Building a Bridge (BAB) Between Clinical and Community Care
Condition: Caregiver Burden
MeSH terms: Caregiver Burden
Study type: Interventional

Summary: 
      Dementia diagnosis triggers a transitional phase for the individuals and their families,
      often causing emotional distress and family conflicts due to the ambiguity of the illness and
      future trajectories. Families often report a lack of information and guidance during the
      period immediately following diagnosis, suggesting a missed opportunity for prevention of
      family distress at the outset of the caregiver and patient career. With large and increasing
      numbers of individuals newly diagnosed with Alzheimer's Disease and Related Dementias (ADRD)
      each year, there is an urgent need to develop effective intervention models to support role
      transitions and minimize distress related to ADRD diagnosis. The long-term goal of this
      research is to minimize negative consequences of ADRD by enhancing the support systems of the
      affected families as they start their new and challenging phase of life as patients and
      family caregivers. The aim of this research is to evaluate the impact of this new Options
      Counselor-Health Education (OC-HE) intervention on bridging the medical and
      community-settings through potential mechanisms of influence, enhancement of social networks
      and support. Implementation strategies will be developed in collaboration with partnering
      clinics and local Area Agencies on Aging. Participants will be recruited from three clinics
      at the University of Iowa Hospitals and Clinics (UIHC) that provide dementia diagnostic
      services and randomized into an intervention or control arm; and complete baseline and three-
      and six-month follow-up interviews. This study is innovative in its consideration of
      contributing factors at multiple levels of the ecological model (i.e., individual, social
      network, and organizational) and its collaborative approach, involving medical clinics, an
      Area Agency on Aging (AAA), and Alzheimer's Association (AA) to develop and evaluate a new
      care model that bridges between the medical and community settings.
    

Detailed description: 
      Once the participant has consented, the research assistant will set up a time to complete a
      baseline interview, either in-person or via telephone. The baseline interview will take 40-50
      minutes to complete. After the baseline survey has been completed, the participant will be
      randomized using simple randomization based on a computer-generated random numbers to assign
      the family into the intervention or standard care (control group). If the participant is
      randomized into the intervention group, the options counselor will be given the participant's
      contact information and will establish contact with the participant to make an in-home or
      telephone (if preferred) visit within two weeks of the participant's consent. The participant
      and patient can jointly participate in the initial meeting. The options counselor may make
      additional calls to the participant if more information is needed in the absence of the
      patient as requested by the participant. During the initial visit/call, the options counselor
      will use the modified Options Counseling (OC) assessment tool and caregiver intake form
      (attached) to assess patient and family needs and to develop family actions plans (see
      attached family action plan form) using LifeLong Links to identify services available in
      their local areas, and to connect them to providers. The options counselor will also provide
      dementia education on the topics that the family desires to discuss. Modules to discuss with
      the participant include About Alzheimer's Disease and Dementia, Social Relationships and
      Daily Life, Anticipating Changes and Challenges, Interacting with Providers, and Addressing
      Future Needs. This initial visit should take between 1 and 2 hours. The options counselor
      will conduct 5 additional follow-up intervention calls, which will last between 30 minutes to
      1 hour. These calls will happen each month, in the 5 months following the initial visit/call.
      The follow up intervention calls will be used to adjust action plans and implement additional
      training modules selected by the participant. The attached intervention log will be filled
      out by the options counselor after each session (6 sessions per participant) to track what
      was covered. The research team will use the intervention logs as fidelity checks. The
      sessions will also be recorded so that the research team can check for fidelity to
      intervention protocol. The options counselor, Maria Donohoe, is a research team member on
      this IRB.

      Both intervention and standard care participants will complete 3 month and 6 month
      interviews, conducted by the research team members. The standard care group will have 3 and 6
      month interviews prior to their receiving a call from an options counselor. The call and work
      that the standard care group does with an options counselor is not the intervention because
      the intervention protocol for this research will not be used. This phone call is made for the
      standard care group to receive support after the study data is collected if desired. Each
      follow up interview will take between 30 and 40 minutes to complete. All three interviews
      will be recorded so that research team members can review the data for accuracy. Participants
      will be asked by the research assistant for permission to record and will be invited to let
      the researcher know if they would not like to be recorded or if they would like to turn off
      the recorder at any time. Participants will still be able to participate in the study if they
      do not elect to be recorded. The responses questions will be recorded on paper and then
      entered into an online survey database on Qualtrics. Those in the intervention group wishing
      to continue and those in the standard care group wishing to receive Options Counseling after
      completing the 6 month interview will receive a call from a local options counselor in their
      area. Options Counseling services are provided using the Older American's Act funding by the
      local Area Agencies on Aging, thus, there will be no cost for older individuals and their
      family. . For each interview, the research assistant will make up to three calls to schedule
      a time, leaving a voicemail (if available) and a phone number to call if the participant
      would like to continue their participation. On the final call, the research assistant will
      let the participant know that this is the last call and if the participant would like to
      continue with the study, they are welcome to call back. Those who miss the 3-month follow-up
      interview will be contacted again for the 6-month follow up interview, and the same protocol
      will be used to establish contact.

      At the end of the study (after the 6 month follow up interview), all study participants,
      regardless of study arm, will be given the option to receive a call from an options counselor
      who will offer options counseling services in their own community.
    

Intervention name(s): Options Counselor Health Educator (OC-HE) Intervention
Intervention type(s): Behavioral
Intervention description(s): The OC-HE will meet in person with the participant one time and five times via telephone to provide options counseling based on modules developed by the research team
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Alzheimer's disease; Dementia; Caregiver; Bridging community; Bridging medical settings