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Integrated physical and mental health self-management compared to chronic disease self-management
Investigator (PI): Pratt, Sarah I
Performing Organization (PO): (Current): Dartmouth College, Geisel School of Medicine, Department of Psychiatry / (603) 650-1200
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2019
Final Year: 2025
Record Source/Award ID: PCORI/PCS-2017C2-7724-IC
Funding: Total Award Amount: $7,767,394
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Comparing Two Programs for Managing Long-Term Health Problems for People with Lived Experience of Mental Illness PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project. This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. What is the research about? People with lived experience of a mental illness, like schizophrenia or bipolar disorder, die on average 11–30 years earlier than people who don’t. They are more likely to have health problems like heart disease, diabetes, high cholesterol, and lung disease than the rest of the population. In this study, the research team is comparing two programs to help people with lived experience of mental illness manage their health problems. One program is led by a mental health worker. The other program is led by two peer support specialists, people with lived experience of mental illness who have learned to manage their long-term health problems. Who can this research help? People with lived experience of mental illness and their clinicians, such as doctors and nurses, can use the results of this study when considering ways for service users to better manage their health. What is the research team doing? The research team is recruiting 600 adults with lived experience of mental illness who also have a long-term heart or lung problem. People in the study are receiving care at a Centerstone mental health clinic in Kentucky or Tennessee. The research team is assigning people to one of two programs by chance. In the first program, a mental health professional teaches people how to take better care of their physical and mental health. This program includes 2 one-on-one meetings and 14 group meetings. In the second program, two peer support specialists teach people how to take care of their long-term health problem during six group meetings. After one year, the research team is looking at changes in people’s knowledge of how to take care of their health and their ability to do so. The team is also looking at changes in people’s confidence in managing their own health care. Using health records, the team is checking for changes in how many times people go to the hospital for their health problems. People with lived experience of mental illness and their families are working with the research team to plan the study. Research methods at a glance Design Element Description Design Randomized controlled trial Population Adults ages 18 and older with lived experience of mental illness, a chronic health problem increasing risk of early mortality from cardiovascular or respiratory disease, and at least one emergency room or hospital visit in the past year or the determination by the treatment team that the person needs illness self-management training. Must receive services at Centerstone (Kentucky, Tennessee). Interventions/ Comparators Integrated Illness Management and Recovery: 2 individual and 14 group education and skills training sessions with a mental health professional Stanford Chronic Disease Self-Management Program: 6 group education and skills training sessions with 2 peer support specialists—lay people who have successfully managed chronic illness—or a peer support specialist and a mental health professional Outcomes Change in knowledge and skills in illness self-management, patient activation, and acute hospital events   Timeframe 1-year follow-up for study outcomes
Abstract Archived: Description of the problem that the proposed project seeks to solve: People with a serious mental illness (SMI), which includes people who have a major mental illness such as schizophrenia or bipolar disorder and also struggle to work and function, die on average 11-30 years earlier compared to people who do not have a mental illness. The primary reason for this is that it is much more common for people with serious mental illness to have heart diseases that can cause heart attacks and strokes. They develop these heart diseases because they are more likely to be overweight or obese and to smoke and less likely to exercise and eat healthy. These unhealthy lifestyle behaviors lead to heart disease and also other medical problems like diabetes, high cholesterol, and lung diseases. There are some programs that have been developed to help teach people to take better care of their health. These include integrated-illness management and recovery (I-IMR), which was developed by members of the team who would carry out this study, and the Chronic Disease Self-Management Program (CDSMP), which was developed by Kate Lorig and members of her research group at Stanford University. A mental health professional using I-IMR teaches people facts about physical and mental illnesses, how they can affect each other, and how to better manage them together, using handouts and discussion, in two 1:1 meetings followed by 14 group meetings. Someone who has lived with a chronic medical illness teaches CDSMP, which includes training on how to better manage chronic medical illness in 6 group meetings, using handouts. Although the I-IMR and CDSMP programs have been used all over the country and seem to help people, it is not clear which program is most effective at helping people learn to manage their illnesses better so they can lead longer and healthier lives, so we want to compare I-IMR and CDSMP to learn which one is more effective at improving illness self-management in people with serious mental illness. We have partnered with a very large mental health center, Centerstone (in Kentucky and Tennessee) to carry out this project. Our goal is to invite 600 people who have a serious mental illness and also a chronic medical illness to participate in the project. Interested consumers will sign some paperwork describing the requirements of the study and will meet with a research team member to answer some questions about various aspects of their health. Then, they will be randomly assigned, like flipping a coin, to receive I-IMR or CDSMP. They will come back 4, 8, and 12 months later to answer the same set of questions so that we can learn which people improve in terms of their health. We will share the results of the study with national organizations such as the National Council for Behavioral Health and National Alliance on Mental Illness. Outcomes we hope to achieve: We hope that improving illness self-management skills in the people with SMI who are also living with a chronic health condition and join the study will lower the chance that they will develop serious heart diseases, keep them out of the hospital, and help them live better lives. We also hope that results from this study will help people with serious mental illness, mental health professionals, directors of mental health centers, and insurance companies to make better decisions about which illness self-management programs to select. Brief background on why this project is important to consumers: Consumers have told us how much they struggle to manage their physical health and how chronic health conditions make it harder to work towards important and meaningful life goals. They have also told us how much they want to take more control of their health care and to better manage their physical and mental health symptoms. As a project team, we talked to many consumers to get input on this project and repeatedly consumers mentioned the importance of learning about self-management of both physical and mental health. Learning which disease self-management training program is best at improving people's ability to manage chronic health conditions would provide important information to consumers about which programs to use and it would provide mental health providers with evidence to help them decide what clinical services to offer. Explanation of how consumers and other stakeholder partners will help to make the project successful: We already created a Local Consumer Advisory Board for this project. It includes consumers from Centerstone Kentucky and Centerstone Tennessee. The purpose of the board is to partner with the research team to help with planning, implementing, and evaluating the project in monthly meetings where they will discuss the project. A representative of the group, who is the director of Peer Support Services at Centerstone Kentucky, will participate in weekly project management meetings and share the recommendations from the board meetings with the research project team. We also created a National Advisory Panel, made up of Peer Leaders, consumers, and family members that will help to offer advice on the project. Finally, we created a Key Stakeholder Advisory Group, made up of peer support leaders, representatives from Centerstone, officials from the Departments of Mental Health for Kentucky and Tennessee, and officials from the Medicaid health plan provider in Kentucky. They will meet four times each year for the entire 5 years of the project to hear how it is going and give the research team their opinions. All of these people will play a crucial role through all stages of this project from beginning to end.

MeSH Terms:
  • Chronic Disease /*therapy
  • Continuity of Patient Care
  • Humans
  • Kentucky
  • Lifestyle
  • Medicaid
  • Mental Disorders /*therapy
  • Mental Health Services /*organization & administration
  • Peer Group
  • Randomized Controlled Trials as Topic
  • Self Care /*methods
  • Social Support
  • Tennessee
Country: United States
State: New Hampshire
Zip Code: 03756
UI: 20193316
CTgovId: NCT03966872
Project Status: Ongoing
Record History: ('2020: Abstract archive and replaced; Project initial year changed from 2018 to 2019 per PCORI, institutional change.',)