Feasibility study of a multicentre cluster randomised control trial to investigate the clinical and cost-effectiveness of a structured diagnostic pathway in primary care for chronic breathlessness: protocol paper

IntroductionChronic breathlessness is a common and debilitating symptom, associated with high healthcare use and reduced quality of life. Challenges and delays in diagnosis for people with chronic breathlessness frequently occur, leading to delayed access to therapies. The overarching hypothesis is a symptom-based approach to diagnosis in primary care would lead to earlier diagnosis, and therefore earlier treatment and improved longer-term outcomes including health-related quality of life. This study aims to establish the feasibility of a multicentre cluster randomised controlled trial to assess the clinical and cost-effectiveness of a structured diagnostic pathway for breathlessness in primary care.Methods and analysisTen general practitioner (GP) practices across Leicester and Leicestershire will be cluster randomised to either a structured diagnostic pathway (intervention) or usual care. The structured diagnostic pathway includes a panel of investigations within 1 month. Usual care will proceed with patient care as per normal practice. Eligibility criteria include patients presenting with chronic breathlessness for the first time, who are over 40 years old and without a pre-existing diagnosis for their symptoms. An electronic template triggered at the point of consultation with the GP will aid opportunistic recruitment in primary care. The primary outcome for this feasibility study is recruitment rate. Secondary outcome measures, including time to diagnosis, will be collected to help inform outcomes for the future trial and to assess the impact of an earlier diagnosis. These will include symptoms, health-related quality of life, exercise capacity, measures of frailty, physical activity and healthcare utilisation. The study will include nested qualitative interviews with patients and healthcare staff to understand the feasibility outcomes, explore what is ‘usual care’ and the study experience.Ethics and disseminationThe Research Ethics Committee Nottingham 1 has provided ethical approval for this research study (REC Reference: 19/EM/0201). Results from the study will be disseminated by presentations at relevant meetings and conferences including British Thoracic Society and Primary Care Respiratory Society, as well as by peer-reviewed publications and through patient presentations and newsletters to patients, where available.Trial registration numberISRCTN14483247.

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Effects of the “Living well with COPD” intervention in primary care: a comparative study

European Respiratory Journal ◽

10.1183/13993003.01375-2017 ◽

2018 ◽

Vol 51 (1) ◽

pp. 1701375 ◽

Cited By ~ 12

Author(s):

Claudia Steurer-Stey ◽

Kaba Dalla Lana ◽

Julia Braun ◽

Gerben ter Riet ◽

Milo A. Puhan

Keyword(s):

Quality Of Life ◽

Primary Care ◽

Usual Care ◽

Self Management ◽

Health Related Quality ◽

Management Intervention ◽

Living Well ◽

Related Quality ◽

Health Related

The pivotal objective of chronic obstructive pulmonary disease (COPD) self-management programmes is behaviour change to avoid moderate and severe exacerbations and improve health related quality of life.In a prospectively planned, controlled study, COPD patients who participated in the “Living well with COPD” (LWWCOPD) self-management intervention were compared with usual care patients from the primary care COPD Cohort ICE COLD ERIC, who did not receive self-management intervention (NCT00706602) The primary outcome was behaviour change and disease-specific health related quality of life after 1 year. Secondary end-points included exacerbation rates. We calculated mixed linear, zero-inflated negative binomial and logistic regression models and used propensity scores to counteract confounding.467 patients, 71 from the LWWCOPD and 396 from the usual care cohort, were included. The differences between intervention and control were 0.54 (95% CI 0.13−0.94) on the Chronic Respiratory Questionnaire domain “mastery”, 0.55 (95% CI 0.11−0.99) on “fatigue”, 0.54 (0.14−0.93) on “emotional function” and 0.64 (95% CI 0.14−1.14) on “dyspnoea”. The intervention considerably reduced the risk of moderate and severe exacerbations (incidence rate ratio 0.36, 95% CI 0.25−0.52).Self-management coaching in primary care improves health-related quality of life and lowers exacerbation rates and health care use.

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Randomized controlled study of the impact of a participatory patient care plan among primary care patients with common chronic diseases: a one-year follow-up study

BMC Health Services Research ◽

10.1186/s12913-021-06716-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Nina Tusa ◽

Hannu Kautiainen ◽

Pia Elfving ◽

Sanna Sinikallio ◽

Pekka Mäntyselkä

Keyword(s):

Quality Of Life ◽

Patient Care ◽

Usual Care ◽

Care Plan ◽

Health Related Quality ◽

Related Quality ◽

Health Related ◽

Disease Specific

Abstract Backround Chronic diseases and multimorbidity are common in the ageing population and affect the health related quality of life. Health care resources are limited and the continuity of care has to be assured. Therefore it is essential to find demonstrable tools for best treatment practices for patients with chronic diseases. Our aim was to study the influence of a participatory patient care plan on the health-related quality of life and disease specific outcomes related to diabetes, ischemic heart disease and hypertension. Methods The data of the present study were based on the Participatory Patient Care Planning in Primary Care. A total of 605 patients were recruited in the Siilinjärvi Health Center in the years 2017–2018 from those patients who were followed up due to the treatment of hypertension, ischemic heart disease or diabetes. Patients were randomized into usual care and intervention groups. The intervention consisted of a participatory patient care plan, which was formulated in collaboration with the patient and the nurse and the physician during the first health care visit. Health-related quality of life with the 15D instrument and the disease-specific outcomes of body mass index (BMI), low density lipoprotein cholesterol (LDL-C), hemoglobin A1c (HbA1C) and blood pressure were assessed at the baseline and after a one-year follow-up. Results A total of 587 patients with a mean age of 69 years were followed for 12 months. In the intervention group there were 289 patients (54% women) and in the usual care group there were 298 patients (50% women). During the follow-up there were no significant changes between the groups in health-related quality and disease-specific outcomes. Conclusions During the 12-month follow-up, no significant differences between the intervention and the usual care groups were detected, as the intervention and the usual care groups were already in good therapeutic equilibrium at the baseline. Trial registration ClinicalTrials.gov Identifier: NCT02992431. Registered 14/12/2016

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