The Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program

Study Overview
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Brief Summary
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Patients in fast-track programmes are required to take an active part in their treatment and rehabilitation. Spouses of older patients can often provide valued practical and emotional support, reducing stress, pain and length of stay - yet they are seldom invited to participate in a supporting role. The aim of this study is to investigate the effect of spouses' involvement in older patients fast-track treatment programs using case management as intervention. A two-group quasi-experimental design with pre-test and repeated post-test measures (protocol approved in November 2012) was used. Patients aged 65 years or older going through a fast-track programme for a total hip replacement and their spouses was recruited in dyads from one Danish orthopaedic ward for the intervention group (n=15) and for the control group (n=14). Data was collected from both groups at baseline, two weeks and three months after surgery. Outcome measures for patients include: functional status, nutrition, pain, depression and healthcare consumptions; and for spouses: caregiver satisfaction and difficulties and anxiety.

Official Title
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The SICAM-trial: Studying the Effect of Spouses' Involvement Through Case Management in Older Patients' Fast-track Program During and After Total Hip Replacement - A Quasi-experimental Study With a Complex Intervention

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Behavioral: Case management
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 65 years of age or older undergoing a total hip replacement due to arthritis live with their spouses speak, read and understand Danish without an interpreter have their spouses present at the mandatory pre-information meeting in the outpatient facilities. Inclusion Criteria: Spouses presence at the pre-information meeting Exclusion Criteria: Patients They cannot receive home care, be placed in a nursing home or be permanent users of wheelchairs Exclusion criteria: Both Index score at >24 assessed on the Mini-Mental Stats Examination (MMSE) Index score of <6 assessed on the Charlson Comorbidity Index

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case management<br>Before admission the spouse-patient dyads will take part in an interview with the case manager assessing the spouses' needs during admission through an individual care plan. During admission the case manager will follow-up and assess the goals and actions of the individual care plan and coordinate with other health professionals. During the discharge meeting the case manager will provide additional information to the spouse according to needs assessed in the care plan. After discharge the case manager will conduct a follow-up telephone call for the spouse 3-4 days and 10 days after the patient's discharge consisting of information similar to that provided at the discharge meeting. | Behavioral: Case management<br> <br> |
| Other: Control group<br>Spouses and patients in the control group will receive usual care and written and oral information about the fast-track program and principles in general from the nursing staff. The usual care and information is provided before admission in the out-patient facilities and during admission | Behavioral: Control group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status/ activities of daily living measured by the Barthel-100, which is a 10-item scale |  | Three months | 
| Caregiver satisfaction assessed using the 30-item Carer's Assessment of Satisfaction Index (CASI) |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional improvements measured using the Mini Nutritional Assessment tool (MNA-SF) |  | Three months | 
| Pain improvements measured using the separate patient-relevant dimension of pain in the Hip Disability and Osteoarthritis Outcome Score (HOOS) |  | Three months | 
| Depression using the 15-item short form binary reported measurement of the Geriatric Depression Scale (GDS-15) |  | Three months | 
| Caregiver difficulties assessed through 15 items selected from the 30-item Carer's Assessment of Difficulties (CADI) |  | Three months | 
| Anxiety assessed using the Generalized anxiety disorder (GAD-7) scale |  | Three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Case management