Cancer PreventionCP-CDSNCT02986230

Cancer Prevention Clinical Decision Support

A study testing CP-CDS in people with Cancer Prevention, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Cancer Prevention
What is being tested?: CP-CDS
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35,953 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2018to 28 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

meet above age criteria
pcp practice at randomized clinic

Who cannot join

current or past cancer diagnosis (excludes nonmelanoma skin cancer)
hospice care or cancer chemotherapy
Alzheimer's disease codes
major cardiovascular event in 12 months prior to index date

Trial locations and contacts

1 site in 1 country.

United States1 site

Essentia Health
Duluth, Minnesota, 55805

Other trials in United States

About this study

Official title: Implementing Cancer Prevention Using Patient-Provider Clinical Decision Support

This project will engage a rural population with substantial healthcare disparities and gaps in the receipt of primary and secondary cancer prevention. Results will advance dissemination and implementation research methods that can reduce health disparities and improve healthcare for millions in medically under-served areas.

Read the detailed description

The objective of this project is to implement and evaluate the effectiveness of a sophisticated Web-based, electronic health record (EHR)-linked clinical decision support (CDS) system designed to improve primary and secondary cancer preventive care. To achieve this objective, EHR data is sent to evidence-based cancer prevention algorithms, housed on a secure Web site. The algorithms: (a) identify at the point of care all eligible patients not up to date on their cancer prevention interventions; and (b) present to both patient and primary care provider (PCP), appropriate evidence-based primary cancer prevention interventions and cancer screening options at the point of care. The cancer prevention (CP)-CDS will focus on breast cancer screening in women aged 50-74, colorectal cancer screening for both sexes aged 50-75, cervical cancer screening for women aged 21-65, human papilloma virus (HPV) vaccination for both sexes aged 11-26, and referrals for weight management and smoking cessation in all adults aged 18 and older. Effectiveness is assessed by cluster-randomizing 30 primary care clinics with roughly 285 PCPs and 153,000 study-eligible patients into one of three experimental conditions: Group 1: CP-CDS intervention in which the decision support is printed for the PCP and patient, designed to engage patients in discussions about appropriate cancer prevention strategies. Group 2: CP-CDS + shared decision making tools (SDMT) intervention in which the CP-CDS is printed along with additional shared decision making tools. Group 3: clinics provide usual care (UC) with no intervention-related activity related to cancer prevention.

With 10 clinics, 95 PCPs, and 51,000 potentially eligible patients per study arm, this study will formally test the hypothesis that Groups 1 and 2 are superior to Group 3 over an 12-month follow-up period with respect to: (a) significantly higher rates of appropriate screening for breast, cervix, and colorectal cancer, as defined by the United States Preventive Services Task Force; and (b) significantly higher rates of human papillomavirus (HPV) vaccination in males and females aged 11-26 years. Secondary analysis will evaluate the impact of the intervention on lung cancer screening. The investigators further posit that Groups 1 and 2 will have higher short-term health care costs but better long-term cost-effectiveness than Group 3. The Consolidated Framework for Implementation Research (CFIR) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) conceptual frameworks will be used to guide implementation planning, organization, conduct, and impact evaluation of the intervention in a large rural healthcare system.

Conditions: Cancer Prevention
Being tested: CP-CDS
Keywords: Cancer prevention, Clinical Decision Support, Rural Health, Shared Decision Making

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CP-CDSOther
Also called Cancer Prevention Wizard
The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.

Study groups in NCT02986230
Study group	Role	What they receive
CP-CDS	Experimental	The CP-CDS group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. Receives: Other: CP-CDS
CP-CDS + SDMT	Experimental	The CP-CDS + SDMT group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The CP-CDS + SDMT arm also provides shared decision making tools to patient and provider at the time of the visit. Receives: Other: CP-CDS
Usual Care	No intervention	The usual care group will have no access to the CP-CDS, or the CP-CDS + SDMT.

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite Cancer Screening Tests up to Date
Participants up to date on composite endpoint of breast, cervical, and colorectal cancer screening at 1 year post index date.
Measured: 1 year post index date
HPV Vaccination up to Date
Participants up to date on HPV vaccination at 1 year post index date.
Measured: 1 year post index date

Secondary outcomes (1)

Lung Cancer Screening up to Date
Participants up to date on lung cancer screening at 1 year post index date.
Measured: 1 year post index date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201828 Feb 2021

