scholarly journals A study protocol for a non-randomised comparison trial evaluating the feasibility and effectiveness of a mobile cognitive–behavioural programme with integrated coaching for anxious adults in primary care

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019108 ◽  
Author(s):  
Eva Szigethy ◽  
Francis Solano ◽  
Meredith Wallace ◽  
Dina L Perry ◽  
Lauren Morrell ◽  
...  

IntroductionGeneralised anxiety disorder (GAD) and subclinical GAD are highly prevalent in primary care. Unmanaged anxiety worsens quality of life in patients seen in primary care practices and leads to increased medical utilisation and costs. Programmes that teach patients cognitive–behavioural therapy (CBT) techniques have been shown to improve anxiety and to prevent the evolution of anxiety symptoms to disorders, but access and engagement have hampered integration of CBT into medical settings.Methods and analysisThis pragmatic study takes place in University of Pittsburgh Medical Center primary care practices to evaluate a coach-supported mobile cognitive– behavioural programme (Lantern) on anxiety symptoms and quality of life. Clinics were non-randomly assigned to either enhanced treatment as usual or Lantern. All clinics provide electronic screening for anxiety and, within clinics assigned to Lantern, patients meeting a threshold level of mild anxiety (ie, >5 on Generalised Anxiety Disorder 7-Item Questionnaire (GAD-7)) are referred to Lantern. The first study phase is aimed at establishing feasibility, acceptability and effectiveness. The second phase focuses on long-term impact on psychosocial outcomes, healthcare utilisation and clinic/provider adoption/sustainable implementation using a propensity score matched parallel group study design. Primary outcomes are changes in anxiety symptoms (GAD-7) and quality of life (Short-Form Health Survey) between baseline and 6-month follow-ups, comparing control and intervention. Secondary outcomes include provider and patient satisfaction, patient engagement, durability of changes in anxiety symptoms and quality of life over 12 months and the impact of Lantern on healthcare utilisation over 12 months. Patients from control sites will be matched to the patients who use the mobile app.Ethics and disseminationEthics and human subject research approval were obtained. A data safety monitoring board is overseeing trial data and ethics. Results will be communicated to participating primary care practices, published and presented at clinical and scientific conferences.Trial registration numberNCT03035019.

2021 ◽  
Author(s):  
Carolyn Steele Gray ◽  
Phat (Eduard) Chau ◽  
Farah Tahsin ◽  
Sarah Harvey ◽  
Mayura Loganathan ◽  
...  

BACKGROUND Goal-oriented care is being adopted to deliver person-centred primary care to older adults with multimorbidity and complex care needs. While this model holds promise, implementation remains a challenge. Digital health solutions may enable processes to improve adoption, however, they require evaluation to determine feasibility and impact. OBJECTIVE This study evaluates the implementation and effectiveness of the electronic Patient Reported Outcome (ePRO) mobile application and portal system, designed to enable goal-oriented care delivery in inter-professional primary care practices. The research questions driving this study are: 1) Does ePRO improve quality of life and self-management in older adults with complex needs, and 2) what mechanisms are likely driving observed outcomes? METHODS A multi-method pragmatic randomized control trial using a stepped-wedge design and ethnographic case studies was conducted over a 15-month period in 6 comprehensive primary care practices across Ontario with a target enrolment of 176 patients. The 6 practices were randomized into either early (3-month control period; 12-month intervention) or late (6-month control period; 9-month intervention) groups. The primary outcome measure of interest was the Assessment of Quality of Life-4D (AQoL-4D). Data were collected at baseline and at 3 monthly intervals for the duration of the trial. Ethnographic data included observations and interviews with patients and providers at the mid-point and end of the intervention. Outcome data were analyzed using linear models conducted at the individual level, accounting for cluster effects at the practice level, and ethnographic data was analyzed using qualitative description and framework analysis methods. RESULTS Recruitment challenges resulted in fewer sites and participants than expected; only 142 of the 176 eligible patients were identified due to lower than expected provider participation and fewer than expected patients willing to participate or perceived as ready to engage in goal setting. Of 142 patients approached, 45 patients participated (32%). Patients set a variety of goals related to self-management, mental health, social health and overall well-being. Due to underpowering, the impact of ePRO on quality of life could not be definitively assessed; however the intervention group, ePRO plus usual care (M = 15.28, SD = 18.60), demonstrated non-significant slight decrease in quality of life, t(24)= -1.20, P = 0.24, when compared to usual care only (M = 21.76, SD = 2.17). The ethnographic data reveals a complex implementation process, in which the meaningfulness (or coherence) of the technology to individuals lives and work acted as a key driver to adoption and tool appraisal. CONCLUSIONS This trial experienced many unexpected and significant implementation challenges related to recruitment and engagement. Future studies could be improved through better alignment of the research methods and intervention to the complex and diverse clinic settings, dynamic goal-oriented care process, and readiness of provider and patient participants. CLINICALTRIAL ClinicalTrials.gov NCT02917954; https://clinicaltrials.gov/ct2/show/NCT02917954?intr=epro&cntry=CA&rank=1


2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Michael E Green ◽  
William Hogg ◽  
Colleen Savage ◽  
Sharon Johnston ◽  
Grant Russell ◽  
...  

