Clinical trial NCT04258813: Onco-primary Care Networking to Support TEAM-based Care
Official title: Onco-primary Care Networking to Support TEAM-based Care - the ONE TEAM Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blood Pressure
Hypertension
Cancer
Cancer, Breast
Cancer of Prostate
Cancer Colorectal
Cancer, Endometrial
Cancer of Head and Neck
Non Small Cell Lung Cancer
CVD - Cardiovascular Disease
Diabetes Mellitus
Hypercholesterolemia
Diabetes
Cancer of Esophagus
Cancer of Liver
Cancer, Renal Cell
Cancer of Pancreas
Cancer Ovaries
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Investigators will use a SMART design with 2 randomizations - at the time of enrollment and after the 12-month measurement. At enrollment, participants will be cluster randomized to the self-guided multi-level iGuide intervention or control arm. An adaptive intervention will be used for the second randomization. PCP clinics in the intervention arm in which 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 12-month measurement will be considered 'non-responders' and randomized to a tailored/targeted intervention (iGuide2) or a control (iGuide).
Primary purpose: PREVENTION

Brief summary: The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with \>1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be \~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers.

A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

Detailed description: This is an 18-month cluster randomized controlled trial using a SMART design with two randomizations (the second using an embedded dynamic treatment regimen), with a target enrollment of 800 patients with one of six solid tumors (stage I-III breast, prostate, colorectal, endometrial, and head/neck cancer; stage I-II non-small cell lung cancer) who are being treated with curative intent. To engage the PCP early in the process, the investigators will enroll patients at one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). The investigators estimate that 80 unique community-based PCP clinics across North Carolina will be involved in the study. The investigators will determine the effectiveness of the multi-level intervention compared with usual care on (1) Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of the three CVD comorbidities using laboratory testing (glycated hemoglobin \[A1c\], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36).

Key aspects of the intervention are to: reframe the message to patients, PCPs, oncologists, and the respective health care teams in these two settings to emphasize the importance of optimizing the management of comorbidities during and after cancer therapy; promote a change in the workflow in both PCP and oncology practices; enhance PCP-oncologist relationships, and utilize EHR technology. There are two phases of the intervention, both having patient- and PCP-level components. During the first phase of the intervention, occurring with the first randomization, the investigators will test the effectiveness of a self-guided, informational strategy (iGuide). For PCP clinics that do not achieve the HEDIS targets, a booster phase with tailored (patient-level) and targeted (PCP-level) strategies will be tested with a second randomization (iGuide2).

The intervention has been designed to leverage communication tools with in our electronic health record (EHR), Epic . For patients who agree to receive study communications through Epic's patient portal, MyChart, we created an automated messaging system using a dynamic, rules-based protocol which determines the proper language to send each subject based on their study arm and time since enrollment. We developed a similar rules-based automated messaging system for provider communications. This method sends letters to a provider's Epic inbox, called InBasket, for Duke providers and PCPs in the community who have limited access to the Duke EMR through a portal called MedLink. Epic will send letters to PCPs outside of Duke who do not have MedLink access by fax. These outside providers will also be given the opportunity to enroll in MedLink if they are interested.

All participants in the study will be given a survivorship care plan based on the American Society of Clinical Oncology (ASCO) template. Because the investigators will be recruiting participants at our cancer centers and community practices, there will be an inevitable contamination across cancer specialists. Thus, the investigators did not include an oncology-level intervention. However, cancer specialists are integral to the patient- and PCP-level interventions. At the end of the study, patients and PCPs will be mailed a newsletter with a summary of the study findings. Lastly, it is inevitable that some patients will change their PCP during the study. When notified of the change, the research team will send the new PCP the intervention materials.

Supplement:

A retrospective data analysis of Duke cancer registry data integrated with EHR data elements linked by the medical record number will done. The study cohort will consist of older adults ≥65 years who have ≥1 cardiovascular comorbidity (hypertension, type 2 diabetes, dyslipidemia) and underwent cancer surgery for solid tumors at DUHS from January 1st, 2017 to December 31st 2019. Cancers of interest are breast, prostate, colorectal, endometrial, gastric, esophageal, liver, pancreatic, renal cell, bladder, ovarian, head/neck, and non-small cell lung cancer. Cancer diagnoses will be grouped according to the International Classification of Diseases for Oncology, 3rd revision (ICD-O-3). Key variables to be abstracted include demographic, clinical (comorbidities \& pertinent history, medications, cancer treatment, labs), geriatric-specific (frailty, function, cognition, operative, post-operative, and PCP follow-up data.

The qualitative component will involve semi-structured interviews with PCPs of older adults with solid tumors who underwent cancer surgery within a 12-month period in the DUHS. Participating PCPs will complete an audio-recorded semi-structured interview that will last approximately 30 minutes. Qualitative interview: We will design a semi-structured interview guide assessing perspectives on (1) frequency, modes, and perceived quality of communication with surgical providers during transitions in care from surgery (2) perceived barriers to effective care coordination with surgical providers (3) how communication and care coordination can be improved. Open-ended prompts may include "Please describe your experience with care coordination with surgical providers of older adults undergoing cancer surgery?" "What challenges have you faced when communicating with surgical providers of your older adult patients?"; "What are your thoughts on ways to improve communication and care coordination after an older adult with solid tumor undergoes surgery?", "Please give examples of particularly good or poor care coordination with surgical providers?" The interview guide will be designed with assistance from the experienced research staff in the Duke Behavioral Health and Survey Research Core.

