Proactive Health Support

Study Overview
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Brief Summary
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Proactive Health Support is a randomized controlled trial of telephone-based self-management support. The primary aim of the intervention is to reduce hospital admissions and improve quality of life in patients with a high risk of hospital admission.

Detailed Description
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Participants are identified through an algorithm, that assigns each patient with a risk score of 0-100%. Patients with the highest risk in each of the five regions of Denmark are invited to participate.

Official Title
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Proactive Health Support - a Randomized Controlled Trial of Telephone-based Self-management Support

Conditions
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Patients at Risk of Hospital Admission

Intervention / Treatment
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* Behavioral: Proactive Health Support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons with a hospital contact within the last year caused by ≥ 1 of the following diagnoses: heart diseases (DI110, DI130, DI132, DI50), connective tissue diseases (DD86, DM05, DM06, DM08, DM09, DM30, DM31, DM32, DM33, DM34, DM35, DM36), pulmonary diseases (DJ40, DJ41, DJ42, DJ43, DJ44, DJ45, DJ46, DJ47, DJ60, DJ61, , DJ62, DJ63, DJ64, DJ65, DJ66, DJ67, DJ684, DJ701, DJ703, DJ841, DJ842, DJ843, DJ848, DJ849, DJ920, DJ961, DJ982, DJ983) or diabetes (DE10, DE11, DE14) Or Persons ≥ 18 years and ≥ three unplanned hospital admissions in the last six months Or Persons ≥ 65 years with a preventable hospital admission (predefined diagnoses: dehydration, constipation, lower respiratory tract infections, urinary tract infections, gastroenteritis, fractures, nutrition deficiency anemia, social causes and pressure ulcers) or a readmission (within 30 days) Exclusion Criteria: Selected psychiatric diagnoses: substance abuse disorder (DF1), schizophrenia (DF2) or dementia (DF00, DF01, DF02, DF03, DF051) Metastatic cancer (DC77, DC78, DC79, DC80) Assisted living Facility Documented terminal illness or life expectancy < one year Assessment of dementia Major surgery planned within 6 months Hearing impairment Not speaking Danish Cognitive impairment Substance abuse, that impairs adherence No telephone Receiving similar trial intervention Other (including intervention not suitable)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with 1:1 randomization stratified for risk of hospital admission and region
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proactive Health Support<br>The purpose of the intervention is to enhance patients' self-management strategies and thereby enable patients to cope with illness at home and prevent the development of those conditions, that are sensitive to preventive efforts.The intervention includes active listening, coaching and counselling and elements from case management such as assessing the need for healthcare services. Emphasis is on supporting and empowering the patient to make the necessary contacts to healthcare professionals. | Behavioral: Proactive Health Support<br>* Active listening, coaching and counselling<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital admissions |  | 6 months | 
| Quality of life | Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient education | Questionnaire Hei-Q - all 8 subscales (health-directed activities, positive and active engagement in life, emotional distress, self-monitoring and insight, constructive attitudes and approaches, skill and technique acquisition, social integration and support, health service navigation, range 1-4) | 3, 6 and 12 months | 
| Outpatient consultations |  | 3, 6 and 12 months | 
| Use of primary healthcare |  | 3, 6 and 12 months | 
| Use of prescription medication |  | 3, 6 and 12 months | 
| Survival |  | 1 year | 
| Quality of life | Questionnaire SF36: All eight subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health and health transition, range 0-100. Furthermore, norm-based T-scores are reported, 45-55 is considered normal) and two composite scores (mental and physical health, norm-based T-score of 45-55 is considered normal) | 3, 6 and 12 months | 
| Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years |  | 3, 6 and 12 months | 
| Regional differences in resource use and costs |  | 3, 6 and 12 months | 
| Resource use in primary care and rehabilitation |  | 3, 6 and 12 months |