Clinical trial NCT02188732: Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes
Official title: Self-Management Training and Automated Telehealth to Improve SMI Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Depression
Keywords: Community Mental Health
Serious Mental Illness
Medical Comorbidity
Self-Management
Automated Telehealth
Early Mortality
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-07-14
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized clinical trial (RCT) of 300 persons with serious mental illness (SMI) and medical comorbidity will evaluate outcomes for n=100 in a Community Based Health Home alone (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3 hypotheses:

Hypothesis 1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater health self-management and greater mental health self-management.

Hypothesis 2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater reduction in risk of early mortality and (Exploratory E2) in psychiatric symptoms.

Hypothesis 3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute service use and less acute service use costs.

Detailed description: Efforts to reduce early mortality in persons with serious mental illness (SMI) have largely focused on providing integrated primary care in a "health home". Yet medical care alone accounts for a disproportionately small contribution to reductions in early morality in comparison to improving self-management and health behaviors. Illness self-management training (SMT) in the general population has been shown to improve health outcomes and lower costs associated with chronic health conditions by teaching and coaching individuals on monitoring symptoms, self-administering treatments, and improving health behaviors. More recently, the use of technologies such as Automated Telehealth (AT) has been shown to improve outcomes and potentially prevent expensive emergency room and acute hospitalizations in the general population by daily prompting of self-management and remote monitoring by a nurse who can pre-emptively intervene, guided by disease management algorithms. To the investigators knowledge, neither of these approaches has been empirically evaluated as an integrated component in a behavioral health home for persons with SMI. The investigators will conduct a randomized clinical trial (RCT) of 300 persons with SMI and medical comorbidity to evaluate outcomes for n=100 in a Community Based Health Home alone (CBHH), compared to n=100 also receiving Self-Management Training (CBHH+SMT), and n=100 also receiving Automated Telehealth (CBHH+AT). The investigators will test the following 3 hypotheses:

Primary H1: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater health self-management (measured by the Self Rated Abilities for Health Practices Scale) and (Exploratory E1) greater mental health self-management (measured by the Illness Management and Recovery Scale) at 4, 8, 12, and 24-months. Primary H2: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with greater reduction in risk of early mortality (as measured by the Avoidable Mortality Risk Index) and (Exploratory E2) in psychiatric symptoms (BPRS) at 4, 8, 12, and 24 months. Primary H3: CBHH+SMT and CBHH+AT compared to CBHH alone, will be associated with less acute service use (emergency room visits and hospitalizations) and (Exploratory E3) less acute service use costs at 4, 8, 12, and 24-months.

In order to differentiate CBHH+SMT and CBHH+AT if both are found to be effective, the investigators will evaluate the persistence of primary outcomes from intervention endpoint (at 12 months) to the final follow-up (at 24 months) and will calculate the additional incremental costs of implementing and providing SMT and AT. The investigators will also explore differences in subjective health (SF-12) and in individual cardiovascular risk factors (e.g., BMI, tobacco use, blood pressure, glucose, lipids), comparing CBHH+SMT, CBHH+AT, and CBHH alone. Finally, the investigators will explore hypothesized mechanisms of action (potential mediators) for the Aim 2 primary outcome of reduced risk of early mortality (i.e., improvement in health self-management) and for the Aim 3 primary outcome of less acute service use (i.e., medication adherence and number of nurse preemptive interventions).

Eligibility criteria: Inclusion Criteria:

1. Age 18 or older and enrolled in treatment for at least 3 months;
2. SMI as defined by (i) primary DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder; (ii) moderate impairment across multiple areas of psychosocial functioning, including social relationships, self-care, community/work activity, treatment self-management, and community living skills; (iii) GAF (Global Assessment of Functioning) score less than 61. The broad range of SMI are included primarily because findings will be more generalizable to routine mental health settings, but also because we included this group in our pilot studies;
3. Diagnosis of one of the following medical illnesses or health conditions: diabetes, heart disease, chronic obstructive pulmonary disease, chronic pain, hyperlipidemia, hypertension, obesity, tobacco dependence;
4. Voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian;
5. An expressed willingness to participate in self-management training or a telehealth program;
6. Ability to read the telehealth display in English.

Exclusion Criteria:

1. Currently residing in a nursing home or group home;
2. Terminal physical illness expected to result in the death of the study subject within 12-24 months; or
3. Primary diagnosis of dementia, co-morbid diagnosis of dementia, or significant cognitive impairment as indicated by a Mini Mental State Examination (MMSE)74 score \<24.

Primary outcomes:
measure: Change in Health Self-management
timeFrame: Change from baseline at 4,8,12, and 24 months
measure: Change in risk of early mortality
timeFrame: Change from baseline at 4,8,12, and 24 months
measure: Change in acute service use
timeFrame: Change from baseline at 4,8,12, and 24 months
Secondary outcomes:
measure: Change in mental health self-management
timeFrame: Change from baseline at 4,8,12, and 24 months
measure: Change in psychiatric symptom severity
timeFrame: Change from baseline at 4,8,12, and 24 months
measure: Change in acute care costs
timeFrame: Change from baseline at 12 and 24 months
Other outcomes:
measure: Change in Subjective Health Status
timeFrame: Change from baseline at 4,8,12, and 24 months
measure: Change in Cardiovascular Risk Factors
timeFrame: Change from baseline at 4,8,12, and 24 months
Locations:
city: Boston
country: United States
facility: Bay Cove Human Services
state: Massachusetts
city: Cambridge
country: United States
facility: Vinfen
state: Massachusetts
Study officials:
References:
citation: Bartels SJ, Pratt SI, Mueser KT, Naslund JA, Wolfe RS, Santos M, Xie H, Riera EG. Integrated IMR for psychiatric and general medical illness for adults aged 50 or older with serious mental illness. Psychiatr Serv. 2014 Mar 1;65(3):330-7. doi: 10.1176/appi.ps.201300023.
citation: Pratt SI, Bartels SJ, Mueser KT, Naslund JA, Wolfe R, Pixley HS, Josephson L. Feasibility and effectiveness of an automated telehealth intervention to improve illness self-management in people with serious psychiatric and medical disorders. Psychiatr Rehabil J. 2013 Dec;36(4):297-305. doi: 10.1037/prj0000022.