2008 ◽  
Vol 17 (10) ◽  
pp. 1285-1294 ◽  
Author(s):  
Dennis A. Revicki ◽  
Nancy Brandenburg ◽  
Louis Matza ◽  
Mark C. Hornbrook ◽  
David Feeny

2013 ◽  
Vol 185 (12) ◽  
pp. E590-E596 ◽  
Author(s):  
M.-D. Beaulieu ◽  
J. Haggerty ◽  
P. Tousignant ◽  
J. Barnsley ◽  
W. Hogg ◽  
...  

1999 ◽  
Vol 29 (3) ◽  
pp. 583-593 ◽  
Author(s):  
E. de BEURS ◽  
A. T. F. BEEKMAN ◽  
A. J. L. M. van BALKOM ◽  
D. J. H. DEEG ◽  
R. van DYCK ◽  
...  

Background. Although anxiety is quite prevalent in late life, its impact on disability, well-being, and health care utilization of older persons has not been studied. Older persons are a highly relevant age group for studying the consequences of anxiety, since their increasing numbers put an extra strain on already limited health care resources.Methods. Data of a large community-based random probability sample (N=659) of older subjects (55–85 year) in the Netherlands were used to select three groups: subjects with a diagnosed anxiety disorder, subjects with merely anxiety symptoms and a reference group without anxiety. These groups were compared with regard to their functioning, subjective well-being, and use of health care services, while controlling for potentially confounding variables.Results. Anxiety was associated with increased disability and diminished well-being. Older persons with a diagnosed anxiety disorder were equally affected in their functioning as those with merely anxiety symptoms. Although use of health services was increased in anxiety sufferers, their use of appropriate care was generally low.Conclusions. Anxiety has a clear negative impact on the functioning and well-being of older subjects. The similarity of participants with an anxiety disorder and those having merely anxiety symptoms regarding quality of life variables and health care use was quite striking. Finally, in spite of its grave consequences for the quality of life, appropriate care for anxiety is seldom received. Efforts to improve recognition, disseminate effective treatments in primary care, and referring to specialized care may have positive effects on the management of anxiety in late life.


2018 ◽  
Vol 11 (4) ◽  
pp. 537-544 ◽  
Author(s):  
Lisa I. Iezzoni ◽  
Yuchiao Chang ◽  
Holly Matulewicz ◽  
Dennis Heaphy ◽  
Kimberley S. Warsett ◽  
...  

2002 ◽  
Vol 20 (14) ◽  
pp. 3137-3148 ◽  
Author(s):  
D. Stark ◽  
M. Kiely ◽  
A. Smith ◽  
G. Velikova ◽  
A. House ◽  
...  

PURPOSE: We aimed to estimate the prevalence and types of anxiety disorders diagnosed according to standardized criteria in cancer patients, to compare screening tools in detecting them, and to examine their demographic, oncologic, and psychosocial associations. METHODS: In this cross-sectional observational study of 178 subjects with lymphoma, renal cell carcinoma, malignant melanoma, or plasma cell dyscrasia, we related responses to questionnaires (administered by computer touch-screen) measuring psychological symptoms, quality of life (QOL), and social support to standardized psychiatric interviews and cancer management. RESULTS: Forty-eight percent of subjects reported sufficient anxiety for anxiety disorder to be considered. At subsequent diagnostic interview, 18% fulfilled International Classification of Disorders, 10th Revision criteria for anxiety disorder, including 6% of patients who reported low levels of anxiety by questionnaire. When subjects reported anxiety by questionnaire, if disruptive somatic anxiety was present, this increased the probability of diagnosable anxiety disorder from .31 to .7. The most accurate screening questionnaires were the trait scale of the State-Trait Anxiety Inventory and the Hospital Anxiety and Depression scale. Female sex and negative aspects of social support were associated with anxiety disorder in multivariate analyses. Anxiety disorder was independently associated with a deficit in QOL, particularly insomnia. CONCLUSION: Anxiety symptoms are common in cancer patients. Screening by questionnaire seems to assess anxiety symptoms adequately but discriminates abnormal anxiety inadequately. To improve this, we may need to use criteria such as disruption from anxiety, as illustrated by the impact of anxiety disorders on QOL. There seem to be few oncologic variables that could target screening for anxiety disorders.


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