Using specialist screening practitioners (SSPs) to increase uptake of bowel scope (flexible sigmoidoscopy) screening: results of a feasibility single-stage phase II randomised trial

ObjectiveTo determine the feasibility of specialist screening practitioners (SSPs) offering patient navigation (PN) to facilitate uptake of bowel scope screening (BSS) among patients who do not confirm or attend their appointment.DesignA single-stage phase II trial.SettingSouth Tyneside District Hospital, Tyne and Wear, England, UK.ParticipantsIndividuals invited for BSS at South Tyneside District Hospital during the 6-month recruitment period were invited to participate in the study.InterventionConsenting individuals were randomly assigned to either the PN intervention or usual care group in a 4:1 ratio. The intervention involved BSS non-attenders receiving a phone call from an SSP to elicit their reasons for non-attendance and offer educational, practical and emotional support as required. If requested by the patient, another BSS appointment was then scheduled.Primary outcome measureThe number of non-attenders in the intervention group who were navigated and then rebooked and attended their new BSS appointment.Secondary outcome measuresBarriers to BSS attendance, patient-reported outcomes including informed choice and satisfaction with BSS and the PN intervention, reasons for study non-participation, SSPs’ evaluation of the PN process and a cost analysis.ResultsOf those invited to take part (n=1050), 152 (14.5%) were randomised into the study: PN intervention=109; usual care=43. Most participants attended their BSS appointment (PN: 79.8%; control: 79.1%) leaving 22 eligible for PN: only two were successfully contacted. SSPs were confident in delivering PN, but were concerned that low BSS awareness and information overload may have deterred patients from taking part in the study. Difficulty contacting patients was reported as a burden to their workload.ConclusionsPN, as implemented, was not a feasible intervention to increase BSS uptake in South Tyneside. Interventions to increase BSS awareness may be better suited to this population.Trial registration numberISRCTN13314752; Results.

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Abstract 225: A Depression Quality Program and Cardiovascular Disease: Assessing the Impact on Care

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.10.suppl_3.225 ◽

2017 ◽

Vol 10 (suppl_3) ◽

Author(s):

Linda Gordon ◽

Amanda Malecky ◽

Andrew Althouse ◽

Nicole Ansani

Keyword(s):

Usual Care ◽

Goal Attainment ◽

Intervention Group ◽

Phone Call ◽

Categorical Variables ◽

Care Group ◽

Control Group ◽

Surrogate Outcome ◽

The Impact

Background: Data demonstrate an adverse association between depression and coronary artery disease prognosis. Therefore, a depression screening program was initiated in the catheterization (cath) lab. The goals were to improve HEDIS depression compliance rates and determine the impact on clinical outcomes. Methods: Adult patients in an inpatient cath lab from 3 cardiology practices were screened for enrollment in a randomized controlled trial. All cath lab patients received a PHQ-9 depression screener. Those who screened positive for depression (score ≥ 10) were randomized to intervention or usual care. The usual care group received a follow-up phone call to re-administer the PHQ-9 at 6-8 weeks and within 210 days of discharge. The intervention group was administered the PHQ-9 and received intensive education at baseline, 6-8 weeks, and within 210 days of discharge. Education included targeted depression information with a mental health care provider and comprehensive disease management education with a cardiovascular nurse practitioner. Outcomes included: differences in HEDIS depression goal attainment; depression response/remission rates; and cardiovascular goals. Differences between groups were tested using chi-squared tests (categorical variables) and t-tests (continuous variables). Results: Baseline characteristics were similar between control (N=43) and intervention (N=40) groups, with the exception of significantly fewer African American patients in the control group (N=2, 4.7%) vs intervention (N=9, 22.5%). Changes in HEDIS goal attainment show that patients in the intervention group were slightly more likely to be referred to a provider to address depression (95.0% vs 86.0%, p=0.314), or receive meds for depression (65.0% vs 51.2%, p=0.219), but these differences are not statistically significant. More patients in the intervention group refused meds for depression compared to control (15.0% vs. 2.3%, p=0.041); have received blood work (65.0% vs 41.9%, p=0.030); and have received follow-up within 210 days (82.5% vs 46.5%, p<0.001). Treatment adjustment rate was higher in the intervention group compared to control (85.0% vs. 65.1%, p=0.037). Hospital readmission rate was similar between groups (p=0.896) and there was no difference in depression remission or response rates (p=0.426). Further, no differences were seen in cardiovascular surrogate outcome parameters, including cholesterol, A1c, CRP, or BNP between groups; except SGOT was significantly different between groups (-5.0 intervention vs 2.0 control p=0.045). Conclusions: These data demonstrate improvements in attaining a surrogate outcome measure of quality (HEDIS goals); however, this does not appear to translate to a significant clinical impact. Quality measures may need to be continuously reassessed to ensure efficiency and effectiveness of care.

