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The INCLUDE study: INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community; identifying multimorbidity: Protocol for a pilot randomized controlled trial.

Healey, E; Herron, D; Hider, S; Bucknall, M; Cooke, K; Finney, A; Goddin, D; Hennings, S; Jinks, C; Lewis, M; Machin, A; Mallen, C; Wathall, S; Chew-Graham, C

The INCLUDE study: INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community; identifying multimorbidity: Protocol for a pilot randomized controlled trial. Thumbnail


Authors

D Herron

K Cooke

D Goddin

S Hennings

A Machin



Abstract

Background: Patients with inflammatory rheumatic conditions such as rheumatoid arthritis, polymyalgia rheumatica and ankylosing spondylitis are at increased risk of common comorbidities such as cardiovascular disease, osteoporosis and anxiety and depression which lead to increased morbidity and mortality. These associated morbidities are often un-recognized and under-treated. While patients with other long-term conditions such as diabetes are invited for routine reviews in primary care, which may include identification and management of co-morbidities, at present this does not occur for patients with inflammatory conditions, and thus, opportunities to diagnose and optimally manage these comorbidities are missed. Objective: To evaluate the feasibility and acceptability of a nurse-led integrated care review (the INtegrating and improving Care for patients with infLammatory rheUmatological DisordErs in the community (INCLUDE) review) for people with inflammatory rheumatological conditions in primary care. Design: A pilot cluster randomized controlled trial will be undertaken to test the feasibility and acceptability of a nurse-led integrated primary care review for identification, assessment and initial management of common comorbidities including cardiovascular disease, osteoporosis and anxiety and depression. A process evaluation will be undertaken using a mixed methods approach including participant self-reported questionnaires, a medical record review, an INCLUDE EMIS template, intervention fidelity checking using audio-recordings of the INCLUDE review consultation and qualitative interviews with patient participants, study nurses and study general practitioners (GPs). Discussion: Success of the pilot study will be measured against the engagement, recruitment and study retention rates of both general practices and participants. Acceptability of the INCLUDE review to patients and practitioners and treatment fidelity will be explored using a parallel process evaluation. Trial Registration: ISRCTN12765345.

Journal Article Type Article
Acceptance Date Jan 1, 2018
Online Publication Date Aug 2, 2018
Publication Date Jan 1, 2018
Publicly Available Date Mar 28, 2024
Journal Journal of Comorbidity
Print ISSN 2235-042X
Publisher SAGE Publications
Peer Reviewed Peer Reviewed
Volume 8
Issue 1
DOI https://doi.org/10.1177/2235042X18792373
Keywords Integrated care, anxiety, depression, long-term conditions, multimorbidity, rheumatoid arthritis
Publisher URL http://journals.sagepub.com/doi/10.1177/2235042X18792373