NCT02986230

Brief Summary

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35,953

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

January 11, 2024

Completed
Last Updated

January 24, 2024

Status Verified

February 1, 2022

Enrollment Period

1.6 years

First QC Date

December 6, 2016

Results QC Date

February 9, 2022

Last Update Submit

January 22, 2024

Conditions

Cancer Prevention

Keywords

Cancer preventionClinical Decision SupportRural HealthShared Decision Making

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 year post index date

  • HPV Vaccination up to Date

    Participants up to date on HPV vaccination at 1 year post index date.

    1 year post index date

Secondary Outcomes (1)

  • Lung Cancer Screening up to Date

    1 year post index date

Study Arms (3)

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.

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.

Other: CP-CDS

Usual Care

NO INTERVENTION

The usual care group will have no access to the CP-CDS, or the CP-CDS + SDMT.

Interventions

CP-CDSOTHER

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.

Also known as: Cancer Prevention Wizard
CP-CDSCP-CDS + SDMT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meet above age criteria
  • pcp practice at randomized clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essentia Health

Duluth, Minnesota, 55805, United States

Location

Related Publications (9)

  • 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.

    PMID: 33503497BACKGROUND

  • 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.

    PMID: 34991570BACKGROUND

  • 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.

    PMID: 34722797BACKGROUND

  • 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.

    PMID: 34154588BACKGROUND

  • 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.

    PMID: 32576202BACKGROUND

  • 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.

    PMID: 31888630BACKGROUND

  • 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.

    PMID: 31366355BACKGROUND

  • 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.

    PMID: 35302909BACKGROUND

  • 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.

    PMID: 35209775BACKGROUND

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Tom Elliott
Organization
HealthPartners Institute
elliottt793@gmail.com
218-525-7268

Study Officials

  • Thomas E Elliott, MD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 8, 2016

Study Start

August 1, 2018

Primary Completion

March 15, 2020

Study Completion

February 28, 2021

Last Updated

January 24, 2024

Results First Posted

January 11, 2024

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)