-face.
Five types of health care professionals will be involved in the telemedicine-based collaborative care model: 1) primary care providers (MD and RNP); 2) a depression nurse care manager (RN); 3) clinical pharmacist (PharmD); 4) tele-psychologist (PhD); and 5) a tele-psychiatrist (MD). The primary care providers will be located at the Community Health Centers. The off-site depression care team will be located at the clinics of the University of Arkansas for Medical Sciences, Department of Psychiatry. The on-site primary care providers will prescribe medications and schedule all appointments. The off-site nurse care manager will conduct all care management activities by telephone. The off-site clinical pharmacist will conduct medication histories and provide medication management by telephone. The off-site tele-psychologist will conduct evidence-based psychotherapy (cognitive behavioral therapy) via interactive video. The off-site tele-psychiatrist will conduct interactive-video consultations, train and supervise the depression care team, and conduct provider education.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Science
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinically Significant Depression
Exclusion Criteria:
- Sub-threshold Depression,
- Non-english speaking,
- Patients not having telephone access,
- Bereaved,
- Suicidal,
- Currently being treated by a mental health specialist,
- Bipolar disorder,
- Psychotic disorders,
- Drug or alcohol dependence,
- Cognitively impaired,
- Terminal illness,
- Having a court appointed guardian, or
- Pregnant (if applicable)
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 |
|---|---|
|
Active Comparator: Telemedicine-Based Collaborative Care
Telemedicine-Based Collaborative Care - Off-site depression care team (telephone nurse care manager, telephone pharmacist, tele-psychologist and tele-psychiatrist) works collaboratively with on-site primary care providers.
Telephone nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response.
Telephone pharmacist activities include documenting medication histories and conducting medication management.
Tele-psychologist activities include providing cognitive behavioral therapy via interactive video.
Tele-psychiatrist activities include conducting patient consultation via interactive video.
|
Off-site depression care team (telephone nurse care manager, telephone pharmacist, tele-psychologist and tele-psychiatrist) works collaboratively with on-site primary care providers.
Telephone nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response.
Telephone pharmacist activities include documenting medication histories and conducting medication management.
Tele-psychologist activities include providing cognitive behavioral therapy via interactive video.
Tele-psychiatrist activities include conducting patient consultation via interactive video.
|
|
Active Comparator: Practice Based Collaborative Care
One-site nurse care manager works collaboratively with on-site primary care providers.
Nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response.
|
One-site nurse care manager works collaboratively with on-site primary care providers.
Nurse care manager activities include promoting patient activation and self management, assessing symptoms and comorbidities, and monitoring adherence, side-effects and treatment response.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare processes and outcomes between CHC patients receiving practice-based collaborative care to CHC patients receiving telemedicine-based collaborative care (OUTREACH intervention).
Time Frame: 6, 12, 18 months after baseline
|
6, 12, 18 months after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John C Fortney, PhD, University of Arkansas
Publications and helpful links
General Publications
- Grubbs KM, Fortney JC, Pyne J, Mittal D, Ray J, Hudson TJ. A Comparison of Collaborative Care Outcomes in Two Health Care Systems: VA Clinics and Federally Qualified Health Centers. Psychiatr Serv. 2018 Apr 1;69(4):431-437. doi: 10.1176/appi.ps.201700067. Epub 2018 Jan 16.
- Pyne JM, Fortney JC, Mouden S, Lu L, Hudson TJ, Mittal D. Cost-effectiveness of on-site versus off-site collaborative care for depression in rural FQHCs. Psychiatr Serv. 2015 May 1;66(5):491-9. doi: 10.1176/appi.ps.201400186. Epub 2015 Feb 17.
- Mittal D, Chekuri L, Lu L, Fortney JC. Demographic, Economic, and Clinical Correlates of Depression Treatment Response in an Underserved Primary Care Population. J Clin Psychiatry. 2014 Aug 26;75(8):848-854. doi: 10.4088/JCP.13m08954.
- Fortney JC, Pyne JM, Mouden SB, Mittal D, Hudson TJ, Schroeder GW, Williams DK, Bynum CA, Mattox R, Rost KM. Practice-based versus telemedicine-based collaborative care for depression in rural federally qualified health centers: a pragmatic randomized comparative effectiveness trial. Am J Psychiatry. 2013 Apr;170(4):414-25. doi: 10.1176/appi.ajp.2012.12050696.
- Deen TL, Fortney JC, Schroeder G. Patient acceptance of and initiation and engagement in telepsychotherapy in primary care. Psychiatr Serv. 2013 Apr 1;64(4):380-4. doi: 10.1176/appi.ps.201200198.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 61251
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 Depression
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
Clinical Trials on Telemedicine-Based Collaborative Care
-
VA Office of Research and DevelopmentCompletedPosttraumatic Stress DisorderUnited States
-
VA Palo Alto Health Care SystemCompletedCrohn's Disease | Ulcerative Colitis | Inflammatory Bowel DiseaseUnited States
-
University of PittsburghNational Institute of Mental Health (NIMH)CompletedAnxiety Disorders | Panic DisorderUnited States
-
University of PittsburghNational Institute of Mental Health (NIMH)CompletedPanic Disorder | Anxiety DisorderUnited States
-
National University Hospital, SingaporeNational University, SingaporeCompleted
-
Shanxi Bethune HospitalRecruitingDiabetes Mellitus, Type 2 | Telemedicine | Digital Health | Chronic Disease Management | Integrated Traditional Chinese Medicine and Western MedicineChina
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingActive Malignancies | Life Threatening Complication of the Malignancy or Its Treatments
-
Can Tho University of Medicine and PharmacyRecruitingUncontrolled Asthma | Telemedicine-Based EducationVietnam
-
Boston Medical CenterCodman Square Health Center; Dorchester House Health CenterCompletedAttention Deficit/Hyperactivity DisorderUnited States
-
Jiangsu Taizhou People's HospitalNot yet recruitingHeart Failure | Atrial Fibrillation