Power re-estimation:

Our original power calculations were completed using methods described in Eldridge et al (ref). At the time of project development, the number of practices (40 per arm) and number of patients per practice (10) were unknown, but we estimated the 10 when computing planned sample size for the study. Following enrollment patterns over time, it has been determined that the average number of patients per practice is much smaller, 1.81, presently. If we had this information at time of study planning, based on the design effect and our original effect size, we see that with smaller sample size than originally planned/proposed, we still retain high power, primarily due to the reduction in the design effect (DE). Using the revised calculations, we estimate a power of 0.85-0.9 for 250 projected randomized participants and a power of 0.9 for 275 projected randomized participants.

Eligibility criteria: Inclusion Criteria:

A total of 800 individuals who fall under the following criteria will be enrolled:

* Diagnosed with -

  * Stage I-III breast \[female\], colorectal, endometrial (carcinomas), head/neck \[H/N\] and non-small cell lung cancer \[NSCLC\]
  * Stage I-IV prostate cancer
  * Organ transplant recipients are not excluded as long as kidney function is within eligible range
  * Chronic Lymphocytic Leukemia or small lymphocytic lymphoma on first or second line treatment
* Treated with curative intent (not applicable for patients diagnosed with CLL/SLL)
* 18-79 years old
* Has at least one of three CVD comorbidities (hypertension, diabetes, or hypercholesterolemia) - based upon whether the patient is currently on a medication for the comorbidity at time of recruitment
* Had a visit with their PCP in the previous 12 months

Patients will be approached for study participation within 120 days of starting their cancer treatment at Duke (except for men with prostate cancer on androgen deprivation therapy \[ADT\] and those previously on active surveillance). Those coming off active surveillance to receive treatment will be approached within the next 120 days. Men with prostate cancer that are on ADT can be approached for consent at any time while on treatment.

Supplement:

A sample size of 2800-3000 patients will be pulled from the Duke Cancer Registry. The retrospective cohort will consist of older adults ≥65 years who have ≥1 CVD comorbidity (hypertension, type 2 diabetes, dyslipidemia) and underwent cancer surgery for solid tumors (breast, prostate, colorectal, endometrial, gastric, esophageal, liver, pancreatic, renal cell, bladder, ovarian, head/neck, and non-small cell lung cancer) at DUHS from January 1st, 2017 to December 31st 2019.

The qualitative component of the supplement (Appendix IV: Aim 3) will involve 12-20 PCPs who arepart of the Duke Primary Care Research Consortium. Eligible PCP participants will be English-speaking providers who have provided care to ≥1 older adult patient who has undergone cancer surgery within a 12-month period at DUHS.

Exclusion Criteria:

Individuals with a history of the following conditions will be ineligible:

* Myocardial infarction in the previous 24 months
* Stage III-IV heart failure (EF \<30%)
* Stage IV-V chronic kidney disease (eGFR \<30)
* Neuroendocrine tumors
* Uterine sarcomas
* Bilateral axillary dissections - due to the inability to collect an upper extremity BP

Patients who are coming to Duke for surgery only and not planning to return are ineligible. Patients who cannot read, are blind or do not understand/speak English will not be enrolled.

Participants who progress to metastatic disease during the course of the 18-month study period will be allowed to continue to participate unless they voluntarily withdraw from the study.

Additional health information may be assessed on a case by case basis by the PI to determine if the individual is an appropriate candidate for the intervention.

Primary outcomes:
measure: HEDIS quality measure of management hypertension
timeFrame: 18 months
measure: HEDIS quality measure of management of diabetes
timeFrame: 18 months
measure: HEDIS quality measure of management of statin use
timeFrame: 18 months
measure: Patient-Centered Communication in Cancer Care
timeFrame: 18 months
measure: Medication adherence
timeFrame: 18 months
measure: Diversity supplement primary outcome: 90-day postoperative cardiovascular complications
timeFrame: 90 days
Secondary outcomes:
measure: Medication adherence defined through patient self-report
timeFrame: 18 months
measure: Clinical laboratory values
timeFrame: 18 months
measure: Clinical laboratory values
timeFrame: 18 months
measure: Patient activation
timeFrame: 18 months
measure: Financial burden
timeFrame: 18 months
measure: Patient-reported care coordination
timeFrame: 18 months
measure: Provider-reported care coordination
timeFrame: 18 months
Other outcomes:
measure: Risk index for cardiovascular complications
timeFrame: 90 days
measure: PCP-reported care coordination
timeFrame: 12 months
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
citation: Zullig LL, Shahsahebi M, Neely B, Hyslop T, Avecilla RAV, Griffin BM, Clayton-Stiglbauer K, Coles T, Owen L, Reeve BB, Shah K, Shelby RA, Sutton L, Dinan MA, Zafar SY, Shah NP, Dent S, Oeffinger KC. Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial. BMC Fam Pract. 2021 Nov 18;22(1):234. doi: 10.1186/s12875-021-01569-8.