Shared Health Appointments and Reciprocal Enhanced Support

Completed

• Conditions: Diabetes Insipidus

• Registration Number: NCT02132676
• Lead Sponsor: VA Office of Research and Development

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 Description

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).

Study Timeline

• Study First Submitted: 2013-08-21
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-07
• Study Start: 2016-04-25
• Primary Completion: 2019-06-28
• Study Completion: 2019-07-30
• Results First Submitted: 2020-06-30
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-07
• Results First Posted: 2020-08-19
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1536

Inclusion Criteria

Veterans enrolled into diabetes Shared Medical Appointments (SMAs) at participating sites, and a random subset of those meeting criteria for diabetes SMAs who have not yet participated:

• Veteran receiving care at a participating VA Medical Center

• Meets at least one of the following criteria in the past 2 years;

  • at least 1 VA hospitalization with a diabetes-related International Classification Of Diseases-9 (ICD-9) code,
  • at least 2 VA outpatient visits with a diabetes-related ICD-9 code, or
  • At least 1 VA prescription for a glucose control medication (insulin or oral agent) or monitoring supplies

• Poor glycemic control, indicated by a HbA1c in the past 6 months or:

  • at least 7.5% if age <70, or
  • at least 8% if age 70+

• Has a current address and telephone number listed in VA databases

• Is competent to provide informed consent

• Can communicate in English and by telephone

• Able to participate in an outpatient program

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Exclusion Criteria

For no intervention control group:

• Active substance abuse disorder (smoking cigarettes is not an exclusion)
• Serious psychiatric illness (bipolar disorder, dementia, schizophrenia, or personality disorders)
• Terminally ill
• Prisoner

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Glycemic Control	6 months and 12 months post-enrollment	Glycemic control (measured by Hemoglobin A1c) 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 of A1c, the investigators will also examine the change in the percentage of patients with an average A1c \> 8%.

Secondary Outcome Measures

Name	Time	Method
Statin Starts	6 months and 12 months post-enrollment	The number of participants who are not on a statin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA 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 group, baseline will be the date of the first SMA.
Emergency Department (ED) Visits	6 months and 12 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).
Insulin Starts	6 months and 12 months post-enrollment	The number of participants who are not on insulin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA 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 group, baseline will be the date of the first SMA.
Change in Number of Classes of Anti-hypertensive Meds	6 months and 12 months post-enrollment	Change in antihypertensive use (number of classes 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 group, baseline will be the date of the first SMA.
Change in Patient-reported Degree of Self-Efficacy	6 months and 12 months post-enrollment	Patients' degree of self-efficacy will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: Williams Self-Efficacy Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome
PCP Visits	6 months and 12 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).
Endocrinology Visits	6 months and 12 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 Systolic Blood Pressure (SBP)	6 months and 12 months post-enrollment	Systolic blood pressure (SBP) 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 SBP \> 140.
Change in Patient-reported Satisfaction With VA Care	6 months and 12 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. The following relates to the scale used: Scale name: VA Healthcare Satisfaction Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome
Change in Patient-reported Degree of Diabetes Support	6 months and 12 months post-enrollment	Patients' degree of diabetes support will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: Diabetes Support Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome
Change in Patient-reported Diabetes Distress	6 months and 12 months post-enrollment	Patients' level of diabetes distress will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: Diabetes Distress Scale Scale ranges: 1-5 (Not a Problem=1, Minor Problem=2, Moderate Problem=3, Somewhat Serious Problem=4, Serious Problem=5) Direction of range: Lower score indicates a better outcome
Hospitalizations	6 months and 12 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).
Length of Hospitalizations	6 months and 12 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).
Nurse Case Manager Visits	6 months and 12 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).

Trial Locations

Locations (5)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT; 🇺🇸 West Haven, Connecticut, United States

VA Palo Alto Health Care System, Palo Alto, CA; 🇺🇸 Palo Alto, California, United States

VA Northern California Health Care System, Mather, CA; 🇺🇸 Sacramento, California, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States

Providence VA Medical Center, Providence, RI; 🇺🇸 Providence, Rhode Island, United States