First posted8 Dec 2016 (estimated)
Study start1 Aug 2018
Primary completion15 Mar 2020
Study completion28 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Cancer PreventionStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 35,953 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02986230
Sponsor's protocol ID: 15-010
Acronym: CP-CDS
Status last verified: Feb 2022
First submitted: 6 Dec 2016
Last updated: 24 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Elliott TE, O'Connor PJ, Asche SE, Saman DM, Dehmer SP, Ekstrom HL, Allen CI, Bianco JA, Chrenka EA, Freitag LA, Harry ML, Truitt AR, Sperl-Hillen JM. Design and rationale of an intervention to improve cancer prevention using clinical decision support and shared decision making: A clinic-randomized trial. Contemp Clin Trials. 2021 Mar;102:106271. doi: 10.1016/j.cct.2021.106271. Epub 2021 Jan 24.
PubMed 33503497
Harry ML, Chrenka EA, Freitag LA, Saman DM, Allen CI, Asche SE, Truitt AR, Ekstrom HL, O'Connor PJ, Sperl-Hillen JAM, Ziegenfuss JY, Elliott TE. Primary care clinicians' opinions before and after implementation of cancer screening and prevention clinical decision support in a clinic cluster-randomized control trial: a survey research study. BMC Health Serv Res. 2022 Jan 6;22(1):38. doi: 10.1186/s12913-021-07421-0.
PubMed 34991570
Saman DM, Harry ML, Freitag LA, Allen CI, O'Connor PJ, Sperl-Hillen JM, Bianco JA, Truitt AR, Ekstrom HL, Elliott TE. Patient Perceptions of Using Clinical Decision Support for Cancer Screening and Prevention: "I wouldn't have thought about getting screened without it.". J Patient Cent Res Rev. 2021 Oct 18;8(4):297-306. doi: 10.17294/2330-0698.1863. eCollection 2021 Fall.
PubMed 34722797
Saman DM, Chrenka EA, Harry ML, Allen CI, Freitag LA, Asche SE, Truitt AR, Ekstrom HL, O'Connor PJ, Sperl-Hillen JM, Ziegenfuss JY, Elliott TE. The impact of personalized clinical decision support on primary care patients' views of cancer prevention and screening: a cross-sectional survey. BMC Health Serv Res. 2021 Jun 21;21(1):592. doi: 10.1186/s12913-021-06551-9.
PubMed 34154588
Harry ML, Saman DM, Truitt AR, Allen CI, Walton KM, O'Connor PJ, Ekstrom HL, Sperl-Hillen JM, Bianco JA, Elliott TE. Pre-implementation adaptation of primary care cancer prevention clinical decision support in a predominantly rural healthcare system. BMC Med Inform Decis Mak. 2020 Jun 23;20(1):117. doi: 10.1186/s12911-020-01136-8.
PubMed 32576202
Saman DM, Walton KM, Harry ML, Asche SE, Truitt AR, Henzler-Buckingham HA, Allen CI, Ekstrom HL, O'Connor PJ, Sperl-Hillen JM, Ziegenfuss JY, Bianco JA, Elliott TE. Understanding primary care providers' perceptions of cancer prevention and screening in a predominantly rural healthcare system in the upper Midwest. BMC Health Serv Res. 2019 Dec 30;19(1):1019. doi: 10.1186/s12913-019-4872-9.
PubMed 31888630
Harry ML, Truitt AR, Saman DM, Henzler-Buckingham HA, Allen CI, Walton KM, Ekstrom HL, O'Connor PJ, Sperl-Hillen JM, Bianco JA, Elliott TE. Barriers and facilitators to implementing cancer prevention clinical decision support in primary care: a qualitative study. BMC Health Serv Res. 2019 Jul 31;19(1):534. doi: 10.1186/s12913-019-4326-4.
PubMed 31366355
Harry ML, Asche SE, Freitag LA, Sperl-Hillen JM, Saman DM, Ekstrom HL, Chrenka EA, Truitt AR, Allen CI, O'Connor PJ, Dehmer SP, Bianco JA, Elliott TE. Human Papillomavirus vaccination clinical decision support for young adults in an upper midwestern healthcare system: a clinic cluster-randomized control trial. Hum Vaccin Immunother. 2022 Dec 31;18(1):2040933. doi: 10.1080/21645515.2022.2040933. Epub 2022 Mar 18.
PubMed 35302909
Elliott TE, Asche SE, O'Connor PJ, Dehmer SP, Ekstrom HL, Truitt AR, Chrenka EA, Harry ML, Saman DM, Allen CI, Bianco JA, Freitag LA, Sperl-Hillen JM. Clinical Decision Support with or without Shared Decision Making to Improve Preventive Cancer Care: A Cluster-Randomized Trial. Med Decis Making. 2022 Aug;42(6):808-821. doi: 10.1177/0272989X221082083. Epub 2022 Feb 25.
PubMed 35209775

