Health PromotionNCT04526873
Encouraging Annual Wellness Visits Among ACO Beneficiaries
A study testing Postcard, Phone call and Humor/Salience in people with Health Promotion and Prevention, run by Geisinger Clinic at 1 site in United States.
Trial summary
Annual Wellness Visits (AWVs) are a type of detailed healthcare checkup to which Medicare beneficiaries are entitled, free of charge, once per year. The purpose of the current study is to assess what content and communication modality results in the most effective messaging campaign to encourage Medicare beneficiaries… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Health Promotion, Prevention, Risk Reduction Behavior
- What is being tested?
- Postcard, Phone call and Humor/Salience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41,472 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2020to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Encouraging Annual Wellness Visits Among Keystone ACO Beneficiaries
Annual Wellness Visits (AWVs) are a type of detailed healthcare checkup to which Medicare beneficiaries are entitled, free of charge, once per year. The purpose of the current study is to assess what content and communication modality results in the most effective messaging campaign to encourage Medicare beneficiaries to schedule their AWVs.
Read the 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.
- Conditions
- Health Promotion, Prevention, Risk Reduction Behavior, Telehealth
- Being tested
- Postcard, Phone call, Humor/Salience, Telehealth
- Keywords
- Behavioral Economics, Humor, Salience, Present Bias
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostcardBehavioural
Mailed
Phone callBehavioural
May be automated or by human
Humor/SalienceBehavioural
Funny cartoon + health risk examples
TelehealthBehavioural
Information about video visit
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention control group |
| Postcard: non-telehealth, photo | Experimental | This group receives a postcard that does not include telehealth information and features a stock photo Receives: Behavioral: Postcard |
| Postcard: non-telehealth, salience/humorous cartoon | Experimental | 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) Receives: Behavioral: Postcard; Behavioral: Humor/Salience |
| Postcard: telehealth, photo | Experimental | This group receives a postcard that does includes telehealth information and features a stock photo Receives: Behavioral: Postcard; Behavioral: Telehealth |
| Postcard: telehealth, salience/humorous cartoon | Experimental | 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) Receives: Behavioral: Postcard; Behavioral: Humor/Salience; Behavioral: Telehealth |
| Phone call | Experimental | This group receives a phone call Receives: Behavioral: Phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who scheduled an AWV appointment
Patient scheduled an AWV appointment
Measured: 1 month after start of intervention
Proportion of patients who completed an AWV visit
Patient completed an AWV
Measured: 3 months after start of intervention
Secondary outcomes (3)
Proportion of patients who scheduled an AWV appointment
Patient scheduled an AWV appointment
Measured: 3 months after start of intervention
Proportion of patients who initiated contact
Patient called one of the phone numbers provided on postcards regarding AWV
Measured: 3 months after start of intervention
Proportion of visits that were in-person vs. tele-visit
Whether patient AWV was in person or a telehealth visit
Measured: 3 months after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start11 Sep 2020
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Postcard content will follow a factorial design (crossing telehealth vs. non-telehealth with cartoon/salience vs. stock photo). In addition, there will be a no-contact control group and a phone call group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 41,472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Goren, Geisinger Clinic
- Investigators
- Amir Goren, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526873
- Sponsor's protocol ID
- 2020-0577
- Status last verified
- Jan 2021
- First submitted
- 14 Aug 2020
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Annual Wellness Visits Among Keystone ACO Beneficiaries
- ClinicalTrials.gov ID
- NCT04526873
- Acronym / sponsor ID
- 2020-0577
- Conditions
- Health Promotion, Prevention, Risk Reduction Behavior, Telehealth
- Keywords
- Behavioral Economics, Humor, Salience, Present Bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41,472 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Annual Wellness Visits (AWVs) are a type of detailed healthcare checkup to which Medicare beneficiaries are entitled, free of charge, once per year. The purpose of the current study is to assess what content and communication modality results in the most effective messaging campaign to encourage Medicare beneficiaries to schedule their AWVs.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
- Model description
- Postcard content will follow a factorial design (crossing telehealth vs. non-telehealth with cartoon/salience vs. stock photo). In addition, there will be a no-contact control group and a phone call group.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention control group |
| Postcard: non-telehealth, photo | Experimental | Behavioral: PostcardThis group receives a postcard that does not include telehealth information and features a stock photo |
| Postcard: non-telehealth, salience/humorous cartoon | Experimental | Behavioral: Postcard, Behavioral: Humor/SalienceThis 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) |
| Postcard: telehealth, photo | Experimental | Behavioral: Postcard, Behavioral: TelehealthThis group receives a postcard that does includes telehealth information and features a stock photo |
| Postcard: telehealth, salience/humorous cartoon | Experimental | Behavioral: Postcard, Behavioral: Humor/Salience, Behavioral: TelehealthThis 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) |
| Phone call | Experimental | Behavioral: Phone callThis group receives a phone call |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PostcardMailed | Behavioural | Postcard: non-telehealth, photo, Postcard: non-telehealth, salience/humorous cartoon, Postcard: telehealth, photo, Postcard: telehealth, salience/humorous cartoon |
| Phone callMay be automated or by human | Behavioural | Phone call |
| Humor/SalienceFunny cartoon + health risk examples | Behavioural | Postcard: non-telehealth, salience/humorous cartoon, Postcard: telehealth, salience/humorous cartoon |
| TelehealthInformation about video visit | Behavioural | Postcard: telehealth, photo, Postcard: telehealth, salience/humorous cartoon |
Primary outcome
Proportion of patients who scheduled an AWV appointment
Time frame: 1 month after start of intervention
Patient scheduled an AWV appointment
Proportion of patients who completed an AWV visit
Time frame: 3 months after start of intervention
Patient completed an AWV
3 secondary outcomes
Proportion of patients who scheduled an AWV appointment
Time frame: 3 months after start of intervention
Proportion of patients who initiated contact
Time frame: 3 months after start of intervention
Proportion of visits that were in-person vs. tele-visit
Time frame: 3 months after start of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Goren, PhD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postcard, Phone call and Humor/Salience in people with Health Promotion and Prevention, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who scheduled an AWV appointment (time frame: 1 month after start of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.