Expired Study
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Ann Arbor, Michigan 48105


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.


Study summary:

Background: Veterans with diabetes must control cardiovascular risk factors in order to prevent disabling and life-threatening complications. However, despite system wide advances in diabetes quality of care, over 30% of VHA patients with diabetes continue to have uncontrolled blood pressure, hyperglycemia, or hyperlipidemia. The nationwide VA PACT (Patient-Aligned Care Teams) initiative seeks to provide patients comprehensive, team-based support for following diabetes care regimens. PACT's success, however, hinges on its ability to effectively engage patients in care. One relatively untapped resource for supporting engagement in PACT is patients' family and friends. Three out of four adults with diabetes reach out to an unpaid family member or friend (a 'Care Partner') for ongoing help with diabetes management. These supporters help patients with medication adherence, tracking home glucose measurements, maintaining a healthy eating plan, and often accompany patients to their medical visits. However, while PACT emphasizes the importance of family members as part of the care team, PACT does not have formal mechanisms to involve health supporters in PACT care. Health supporters report that, in order to be more effective, they need more information on patient's medical care plans, clear channels for communicating with PACT team members, and information on navigating PACT resources. Objectives: The overall objective of this randomized trial is to test a strategy to strengthen the capacity of supporters to help patients with high-risk diabetes engage in PACT care and successfully enact care plans. The central hypothesis is that providing health care engagement tools to both Care Partners and patients will increase patient activation and improve management of diabetes complication risks. Methods: This is a randomized controlled trial evaluating an intervention (Caring Others Increasing EngageMent in PACT, or CO-IMPACT) designed to structure and facilitate health supporter involvement in PACT so that patients can become more actively engaged in PACT care. 240 patients with diabetes receiving PACT primary care who: 1) are at high risk for diabetes complications due to hyperglycemia OR high blood pressure and 2) have a health supporter involved in their care will be recruited along with their health supporter. Patient-supporter dyads are randomized to the CO-IMPACT intervention or usual PACT care for high-risk diabetes, for 12 months. The intervention provides patient-supporter dyads: one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns. CO-IMPACT builds on medical record-integrated patient activation tools in the PACT toolkit and is designed to be implementable within existing PACT nurse encounters. Primary outcomes for this study include a validated measure of patient activation (Patient Activation Measure-13) and a cardiac event 5-year risk score designed for patients with diabetes (UKPDS Risk Engine). Secondary outcomes include patients' self-efficacy for diabetes self-care; diabetes self-management behaviors including medication adherence; diabetes distress; and glycemic and blood pressure control. Measures among supporters include supporter activation, use of effective support techniques, distress about patient's diabetes care, and caregiver burden. We are also measuring patient-supporter and patient-provider relationship quality, patient safety (e.g. hypoglycemia), utilization, potential moderators of intervention effect such as patient health literacy level, and facilitators and barriers to wider implementation. Status: Recruitment was scheduled to begin in early 2016 but was delayed while the study team secured a cloud-based server that meets VA security requirements. Recruitment began in November 2016, and we are surpassing our monthly recruitment goals. As of late May 2017, 78 dyads have been enrolled. Approximately half have been randomized to the intervention and are receiving the year-long intervention.


Criteria:

Inclusion Criteria: - Provide signed and dated informed consent form - Willing to comply with all study procedures and 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 Ann Arbor VA 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 VAAAHS primary care provider and at least 2 visits to VA Ann Arbor Healthcare System (VAAAHS) primary care in the previous 12 months, (3) poor glycemic control (last HbA1C >8) OR poor blood pressure control (last BP 160/100 or mean 6 month BP >150/90) - Active Ann Arbor VA primary care patients - at least 2 visits in last 12 months Care Partner Inclusion Criteria: - Validated through completion of Care Partner study screener: - Between 21 and 75 years old - Fluent in English - Have continuous phone service (land line or mobile) or internet access - Live in the United States Exclusion Criteria: - Expect to have >1 month gap in VAAAHS 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-PACTprovider 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 one 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, at time of enrollment, that could conflict with CO-IMPACT's protocol (e.g. another diabetes management research intervention) - Do not have a working phone or are not able to use a telephone to respond to automated IVR calls - Currently Pregnant - Validated through patient medical record: - Have a serious mental illness or active substance abuse issue as determined by a diagnosis of a mental illness Care Partner Exclusion Criteria: - Validated through completion of Care Partner study screener: - 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 one 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)


NCT ID:

NCT02328326


Primary Contact:

Principal Investigator
Ann-Marie Rosland, MD MS
VA Ann Arbor Healthcare System, Ann Arbor, MI


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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