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Randomised trial to evaluate the effectiveness and impact of offering postvisit decision support and assistance in obtaining physician-recommended colorectal cancer screening: the e-assist: Colon Health study—a protocol study

BMJ Open ◽

10.1136/bmjopen-2018-023986 ◽

2019 ◽

Vol 9 (1) ◽

pp. e023986 ◽

Cited By ~ 2

Author(s):

Jennifer Elston Lafata ◽

Yongyun Shin ◽

Susan A Flocke ◽

Sarah T Hawley ◽

Resa M Jones ◽

...

Keyword(s):

Colorectal Cancer ◽

Decision Support ◽

Usual Care ◽

Randomised Trial ◽

Health Study ◽

Care Group ◽

Average Risk ◽

Patient Portal ◽

Crc Screening ◽

Patient Reported

IntroductionHow to provide practice-integrated decision support to patients remains a challenge. We are testing the effectiveness of a practice-integrated programme targeting patients with a physician recommendation for colorectal cancer (CRC) screening.Methods and analysisIn partnership with healthcare teams, we developed ‘e-assist: Colon Health’, a patient-targeted, postvisit CRC screening decision support programme. The programme is housed within an electronic health record (EHR)-embedded patient portal. It leverages a physician screening recommendation as the cue to action and uses the portal to enrol and intervene with patients. Programme content complements patient–physician discussions by encouraging screening, addressing common questions and assisting with barrier removal. For evaluation, we are using a randomised trial in which patients are randomised to receive e-assist: Colon Health or one of two controls (usual care plus or usual care). Trial participants are average-risk, aged 50–75 years, due for CRC screening and received a physician order for stool testing or colonoscopy. Effectiveness will be evaluated by comparing screening use, as documented in the EHR, between trial enrollees in the e-assist: Colon Health and usual care plus (CRC screening information receipt) groups. Secondary outcomes include patient-perceived benefits of, barriers to and support for CRC screening and patient-reported CRC screening intent. The usual care group will be used to estimate screening use without intervention and programme impact at the population level. Differences in outcomes by study arm will be estimated with hierarchical logit models where patients are nested within physicians.Ethics and disseminationAll trial aspects have been approved by the Institutional Review Board of the health system in which the trial is being conducted. We will disseminate findings in diverse scientific venues and will target clinical and quality improvement audiences via other venues. The intervention could serve as a model for filling the gap between physician recommendations and patient action.Trial registration numberNCT02798224; Pre-results.

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Improving Follow-Up Adherence in a Primary Eye Care Setting

American Journal of Medical Quality ◽

10.1177/1062860615616860 ◽

2016 ◽

Vol 32 (1) ◽

pp. 73-79 ◽

Cited By ~ 5

Author(s):

Catherine E. Callinan ◽

Brianna Kenney ◽

Lisa A. Hark ◽

Ann P. Murchison ◽

Yang Dai ◽

...