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing Cancer Prevention Using Patient-Provider Clinical Decision Support
ClinicalTrials.gov ID: NCT02986230
Acronym / sponsor ID: CP-CDS / 15-010
Conditions: Cancer Prevention
Keywords: Cancer prevention, Clinical Decision Support, Rural Health, Shared Decision Making
Study type: Interventional
Recruitment status: Completed
Enrolment: 35,953 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Study start: 1 Aug 2018 (actual)
Primary completion: 15 Mar 2020 (actual)
Study completion: 28 Feb 2021 (actual)
First posted: 8 Dec 2016 (estimated)
Results: Posted 11 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
CP-CDS	Experimental	Other: CP-CDSThe CP-CDS group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services.
CP-CDS + SDMT	Experimental	Other: CP-CDSThe CP-CDS + SDMT group will receive a point of care clinical decision support tool called cancer prevention wizard (CP Wizard) that is integrated into the EHR. The CP Wizard provides evidenced- based recommendations to the provider and patient related to overdue cancer prevention screening services. The CP-CDS + SDMT arm also provides shared decision making tools to patient and provider at the time of the visit.
Usual Care	No intervention	–The usual care group will have no access to the CP-CDS, or the CP-CDS + SDMT.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

meet above age criteria
pcp practice at randomized clinic

Key exclusion criteria (4 listed)

current or past cancer diagnosis (excludes nonmelanoma skin cancer)
hospice care or cancer chemotherapy
Alzheimer's disease codes
major cardiovascular event in 12 months prior to index date

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
CP-CDSAlso: Cancer Prevention WizardThe cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.	Other	CP-CDS, CP-CDS + SDMT

Primary outcome

Composite Cancer Screening Tests up to Date
Time frame: 1 year post index date
Participants up to date on composite endpoint of breast, cervical, and colorectal cancer screening at 1 year post index date.
HPV Vaccination up to Date
Time frame: 1 year post index date
Participants up to date on HPV vaccination at 1 year post index date.

1 secondary outcome

Lung Cancer Screening up to Date
Time frame: 1 year post index date

Results and safety

Results posted to the registry on 11 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CP-CDS	11,402	10,122
CP-CDS + SDMT	10,138	9,034
Usual Care	14,413	12,960

Primary outcome: Composite Cancer Screening Tests up to Date

Time frame: 1 year post index date. Count of participants. Unit: Participants

Measure	CP-CDS n = 7987	CP-CDS + SDMT n = 7105	Usual Care n = 10106
Value	3087	2590	3866

CP-CDS vs Usual Care: Odds Ratio (OR): 1.07, p = .025, Mixed Models Analysis
CP-CDS + SDMT vs Usual Care: Odds Ratio (OR): 0.91, p = .025, Mixed Models Analysis

Population analysed: Analysis population included adult patients ages 21-75 who had a visit at a study clinic over the accrual period, and who were due for one or more breast, cervical, or colorectal cancer screening test.

Primary outcome: HPV Vaccination up to Date

Time frame: 1 year post index date. Count of participants. Unit: Participants

Measure	CP-CDS n = 1511	CP-CDS + SDMT n = 1470	Usual Care n = 2073
Value	90	69	126

CP-CDS vs Usual Care: Odds Ratio (OR): 1.04, p = .025, Mixed Models Analysis
CP-CDS + SDMT vs Usual Care: Odds Ratio (OR): 0.71, p = .025, Mixed Models Analysis

Population analysed: Young adults ages 18-26 with a visit at a study clinic during the accrual period, and not up to date on HPV vaccination.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Actual compared to expected accrual was reported at 6 months, 12 months, and 15 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CP-CDS	0 of 10,122 (0%)	0 of 10,122 (0%)	22 of 10,122
CP-CDS + SDMT	0 of 9,034 (0%)	0 of 9,034 (0%)	15 of 9,034
Usual Care	0 of 12,960 (0%)	0 of 12,960 (0%)	26 of 12,960

