59
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial

      research-article

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Background

          Increasing numbers of patients are surviving critical illness, but survival may be associated with a constellation of physical and psychological sequelae that can cause ongoing disability and reduced health-related quality of life. Limited evidence currently exists to guide the optimum structure, timing, and content of rehabilitation programmes. There is a need to both develop and evaluate interventions to support and expedite recovery during the post-ICU discharge period. This paper describes the construct development for a complex rehabilitation intervention intended to promote physical recovery following critical illness. The intervention is currently being evaluated in a randomised trial (ISRCTN09412438; funder Chief Scientists Office, Scotland).

          Methods

          The intervention was developed using the Medical Research Council (MRC) framework for developing complex healthcare interventions. We ensured representation from a wide variety of stakeholders including content experts from multiple specialties, methodologists, and patient representation. The intervention construct was initially based on literature review, local observational and audit work, qualitative studies with ICU survivors, and brainstorming activities. Iterative refinement was aided by the publication of a National Institute for Health and Care Excellence guideline (No. 83), publicly available patient stories (Healthtalkonline), a stakeholder event in collaboration with the James Lind Alliance, and local piloting. Modelling and further work involved a feasibility trial and development of a novel generic rehabilitation assistant (GRA) role. Several rounds of external peer review during successive funding applications also contributed to development.

          Results

          The final construct for the complex intervention involved a dedicated GRA trained to pre-defined competencies across multiple rehabilitation domains (physiotherapy, dietetics, occupational therapy, and speech/language therapy), with specific training in post-critical illness issues. The intervention was from ICU discharge to 3 months post-discharge, including inpatient and post-hospital discharge elements. Clear strategies to provide information to patients/families were included. A detailed taxonomy was developed to define and describe the processes undertaken, and capture them during the trial. The detailed process measure description, together with a range of patient, health service, and economic outcomes were successfully mapped on to the modified CONSORT recommendations for reporting non-pharmacologic trial interventions.

          Conclusions

          The MRC complex intervention framework was an effective guide to developing a novel post-ICU rehabilitation intervention. Combining a clearly defined new healthcare role with a detailed taxonomy of process and activity enabled the intervention to be clearly described for the purpose of trial delivery and reporting. These data will be useful when interpreting the results of the randomised trial, will increase internal and external trial validity, and help others implement the intervention if the intervention proves clinically and cost effective.

          Related collections

          Most cited references29

          • Record: found
          • Abstract: found
          • Article: not found

          Early intensive care unit mobility therapy in the treatment of acute respiratory failure.

          Immobilization and subsequent weakness are consequences of critical illness. Despite the theoretical advantages of physical therapy to address this problem, it has not been shown that physical therapy initiated in the intensive care unit offers benefit. Prospective cohort study in a university medical intensive care unit that assessed whether a mobility protocol increased the proportion of intensive care unit patients receiving physical therapy vs. usual care. Medical intensive care unit patients with acute respiratory failure requiring mechanical ventilation on admission: Protocol, n = 165; Usual Care, n = 165. An intensive care unit Mobility Team (critical care nurse, nursing assistant, physical therapist) initiated the protocol within 48 hrs of mechanical ventilation. The primary outcome was the proportion of patients receiving physical therapy in patients surviving to hospital discharge. Baseline characteristics were similar between groups. Outcome data are reflective of survivors. More Protocol patients received at least one physical therapy session than did Usual Care (80% vs. 47%, p < or = .001). Protocol patients were out of bed earlier (5 vs. 11 days, p < or = .001), had therapy initiated more frequently in the intensive care unit (91% vs. 13%, p < or = .001), and had similar low complication rates compared with Usual Care. For Protocol patients, intensive care unit length of stay was 5.5 vs. 6.9 days for Usual Care (p = .025); hospital length of stay for Protocol patients was 11.2 vs. 14.5 days for Usual Care (p = .006) (intensive care unit/hospital length of stay adjusted for body mass index, Acute Physiology and Chronic Health Evaluation II, vasopressor). There were no untoward events during an intensive care unit Mobility session and no cost difference (survivors + nonsurvivors) between the two arms, including Mobility Team costs. A Mobility Team using a mobility protocol initiated earlier physical therapy that was feasible, safe, did not increase costs, and was associated with decreased intensive care unit and hospital length of stay in survivors who received physical therapy during intensive care unit treatment compared with patients who received usual care.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Exercise rehabilitation for patients with critical illness: a randomized controlled trial with 12 months of follow-up

