- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04526873
Encouraging Annual Wellness Visits Among ACO Beneficiaries
Encouraging Annual Wellness Visits Among Keystone ACO Beneficiaries
Study Overview
Status
Intervention / Treatment
Detailed Description
Annual Wellness Visits (AWVs) are a type of detailed healthcare checkup to which Medicare beneficiaries are entitled, free of charge, once per year. The Keystone Affordable Care Organization (KACO), of which Geisinger is a part, is working to increase the number of eligible patients who take advantage of AWVs via mail and telephone outreach.
The purpose of the current study is to assess what content and communication modality results in the most effective messaging campaign. Patients will either receive a phone call or a mailed postcard, or they will be part of a no-contact control condition. Furthermore, the content of the postcard will vary in terms of humor and salience, as well as whether telehealth is mentioned as an AWV option.* Although telehealth is a great option for patients who are unable to attend an in-person visit, the latter is preferable in terms of quality of care. Furthermore, insurance coverage for telehealth visits may not extend indefinitely beyond the COVID-19 pandemic. Highlighting the telehealth option may help attract patients who would not otherwise get an AWV, increasing the effectiveness of the intervention. On the other hand, it may unintentionally nudge patients who would otherwise have scheduled an in-person visit to opt for telehealth instead.
The following research questions will assess effectiveness in increasing patient scheduling of an AWV:
- Are postcards effective compared with a no-contact control condition?
- How effective are postcards when compared with phone calls, a presumably more intrusive type of intervention?
- Is a humorous cartoon, accompanied by language using examples to make salient the future health risks that could be prevented, more effective than stock photography of similar patient-doctor situations (typically used in outreach), accompanied by prevention language that is less specific?
- Is it more effective to highlight the availability of telehealth video visits than not to mention that option?
- Are in-person AWVs are scheduled at least as frequently when the telehealth option is highlighted as when it is not?
Included in the study will be patients from 7 KACO partner sites: Caring Community Health Center, Evangelical Community Hospital, Geisinger, Geisinger-Hm Joint Venture, Holy Spirit, Wayne Memorial Hospital, and Wright Center. Generalized linear mixed models (GLMMs) will examine the primary study outcomes as a function of the study arms (between-subjects), with partner site included as a random effect, assuming high intraclass correlation coefficients.
* Wayne Memorial Hospital patients will not receive postcards with tele-health content. In addition, only patients from the following partner sites will be randomized to receive a phone call: Evangelical Community Hospital, Wayne Memorial Hospital, and the Wright Center. Geisinger patients will not be randomized to receive phone calls, but Geisinger patients who are randomized to other conditions may receive phone calls as part of regular operations. This will be accounted for during analysis as a model regressor.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Geisinger
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- KACO Medicare beneficiary
- Haven't had an AWV or due for their next one
- For phone call condition only: patients of Evangelical Community Hospital, Wayne Memorial Hospital, and the Wright Center
Exclusion Criteria:
- Patient has already been called about AWV or had a visit scheduled
- For "patient initiated contact" outcome only: patients of Wayne Memorial Hospital or who have not been assigned to a partner site. This is because postcards received by these patients will not include a specific phone number to call.
- For telehealth conditions only: patients of Wayne Memorial Hospital
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention control group
|
|
Experimental: Postcard: non-telehealth, photo
This group receives a postcard that does not include telehealth information and features a stock photo
|
Mailed
|
Experimental: Postcard: non-telehealth, salience/humorous cartoon
This group receives a postcard that does not include telehealth information and features a humorous cartoon as well as examples of serious health risks that the visit could help prevent (stroke and heart attack)
|
Mailed
Funny cartoon + health risk examples
|
Experimental: Postcard: telehealth, photo
This group receives a postcard that does includes telehealth information and features a stock photo
|
Mailed
Information about video visit
|
Experimental: Postcard: telehealth, salience/humorous cartoon
This group receives a postcard that includes telehealth information and features a humorous cartoon as well as examples of serious health risks that the visit could help prevent (stroke and heart attack)
|
Mailed
Funny cartoon + health risk examples
Information about video visit
|
Experimental: Phone call
This group receives a phone call
|
May be automated or by human
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who scheduled an AWV appointment
Time Frame: 1 month after start of intervention
|
Patient scheduled an AWV appointment
|
1 month after start of intervention
|
Proportion of patients who completed an AWV visit
Time Frame: 3 months after start of intervention
|
Patient completed an AWV
|
3 months after start of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who scheduled an AWV appointment
Time Frame: 3 months after start of intervention
|
Patient scheduled an AWV appointment
|
3 months after start of intervention
|
Proportion of patients who initiated contact
Time Frame: 3 months after start of intervention
|
Patient called one of the phone numbers provided on postcards regarding AWV
|
3 months after start of intervention
|
Proportion of visits that were in-person vs. tele-visit
Time Frame: 3 months after start of intervention
|
Whether patient AWV was in person or a telehealth visit
|
3 months after start of intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Per patient campaign cost
Time Frame: 3 months after start of intervention
|
Cost of campaign for whole study arm divided by number of patients who completed an AWV for that study arm.
|
3 months after start of intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020-0577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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