Positive Results on Fecal Blood Tests

Transcription

1 Interventions to Improve Follow-up of Positive Results on Fecal Blood Tests Results of a systematic review and Kaiser experience Kevin Selby, M.D. kevin.j.selby@kp.org National Colorectal Cancer Roundtable 2017 Kaiser Permanente Research

2 No conflicts of interest to disclose Funding: - National Cancer Institute PROSPR (Population-based Research Optimizing Screening through Personalized Regimens) consortium (U54 CA [Corley]) - Swiss Cancer Research Foundation (BIL KFS [Selby])

3 Low rates of follow-up colonoscopy after positive fecal blood tests are a problem Fecal immunochemical tests are ideal for mass screening Real-world efficacy depends on colonoscopy follow-up of positive tests As low as 50% after 6 months Challenging: follow-up involves interaction of multiple levels of care Patients are often reluctant Dis Colon Rectum. 2006;49: J Natl Cancer Inst Monogr. 2010;2010(40):58-71 Cancer Epidemiol Biomarkers Prev. 2016; 25:344-50

4 Colonoscopy delays after a positive fecal test are important Analysis of 70,000+ FIT-positive patients shows an increased risk of CRC, and specifically advancedstage CRC, when time to colonoscopy is greater than 6 months Corley et al. JAMA. 2017;317(16):

5 Systematic review objective: Evaluate interventions to improve rates of follow-up colonoscopy for adults after a positive result on fecal immunochemical tests (FIT) or guaiac fecal occult blood tests (gfobt)

6 Methods Data Sources: English-language studies Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and Embase through June 2017 Study Selection: Randomized and nonrandomized studies Interventions to improve colonoscopy (or DCBE in older studies) follow-up of positive fecal test results in the screening setting Focus on absolute change in colonoscopy completion at 6 months, if available Data Extraction: Two reviewers extracted data and ranked study quality, and then rated overall strength of evidence for each study category Protocol available: PROSPERO: CRD

7 Results 23 studies eligible for analysis 7 randomized and 16 nonrandomized studies Only 3 at low risk of bias Interventions at 3 levels: Patient-level (11 studies) Provider level (5 studies) System level (7 studies) Number of patients ranged from 14 to of FIT follow-up, 18 of gfobt follow-up No meta analysis performed given significant heterogeneity in outcomes reported

8 1. Patient-level Interventions Changes to invitation strategy to screening 2 studies, 1 randomized trial at low-risk of bias Showed that interventions to increase screening rates don t worsen, and may improve follow-up of positive tests Provision to patients of test results or follow-up appointments 4 studies, 1 randomized trial at moderate risk of bias Mailing or calling all patients to provide tests results or directly providing appointments to discuss follow-up colonoscopy RCT: among initial non-responders, a specialized nurse increased follow-up (+12% (CI 0.5 to 24)), while a telephone reminder from a generalist physician showed trend towards decreased follow-up (-7% (CI -19 to 4.3)

9 1. Patient-level Interventions - continued Patient navigation 5 studies, 2 randomized trials at low-risk of bias RCT 1: Addition of registered nurse patient navigators increased follow-up from 80.8% to 91.0% at 6 months (+ 10.1% (CI -1.5 to 22)). Trial was underpowered RCT 2: Addition of patient navigators for multiple cancers using strengthsbased approach increased from 58% to 79% at 1 year (+ 21% (CI 9.5 to 33))

10 2. Provider-level Interventions Provision to providers of reminders and/or performance data 5 studies, 2 cluster randomized All used electronic algorithms to clearly identify ordering providers / assigned primary care physician Remind those with no / inadequate action after 60 or 90 days 4 from integrated systems in the US, generally multi-component interventions, showed positive results (+9 to +25%) 1 used centrally generated reports in a provincial screening program, showed no difference (HR 0.95, CI 0.79 to 1.13)

11 System-level Interventions Automated referral to gastroenterologist 2 studies, all positive fecal test results sent to gastroenterologists, instead of manual referral Both done within VA medical centers, integrated EHR allowed transfer of patient information Replacement of precolonoscopy visit with telephone call 1 study, patients given choice of phone call instead of face-to-face consultation Registry to track patients with positive results 1 study, registry of all positive tests without colonoscopy at 4 months, reviewed regularly by nurse manager, +23% improvement over several years (CI 21 to 26) Multicomponent quality improvement efforts 3 studies, all from VA, Pre-post or observational designs, only 6 to 10% improvement