            Introduction The purpose of this trial was to investigate the effectiveness of an exercise rehabilitation program commencing during ICU admission and continuing into the outpatient setting compared with usual care on physical function and health-related quality of life in ICU survivors. Methods We conducted a single-center, assessor-blinded, randomized controlled trial. One hundred and fifty participants were stratified and randomized to receive usual care or intervention if they were in the ICU for 5 days or more and had no permanent neurological insult. The intervention group received intensive exercises in the ICU and the ward and as outpatients. Participants were assessed at recruitment, ICU admission, hospital discharge and at 3-, 6- and 12-month follow-up. Physical function was evaluated using the Six-Minute Walk Test (6MWT) (primary outcome), the Timed Up and Go Test and the Physical Function in ICU Test. Patient-reported outcomes were measured using the Short Form 36 Health Survey, version 2 (SF-36v2) and Assessment of Quality of Life (AQoL) Instrument. Data were analyzed using mixed models. Results The a priori enrollment goal was not reached. There were no between-group differences in demographic and hospital data, including acuity and length of acute hospital stay (LOS) (Acute Physiology and Chronic Health Evaluation II score: 21 vs 19; hospital LOS: 20 vs 24 days). No significant differences were found for the primary outcome of 6MWT or any other outcomes at 12 months after ICU discharge. However, exploratory analyses showed the rate of change over time and mean between-group differences in 6MWT from first assessment were greater in the intervention group. Conclusions Further research examining the trajectory of improvement with rehabilitation is warranted in this population. Trial registration The trial was registered with the Australian New Zealand Clinical Trials Registry ACTRN12605000776606.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Two-year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome.

              Little is known about the long-term outcomes and costs of survivors of acute respiratory distress syndrome (ARDS). To describe functional and quality of life outcomes, health care use, and costs of survivors of ARDS 2 yr after intensive care unit (ICU) discharge. We recruited a cohort of ARDS survivors from four academic tertiary care ICUs in Toronto, Canada, and prospectively monitored them from ICU admission to 2 yr after ICU discharge. Clinical and functional outcomes, health care use, and direct medical costs. Eighty-five percent of patients with ARDS discharged from the ICU survived to 2 yr; overall 2-yr mortality was 49%. At 2 yr, survivors continued to have exercise limitation although 65% had returned to work. There was no statistically significant improvement in health-related quality of life as measured by Short-Form General Health Survey between 1 and 2 yr, although there was a trend toward better physical role at 2 yr (p = 0.0586). Apart from emotional role and mental health, all other domains remained below that of the normal population. From ICU admission to 2 yr after ICU discharge, the largest portion of health care costs for a survivor of ARDS was the initial hospital stay, with ICU costs accounting for 76% of these costs. After the initial hospital stay, health care costs were related to hospital readmissions and inpatient rehabilitation. Survivors of ARDS continued to have functional impairment and compromised health-related quality of life 2 yr after discharge from the ICU. Health care use and costs after the initial hospitalization were driven by hospital readmissions and inpatient rehabilitation.
                Bookmark

                Author and article information

                Contributors
                Journal
                Trials
                Trials
                Trials
                BioMed Central
                1745-6215
                2014
                29 January 2014
                : 15
                : 38
                Affiliations
                [1 ]Lothian University Hospitals Division, 51 Little France Crescent, Old Dalkeith Road, Edinburgh EH16 4SA, UK
                [2 ]Edinburgh Critical Care Research group, Edinburgh University and NHS Lothian, Chancellors Building, 49 Little France Crescent, Old Dalkeith Road, Edinburgh EH16 4SB, UK
                [3 ]Interdisciplinary Social Science in Health/Nursing Studies, University of Edinburgh, Medical School, Teviot Place (Doorway 6), Edinburgh EH8 9AG, UK
                [4 ]School of Nursing and Midwifery, University of Dundee, City Campus, 11 Airlie Place, Dundee DD1 4HJ, UK
                [5 ]NHS Tayside, Perth Royal Infirmary, Perth PH1 1NX, UK
                [6 ]Imperial College Healthcare NHS Trust, The Bays, South Wharf Road, St Mary’s Hospital, London W2 1NY, UK
                [7 ]Centre for Population Health Sciences, University of Edinburgh, Medical School, Teviot Place, Edinburgh EH8 9AG, UK
                [8 ]Centre for Inflammation Research, Queens Medical Research Institute, 47 Little France Crescent, Old Dalkeith Road, Edinburgh, EH16 4TJ, UK
                Author notes
                on behalf of the RECOVER trial collaboration
                Article
                1745-6215-15-38
                10.1186/1745-6215-15-38
                4016544
                24476530
                f56bcb1e-7969-4467-bb6c-25a74cc4fbd7
                Copyright © 2014 Ramsay et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.

                History
                : 24 June 2013
                : 8 January 2014
                Categories
                Methodology

                Medicine
                critical care,rehabilitation,complex intervention
                Medicine
                critical care, rehabilitation, complex intervention

                Comments

                Comment on this article