Clinical trial NCT06791135: Health and Life in Balance an Intervention to Improve Patient Capacity for Older People With Multimorbidity
Official title: Health and Life in Balance an Intervention to Improve Patient Capacity for Older People With Multimorbidity: A Pragmatic Mixed Methods Non-randomised Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity
Keywords: Multimorbidity
Complex intervention
Person-centered care
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2025-01-24
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Convergent Mixed-methods non-randomised pilot study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to examine if the intervention "Health and Life in Balance", was acceptable, feasible and if the intervention needed further development.

Health and Life in Balance is an intervention for patients 65 years and older, with 2 or more chronic diseases, and an increased care need. It involved for the patient to meet with a district nurse during 1-2 meetings to set up a care plan and then have scheduled follow-ups during 6 months. During the 1-2 meetings they went through ICAN discussion aid to discuss aspects of capacity and workload in the patient's life and healthcare. The district nurse and the patient's GP had improved communication during the intervention period.

Researchers will collect data from the patient's medical records, from questionnaires and from interviews with patients and health care providers.

Data will be analysed using both quantitative and qualitative methodologies and finally a mixed methods approach.

No drugs or devices are included in this study.

Detailed description: Patients with multimorbidity, having more than one chronic disease, becomes more and more common as the world's population ages. However, primary care, often focusing on treating one disease at a time in short visits, show poor results in meeting these patients' needs. Hence, primary care needs to become more person-centered to meet patients with multimorbidity's needs.

In this study Health and Life in Balance, a complex intervention to improve relational continuity, person centeredness, and teamwork between the patient's district nurse and GP was piloted. The aim of the intervention was to improve patients with multimorbidity's capacity.

The aim of this study was to assess acceptability, feasibilty and need of further development of the intervention.

The study design was convergent mixed methods non randomised pilot study.

The research questions were:

1. What were the characteristics of patients recruited to the pilot study? (QUAN),
2. What components were delivered in the HLB intervention? (QUAN)
3. Was the HLB intervention associated with improvements in the proposed primary and secondary outcomes? (QUAN)
4. How did patients and health care providers experience HLB regarding participant selection, intervention content and impact on health? (QUAL)
5. What patients should HLB target and how should the intervention be delivered in a future trial? (MIXED)

Recruitment and setting:

In this study, 2 primary care units in Region Stockholm, Sweden were recruited. One was an intervention unit and the other a control unit. In both units patients 65 years and older with 2 or more chronic diseases and an increased care need were recruited by their GPs.

Intervention:

The intervention was conducted during 6 months and involved:

* Improved teamwork between the patient's GP and district nurse
* 1-2 visits with a district nurse. During the visit they went through the discussion aid ICAN. The discussion aid aims to assess patient capacity and workload from life and from health care contacts. And morst important Then they set up a care plan.
* Then they had individualised number and types of follow up contacts.

Patients in the intervention unit received the intervention and patients in the control unit received care as usual.

No drugs or devices are included in this study.

Data collection:

Quantitative data was collected in both units regarding:

1. Baseline data including age, sex, and number and types of diagnoses and medications were collected from patient medical records
2. In questionnaires by a research nurse in both units before and after the intervention. The questionnaires were:

   * Illness intrusiveness: Illness Intrusiveness Rating Scale (IIRS)
   * Treatment burden: Multimorbidity Treatment Burden Questionnaire (MTBQ)
   * Quality of Life: EuroQol -5 Dimensions- 5L (EQ-5D-5L)
   * Depressive symptoms: The Patient Health Questionnaire (PHQ-9)
   * Worry: The Penn State Worry Questionnaire (PSWQ)
   * General health: WHO Disability Assessment Schedule (WHODAS 2.0)
   * Alcohol consumption : The Alcohol Use Disorders Identification Test (AUDIT)
   * Drug consumption The Drug Use Disorders Identification Test (DUDIT)
3. Clinical outcomes was collected from patients' medical records before, and after the intervention

   \* Number of medications
4. Clinical outcomes was collected from participants' medical records after the intervention was finished regarding

   * Number of visits in primary care (apart from the intervention) during the intervention period.
   * Number of visits in secondary care during the intervention period.
   * Number of admissions to hospitals during the intervention period.

Quantitative data was collected from patient medical records in the intervention unit after the intervention was finished regarding:

* Number and types of visits (part of the intervention) during the intervention
* A written care plan
* A written description of GP and DN teamwork.

Qualitative data was collected from:

* Individual interviews with participating patients in the intervention unit
* Focus group interviews with district nurses in the middle and after the intervention period.
* Focus group interviews with GPs after the intervention concluded.
* Patient medical records in the intervention unit.

Data analysis:

Quantitative data analysis:

* Descriptive statistical analyses were used to assess baseline differences between both units.
* Statistical analyses were used to assess between group differences between intervention and control group after 6 months regarding questionnaires and number of medications.

Qualitative data analysis:

\* Thematic analysis by Braun and Clark was used to qualitatively analyse all qualitative data.

Mixed methods data analysis:

Quantitative and qualitative data analyses were merged together to answer the mixed methods question using joint display on interpretation level.

Eligibility criteria: Inclusion Criteria:

* 65 years and older
* 2 or more chronic diseases
* Increased care need defined by patient's GP

Exclusion Criteria:

* home health care,
* on-going treatment in a secondary unit making them unable to assimilate the intervention, for example ongoing oncological treatment,
* cognitive impairment that restricted ability to give informed consent.

Primary outcomes:
measure: Illness Intrusivenss Rating Scale
timeFrame: From enrollment to the end of the treatment at 6 months.
Secondary outcomes:
measure: Multimorbidty Treatment Burden Questionnaire
timeFrame: From enrollment to the end of the treatment at 6 months.
measure: EQ-5D-5L - EuroQol -5 Dimensions- 5L
timeFrame: From enrollment to the end of the treatment at 6 months.
measure: PHQ-9 - The Patient Health Questionnaire
timeFrame: From enrollment to the end of the treatment at 6 months.
measure: PSWQ - The Penn State Worry Questionnaire
timeFrame: From enrollment to the end of the treatment at 6 months.
measure: WHODAS 2.0 - WHO Disability Assessment Schedule
timeFrame: From enrollment to the end of the treatment at 6 months.
measure: AUDIT - The Alcohol Use Disorders Identification Test, 12-item version
timeFrame: From enrollment to the end of the treatment at 6 months.
measure: DUDIT - The Drug Use Disorders Identification Test
timeFrame: From enrollment to the end of the treatment at 6 months.
measure: Number of medications
timeFrame: From enrollment to the end of the treatment at 6 months.
measure: Number of visits in primary care (apart from the intervention)
timeFrame: Collected post-intervention (up to 1 year)
measure: Number of admissions to hospitals
timeFrame: Collected post-intervention (up to 1 year)
Other outcomes:
measure: Descriptive outcome - Number and types of follow-up visits
timeFrame: Collected post-intervention (up to 1 year)
measure: Descriptive outcome - proportion of first visit(s) involving a follow-up booking
timeFrame: Collected post-intervention (up to 1 year)
measure: Descriptive outcome - Number of first visit (s)
timeFrame: Collected post-intervention (up to 1 year)
measure: Descriptive outcome - proportion of first visit(s) involving a written care plan
timeFrame: Collected post-intervention (up to 1 year)
measure: Descriptive outcome - ICAN used at the initial visit(s)
timeFrame: Collected post-intervention (up to 1 year)
measure: Descriptive outcome - Final visit offered and completed
timeFrame: Collected post-intervention (up to 1 year)
measure: Descriptive outcome - Documented GP and DN teamwork
timeFrame: Collected post-intervention (up to 1 year)
Locations:
city: Saltsjö-Boo
country: Sweden
facility: Boo Vårdcentral
state: Nacka
Study officials:
affiliation: Karolinska Institute and Region Stockholm
name: Caroline Wachtler, MD, PhD, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References: