Caring Others Increasing EngageMent in PACT

Not Recruiting

Trial ID: NCT02328326

Purpose

This trial will compare two methods of increasing engagement in care and success in diabetes management, among patients with diabetes with high-risk features, who also have family members involved in their care.

Official Title

Engaging Veterans and Family Supporters in PACT to Improve Diabetes Management

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

Patient Inclusion Criteria:

   - Provide signed and dated informed consent form

   - Plan to be be available for the duration of the study

   - Male or female, age 30-70 years old

   - Plan to get most diabetes care at recruiting VA primary care clinic over the
   subsequent 12 months

   - Able to use telephone to respond to bi-weekly automated Interactive Voice Response
   (IVR) calls

   - Be able to identify an adult family member or friend who is regularly involved in
   their health management or health care (involved with medications, managing sugars,
   coming to appointments, etc)

   - Have a diagnosis of diabetes and be at high-risk for diabetes complications, defined
   as: (1) a diagnosis of diabetes based on encounter diagnoses from 1 inpatient or 2
   outpatient encounters (OR a diabetes medication (at least one >3 month prescription
   from VA drug classes HS501 (insulin) or HS502, other than metformin), (2) have an
   assigned VAprimary care provider and at least 2 visits to VA primary care in the
   previous 12 months, (3) poor glycemic control (last HbA1C within 9 months >8%) OR poor
   blood pressure control (last BP 160/100 or mean 6 month BP >150/90)

Care Partner Inclusion Criteria:

   - 21 years old or older

   - Fluent in English

   - Live in the United States

Exclusion Criteria:

Patient Exclusion Criteria:

   - Expect to have >1 month gap in VA care in the 12 months following enrollment (e.g.
   snowbird travel).

   - Plan to receive the majority of their care for diabetes mainly from a non-Primary Care
   provider in the 12 months following enrollment

   - Have a VA resident/trainee as their main primary care provider

   - Live in a nursing home OR assisted living

   - Have significant cognitive impairment as measured by an Electronic Medical Record
   (EMR) diagnosis of Alzheimer's disease or dementia, or a score of <4 on the Callahan
   screener to identify cognitive impairment

   - Need help with more than two basic activities of daily living (ADLs) as measured by
   the Katz Basic Activities of Daily Living Scale

   - Do not speak English

   - Have a life-limiting severe illness (such as stage renal disease [ESRD] requiring
   dialysis, chronic obstructive pulmonary disease (COPD) requiring oxygen, cancer
   undergoing active treatment, receiving palliative/hospice care)

   - Are concurrently enrolled in another research study or clinical program, at time of
   enrollment, that could conflict with the current study's protocol (e.g. another
   diabetes management research intervention, or VA tele-buddy program involving frequent
   phone calls)

   - Do not have a working phone or are not able to use a telephone to respond to automated
   IVR calls

   - Currently Pregnant or planning to become pregnant at time of enrollment

   - Have a serious mental illness or active substance abuse issue

Care Partner Exclusion Criteria:

   - Receive pay for caring for the patient

   - talks with patient about health less than two times per month

   - Have significant cognitive impairment as measured by a score of 4 or less <4 on the
   Callahan screener to identify cognitive impairment

   - Need help with more than two basic ADL as measured by the Katz Basic Activities of
   Daily Living Scale

   - Have a life-limiting severe illness (such as end-stage renal disease requiring
   dialysis, chronic lung disease requiring oxygen, cancer undergoing active treatment,
   receiving palliative/hospice care)

   - Ever told by a doctor they have dementia, schizophrenia, or manic depression

Intervention(s):

other: CO-IMPACT

other: PACT

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305