Personalized Health Planning in Shared Medical Appointments for Individuals With Type II Diabetes Pilot Study

Personalized Health Planning in Shared Medical Appointments for Individuals With Type II

The primary aim of this study is to examine the feasibility of implementing an evidence based patient engagement strategy, known as personalized health planning (PHP), in the context of a a shared medical appointment (SMA) for individuals with type II diabetes in a primary care setting.

Study Overview

• Status: Completed
• Conditions: Type II Diabetes
• Intervention / Treatment: Behavioral: Personalized Health Planning Shared Medical Appointment

Detailed Description

All data for the prospective portion of this study was done being collected in September 2016. The retrospective chart review will collect data up until March of 2017 (six months after the last subject completed the prospective phase by attending their last SMA session).

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Family Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A diagnosis of Type 2 diabetes within the last year
• A current patient at Duke Family Medicine.
• An A1C score greater than 7 and less than 14.

Exclusion Criteria:

• A diagnosis of Pre-diabetes
• A diagnosis of Type I diabetes
• Individuals with amputations as a result of their diabetes are excluded form this study.
• Individuals with renal dialysis will not be included in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Shared Medical Appointment; The SMA group will be a standard shared diabetes medical appointment group consisting of up to 10 patients that utilizes the design and curriculum of the SMAs that are currently being held at the Duke Family Medicine Center.
Experimental: Personalized Health Planning Shared Medical Appointment; The PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum.	Behavioral: Personalized Health Planning Shared Medical Appointment; The PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum
No Intervention: Retrospective; A retrospective chart review will be conducted once all participants (both SMA group and PHP SMA group) complete the intervention. The retrospective chart review will collect healthcare utilization data six months prior, during, and after each subject's participation in the SMA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility measured using a patient satisfaction survey	12 months
Change in patient activation measured using the patient activation measure	baseline; 6 months; 12 months
Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale	baseline; 6 months; 12 months
Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale	baseline; 6 months; 12 months
Change in A1C using the A1C blood test	baseline; 3 months; 6 months; 9 months; 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in depression screening score using the Patient Health Questionnaire (PHQ-9)	baseline; 6 months; 12 months
Change in functional health and well-being using the short form health survey	baseline; 6 months; 12 months
Change in general self-rated health using the general self rated health survey (GSRH)	baseline; 6 months; 12 months
Change in health goal progress using a goal progress visual analog scale	3 months; 10 months
change in body mass index using weight and height measurements	baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
change in blood pressure using blood pressure measurement	baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months
Change in low-density lipoprotein cholesterol (LDL) using LDL measurement	baseline; 6 months; 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Sharon Hull, MD MPH, Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: June 11, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Type II Diabetes; Shared Medical Appointments; Personalized Health Planning
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Pro00063493