Implementation of a ColoRectal Cancer Screening Tool in US Primary Care Practices - Usual Quality Improvement (10 Clinics) vs Normalization Process Theory-Participatory Learning in Action (10 Clinics)

NCT06682650 | Recruiting

• 2 other identifiers: STUDY00150145R01CA289772
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief Summary

Although implementation intentions (I2)-based tools enhance colorectal cancer (CRC) screening uptake, prior studies have not tested their implementation into routine primary care delivery. In this study, investigators will conduct a cluster-randomized trial in 20 US primary care clinics. Specific aims for the project will be: 1) to test whether a Normalization Process Theory-informed Participatory Learning in Action (NPT-PLA intervention) implementation of a proven implementation Intentions-based colorectal cancer screening tool ("I2") improves screening uptake (i.e. screening order and completion) within 6 months of patient enrollment versus usual quality improvement (control) implementation; and 2) to evaluate the facilitators and barriers of each implementation arm using the 2022 expanded Normalization Process Theory (NPT) framework. Multi-disciplinary clinic 'implementation teams' that include clinic staff and patients whose preferred language is Spanish will meet monthly during the first 6 months of clinic participation and aim to integrate into routine primary care the "I2" CRC screening tool, using the NPT-PLA intervention or control approach. The I2 tool addresses the "when," "where" and "how" details of stool sample or colonoscopy screening. The I2 tool will be delivered via an on-line survey or (if patients prefer) by paper form customized for use in English or Spanish. At least 100 patients in each clinic will be enrolled in the first 6 months of clinic participation (2000 in total). All patients eligible for CRC screening will be offered the I2 tool. Their choices will be communicated automatically to clinics for order entry. Primary (Aim 1) outcomes will be CRC screening orders placed (by clinic staff); completion of the I2 tool and CRC screening completion (by patients) over 6 months of patient follow-up. For Aim 2, surveys based on the NPT domains (the "NOMAD") will be used to assess staff comprehension of their role in implementing the I2-based CRC screening tool, its salience, their buy-in, feasibility of altering workflows, and the potential impact of using the tool in their setting. Investigators will conduct summative qualitative focus group discussions in all participating clinics after 6 months of clinic participation. The study will provide important information on barriers and facilitators of embedding NPT-PLA interventions in "real-world" primary care clinical settings.

Conditions

Colorectal Carcinoma

Keywords

colorectal carcinoma; implementation science; cancer prevention; cancer screening; normalization process theory; participatory health research; cluster randomized trial

Outcome Measures

Primary Outcomes (3)

• Aim 1: Completion of CRC screening orders

  Extracted from patient participant electronic medical records by DARTNet staff, this will be an indicator variable (0= not completed, 1= completed) indicating if the event occurred within 6 months of the date that the patient was first presented the I2 tool

  continuously monitored for 6 months after the patient is invited to complete the I2 tool during each clinic's participation month (0-12)

• Aim 1: Completion of recommended CRC screening

  Extracted from patient participant electronic medical records by DARTNet staff, this will be an indicator variable (0= not completed, 1= completed) indicating if the event occurred within 6 months of the date that the patient was first presented the I2 tool

  Continuously monitored for 6 months after the patient is invited to complete the I2 tool during each clinic's participation month (0-12)

• Aim 2: Summative focus group discussion qualitative data

  We have chosen focus group discussions to collect qualitative data in which I-team members will synergistically identify and clarify their views about implementation intervention, as would not take place in individual interviews. The purpose of the focus group discussions is to (1) review the TIDieR survey responses to clear up any questions about treatment fidelity (2), review the workflow maps they made in the initial session and discuss how workflow has changed; and (3) explore levers and barriers to work flow changes to implement I2. These focus group discussions will focus on levers and barriers to implementing I2 using the approach that each clinic has used (NPT-PLA or usual QI) using the 2022 NPT framework that accounts for context. We will audiorecord and transcribe and deidentify focus group interview data for qualitative thematic analysis.

  Month 7 after inception in each clinic

Secondary Outcomes (3)

• Aim 1: Completion of the I2 shared-decision making tool

  Continuously monitored for 6 months after the patient is invited to complete the I2 tool during each clinic's participation month (0-12).

• Aim 2: NOMAD Survey

  Month 0 and 6 after inception in each clinic

• Aim 2: Qualitative meeting notes

  0-6 months after inception in each clinic

Study Arms (2)

Usual QI

ACTIVE COMPARATOR

I-teams in each Usual QI clinic will be provided a pre-set protocol to implement the I2 tool into routine clinic CRC screening workflow (which they will define via a provided checklist). The protocol instructs the clinic to provide access to I2 zero to two weeks before a clinic visit, review the patient's I2 screening intentions with the patient in the clinic visit, at which time staff will order and schedule CRC screening in the visit. I2 may be completed on-line or via a paper form. I-teams will meet monthly to make progress on their implementation of I2, and complete a report/meet a study staff member monthly (separately) to report on their meetings and progress but will not receive coaching or skill training.

