Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs

• Sponsor: Kaiser Permanente (Other)
• Overall Status: Completed
• CT.gov ID: NCT03200535
• Collaborator: (none)
• Enrollment: 6,588
• Location: 1
• Arms: 4
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 1463.7

Study Details

Study Description

Brief Summary

Individuals with prediabetes are at increased risk for developing diabetes. Higher hemoglobin A1c's (6.1-6.4%) are associated with a high risk of developing diabetes. It is known that programs such weight management classes and one-on-one counseling with registered dieticians can lead to weight loss and decrease the risk of diabetes. However, engagement of Kaiser Permanente Colorado members in these activities is low. The purpose of this study is to determine which of three outreach methods is most effective in increasing engagement in these activities.

Condition or Disease	Intervention/Treatment	Phase
PreDiabetes; Obesity	Other: EHR gaps; Other: Bulk outreach; Other: Dietician call	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6588 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Individuals with a body mass index between 25 and 30 are randomized 1:1 to the Usual Care or EHR Gap arms. Individuals with a body mass index >=30 are randomized to all 4 arms, with n=1000 for the Personalized Outreach arm and 1:1:1 for the other three arms.Individuals with a body mass index between 25 and 30 are randomized 1:1 to the Usual Care or EHR Gap arms. Individuals with a body mass index >=30 are randomized to all 4 arms, with n=1000 for the Personalized Outreach arm and 1:1:1 for the other three arms.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Comparison of Outreach Methods to Encourage Enrollment in Diabetes Prevention and Weight Management Programs
• Actual Study Start Date: Jun 26, 2017
• Actual Primary Completion Date: Nov 10, 2017
• Actual Study Completion Date: Nov 10, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care Usual care
Active Comparator: Electronic health record "gaps" Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient	Other: EHR gaps; Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient
Active Comparator: Bulk outreach Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent	Other: EHR gaps; Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; Other: Bulk outreach; A bulk letter or email will be sent
Active Comparator: Personalized outreach Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian	Other: EHR gaps; Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; Other: Bulk outreach; A bulk letter or email will be sent; Other: Dietician call; Patients will receive a personalized call by a registered dietitian

Outcome Measures

Primary Outcome Measures

1. Enrollment in Diabetes Prevention or Weight Management Class (Online) [4.5 months (6/26/2017-11/10/2017)]

   Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period

Secondary Outcome Measures

1. Enrollment in Diabetes Prevention or Weight Management Class (in Person) [4.5 months (6/26/2017-11/10/2017)]

   Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Kaiser Permanente Member

• Age 18-75

• Prediabetes

• BMI >= 25

• A1c 6.1-6.4%

• No dietitian visit within the past 3 years

Exclusion Criteria:

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Coloado	Denver	Colorado	United States	80014

Sponsors and Collaborators

• Kaiser Permanente

Investigators

• Principal Investigator: Emily Schroeder, MD, PhD, Kaiser Permanente

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 6, 2019

More Information

Publications

None provided.

• Responsible Party: Emily Schroeder, Investigator, Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT03200535
• Other Study ID Numbers: CO-17-2437
• First Posted: Jun 27, 2017
• Last Update Posted: Dec 13, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prediabetic State

Study Results

Participant Flow

Arm/Group Title	Usual Care	Electronic Health Record "Gaps"	Bulk Outreach	Personalized Outreach
Arm/Group Description	Usual care	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian
Period Title: Overall Study
STARTED	1863	1863	1862	1000
COMPLETED	1863	1863	1862	1000
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Usual Care	Electronic Health Record "Gaps"	Bulk Outreach	Personalized Outreach	Total
Arm/Group Description	Usual care	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian	Total of all reporting groups
Overall Participants	1863	1863	1862	1000	6588
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.1 (10.9)	58.2 (11.0)	58.0 (11.1)	58.3 (10.9)	58.2 (11.0)
Sex: Female, Male (Count of Participants)
Female	999 53.6%	1023 54.9%	990 53.2%	544 54.4%	3556 54%
Male	858 46.1%	833 44.7%	871 46.8%	453 45.3%	3015 45.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	36.3 (5.6)	36.3 (6.1)	36.6 (5.9)	36.4 (5.5)	36.4 (5.8)
A1c (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	6.3 (0.18)	6.3 (0.18)	6.3 (0.18)	6.3 (0.18)	6.3 (0.17)

Outcome Measures

1. Primary Outcome

Title	Enrollment in Diabetes Prevention or Weight Management Class (Online)
Description	Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period
Time Frame	4.5 months (6/26/2017-11/10/2017)

Outcome Measure Data

Analysis Population Description

Entire population was analyzed

Arm/Group Title	Usual Care	Electronic Health Record "Gaps"	Bulk Outreach	Personalized Outreach
Arm/Group Description	Usual care	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian
Measure Participants	1863	1863	1862	1000
Count of Participants [Participants]	7 0.4%	12 0.6%	39 2.1%	59 5.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Electronic Health Record "Gaps", Bulk Outreach, Personalized Outreach
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority analysis
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Enrollment in Diabetes Prevention or Weight Management Class (in Person)
Description	Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period
Time Frame	4.5 months (6/26/2017-11/10/2017)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Care	Electronic Health Record "Gaps"	Bulk Outreach	Personalized Outreach
Arm/Group Description	Usual care	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent	Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian
Measure Participants	1863	1863	1862	1000
Count of Participants [Participants]	15 0.8%	14 0.8%	24 1.3%	25 2.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Electronic Health Record "Gaps", Bulk Outreach, Personalized Outreach
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	4.5 months (6/26/2017-11/10/2017)
Arm/Group Title	Usual Care		Electronic Health Record "Gaps"		Bulk Outreach		Personalized Outreach
Arm/Group Description	Usual care		Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient		Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent		Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient; in addition a bulk letter or email will be sent and patients will receive a personalized call by a registered dietitian EHR gaps: Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient Bulk outreach: A bulk letter or email will be sent Dietician call: Patients will receive a personalized call by a registered dietitian
All Cause Mortality
	Usual Care		Electronic Health Record "Gaps"		Bulk Outreach		Personalized Outreach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/1863 (0.1%)		2/1863 (0.1%)		3/1862 (0.2%)		1/1000 (0.1%)
Serious Adverse Events
	Usual Care		Electronic Health Record "Gaps"		Bulk Outreach		Personalized Outreach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1863 (0%)		0/1863 (0%)		0/1862 (0%)		0/1000 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		Electronic Health Record "Gaps"		Bulk Outreach		Personalized Outreach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1863 (0%)		0/1863 (0%)		0/1862 (0%)		0/1000 (0%)

Limitations/Caveats

We were unable to analyze the change in BMI and change in A1c due to the low number of individuals who enrolled in diabetes prevention classes

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.