Clinical trial NCT03628469: Proactive Health Support
Official title: Proactive Health Support - a Randomized Controlled Trial of Telephone-based Self-management Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients at Risk of Hospital Admission
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 5454
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with 1:1 randomization stratified for risk of hospital admission and region
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Hospital admissions
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Patient education
timeFrame: 3, 6 and 12 months
measure: Outpatient consultations
timeFrame: 3, 6 and 12 months
measure: Use of primary healthcare
timeFrame: 3, 6 and 12 months
measure: Use of prescription medication
timeFrame: 3, 6 and 12 months
measure: Survival
timeFrame: 1 year
measure: Quality of life
timeFrame: 3, 6 and 12 months
measure: Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years
timeFrame: 3, 6 and 12 months
measure: Regional differences in resource use and costs
timeFrame: 3, 6 and 12 months
measure: Resource use in primary care and rehabilitation
timeFrame: 3, 6 and 12 months
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Center for Clinical Research and Prevention
Study officials:
affiliation: Frederiksberg University Hospital
name: Ulla Toft, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benthien KS, Rasmussen K, Nielsen CP, Hjarnaa L, Rasmussen MK, Kidholm K, Nielsen BK, Nissen NK, Fredens M, Winther S, Gronkjaer M, Toft U. Proactive health support (PaHS) - telephone-based self-management support for persons at risk of hospital admission: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2020 Jun;93:106004. doi: 10.1016/j.cct.2020.106004. Epub 2020 Apr 19.