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13 Discussion Patient navigators: adds to strong evidence in screening and follow-up of symptomatic patients One RCT calculated an additional $275 USD per patient Promising low cost interventions? Provider reminders in EHR and directly notifying endoscopists of all positive fecal test results Areas for research: Need greater standardization of results reporting and more RCTs Effect of increased endoscopy capacity; stratifying patient populations to target high-cost interventions; better engaging patients

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15 Limitations Heterogeneous outcome measurements prevented summary effect estimates using meta analysis Colonoscopy completion is an intermediate outcome Most U.S. studies (10 of 14) from within the VA Cannot rule out publication bias Inclusion of non-randomized studies is more complete, but higher risk of bias, may be misleading

16 Follow-up of positive FIT at Kaiser Permanente Northern California Mailed FIT outreach since 2006 Approximately 20,000 positive FIT per year Median time to colonoscopy in 2015 of 36 days (IQR 24 to 73), with 83% having had a colonoscopy by 6 months How is this being done? Cancer epidemiology, biomarkers & prevention. 2016;25(2):

17 Traditional flow FIT read as positive Primary care provider (PCP) notified Patient given result and appointment scheduled Sees GI for colonoscopy

18 Increasing responsibility assumed by GI to manage FIT positive patients Primary care provider (PCP) notified FIT read as positive e-consult GI receives FIT+ patient list and/or e- consult Patient given result and appointment scheduled Navigator call to explain colonoscopy logistics, risks and preparation Colonoscopy completed

19 Overall organization of FIT-positive follow-up within Kaiser Permanente Northern California Primary care provider (PCP) notified Minimum 3 attempts to contact patient Registered letter if no phone or contact FIT read as positive e-consult GI receives FIT+ patient list and/or e- consult Patient given result and appointment scheduled Navigator call to explain colonoscopy logistics, risks and preparation Colonoscopy completed

20 Primary care provider (PCP) notified Minimum 3 attempts to contact patient Registered letter if no phone or contact FIT read as positive e-consult GI receives FIT+ patient list and/or e- consult Patient given result and appointment scheduled Navigator call to explain colonoscopy logistics, risks and preparation Colonoscopy completed Adequate colonoscopy capacity (staff and endoscopy suites) Organizational supports in place to ensure success Registry kept of all FIT+ patients with real-time updates (PROMPT) GI Staff member designated responsible follow-up of FIT+ patients Frequent feedback of FIT+ follow-up performance and team goal-setting Financial rewards to service areas for attaining annual colonoscopy access targets

21 Take home points 1. Patient navigators appear to work, but can be expensive 2. Provider reminder systems and direct referral to endoscopists are promising, lower cost interventions for those with integrated EHRs 3. At KPNC, GI departments are increasingly taking primary responsibility for FIT-positive follow-up 4. High-performing KPNC service areas are proactive in patient outreach and have a clearly designated team-member responsible for FIT-positive follow-up

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28 Appendix B: Criteria used for determining risk of bias of individual studies, based on guidelines of the Agency for Healthcare Research and Quality (AHRQ) (36) and the Grading of Recommendations Assessments, Development and Evaluation (GRADE) working group (37) Study type Randomized controlled trial Criteria used Considered to be at low risk of bias. Upgraded to moderate risk if there was concern for the following problems in the study design or reporting. - Lack of allocation concealment - Lack of blinding that influences outcomes - Incomplete accounting of patients and outcome events - Selective outcome reporting bias - Recruitment bias in cluster-randomized trials Observational study or non-randomized interventional study (for example a pre-post or non-randomized parallel group study design) Considered to be at high risk of bias. Downgraded to moderate risk if the study design adequately accounted for and reported all of the following elements. Upgraded to very high risk if there were severe or multiple problems with these elements. - Development and application of appropriate eligibility criteria - Adequate measurement of both exposure and outcome - Adequate control for confounding, with both accurate measurement of all known prognostic factors and adjustment for these factors - Adequate follow-up of all participants