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Trial registered on ANZCTR


Registration number
ACTRN12613001223729
Ethics application status
Approved
Date submitted
4/11/2013
Date registered
6/11/2013
Date last updated
4/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing care coordination plus early rehabilitation in high-risk chronic obstructive pulmonary disease (COPD) patients in transition from hospital to primary care
Scientific title
Implementing care coordination plus early rehabilitation in high-risk chronic obstructive pulmonary disease (COPD) patients in transition from hospital to primary care: investigating outcomes of pilot intervention on feasibility, fidelity, patient and carer satistaction; documentation of and progress toward patient goals; collaboration with general practice; physical activity levels and readmission.
Secondary ID [1] 283509 0
nil
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease (COPD) 290426 0
Condition category
Condition code
Respiratory 290818 290818 0 0
Chronic obstructive pulmonary disease
Public Health 290836 290836 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The care coordination plus early rehabilitation intervention (flexible duration 1-2 months depending on patient needs) will be implemented by a specialist respiratory Nurse Practitioner (NP) and a research assistant physiotherapist (RPT) and include the following components:
(1) Liaison with existing Sub-acute Respiratory Service (SRS) inpatient hospital COPD coordinator for streamlined transition into SRS.
(2) Care coordination by weekly home visit (NP) to patient (30 min- 1 hour each week during 1-2 month intervention) with additional phone contact as required, including the following components:
Needs assessment, problem identification, goal setting and care planning with the patient (using the Flinders Program). The patient’s carer will be invited to participate in care planning discussions.
Facilitation of referrals across all health sectors in collaboration with the patient/carer and relevant members of the health care teams involved.
(3) Early rehabilitation by weekly visit (research assistant physiotherapist; 30 min visits weekly during 1-2 month intervention) including the following components:
Walking program: commence at 2 x10 min walks/day prescribed at 40% of peak speed in 2 minute walk test prior to hospital discharge; optimal walking aid prescription
Interrupt daytime sedentary periods of >1 hour with sit-stand. Use of self-report exercise diary.
(4) Collaboration with patient/carer, local primary care practice nurse and GP to integrate care using existing MBS items (Team Care Arrangement/Case Conference).
Intervention code [1] 288213 0
Rehabilitation
Intervention code [2] 288214 0
Other interventions
Comparator / control treatment
Participants in an existing observational study “Time spent in sedentary and physical activity in people with COPD during and after a hospital admission” will comprise the control group. This study included patients admitted to hospital with a primary diagnosis of COPD, confirmation of COPD diagnosis by previous pulmonary function testing and length of admission at least 48 hours. Potential participants are excluded if they have (a) insufficient English language or cognition to give informed consent; (b) been unable to walk during the previous 3 months. Recruitment commenced in March 2013 and will continue until October 2013. These patients all received standard treatment (eg discharge letter to usual GP, services organised for transitional care by hospital staff as required). Participants in the control group have had physical activity levels measured and hospital readmissions monitored at one month after discharge.
Control group
Active

Outcomes
Primary outcome [1] 290814 0
Documentation of agreed patient goals and progress toward them using Flinders Program Problems and Goals Assessment, Flinders Program Care Plan, documentation of service facilitation
Timepoint [1] 290814 0
End intervention (ie 1 month after hospital discharge)
Secondary outcome [1] 305353 0
Generation of Team Care Arrangement or other evidence of GP collaboration (documented by nurse practitioner)
Timepoint [1] 305353 0
End intervention (1 month post hospital discharge)
Secondary outcome [2] 305354 0
Assessment of pilot intervention feasibility (by examination of recruitment rate, retention rate, and resource capability)
Timepoint [2] 305354 0
End intervention (1 month post hospital discharge)
Secondary outcome [3] 305355 0
Assessment of pilot intervention fidelity (care coordination and early rehabilitation components delivered as planned; exercise sessions completed as planned by participant diary)
Timepoint [3] 305355 0
End intervention (1 month post hospital discharge)
Secondary outcome [4] 305392 0
Physical activity levels as documented by accelerometer and inclinometer worn for one week, compared with control group
Timepoint [4] 305392 0
one month after hospital discharge
Secondary outcome [5] 305393 0
Hospital readmissions compared with control group
Timepoint [5] 305393 0
one month after hospital discharge

