Clinical Trial: Shared Health Appointments and Reciprocal Enhanced Support

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Peer Support to Enhance Diabetes Shared Medical Appointments: Examining Comparative Effectiveness in VA Health Systems

Brief Summary: The purpose of this study is to evaluate the effectiveness of a peer-to-peer program (P2P) in addition to Shared Medical Appointments (SMAs) compared to SMAs alone for the treatment of diabetes in five VA health systems, and to study the implementation process in order to gather information required to disseminate the program more broadly in the VHA system.

Detailed Summary: Providers are often unable to communicate as frequently as needed with diabetes patients who have poor risk factor control and face significant self-management challenges. Moreover, many VA patients face barriers to attending frequent face-to-face visits. This project will evaluate the implementation of a novel program found in a recent VA randomized, controlled trial to significantly improve VA patients' diabetes-specific social support, insulin starts, and glycemic control compared to usual nurse care management. The program uses periodic group sessions in conjunction with calls between paired patients with diabetes to promote more effective care management as well as peer-to-peer (P2P) communication among diabetes patients who both have poor glycemic control and are working on similar care goals. "Peer buddies" are encouraged to talk by phone at least weekly to provide mutual support and share their progress on meeting their self-management goals. The goal of this service is to enhance the effect of shared medical appointments (SMAs), a service model demonstrated to be effective in improving outcomes among patients with diabetes and other chronic conditions and now being widely implemented in VA. Based on the success of the efficacy trial of this intervention, the investigators now seek to evaluate a wider-scale implementation of this program. During implementation of the P2P program in conjunction with shared medical appointments (SMAs) in five diverse VA facilities, the investigators will evaluate the effectiveness of SMAs alone and SMAs+P2P compared to usual care, and study the implementation process in order to gather information required to disseminate the program more broadly in Veterans Health Administration (VHA).
Sponsor: VA Office of Research and Development

Current Primary Outcome: Change in glycemic control [ Time Frame: 6 months and 12-18 months post-enrollment ]

Original Primary Outcome: Change in glycemic control [ Time Frame: 6 months and 12-18 months post-enrollment ]

Current Secondary Outcome:

• Change in systolic blood pressure (SBP) [ Time Frame: 6 months and 12-18 months post-enrollment ]
  Blood pressure (BP) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values, the investigators will also examine the change in percentage of patients with an average systolic blood pressure > 140.
• Insulin starts [ Time Frame: 6 months and 12-18 months post-enrollment ]
  The number of participants who are not on insulin at baseline and are started on insulin during the 6 month and 12-18 month post-enrollment periods will be totaled and compared for the SMA group, the SMA+P2P group, and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA and SMA+P2P groups, baseline will be the date of the first SMA.
• Service utilization [ Time Frame: 6 months and 12-18 months post-enrollment ]
  Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits).
• Change in statin use [ Time Frame: 6 months and 12-18 months post-enrollment ]
  Change in statin use (no statin/low-dose statin/moderate-dose statin) in each group will be assessed at baseline and following the 6 and 12-month post-enrollment evaluation periods. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA and SMA+P2P groups, baseline will be the date of the first SMA.
• Change in number of anti-hypertensives [ Time Frame: 6 months and 12-18 months post-enrollment ]
  Change in antihypertensive use (number of prescribed anti-hypertensives) in each group will be assessed at baseline and following the 6 and 12-month post-enrollment evaluation periods. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA and SMA+P2P groups, baseline will be the date of the first SMA.
• cost [ Time Frame: Pre implementation (starting with training of P2P facilitators) through 24 months post implementation. ]
  Staff effort required in starting and running the P2P program will be recorded and used to evaluate the cost of the program
• Change in patient-reported satisfaction with VA care [ Time Frame: 6 months and 12-18 months post-enrollment ]
  Patients' satisfaction with VA care will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group and the SMA+P2P group.
• Change in patient-reported diabetes-specific quality of life [ Time Frame: 6 months and 12-18 months post-enrollment ]
  Patients' diabetes-specific quality of life will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group and the SMA+P2P group.
• Change in patient-reported degree of social support [ Time Frame: 6 months and 12-18 months post-enrollment ]
  Patients' degree of social support will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group and the SMA+P2P group.

Original Secondary Outcome:

• Change in systolic blood pressure (SBP) [ Time Frame: 6 months and 12-18 months post-enrollment ]
  Blood pressure (BP) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values, we will also examine the change in percentage of patients with an average systolic blood pressure > 140.
• Insulin starts [ Time Frame: 6 months and 12-18 months post-enrollment ]
  The number of participants who are not on insulin at baseline and are started on insulin during the 6 month and 12-18 month post-enrollment periods will be totaled and compared for the SMA group, the SMA+P2P group, and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA and SMA+P2P groups, baseline will be the date of the first SMA.
• Service untilization [ Time Frame: 6 months and 12-18 months post-enrollment ]
  Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). Information on non-VA admissions for the SMA and SMA + P2P groups will be collected by patient survey.
• Satisfaction with care [ Time Frame: 6 months and 12 months post-enrollment ]
  Measured by 8-item version of the Client Satisfaction Questionnaire (CSQ-8), a reliable satisfaction measure designed to elicit satisfaction regarding specific providers, care processes, and time intervals.
• Diabetes-specific quality of life and social support [ Time Frame: 6 months and 12 months post-enrollment ]
  Diabetes-specific Social Support will be measured by the Diabetes Support Scale (DSS), a 12-item scale developed to assess whether an Internet-based diabetes support group changed participants' perceptions of social support, social network size, or actual provision of support. Diabetes-specific quality of life will be measured with the Diabetes-Specific Distress Scale (20 items), which captures the patient's perspective on the emotional burden of diabetes and its treatment.
• evaluation of implementation [ Time Frame: 18 - 24 months post implementation ]
  Consolidated Framework for Implementation (CFIR) constructs will be used to construct a matrix of identifying potential correlations between each construct and program outcomes - strong correlations will then form the basis of specific recommendations for program dissemination
• cost [ Time Frame: Pre implementation (starting with training of P2P facilitators) through 24 months post implementation. ]
  Staff effort required in starting and running the P2P program will be recorded and used to evaluate the cost of the program

Dates:
Date Received: August 21, 2013
Date Started: April 25, 2016
Date Completion: February 2020
Last Updated: March 3, 2017
Last Verified: March 2017