Keyword(s):

Usual Care ◽

Patient Adherence ◽

Intervention Group ◽

Appointment Scheduling ◽

Secondary Outcome ◽

Controlled Study ◽

Care Group ◽

Eye Care ◽

Primary Eye Care

Lack of patient adherence with eye appointments can decrease ocular outcomes. This prospective, randomized, single-blinded controlled study assessed the effectiveness of multiple interventions in improving follow-up adherence to recommended eye appointments. Patients due for follow-up appointments were randomly assigned to usual care, automated intervention, or personal intervention. Automated-intervention patients and personal-intervention patients received a call one month prior to the recommended follow-up date, and a mailed appointment reminder letter. The call was automated for automated-intervention patients and personalized for personal-intervention patients. The primary outcome was adherence to the follow-up appointment. The secondary outcome was rate of appointment scheduling. Patients in the personal-intervention group had greater adherence to follow-up recommendations (38%) than patients in the usual care group (28%) and the automated-intervention group (30%). Personal intervention significantly increased appointment scheduling (51%) over usual care (32%) and automated intervention (36%). These results support systems-level changes to improve patient follow-up adherence in urban primary eye care settings.

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Randomised controlled study of two counselling models at the Swedish alcohol helpline: Effectiveness and sustainability outcomes at 12-month follow-up

Nordic Studies on Alcohol and Drugs ◽

10.1177/14550725211007823 ◽

2021 ◽

pp. 145507252110078

Author(s):

Thi-Thuy-Dung Nguyen ◽

Eleonor Säfsten ◽

Filip Andersson ◽

Maria Rosaria Galanti

Keyword(s):

Alcohol Use ◽

Usual Care ◽

Secondary Outcome ◽

Controlled Study ◽

Risk Level ◽

Care Group ◽

Structured Intervention ◽

Randomised Controlled ◽

Level Reduction

Aim: This two-arm parallel randomised controlled trial explored the effectiveness of a brief counselling model compared with the usual multi-session counselling at an alcohol telephone helpline. Methods: A total of 320 callers who contacted the Swedish Alcohol Helpline (SAH) because of hazardous or harmful alcohol use were randomised to either brief structured intervention (self-help booklet plus one proactive call) or usual care (multi-session telephone counselling). The primary outcome was a downward shift in risk level at 12-month follow-up compared with baseline, based on self-reports. Sustained risk level reduction throughout the whole follow-up was also assessed as secondary outcome. Results: Both interventions were significantly associated with a shift to a lower level of risky alcohol use (75% among participants in the brief structured intervention, and 70% in the usual care group) after 12 months. There was no difference between the two interventions in the proportions changing alcohol use or sustaining risk level reduction. Conclusion: In the context of telephone helplines, minimal and extended interventions appear to be equally effective in promoting long-term change in alcohol use.

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Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

10.2196/preprints.36480 ◽

2022 ◽

Author(s):

Maryam Zahid ◽

Ume Sughra

Keyword(s):

Nutritional Status ◽

Usual Care ◽

Usual Care Group ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Care Group ◽

Randomized Controlled ◽

Nutritional Status Of Children ◽

Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

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Understanding usual care for patients with multimorbidity: baseline data from a cluster-randomised trial of the 3D intervention in primary care

BMJ Open ◽

10.1136/bmjopen-2017-019845 ◽

2018 ◽

Vol 8 (8) ◽

pp. e019845 ◽

Cited By ~ 7

Author(s):

Katherine Chaplin ◽

Peter Bower ◽

Mei-See Man ◽

Sara T Brookes ◽

Daisy Gaunt ◽

...

Keyword(s):

Primary Care ◽

Usual Care ◽

External Validity ◽

Randomised Trial ◽

Baseline Data ◽

Secondary Outcome ◽

Treatment Burden ◽

Practice Staff ◽

Illness Burden ◽

Cluster Randomised

ObjectivesRecent evidence has highlighted the high prevalence and impact of multimorbidity, but the evidence base for improving management is limited. We have tested a new complex intervention for multimorbidity (the 3D model). The paper describes the baseline characteristics of practices and patients in order to establish the external validity of trial participants. It also explores current ‘usual primary care’ for multimorbidity, against which the 3D intervention was tested.DesignAnalysis of baseline data from patients in a cluster-randomised controlled trial and additional data from practice staff.SettingPrimary care in the UK.ParticipantsPatients with multimorbidity (n=5253) and 154 practice staff.Primary and secondary outcome measuresUsing surveys and routinely available data, we compared the characteristics of participating and non-participating practices and participating and non-participating eligible patients.Baseline questionnaire data from patient participants was used to examine participant illness burden, treatment burden and perceptions of receiving patient-centred care. We obtained data about usual care preintervention from practice staff using questionnaires and a structured pro forma.ResultsParticipating practices were slightly larger, in less deprived areas, and with slightly higher scores for patient satisfaction compared with non-participating practices. Patients with dementia or learning difficulties were likely to be excluded by their general practitioners, but comparison of participants with non-participants identified only minor differences in characteristics, suggesting that the sample was otherwise representative. Patients reported substantial illness burden, and an important minority reported high treatment burden. Although patients reported relatively high levels of satisfaction with care, many reported not having received potentially important components of care.ConclusionThis trial achieved good levels of external validity. Although patients were generally satisfied with primary care services, there was significant room for improvement in important aspects of care for multimorbidity that are targeted by the 3D intervention.Trial registration numberISRCTN06180958; Post-results.

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A Proactive Telephone-Delivered Risk Communication Intervention for Smokers Participating in Lung Cancer Screening: A Pilot Feasibility Trial

The Journal of Smoking Cessation ◽

10.1017/jsc.2017.16 ◽

2017 ◽

Vol 13 (3) ◽

pp. 137-144 ◽

Cited By ~ 2

Author(s):

Steven B. Zeliadt ◽

Preston A. Greene ◽

Paul Krebs ◽

Deborah E. Klein ◽

Laura C. Feemster ◽

...

Keyword(s):

Lung Cancer ◽

Cancer Screening ◽

Usual Care ◽

Usual Care Group ◽

Intervention Group ◽

Lung Cancer Screening ◽

Feasibility Trial ◽

Care Group ◽

Telephone Counselling ◽

Tobacco Treatment

Introduction: Many barriers exist to integrating smoking cessation into delivery of lung cancer screening including limited provider time and patient misconceptions.Aims: To demonstrate that proactive outreach from a telephone counsellor outside of the patient's usual care team is feasible and acceptable to patients.Methods: Smokers undergoing lung cancer screening were approached for a telephone counselling study. Patients agreeing to participate in the intervention (n = 27) received two telephone counselling sessions. A 30-day follow-up evaluation was conducted, which also included screening participants receiving usual care (n = 56).Results/Findings: Most (89%) intervention participants reported being satisfied with the proactive calls, and 81% reported the sessions were helpful. Use of behavioural cessation support programs in the intervention group was four times higher (44%) compared to the usual care group (11%); Relative Risk (RR) = 4.1; 95% CI: 1.7 to 9.9), and seven-day abstinence in the intervention group was double (19%) compared to the usual care group (7%); RR = 2.6; 95% CI: 0.8 to 8.9).Conclusions: This practical telephone-based approach, which included risk messages clarifying continued risks of smoking in the context of screening results, suggests such messaging can boost utilisation of evidence-based tobacco treatment, self-efficacy, and potentially increase the likelihood of successful quitting.

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Patient-Centered Preference Assessment to Improve Satisfaction With Care Among Patients With Localized Prostate Cancer: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.18.01091 ◽

2019 ◽

Vol 37 (12) ◽

pp. 964-973 ◽

Cited By ~ 13

Author(s):

Ravishankar Jayadevappa ◽

Sumedha Chhatre ◽

Joseph J. Gallo ◽

Marsha Wittink ◽

Knashawn H. Morales ◽

...

Keyword(s):