Eligibility
Key inclusion criteria
Patients admitted to hospital with a primary diagnosis of COPD; confirmation of COPD diagnosis by previous pulmonary function testing; length of admission at least 48 hours.
Minimum age
40 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants are excluded if they have (a) insufficient English language or cognition to give informed consent; (b) been unable to walk during the previous 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible participants will be receive the pilot intervention, and comparison in two secondary outcomes (physical activity level and hospital readmissions) will be made with a similar group of patients enrolled in an observational study already conducted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Number of participants in this pilot study intervention was determined by the anticipated recruitment capability of suitable patients during the available time frame (Nov 2013-May 2014).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1649 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 288211 0
University
Name [1] 288211 0
Australian Primary Health Care Research Institute, Australian National University
Address [1] 288211 0
Barry Dr, Acton ACT 0200
Country [1] 288211 0
Australia
Primary sponsor type
Individual
Name
Dr Kylie Johnston
Address
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 286934 0
Individual
Name [1] 286934 0
Mrs Mary Young
Address [1] 286934 0
Sub-Acute Respiratory Service
Level 4, North Wing
Room 2D54
Royal Adelaide Hospital, North Terrace, Adelaide SA 5000
Country [1] 286934 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290120 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 290120 0
University of SA
GPO Box 2471
Adelaide SA 5001
Ethics committee country [1] 290120 0
Australia
Date submitted for ethics approval [1] 290120 0
Approval date [1] 290120 0
14/10/2013
Ethics approval number [1] 290120 0
31990
Ethics committee name [2] 290121 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [2] 290121 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [2] 290121 0
Australia
Date submitted for ethics approval [2] 290121 0
Approval date [2] 290121 0
09/10/2013
Ethics approval number [2] 290121 0
131004

Summary
Brief summary
The aim of this project is to pilot the implementation of care coordination plus early rehabilitation in a high-risk COPD population in transition from hospital to primary care. This intervention will dovetail with the existing Sub-Acute Respiratory Services (SRS) of the Central Adelaide Local Health Network (CALHN) and the Central Adelaide and Hills Medicare Local (CAHML) COPD Project. Stronger partnerships will be created to improve the clinical handover of patients and address gaps identified by both services.

This study will determine whether this model of care coordination plus early rehabilitation is feasible, acceptable, carried out with fidelity and effectiveness (compared with a no-intervention control group). If so, this model could be implemented in a larger Australian cluster randomised trial and outcomes examined over a longer duration. If effective, the role of specialist Nurse Practitioners as community care coordinators could be implemented as effective links between primary and acute hospital care of people with chronic lung conditions.

Study Hypotheses
(a) Implementation of the pilot intervention (care coordination plus early rehabilitation) is feasible, satisfactory to patients and carers and can be delivered with fidelity.
(b) Care coordination plus early rehabilitation will result in (i) documentation of agreed patient goals and (ii) demonstrated progress toward them assessed by the four major Flinders Program Care Planning Tools: Partners in Health / Cue and Response / Problems and Goals assessment and Self-Management Plan in at least 85% of cases.
(c) Care coordination plus early rehabilitation will involve collaboration with the patient's GP/practice nurse with generation of a Team Care Arrangement in at least 85% of cases.
(d) People with COPD who participate in care coordination plus early rehabilitation will have lower hospital readmission rates at 28 days and greater physical activity levels at 28 days after discharge than a control group of similar patients.
Trial website
Trial related presentations / publications
Full report published at: https://rsph.anu.edu.au/research/projects/implementing-care-co-ordination-plus-early-rehabilitation-high-risk-copd-patients

Public notes

Contacts
Principal investigator
Name 44058 0
Dr Kylie Johnston
Address 44058 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 44058 0
Australia
Phone 44058 0
+61 8 8302 2086
Fax 44058 0
+61 8 8302 2853
Email 44058 0
kylie.johnston@unisa.edu.au
Contact person for public queries
Name 44059 0
Dr Kylie Johnston
Address 44059 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 44059 0
Australia
Phone 44059 0
+61 8 8302 2086
Fax 44059 0
Email 44059 0
kylie.johnston@unisa.edu.au
Contact person for scientific queries
Name 44060 0
Dr Kylie Johnston
Address 44060 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 44060 0
Australia
Phone 44060 0
+61 8 8302 2086
Fax 44060 0
Email 44060 0
kylie.johnston@unisa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary