Effectiveness of a nurse-led case management home care model in primary health care: A quasi-experimental, controlled, multi-centre study

ISRCTN ISRCTN44054549
DOI https://doi.org/10.1186/ISRCTN44054549
Secondary identifying numbers PI031161I
Submission date
17/03/2008
Registration date
04/04/2008
Last edited
07/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jose Miguel Morales-Asencio
Scientific

Cuesta del Observatorio s/n
Granada
18080
Spain

Phone +34 670948689
Email josem.morales.easp@juntadeandalucia.es

Study information

Study designQuasi-experimental, prospective, multi-centre study, with a concurrent control group
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeOther
Scientific title
Study acronymENMAD
Study objectivesA nurse-led case management home care system improves:
1. Functional status of the patients
2. Use of social and health resources
3. Satisfaction (both patients and caregivers)
Ethics approval(s)Ethics Committees of the Andalusian School of Public Health (Spain). Date of approval: 21/02/2003
Health condition(s) or problem(s) studiedLong term home care.
InterventionPatients and main caregivers were allocated to either the intervention or control group, depending on whether or not they had access to home care services delivered in line with the new model by their Healthcare Centre.

The period for enrolment of subjects and inclusion in the sample started at the various healthcare centres six months after case management nurses initiated the programme. This gave nursing staff sufficient time to adapt to their new functions and roles.

Main activities:
1. Action Plan and Follow-up: Protocol-dependent home visits and care delivery plan
2. Data management: Clinical record, pilot sheet, registry of home care and information system
3. Co-ordination with other members of the Primary Care Basic Teams (PCBTs)
4. Referral criteria
5. Healthcare education guidelines, support to patients and caregivers
6. Review of target population census
7. Home care visit with integral assessment and detection of needs upon request from team members
8. Establishing co-ordination mechanisms with PCBTs
9. Designing and implementing co-ordination mechanisms with other institutions and professionals
10. Arranging technical assistance at home
11. Enrolment of new cases
12. Specific activities with caregivers
13. Taking part in commissions for ongoing assistance
14. Tele-care

Duration of interventions: 2.5 years (30 months)
Intervention typeOther
Primary outcome measure1. Patient's functional capacity (Barthel and Lawton-Brody scales) at 0, 2, 6 and 12 months
2. Satisfaction (SATISFAD, specific questionnaire validated for assessment of satisfaction with home care services) at 2, 6 and 12 months
3. Hospital admissions
4. Accident & Emergency (A&E) visits
5. Home visits by nurses
6. Social worker interventions
7. Physiotherapy sessions
8. Caregiver visits to healthcare centre
9. Patient visits to healthcare centre
Secondary outcome measures1. Caregiver burden (Zarit test) at 0, 2, 6 and 12 months
2. Family role/function (APGAR family test) at 0, 2, 6 and 12 months
3. Cognitive function (Pfeiffer test) at 0, 2, 6 and 12 months
4. Quality of life (Euro-QoL 5D) at 0, 2 and 6 months
5. Institutionalisation
6. Mortality
7. Management of therapeutic regimen
Overall study start date01/11/2003
Completion date30/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants286
Key inclusion criteriaPatients and caregivers initiating the Home Care (HC) programme launched by the Andalusian Healthcare Service and targeting some of the following population sub-groups:
Sub-group 1: Terminally ill patients with advanced stage, progressive, incurable, multi-symptomatic disease with no reasonable chance of responding to specific treatment, with estimated survival not exceeding six months
Sub-group 2: Dependent patients who require assistance for their daily activities (Activities of Daily Living [ADL]) and are immobilised at home, namely subjects not included in Sub-group 1 who, for whatever cause, are forced to spend most of their time in bed and/or require help to move, which prevents them from leaving home, except for rare exceptions
Sub-group 3: Patients not included in Sub-groups 1 and 2, recently discharged from hospital, requiring home care during a short period of time, most likely for under two months
Sub-group 4: Main caregivers for any of the patients described in the previous sub-groups
Key exclusion criteria1. Institutionalisation or change of residence to an area not covered by the study, thus preventing the minimum follow-up required
2. Hospitalisation for longer than seven days, except for terminally ill patients who were readmitted for disease stabilisation and symptom control

Note: With these criteria in mind, the population potentially requiring home care services in the healthcare districts under the scope of the study was estimated at 1,032,333. Malaga with 50.93% of the total potential population was in a position to contribute the largest number of subjects to the study, followed by the Costa del Sol district with 20.46%, Almeria with 20.60% and lastly Granada with 8.55%.
Date of first enrolment01/11/2003
Date of final enrolment30/12/2006

Locations

Countries of recruitment

  • Spain

Study participating centre

Cuesta del Observatorio s/n
Granada
18080
Spain

Sponsor information

Ministry of Health (Spain)
Government

c/ Sinesio Delgado, nº 6 (Pabellón Nº 4)
Madrid
28029
Spain

Email oficina.informacion@isciii.es
Website http://www.isciii.es
ROR logo "ROR" https://ror.org/00y6q9n79

Funders

Funder type

Government

Spanish Health Research Fund of the National Health Ministry (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 23/09/2008 Yes No