Behavioral: Usual Quality Improvement

NPT-PLA

EXPERIMENTAL

Clinics randomized to NPT-PLA will also define their CRC screening workflow via a checklist and preset I2 implementation protocol but will be trained initially then receive monthly support to facilitate a "Participatory Learning in Action" (PLA) session. NPT-PLA i-teams will identify barriers and supports to I2 implementation, and use Normalization Process Theory (NPT) constructs to guide identification, selection and ordering of action steps to progress implementation e.g. "(before taking the step) does everyone understand the step to be taken, does everyone who needs to act 'buy in', (during implementation of the step) is everyone who needs to act actually taking action to complete the step, (after the step is taken) did taking the step have the intended impact, if not what happened?" . NPT-PLA I-teams can adapt the I2 implementation protocol to fit their context, including when and how patients are presented with I2, to maximize I2 implementation and CRC screening completion.

Behavioral: NPT-PLA

Interventions

NPT-PLA BEHAVIORAL

NPT-PLA was developed and initially tested in 5 European countries in the EU-funded RESTORE study. PLA "Participatory Learning in Action" is a set of participatory research techniques in which participants use democratic processes to identify key actions needed to achieve a specific goal e.g. implementation of a tested decision making tool such as I2; and prioritize which of these need to be acted upon first and subsequently (in which order). Normalization Process Theory (NPT) is combined with PLA to help implementation teams using PLA to assess organization capacity and readiness to enact the selected action steps vis-a-vis NPT constructs, iteratively. These are coherence "does everyone understand what needs to be done?"; Cognitive participation "Does everyone who needs to act 'buy in' to take action"; collective action "Is everyone who needs to act taking steps to make the change?'; and reflexive monitoring "After the step has been taken, has it had the desired impact on the goal?"

NPT-PLA

Usual Quality Improvement BEHAVIORAL

Usual quality improvement includes principles of continuous quality improvement, such as Plan-Do-Study-Act cycles, to implement a specific goal. In this study, 'usual QI' methods already in use in 'active comparator' arm will be documented during the baseline assessment of clinical workflows in clinics assigned to that arm; and will be provided with a 'preset protocol' to implement the study shared decision-making tool (I2). Processes that implementation teams in these clinics use to achieve implementation will be documented.

Usual QI

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinics participating in the DARTNet Institute /AAFP-affiliated NRN clinic serving communities in which at least 25% of the population prefers Spanish-language.
• Clinic implementation teams Patients participating in implementation teams for whom Spanish is their preferred language, who are bilingual in English and Spanish, Clinics Staff will be included who have any contact regarding CRC screening with patients eligible for screening.
• Patients whose CRC screening outcomes will be monitored:
• adults 45 to 75 years of age who are due for CRC screening, i.e. who have not received a high-sensitivity fecal occult blood test or a fecal immunochemical test within the past year, fecal DNA testing within 3 years, sigmoidoscopy or barium enema within 5 years, or colonoscopy within 10 years; and who receive primary care at least annually from the site.

You may not qualify if:

• patients ineligible for routine screening based on a personal or close family history of colorectal cancer or who have increased genetic risk of colon cancer.
• cognitive or decisional incapacity will be excluded from the implementation teams, after completion of a brief, validate screening tool, the Mini-Cog Exam.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• DARTNet Institute: collaborator
• University of Kansas Medical Center: lead

Study Sites (1)

DARTNet Institute

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Joseph W LeMaster, MD MPH

  University of Kansas

  PRINCIPAL INVESTIGATOR

• Christina Hester, PhD

  DARTNet Institute

  PRINCIPAL INVESTIGATOR

• Keith A Greiner, MD MPH

  University of Kansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph W LeMaster, MD MPH

CONTACT

573-999-3366; jlemaster@kumc.edu

Traci Buechner

CONTACT

715-661-2422; tbuechner@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective parallel cluster randomized trial, in which clinics are units of randomization (10 in active intervention, 10 in active comparator), and nested within clinics individual patient enrollees (whose CRC screening outcomes are Aim 1 outcomes of the study), and implementation team participants (whose survey and qualitative interview data are Aim 2 outcomes of the study).

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: April 30, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: July 1 , 2025, updates posted every 6 months, once complete no end date
• Access Criteria: ICPSR is publicly available. Data cleared by ICPSR for public access have minimal reidentification and harm risk, and therefore, and no restrictions on access. Public data users must protect human subjects' confidentiality by agreeing to ICPSR's Terms of Use. When necessary, ICPSR will work with the research team to protect respondent confidentiality by removing, masking, or collapsing variables in the deposited data to produce a public version of the dataset; however, all PHI will be removed from both quantitative and qualitative data prior to IPD sharing in the data repository.

Locations

US (1)