Prostate Cancer ◽

Usual Care ◽

Intervention Group ◽

Treatment Choice ◽

Localized Prostate Cancer ◽

Care Group ◽

Satisfaction With Care ◽

Patient Centered ◽

Randomized Controlled ◽

Care Satisfaction

PURPOSE To study the effectiveness of the Patient Preferences for Prostate Cancer Care (PreProCare) intervention in improving the primary outcome of satisfaction with care and secondary outcomes of satisfaction with decision, decision regret, and treatment choice among patients with localized prostate cancer. METHODS In this multicenter randomized controlled study, we randomly assigned patients with localized prostate cancer to the PreProCare intervention or usual care. Outcomes were satisfaction with care, satisfaction with decision, decision regret, and treatment choice. Assessments were performed at baseline and at 3, 6, 12, and 24 months, and were analyzed using repeated measures. We compared treatment choice across intervention groups by prostate cancer risk categories. RESULTS Between January 2014 and March 2015, 743 patients with localized prostate cancer were recruited and randomly assigned to receive PreProCare (n = 372) or usual care (n = 371). For the general satisfaction subscale, improvement at 24 months from baseline was significantly different between groups ( P < .001). For the intervention group, mean scores at 24 months improved by 0.44 (SE, 0.06; P < .001) from baseline. This improvement was 0.5 standard deviation, which was clinically significant. The proportion reporting satisfaction with decision and no regret increased over time and was higher for the intervention group, compared with the usual care group at 24 months ( P < .05). Among low-risk patients, a higher proportion of the intervention group was receiving active surveillance, compared with the usual care group ( P < .001). CONCLUSION Our patient-centered PreProCare intervention improved satisfaction with care, satisfaction with decision, reduced regrets, and aligned treatment choice with risk category. The majority of our participants had a high income, with implications for generalizability. Additional studies can evaluate the effectiveness of PreProCare as a mechanism for improving clinical and patient-reported outcomes in different settings.

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Acceptability and Feasibility of an Isometric Resistance Exercise Program for Abdominal Cancer Surgery: An Embedded Qualitative Study

Cancer Control ◽

10.1177/1073274820950855 ◽

2020 ◽

Vol 27 (1) ◽

pp. 107327482095085

Author(s):

Ferhana Hashem ◽

David Stephensen ◽

Amanda Bates ◽

Tracy Pellatt-Higgins ◽

Ralph (Nobby) Peter Hobbs ◽

...

Keyword(s):

Qualitative Study ◽

Resistance Exercise ◽

Usual Care ◽

Intervention Group ◽

Exercise Program ◽

Cancer Surgery ◽

Feasibility Trial ◽

Moderate Intensity ◽

Care Group ◽

Exercise Interventions

Although it is recognized in the early stages of cancer recovery that changes in lifestyle including increases in physical activity improves physical function, there are no clear findings whether low versus moderate intensity activity or home or gym exercise offer optimal benefit. Isometric-resistance exercises can be carried out with very little equipment and space and can be performed while patients are bed-bound in hospital or at home. This embedded qualitative study, based in an English hospital trust providing specialist cancer care, was undertaken as a component of a feasibility trial to evaluate the acceptability and feasibility of an isometric-resistance exercise program and explore the suitability of functional assessments by drawing from the experiences of abdominal cancer patients following surgery. Telephone interviews were undertaken with 7 participants in the intervention group, and 8 interviews with the usual care group (n = 15). The gender composition consisted of 11 females and 4 males. Participants’ ages ranged from 27 to 84 (M = 60.07, SD = 15.40). Interviews were conducted between August 2017 and May 2018, with audio files digitally recorded and data coded using thematic framework analysis. Our results show that blinding to intervention or usual care was a challenge, participants felt the intervention was safe and suitable aided by the assistance of a research nurse, yet, found the self-completion questionnaire tools hard to complete. Our study provides an insight of trial processes, participants’ adherence and completion of exercise interventions, and informs the design and conduct of larger RCTs based on the experiences of abdominal cancer surgery patients.

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Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial

BMJ Open ◽

10.1136/bmjopen-2017-016269 ◽

2017 ◽

Vol 7 (8) ◽

pp. e016269 ◽

Cited By ~ 7

Author(s):

Mikyung Kim ◽

Jung-Eun Kim ◽

Hye-Yoon Lee ◽

Ae-Ran Kim ◽

Hyo-Ju Park ◽

...

Keyword(s):

Clinical Trial ◽

Sleep Quality ◽

Usual Care ◽

Study Protocol ◽

Usual Care Group ◽

Sleep Diary ◽

Research Centre ◽

Care Group ◽

Patients With Cancer ◽

Patient Reported

IntroductionAlthough insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep.Methods and analysisThis is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment.Ethics and disseminationThis study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences.Trial registration numberKCT0002162; Pre-results.

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