Limitations and caveats (from the sponsor): The study was conducted at one relatively high-performing predominantly rural healthcare system, and generalizability of results to other care systems or patient populations is uncertain. The intervention was delivered during clinic encounters with primary care providers; the impact of the clinical decision support delivered in other clinical venues or directly to patients using mobile health technologies may be greater or less than what we observed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33503497Elliott TE, O'Connor PJ, Asche SE, Saman DM, Dehmer SP, Ekstrom HL, Allen CI, Bianco JA, Chrenka EA, Freitag LA, Harry ML, Truitt AR, Sperl-Hillen JM. Design and rationale of an intervention to improve cancer prevention using clinical decision support and shared decision making: A clinic-randomized trial. Contemp Clin Trials. 2021 Mar;102:106271. doi: 10.1016/j.cct.2021.106271. Epub 2021 Jan 24.
Background: PubMed 34991570Harry ML, Chrenka EA, Freitag LA, Saman DM, Allen CI, Asche SE, Truitt AR, Ekstrom HL, O'Connor PJ, Sperl-Hillen JAM, Ziegenfuss JY, Elliott TE. Primary care clinicians' opinions before and after implementation of cancer screening and prevention clinical decision support in a clinic cluster-randomized control trial: a survey research study. BMC Health Serv Res. 2022 Jan 6;22(1):38. doi: 10.1186/s12913-021-07421-0.
Background: PubMed 34722797Saman DM, Harry ML, Freitag LA, Allen CI, O'Connor PJ, Sperl-Hillen JM, Bianco JA, Truitt AR, Ekstrom HL, Elliott TE. Patient Perceptions of Using Clinical Decision Support for Cancer Screening and Prevention: "I wouldn't have thought about getting screened without it.". J Patient Cent Res Rev. 2021 Oct 18;8(4):297-306. doi: 10.17294/2330-0698.1863. eCollection 2021 Fall.
Background: PubMed 34154588Saman DM, Chrenka EA, Harry ML, Allen CI, Freitag LA, Asche SE, Truitt AR, Ekstrom HL, O'Connor PJ, Sperl-Hillen JM, Ziegenfuss JY, Elliott TE. The impact of personalized clinical decision support on primary care patients' views of cancer prevention and screening: a cross-sectional survey. BMC Health Serv Res. 2021 Jun 21;21(1):592. doi: 10.1186/s12913-021-06551-9.
Background: PubMed 32576202Harry ML, Saman DM, Truitt AR, Allen CI, Walton KM, O'Connor PJ, Ekstrom HL, Sperl-Hillen JM, Bianco JA, Elliott TE. Pre-implementation adaptation of primary care cancer prevention clinical decision support in a predominantly rural healthcare system. BMC Med Inform Decis Mak. 2020 Jun 23;20(1):117. doi: 10.1186/s12911-020-01136-8.
Background: PubMed 31888630Saman DM, Walton KM, Harry ML, Asche SE, Truitt AR, Henzler-Buckingham HA, Allen CI, Ekstrom HL, O'Connor PJ, Sperl-Hillen JM, Ziegenfuss JY, Bianco JA, Elliott TE. Understanding primary care providers' perceptions of cancer prevention and screening in a predominantly rural healthcare system in the upper Midwest. BMC Health Serv Res. 2019 Dec 30;19(1):1019. doi: 10.1186/s12913-019-4872-9.
Background: PubMed 31366355Harry ML, Truitt AR, Saman DM, Henzler-Buckingham HA, Allen CI, Walton KM, Ekstrom HL, O'Connor PJ, Sperl-Hillen JM, Bianco JA, Elliott TE. Barriers and facilitators to implementing cancer prevention clinical decision support in primary care: a qualitative study. BMC Health Serv Res. 2019 Jul 31;19(1):534. doi: 10.1186/s12913-019-4326-4.
Background: PubMed 35302909Harry ML, Asche SE, Freitag LA, Sperl-Hillen JM, Saman DM, Ekstrom HL, Chrenka EA, Truitt AR, Allen CI, O'Connor PJ, Dehmer SP, Bianco JA, Elliott TE. Human Papillomavirus vaccination clinical decision support for young adults in an upper midwestern healthcare system: a clinic cluster-randomized control trial. Hum Vaccin Immunother. 2022 Dec 31;18(1):2040933. doi: 10.1080/21645515.2022.2040933. Epub 2022 Mar 18.
Background: PubMed 35209775Elliott TE, Asche SE, O'Connor PJ, Dehmer SP, Ekstrom HL, Truitt AR, Chrenka EA, Harry ML, Saman DM, Allen CI, Bianco JA, Freitag LA, Sperl-Hillen JM. Clinical Decision Support with or without Shared Decision Making to Improve Preventive Cancer Care: A Cluster-Randomized Trial. Med Decis Making. 2022 Aug;42(6):808-821. doi: 10.1177/0272989X221082083. Epub 2022 Feb 25.
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.

Thomas E Elliott, MD principal investigator

HealthPartners Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CP-CDS in people with Cancer Prevention, run by HealthPartners Institute 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 2 inclusion and 4 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 24 Jan 2024. 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?

Yes. Results are posted in the registry (first posted 11 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Composite Cancer Screening Tests up to Date (time frame: 1 year post index date). 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?

On the ClinicalTrials.gov record for NCT02986230, which also lists 9 linked publications.

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 24 Jan 2024.